## Protocol Section
### Identification Module
**NCT ID:** NCT00791479

**Brief Title:** Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes

**Official Title:** Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions

#### Organization Study ID Info
**ID:** 12565
#### Organization
**Class:** INDUSTRY
**Full Name:** Eli Lilly and Company
#### Secondary ID Infos
**Domain:** Eli Lilly and Company
**ID:** H9X-MC-GBCK
**Type:** OTHER
**Domain:** India
**ID:** CTRI/2009/091/000105
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2010-01

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2010-10-27

**Type:** ESTIMATED

**Disp First Submit Date:** 2010-10-25
**Disp First Submit QC Date:** 2010-10-25

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-12-10

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-12-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-12-10

**Type:** ESTIMATED

**Results First Submit Date:** 2014-10-03

**Results First Submit QC Date:** 2014-12-08

#### Start Date
**Date:** 2008-12

**Status Verified Date:** 2014-12

#### Study First Post Date
**Date:** 2008-11-14
**Type:** ESTIMATED
**Study First Submit Date:** 2008-11-12
**Study First Submit QC Date:** 2008-11-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Eli Lilly and Company

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type 2 diabetes mellitus.

**Detailed Description:** Participants in the trial will be randomized to one of the LY2189265 doses (4 doses are planned, range 0.1-1.5 milligram \[mg\]) or placebo. The main purpose is to assess dose-dependent effect of this new compound on blood glucose over a period of 12 weeks. Therefore, glycosylated hemoglobin (HbA1c) is chosen as the primary efficacy measure. Several other attributes of glycemic control and endocrine function of pancreas will be assessed as secondary objectives. These secondary objectives will be used to compare the effect of the experimental compound and placebo. Since LY2189265 is in early phase of development, comprehensive safety assessment is planned to learn more about possible side-effects and to establish benefit/risk profile of individual doses of the drug. The trial is organized in four phases: screening, lead-in period to establish baseline status of participants in each group, treatment period during which participants will be randomized into 1 of 5 groups (4 will receive one of the LY2189265 doses, 1 group will receive placebo), and safety follow up. Maximum of 9 study visits are planned. Study drug (LY2189265 or placebo) will be administered once weekly via subcutaneous (SC) injections. Rescue intervention was allowed after randomization for those participants whose hyperglycemia reached pre-defined unacceptable high values. Participants on rescue therapy remained in the study and continued to receive study drug. Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified efficacy analyses.

A 3-mg LY2189265 dose was discontinued and replaced with the 1.5 mg dose based on dose finding Study H9X-MC-GBCF; NCT00734474. Except where noted, data summaries from the 3 discontinued 3-mg LY2189265 participants (n=3) are not included due to the small number of participants and the short treatment duration.

### Conditions Module

**Conditions:**

- Diabetes Mellitus, Type 2

**Keywords:**

- Diabetes, type 2 diabetes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 167

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** LY2189265: 0.1 milligram (mg), subcutaneous (SC), once weekly (QW)

**Intervention Names:**

- Drug: LY2189265 and Lifestyle Measures

**Label:** 0.1 milligram (mg) LY2189265

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** LY2189265: 0.5 milligram (mg), subcutaneous (SC), once weekly (QW)

**Intervention Names:**

- Drug: LY2189265 and Lifestyle Measures

**Label:** 0.5 milligram (mg) LY2189265

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** LY2189265: 1.0 milligram (mg), subcutaneous (SC), once weekly (QW)

**Intervention Names:**

- Drug: LY2189265 and Lifestyle Measures

**Label:** 1.0 milligram (mg) LY2189265

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW)

**Intervention Names:**

- Drug: LY2189265 and Lifestyle Measures

**Label:** 1.5 milligram (mg) LY2189265

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Placebo: subcutaneous (SC) once weekly (QW)

**Intervention Names:**

- Drug: Placebo solution and Lifestyle Measures

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 0.1 milligram (mg) LY2189265

- 0.5 milligram (mg) LY2189265

- 1.0 milligram (mg) LY2189265

- 1.5 milligram (mg) LY2189265

**Description:** Subcutaneous injection once-weekly for up to 12 weeks

**Name:** LY2189265 and Lifestyle Measures

**Other Names:**

- Dulaglutide

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Subcutaneous injection once-weekly for up to 12 weeks

**Name:** Placebo solution and Lifestyle Measures

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.

**Measure:** Change From Baseline in Glycosylated Hemoglobin (HbA1c)

**Time Frame:** Baseline, 12 weeks

#### Secondary Outcomes

**Description:** Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.

**Measure:** Change From Baseline in Glycosylated Hemoglobin (HbA1c)

**Time Frame:** Baseline, 4 weeks, 8 weeks

**Description:** Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.

**Measure:** Change From Baseline in Fasting Blood Glucose

**Time Frame:** Baseline, 12 weeks

**Description:** Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of \<7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.

