## Protocol Section
### Identification Module
**NCT ID:** NCT02500979

**Brief Title:** Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus

**Official Title:** A Randomized, Single-Blind, Two-Way Crossover, Placebo-Controlled Phase I Study to Compare the 24-hour Glucose Profile and Safety of Pramlintide and Insulin, Co-Administered in a Fixed-Dose Ratio, Versus Placebo and Insulin in Patients With Type 1 Diabetes Mellitus With Inadequate Glycemic Control

#### Organization Study ID Info
**ID:** D5570C00002
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2016-08-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-11-02

**Type:** ACTUAL

**Last Update Submit Date:** 2018-03-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-08-05

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2018-11-02

**Type:** ACTUAL

**Results First Submit Date:** 2017-08-02

**Results First Submit QC Date:** 2018-03-12

#### Start Date
**Date:** 2015-08-17

**Type:** ACTUAL

**Status Verified Date:** 2018-03

#### Study First Post Date
**Date:** 2015-07-17
**Type:** ESTIMATED
**Study First Submit Date:** 2015-07-10
**Study First Submit QC Date:** 2015-07-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Juvenile Diabetes Research Foundation

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is designed to investigate the clinical efficacy and safety of pramlintide co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

**Detailed Description:** Potentially eligible subjects with Type 1 diabetes mellitus who are treated with with a basal-bolus insulin regimen through multiple daily injections or insulin pump at a total daily insulin dose ≤60 U, will be eligible. Visit 1 is approximately 3-6 weeks prior to randomization. Given some variability in HbA1c and C-peptide assays, re-testing for HbA1c and C-peptide can be performed within 18 days from the initial visit. Visit 2 is approximately 2-5 weeks prior to randomization. Subjects are on lispro insulin throughout study except during Visit 4 and Visit 5, the domicile 24 hr treatment period, when they are switched to regular insulin U-100.

Screen failed patients may be re-screened for inclusion in the study, as long as re-screening takes place at least 3 months after the original screening visit. If a subject is re-screened, he/she must continue to meet all inclusion/exclusion criteria. All study procedures of initial Visit 1 must be repeated at the re-screening visit.

### Conditions Module

**Conditions:**

- Type 1 Diabetes Mellitus

**Keywords:**

- Type 1 Diabetes Mellitus; Pramlintide

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 34

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Pramlintide will be adiministered by sc infusion at a concentration of 1000ug/mL

**Intervention Names:**

- Drug: Pramlintide acetate

- Drug: Lispro insulin U-100

- Drug: Regular insulin U-100

**Label:** Pramlintide acetate & regular insulin

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo is similar sterile solution without pramlintide.

**Intervention Names:**

- Drug: Placebo

- Drug: Lispro insulin U-100

- Drug: Regular insulin U-100

**Label:** Placebo and regular insulin

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pramlintide acetate & regular insulin

**Description:** Pramlintide acetate administered by a separate pump

**Name:** Pramlintide acetate

**Other Names:**

- Pramlintide: SYMLIN

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo and regular insulin

**Description:** Placebo administered by separate pump

**Name:** Placebo

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Placebo and regular insulin

- Pramlintide acetate & regular insulin

**Description:** Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5)

**Name:** Lispro insulin U-100

**Other Names:**

- Humalog insulin lispro U-100

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Placebo and regular insulin

- Pramlintide acetate & regular insulin

**Description:** Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump

**Name:** Regular insulin U-100

**Other Names:**

- Humulin R; U-100

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 24-hour MWG mg/dL, defined as total area under the 24-hour tissue glucose curve obtained with CGM, divided by actual time span in the 24-hour period.

**Measure:** Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM)

**Time Frame:** 24 h

#### Secondary Outcomes

**Description:** Absolute postprandial plasma glucose AUC was measured for the first 3 hours (AUC0-3h) following lunch based on sample availability. (Sample times: 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).

**Measure:** Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch

**Time Frame:** 3 hours

**Description:** Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following dinner based on sample availability. (Sample times: 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours).

**Measure:** Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner

**Time Frame:** 2 hours

**Description:** Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following breakfast based on sample availability. (Sample times: 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours).