**Measure:** Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%

**Time Frame:** 12 weeks

**Description:** Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.

**Measure:** Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles

**Time Frame:** Baseline, 12 weeks

**Description:** Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.

**Measure:** Change From Baseline in Beta-cell Function (HOMA2-%B)

**Time Frame:** Baseline, 12 weeks

**Description:** Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.

**Measure:** Change From Baseline in Insulin Sensitivity (HOMA2-%S)

**Time Frame:** Baseline, 12 weeks

**Description:** The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.

**Measure:** Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval

**Time Frame:** Baseline, 12 weeks

**Description:** Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.

**Measure:** Change From Baseline in Electrocardiograms (ECGs) - Heart Rate

**Time Frame:** Baseline, 12 weeks

**Description:** Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.

**Measure:** Change From Baseline in Pulse Rate

**Time Frame:** Baseline, 12 weeks

**Description:** Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.

**Measure:** Change From Baseline in Blood Pressure (BP)

**Time Frame:** Baseline, 12 weeks

**Description:** Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter \[mmol/L\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

**Measure:** Number of Participants With Self-reported Hypoglycemic Events

**Time Frame:** Baseline through 12 weeks

**Description:** Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter \[mmol/L\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.

**Measure:** Rate of Self-reported Hypoglycemic Events

**Time Frame:** Baseline through 12 weeks

**Description:** A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

**Measure:** Treatment Emergent Adverse Events

**Time Frame:** Baseline through 12 weeks

**Description:** Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.

**Measure:** Change From Baseline in Body Weight

**Time Frame:** Baseline, 12 weeks

**Description:** LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.

**Measure:** Antibody Production and Effects to LY2189265

**Time Frame:** Baseline, 4 weeks, 12 weeks, 16 weeks

**Description:** The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.

**Measure:** Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265

**Time Frame:** 4 weeks, 8 weeks, 12 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diabetes mellitus, type 2
* Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication
* Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)
* Have a qualifying glycosylated hemoglobin (HbA1c) value, as determined by the central laboratory: at screening (for diet and exercise only ≥7.0% to ≤9.5%; for metformin monotherapy \>6.5% to ≤9.0%) and at time of randomization for all participants ≥6.5% to ≤9.5%
* Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
* Have a body mass index (BMI) between 23 and 40 kilograms/meter squared (kg/m\^2), inclusive, for participants who are native to, and reside in, South and/or East Asia; all other participants must have a BMI between 25 and 40 kg/m\^2, inclusive.
* Stable weight for 3 months prior to screening

Exclusion Criteria:

* Diabetes mellitus, type 1
* Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening
* Use of glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)
* Use of medications (prescription or over-the counter) to promote weight loss
* Chronic (\>2 weeks) use of systemic glucocorticoid therapy
* Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs that affect gastrointestinal motility
* Use of central nervous system (CNS) stimulant (for example, Ritalin-sustained release \[SR\])
* Cardiovascular event within 6 months prior to screening
* Poorly controlled hypertension (determined by a mean seated systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or mean seated diastolic BP ≥95 mmHg at screening or randomization)
* Electrocardiogram (ECG) reading considered outside the normal limits by the investigator and relevant for interpretation or indicating cardiac disease
* Liver disease, hepatitis, chronic hepatitis, or alanine transaminase levels \>3.0 times upper limit of normal
* Clinical signs or symptoms of pancreatitis or history of chronic or acute pancreatitis at time of screening
* Amylase ≥3 times the upper limit of normal and/or lipase ≥2 times upper limit of normal which are determined by central labs at the time of screening
* Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) for men or ≥1.4 mg/dL for women or a creatinine clearance \<60 milliliter (mL)/minute which are determined by central labs at the time of screening
* Uncontrolled diabetes (defined as 2 or more episode of hyperosmolar state requiring hospitalization in the 6 months prior to screening)
* Significant active, uncontrolled endocrine or autoimmune abnormality
* History of a transplanted organ (corneal transplants are allowed)
* Active or untreated malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
* Have any other condition, in the opinion of the investigator, that may preclude the participant from following or completing the protocol
* Investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling, whether biological or legally adopted)
* Sponsor employees
* Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to entry into the study
* Have previously completed or withdrawn from this study after providing informed consent

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Concord

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** California

**Zip:** 94520

**Location 2:**

**City:** Lancaster

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** California

**Zip:** 93534

**Location 3:**

**City:** Mission Hills

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** California

**Zip:** 91345

**Location 4:**

**City:** Palm Springs

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** California

**Zip:** 92262

**Location 5:**

**City:** Vincennes

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Indiana

**Zip:** 47591

**Location 6:**

**City:** Wichita

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Kansas

**Zip:** 67208

**Location 7:**

**City:** Bloomfield Hills

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Michigan

**Zip:** 48302

**Location 8:**

**City:** Calabash

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** North Carolina

**Zip:** 28467

**Location 9:**

**City:** Tabor City

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** North Carolina

**Zip:** 28463

**Location 10:**

**City:** Beaver

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Pennsylvania

**Zip:** 15009

**Location 11:**

**City:** North Myrtle Beach

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** South Carolina

**Zip:** 29582

**Location 12:**

**City:** Menomonee Falls

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Wisconsin

**Zip:** 53051

**Location 13:**

**City:** Dubrovnik

**Country:** Croatia

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 20000

**Location 14:**

**City:** Osijek

**Country:** Croatia

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** HR-31000

**Location 15:**

**City:** Varazdin

**Country:** Croatia

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** HR-42000

**Location 16:**

**City:** Zagreb

**Country:** Croatia

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** HR-10000

**Location 17:**

**City:** Aalborg

**Country:** Denmark

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** DK-9000

**Location 18:**

**City:** Aarhus

**Country:** Denmark

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 8000

**Location 19:**

**City:** Copenhagen

**Country:** Denmark

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 2300

**Location 20:**

**City:** Frederiksberg

**Country:** Denmark

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 2000

**Location 21:**

**City:** Hillerod

**Country:** Denmark

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** Dk-3400

**Location 22:**

**City:** Kobenhavn

**Country:** Denmark

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 2400

**Location 23:**

**City:** Bangalore

**Country:** India

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 560052

**Location 24:**

**City:** Bilaspur

**Country:** India

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 495006

**Location 25:**

**City:** Hyderabaad

**Country:** India

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 500001

**Location 26:**

**City:** Indore

**Country:** India

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 452001

**Location 27:**

**City:** Kochin

**Country:** India

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 682026

**Location 28:**

**City:** Mumbai

**Country:** India

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 400 067

**Location 29:**

**City:** New Delhi

**Country:** India

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 110 029

**Location 30:**

**City:** Mexico City

**Country:** Mexico

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 06700

**Location 31:**

**City:** Monterrey

**Country:** Mexico

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 64570

**Location 32:**

**City:** Bialystok

**Country:** Poland

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 15-950

**Location 33:**

**City:** Szczecin

**Country:** Poland

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 71-252

**Location 34:**

**City:** Wroclaw

**Country:** Poland

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 503-349

**Location 35:**

**City:** Carolina

**Country:** Puerto Rico

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 00983

**Location 36:**

**City:** San German

**Country:** Puerto Rico

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 00685

**Location 37:**

**City:** Arkhangelsk

**Country:** Russian Federation

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 163045

**Location 38:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 119881

**Location 39:**

**City:** Rostov-On-Don

**Country:** Russian Federation

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 344022

**Location 40:**

**City:** Saint Petersburg

**Country:** Russian Federation

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 193257

**Location 41:**

**City:** Alcira

**Country:** Spain

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 46600

**Location 42:**

**City:** Dos Hermanas

**Country:** Spain

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 41014

**Location 43:**

**City:** Lleida

**Country:** Spain

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 25198

**Location 44:**

**City:** Malaga

**Country:** Spain

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 29010

**Location 45:**

**City:** Santa Cruz De Tenerife

**Country:** Spain

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 38320

**Location 46:**

**City:** Torrevieja

**Country:** Spain

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 03186

#### Overall Officials

**Official 1:**

**Affiliation:** Eli Lilly and Company

**Name:** Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Grunberger G, Chang A, Garcia Soria G, Botros FT, Bsharat R, Milicevic Z. Monotherapy with the once-weekly GLP-1 analogue dulaglutide for 12 weeks in patients with Type 2 diabetes: dose-dependent effects on glycaemic control in a randomized, double-blind, placebo-controlled study. Diabet Med. 2012 Oct;29(10):1260-7. doi: 10.1111/j.1464-5491.2012.03745.x.

**PMID:** 22804250

#### See Also Links

**Label:** Related Info

**URL:** http://www.ncbi.nlm.nih.gov/pubmed/22804250

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Intervention Browse Module - Ancestors

- ID: D000097789

- Term: Glucagon-Like Peptide-1 Receptor Agonists

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M258626

- Name: Dulaglutide

- Relevance: HIGH

- As Found: Fluconazole

- ID: M9043

- Name: Glucagon

- Relevance: LOW

- As Found: Unknown

- ID: M3401

- Name: Glucagon-Like Peptide-1 Receptor Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M26997

- Name: Glucagon-Like Peptide 1

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000555680

- Term: Dulaglutide

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** 0.1 Milligrams (mg) LY2189265

**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks

**ID:** EG000

**Other Num Affected:** 20

**Other Num at Risk:** 35

**Serious Number At Risk:** 35

**Title:** 0.1 Milligrams (mg) LY2189265

**Group ID:** EG001

**Title:** 0.5 Milligrams (mg) LY2189265

**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks

**ID:** EG001

**Other Num Affected:** 16

**Other Num at Risk:** 34

**Serious Number Affected:** 1

**Serious Number At Risk:** 34

**Title:** 0.5 Milligrams (mg) LY2189265

**Group ID:** EG002

**Title:** 1.0 Milligrams (mg) LY2189265

**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks

**ID:** EG002

**Other Num Affected:** 17

**Other Num at Risk:** 34

**Serious Number Affected:** 1

**Serious Number At Risk:** 34

**Title:** 1.0 Milligrams (mg) LY2189265

**Group ID:** EG003

**Title:** 1.5 Milligrams (mg) LY2189265

**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks

**ID:** EG003

**Other Num Affected:** 15

**Other Num at Risk:** 29

**Serious Number Affected:** 1

**Serious Number At Risk:** 29

**Title:** 1.5 Milligrams (mg) LY2189265

**Group ID:** EG004

**Title:** 3.0 Milligrams (mg) LY2189265

**Description:** LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks

**ID:** EG004

**Other Num Affected:** 1

**Other Num at Risk:** 3

**Serious Number At Risk:** 3

**Title:** 3.0 Milligrams (mg) LY2189265

**Group ID:** EG005

**Title:** Placebo

**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks

**ID:** EG005

**Other Num Affected:** 15

**Other Num at Risk:** 32

**Serious Number Affected:** 1

**Serious Number At Risk:** 32

**Title:** Placebo

**Frequency Threshold:** 3

#### Other Events

**Term:** Vertigo

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Abdominal discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Faeces hard

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Flatulence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Gastrooesophageal reflux disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Hunger

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Injection site haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Non-cardiac chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 12.0

**Term:** Otitis media

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 12.0

**Term:** Pharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 12.0

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 12.0

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 12.0

**Term:** Vulvovaginal mycotic infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 12.0

**Term:** Arthropod bite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 12.0

**Term:** Back injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 12.0

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 12.0

**Term:** Neck injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 12.0

**Term:** Rib fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 12.0

**Term:** Skull fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 12.0

**Term:** Upper limb fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 12.0

**Term:** Laboratory test abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 12.0

**Term:** Lipase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 12.0

**Term:** Pancreatic enzymes increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 12.0

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Dyslipidaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Hyperlipidaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Hypertriglyceridaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Muscle spasms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Neck pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Hypoaesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Neuropathy peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Somnolence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Rhinorrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Sinus congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Cold sweat

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 12.0

**Term:** Hyperhidrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 12.0

#### Serious Events

**Term:** Atrial flutter

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 35

**Group ID:** EG001

**Num At Risk:** 34

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 34

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 29

**Group ID:** EG004

**Num At Risk:** 3

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 35

**Group ID:** EG001

**Num At Risk:** 34

**Group ID:** EG002

**Num At Risk:** 34

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 29

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 3

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 35

**Group ID:** EG001

**Num At Risk:** 34

**Group ID:** EG002

**Num At Risk:** 34

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 29

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 3

**Group ID:** EG005

**Num At Risk:** 32

**Term:** Pancreatitis haemorrhagic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 35

**Group ID:** EG001

**Num At Risk:** 34

**Group ID:** EG002

**Num At Risk:** 34

**Group ID:** EG003

**Num At Risk:** 29

**Group ID:** EG004

**Num At Risk:** 3

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 32

**Num Events:** 1

**Term:** Cholelithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 35

**Group ID:** EG001

**Num At Risk:** 34

**Group ID:** EG002

**Num At Risk:** 34

**Group ID:** EG003

**Num At Risk:** 29

**Group ID:** EG004

**Num At Risk:** 3

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 32

**Num Events:** 1

**Term:** Breast cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 35

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 34

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 34

**Group ID:** EG003

**Num At Risk:** 29

**Group ID:** EG004

**Num At Risk:** 3

**Group ID:** EG005

**Num At Risk:** 32

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 35

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 34

**Group ID:** BG003

**Value:** 29

**Group ID:** BG004

**Value:** 3

**Group ID:** BG005

**Value:** 32

**Group ID:** BG006

**Value:** 167

**Units:** Participants

### Group

**ID:** BG000

**Title:** 0.1 Milligrams (mg) LY2189265

**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks

### Group

**ID:** BG001

**Title:** 0.5 Milligrams (mg) LY2189265

**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks

### Group

**ID:** BG002

**Title:** 1.0 Milligrams (mg) LY2189265

**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks

### Group

**ID:** BG003

**Title:** 1.5 Milligrams (mg) LY2189265

**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks

### Group

**ID:** BG004

**Title:** 3.0 Milligrams (mg) LY2189265

**Description:** LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks

### Group

**ID:** BG005

**Title:** Placebo

**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks

### Group

**ID:** BG006

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.15

**Value:** 56.33

#### Measurement

**Group ID:** BG001

**Spread:** 9.06

**Value:** 56.91

#### Measurement

**Group ID:** BG002

**Spread:** 8.76

**Value:** 57.16

#### Measurement

**Group ID:** BG003

**Spread:** 7.88

**Value:** 57.45

#### Measurement

**Group ID:** BG004

**Spread:** 7.15

**Value:** 60.82

#### Measurement

**Group ID:** BG005

**Spread:** 9.33

**Value:** 55.03

#### Measurement

**Group ID:** BG006

**Spread:** 8.78

**Value:** 56.64

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 24

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 18

#### Measurement

**Group ID:** BG003

**Value:** 16

#### Measurement

**Group ID:** BG004

**Value:** 2

#### Measurement

**Group ID:** BG005

**Value:** 14

#### Measurement

**Group ID:** BG006

**Value:** 92

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 16

#### Measurement

**Group ID:** BG003

**Value:** 13

#### Measurement

**Group ID:** BG004

**Value:** 1

#### Measurement

**Group ID:** BG005

**Value:** 18

#### Measurement

**Group ID:** BG006

**Value:** 75

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 3

**Class Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 4

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 5

#### Measurement

**Group ID:** BG006

**Value:** 23

**Class Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 1

#### Measurement

**Group ID:** BG005

**Value:** 1

#### Measurement

**Group ID:** BG006

**Value:** 5

**Class Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 1

**Class Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 29

#### Measurement

**Group ID:** BG001

**Value:** 28

#### Measurement

**Group ID:** BG002

**Value:** 26

#### Measurement

**Group ID:** BG003

**Value:** 24

#### Measurement

**Group ID:** BG004

**Value:** 2

#### Measurement

**Group ID:** BG005

**Value:** 25

#### Measurement

**Group ID:** BG006

**Value:** 134

**Class Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 1

#### Measurement

**Group ID:** BG006

**Value:** 1

**Class Title:** Multiple

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 13

#### Measurement

**Group ID:** BG003

**Value:** 11

#### Measurement

**Group ID:** BG004

**Value:** 3

#### Measurement

**Group ID:** BG005

**Value:** 17

#### Measurement

**Group ID:** BG006

**Value:** 75

**Class Title:** United States

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 4

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 5

#### Measurement

**Group ID:** BG006

**Value:** 23

**Class Title:** Mexico

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 2

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 5

**Class Title:** Puerto Rico

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 1

#### Measurement

**Group ID:** BG006

**Value:** 8

**Class Title:** Spain

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 2

#### Measurement

**Group ID:** BG006

**Value:** 16

**Class Title:** Poland

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 3

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 3

#### Measurement

**Group ID:** BG006

**Value:** 14

**Class Title:** Croatia

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 5

**Class Title:** Russian Federation

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 3

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 4

#### Measurement

**Group ID:** BG006

**Value:** 21

**Class Title:** India

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 4.75

**Value:** 32.92

#### Measurement

**Group ID:** BG001

**Spread:** 5.39

**Value:** 32.26

#### Measurement

**Group ID:** BG002

**Spread:** 4.50

**Value:** 32.22

#### Measurement

**Group ID:** BG003

**Spread:** 4.29

**Value:** 31.04

#### Measurement

**Group ID:** BG004

**Spread:** 3.96

**Value:** 35.38

#### Measurement

**Group ID:** BG005

**Spread:** 5.23

**Value:** 32.07

#### Measurement

**Group ID:** BG006

**Spread:** 4.83

**Value:** 32.20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3.19

**Value:** 3.90

#### Measurement

**Group ID:** BG001

**Spread:** 3.80

**Value:** 3.72

#### Measurement

**Group ID:** BG002

**Spread:** 2.54

**Value:** 3.28

#### Measurement

**Group ID:** BG003

**Spread:** 4.08

**Value:** 4.62

#### Measurement

**Group ID:** BG004

**Spread:** 3.04

**Value:** 5.00

#### Measurement

**Group ID:** BG005

**Spread:** 4.74

**Value:** 3.91

#### Measurement

**Group ID:** BG006

**Spread:** 3.68

**Value:** 3.88

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 17.28

**Value:** 87.08

#### Measurement

**Group ID:** BG001

**Spread:** 21.34

**Value:** 90.20

#### Measurement

**Group ID:** BG002

**Spread:** 16.95

**Value:** 86.89

#### Measurement

**Group ID:** BG003

**Spread:** 18.63

**Value:** 85.81

#### Measurement

**Group ID:** BG004

**Spread:** 25.51

**Value:** 100.90

#### Measurement

**Group ID:** BG005

**Spread:** 18.94

**Value:** 90.87

#### Measurement

**Group ID:** BG006

**Spread:** 18.68

**Value:** 88.43

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.55

**Value:** 7.13

#### Measurement

**Group ID:** BG001

**Spread:** 0.60

**Value:** 7.18

#### Measurement

**Group ID:** BG002

**Spread:** 0.66

**Value:** 7.28

#### Measurement

**Group ID:** BG003

**Spread:** 0.43

**Value:** 7.25

#### Measurement

**Group ID:** BG004

**Spread:** 0.15

**Value:** 7.63

#### Measurement

**Group ID:** BG005

**Spread:** 0.63

**Value:** 7.36

#### Measurement

**Group ID:** BG006

**Spread:** 0.58

**Value:** 7.24

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Description:** Body mass index is an estimate of body fat based on body weight divided by height squared.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Body Mass Index (BMI)
**Unit of Measure:** kilograms/square meters (kg/m^2)
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Duration of Diabetes
**Unit of Measure:** years
### Measure 7
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Body Weight
**Unit of Measure:** kilogram (kg)
### Measure 8
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Glycosylated Hemoglobin (HbA1c)
**Unit of Measure:** percentage of glycosylated hemoglobin
**Population Description:** Participants who received at least one dose of study drug.
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** GT60
**Restrictive Agreement:** True
### Point of Contact
**Organization:** Eli Lilly and Company
**Phone:** 800-545-5979
**Title:** Chief Medical Officer
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.069
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.37
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.89
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.04
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.04
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.023
**P-Value Comment:** Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** Treatment comparison at Week 8. A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** Treatment comparison at Week 8. A priori threshold for statistical significance was P\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.456
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -7.81
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -26.53
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -29.96
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -33.71
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** Treatment comparison of glycosylated hemoglobin (HbA1c) levels \<7.0%.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** The Cochran-Armitage trend test included the placebo arm.
**Statistical Method:** Cochran-Armitage trend test
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** Treatment comparison of glycosylated hemoglobin (HbA1c) levels ≤6.5%.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** The Cochran-Armitage trend test included the placebo arm.
**Statistical Method:** Cochran-Armitage trend test
**Tested Non-Inferiority:** False
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.378
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -9.65
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -26.09
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -36.34
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -38.67
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.036
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.450
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.329
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.969
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.009
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.140
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 1.19
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.247
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 1.04
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.975
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.27
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 1.00
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.11
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 16
### Outcome Measure 17
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.11
- **Upper Limit:** 
- **Value:** -0.37
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.12
- **Upper Limit:** 
- **Value:** -0.89
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.11
- **Upper Limit:** 
- **Value:** -1.03
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.13
- **Upper Limit:** 
- **Value:** -1.04
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.13
- **Upper Limit:** 
- **Value:** 0.01
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.09
- **Upper Limit:** 
- **Value:** -0.28
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.09
- **Upper Limit:** 
- **Value:** -0.51
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.08
- **Upper Limit:** 
- **Value:** -0.46
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.10
- **Upper Limit:** 
- **Value:** -0.53
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.10
- **Upper Limit:** 
- **Value:** -0.01
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.10
- **Upper Limit:** 
- **Value:** -0.33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.10
- **Upper Limit:** 
- **Value:** -0.74
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.10
- **Upper Limit:** 
- **Value:** -0.78
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.12
- **Upper Limit:** 
- **Value:** -0.90
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.11
- **Upper Limit:** 
- **Value:** -0.00
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.09
- **Upper Limit:** 
- **Value:** -11.59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.26
- **Upper Limit:** 
- **Value:** -30.31
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 4.18
- **Upper Limit:** 
- **Value:** -33.73
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 4.78
- **Upper Limit:** 
- **Value:** -37.49
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 4.44
- **Upper Limit:** 
- **Value:** -3.78
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 73.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75.0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71.4
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 52.4
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7.1
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.74
- **Upper Limit:** 
- **Value:** -15.77
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.88
- **Upper Limit:** 
- **Value:** -32.21
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 4.68
- **Upper Limit:** 
- **Value:** -42.46
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 5.46
- **Upper Limit:** 
- **Value:** -44.79
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 5.05
- **Upper Limit:** 
- **Value:** -6.12
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.76
- **Upper Limit:** 
- **Value:** 13.18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.04
- **Upper Limit:** 
- **Value:** 31.66
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 7.64
- **Upper Limit:** 
- **Value:** 39.04
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 8.11
- **Upper Limit:** 
- **Value:** 29.29
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 7.44
- **Upper Limit:** 
- **Value:** -2.06
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.62
- **Upper Limit:** 
- **Value:** -2.41
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.92
- **Upper Limit:** 
- **Value:** 6.10
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 7.44
- **Upper Limit:** 
- **Value:** -4.80
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 7.95
- **Upper Limit:** 
- **Value:** 12.98
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 7.34
- **Upper Limit:** 
- **Value:** 0.58
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.09
- **Upper Limit:** 
- **Value:** 1.34
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.11
- **Upper Limit:** 
- **Value:** -1.18
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.01
- **Upper Limit:** 
- **Value:** 4.56
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 2.33
- **Upper Limit:** 
- **Value:** -0.63
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 2.19
- **Upper Limit:** 
- **Value:** 0.70
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.20
- **Upper Limit:** 
- **Value:** 3.22
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.23
- **Upper Limit:** 
- **Value:** 4.57
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.15
- **Upper Limit:** 
- **Value:** -0.55
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 2.46
- **Upper Limit:** 
- **Value:** 2.83
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 2.33
- **Upper Limit:** 
- **Value:** -0.89
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.48
- **Upper Limit:** 
- **Value:** 1.38
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.51
- **Upper Limit:** 
- **Value:** 1.16
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.44
- **Upper Limit:** 
- **Value:** 1.88
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 1.67
- **Upper Limit:** 
- **Value:** 4.18
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 1.58
- **Upper Limit:** 
- **Value:** 0.67
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.44
- **Upper Limit:** 
- **Value:** 0.19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.49
- **Upper Limit:** 
- **Value:** 0.25
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.43
- **Upper Limit:** 
- **Value:** 1.02
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 1.65
- **Upper Limit:** 
- **Value:** 1.34
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 1.54
- **Upper Limit:** 
- **Value:** 1.29
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.04
- **Upper Limit:** 
- **Value:** -2.21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.12
- **Upper Limit:** 
- **Value:** 0.51
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.02
- **Upper Limit:** 
- **Value:** -2.57
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 2.33
- **Upper Limit:** 
- **Value:** 1.88
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 2.18
- **Upper Limit:** 
- **Value:** -0.68
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.21
- **Upper Limit:** 
- **Value:** -0.24
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.26
- **Upper Limit:** 
- **Value:** 0.59
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.20
- **Upper Limit:** 
- **Value:** 0.42
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 1.39
- **Upper Limit:** 
- **Value:** 1.56
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 1.30
- **Upper Limit:** 
- **Value:** 1.07
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.72
- **Upper Limit:** 
- **Value:** -0.08
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.73
- **Upper Limit:** 
- **Value:** 0.25
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.73
- **Upper Limit:** 
- **Value:** 1.68
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.79
- **Upper Limit:** 
- **Value:** 0.61
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.75
- **Upper Limit:** 
- **Value:** -0.09
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.10
- **Upper Limit:** 
- **Value:** 0.19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.10
- **Upper Limit:** 
- **Value:** -0.01
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.10
- **Upper Limit:** 
- **Value:** -0.01
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.11
- **Upper Limit:** 
- **Value:** 0.02
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.11
- **Upper Limit:** 
- **Value:** 0.01
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.62
- **Upper Limit:** 
- **Value:** 0.20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.64
- **Upper Limit:** 
- **Value:** 0.16
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.62
- **Upper Limit:** 
- **Value:** 1.21
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.71
- **Upper Limit:** 
- **Value:** 0.21
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.67
- **Upper Limit:** 
- **Value:** -0.08
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.42
- **Upper Limit:** 
- **Value:** -0.19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.43
- **Upper Limit:** 
- **Value:** -0.34
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.42
- **Upper Limit:** 
- **Value:** -1.11
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.48
- **Upper Limit:** 
- **Value:** -1.49
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.45
- **Upper Limit:** 
- **Value:** -1.38
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1503
- **Upper Limit:** 
- **Value:** 2294
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4356
- **Upper Limit:** 
- **Value:** 6650
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 7645
- **Upper Limit:** 
- **Value:** 11671
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 10905
- **Upper Limit:** 
- **Value:** 16649
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 20657
- **Upper Limit:** 
- **Value:** 31538
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Glycosylated Hemoglobin (HbA1c)
**Type:** PRIMARY
**Unit of Measure:** percentage of glycosylated hemoglobin
##### Group
**Description:** LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 2
**Description:** Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 4 weeks, 8 weeks
**Title:** Change From Baseline in Glycosylated Hemoglobin (HbA1c)
**Type:** SECONDARY
**Unit of Measure:** percentage of glycosylated hemoglobin
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 3
**Description:** Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have fasting blood glucose change from baseline data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Fasting Blood Glucose
**Type:** SECONDARY
**Unit of Measure:** milligrams per deciliter (mg/dL)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 4
**Description:** Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of \<7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.
**Parameter Type:** NUMBER
**Population Description:** Participants who received at least one dose of study drug and have HbA1c data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 5
**Description:** Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have blood glucose change from baseline data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles
**Type:** SECONDARY
**Unit of Measure:** milligrams per deciliter (mg/dL)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 6
**Description:** Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have beta-cell function (HOMA2-%B) change from baseline data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Beta-cell Function (HOMA2-%B)
**Type:** SECONDARY
**Unit of Measure:** percentage of HOMA2-%B
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 7
**Description:** Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have insulin sensitivity change from baseline data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Insulin Sensitivity (HOMA2-%S)
**Type:** SECONDARY
**Unit of Measure:** percentage of HOMA2-%S
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 8
**Description:** The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have Fridericia-corrected QT (QTcF) or PR interval change from baseline data available.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval
**Type:** SECONDARY
**Unit of Measure:** millisecond (msec)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 9
**Description:** Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have heart rate change from baseline data available.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Electrocardiograms (ECGs) - Heart Rate
**Type:** SECONDARY
**Unit of Measure:** beats per minute (bpm)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 10
**Description:** Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have pulse rate change from baseline data available.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Pulse Rate
**Type:** SECONDARY
**Unit of Measure:** beats per minute (bpm)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 11
**Description:** Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have blood pressure change from baseline data available.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Blood Pressure (BP)
**Type:** SECONDARY
**Unit of Measure:** millimeters of mercury (mmHg)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 12
**Description:** Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter \[mmol/L\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
**Parameter Type:** NUMBER
**Population Description:** Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline through 12 weeks
**Title:** Number of Participants With Self-reported Hypoglycemic Events
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 13
**Description:** Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter \[mmol/L\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline through 12 weeks
**Title:** Rate of Self-reported Hypoglycemic Events
**Type:** SECONDARY
**Unit of Measure:** Events per participant per year
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 14
**Description:** A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
**Parameter Type:** NUMBER
**Population Description:** Participants who received at least one dose of study drug.
**Reporting Status:** POSTED
**Time Frame:** Baseline through 12 weeks
**Title:** Treatment Emergent Adverse Events
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** 3.0 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG005
**Title:** Placebo
#### Outcome Measure 15
**Description:** Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have body weight change from baseline data available.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Body Weight
**Type:** SECONDARY
**Unit of Measure:** kilogram (kg)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 16
**Description:** LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.
**Parameter Type:** NUMBER
**Population Description:** Participants who received at least one dose of study drug with evaluable LY2189265 anti-drug antibodies (ADA) data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 4 weeks, 12 weeks, 16 weeks
**Title:** Antibody Production and Effects to LY2189265
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 17
**Description:** The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received at least one dose of LY2189265 (0.1-3.0 milligrams \[mg\]) with evaluable pharmacokinetic data.
**Reporting Status:** POSTED
**Time Frame:** 4 weeks, 8 weeks, 12 weeks
**Title:** Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265
**Type:** SECONDARY
**Unit of Measure:** nanograms*hour/milliliter (ng*h/mL)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** 3.0 Milligrams (mg) LY2189265
### Participant Flow Module
#### Group
**Description:** LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** FG000
**Title:** 0.1 Milligrams (mg) LY2189265
#### Group
**Description:** LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** FG001
**Title:** 0.5 Milligrams (mg) LY2189265
#### Group
**Description:** LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** FG002
**Title:** 1.0 Milligrams (mg) LY2189265
#### Group
**Description:** LY2189265: 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** FG003
**Title:** 1.5 Milligrams (mg) LY2189265
#### Group
**Description:** LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** FG004
**Title:** 3.0 Milligrams (mg) LY2189265
#### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** FG005
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Dose Discontinued per Sponsor Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 3
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 2
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 1
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 1
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 35
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 29
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 32
##### Milestone
**Type:** Received at Least One Dose of Study Drug
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 35
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 29
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 32
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 33
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 31
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 25
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 29
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 3
**Has Results:** True