**Measure:** Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast

**Time Frame:** 2 hours

**Description:** Incremental (i.e., baseline-corrected) area under the 24-hour tissue glucose concentration curve (AUC0-24h) measured by continuous glucose monitoring (CGM) with a pre-test, non-fasting tissue glucose value as baseline. (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).

**Measure:** Efficacy of Pramlintide by Measurement of Incremental 24-hour Tissue Glucose Area Under the Plasma Concentration-time Curve (AUC) Obtained With Continuous Glucose Monitoring (CGM)

**Time Frame:** 24 h

**Description:** Absolute mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).

**Measure:** Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)

**Time Frame:** 24 h

**Description:** Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).

**Measure:** Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)

**Time Frame:** 24 hours

**Description:** Percent time spent in the normoglycemic range of tissue glucose concentrations between \>70 mg/dL and \<180 mg/dL, measured by CGM. (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).

**Measure:** Efficacy of Pramlintide Measured by Percent Time Spent in the Range of >70 mg/dL to <180 mg/dL Tissue Glucose Obtained With Continuous Glucose Monitoring (CGM)

**Time Frame:** 24 h

**Description:** Absolute mean area under the 24-hour plasma glucagon concentration curve, measured as total area under the curve (total AUC0-24). (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).

**Measure:** Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)

**Time Frame:** 24 h

**Description:** Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucagon concentration curve with a pre-test, non-fasting plasma glucagon value as baseline. (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).

**Measure:** Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)

**Time Frame:** 24 h

**Description:** Fasting plasma glucose concentration at 0600 hours (6:00 AM)

**Measure:** Fasting Plasma Glucose Concentration

**Time Frame:** 12 hours after dinner meal

**Description:** Mean areas under the plasma insulin concentration curves for the 24-hour periods of pramlintide and placebo administration (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours \[dinner\], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours \[breakfast\], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours \[lunch\], 24 hours).

**Measure:** Pharmacokinetics of Insulin as Demonstrated by 24-hour Plasma Insulin Area Under the Plasma Concentration-time Curve (AUC)

**Time Frame:** 24 hours

**Description:** Mean values of the average plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours \[dinner\], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours \[breakfast\], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours \[lunch\], 24 hours).

**Measure:** Pharmacokinetics of Insulin as Demonstrated by 24-hour Average Plasma Insulin Concentration.

**Time Frame:** 24 hours

**Description:** Mean maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours \[dinner\], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours \[breakfast\], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours \[lunch\], 24 hours).

**Measure:** Pharmacokinetics of Insulin as Demonstrated by Maximum Plasma Insulin Concentration

**Time Frame:** 24 hours

**Description:** Mean time to maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours \[dinner\], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours \[breakfast\], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours \[lunch\], 24 hours).

**Measure:** Pharmacokinetics of Insulin as Demonstrated by the Time to the Maximum Plasma Insulin Concentration

**Time Frame:** 24 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures
* Female and/or male aged between 18 and 70 years
* Must have a prior diagnosis of T1DM
* Body mass index (BMI) \<30 kg/m2
* Subjects are not on current treatment with pramlintide (Symlin) and have not received pramlintide during the 6-month period prior to enrollment
* Subjects should be willing to consume all of the components of the standardized meals administered during the study
* Negative serum pregnancy test for female subjects of childbearing potential
* Female subjects of childbearing potential must be 1 year postmenopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study
* Male subjects must be surgically sterile or using an acceptable method of contraception for the duration of the study

Exclusion Criteria:

* Recurrent severe hypoglycemia requiring assistance within 6 months before screening
* A history of hypoglycemia unawareness
* A confirmed diagnosis of gastroparesis
* Has been treated, is currently being treated, or is expected to require or undergo treatment with the following medications:
* Any oral antihyperglycemic agent or any other injectable antihyperglycemic agent that is not insulin
* Drugs that directly affect GI motility (eg, anticholinergic agents such as atropine)
* Drugs that slow the intestinal absorption of nutrients (eg, α-glucosidase inhibitors
* A history of gastric surgery (such as gastric banding, Roux- and Y bypass)
* Is expected to require or undergo treatment with acetaminophen after enrollment and at any point during the study
* Has experienced diabetic ketoacidosis within the last 24 weeks
* History of hospitalization within the last 6 months for glycemic control (for both hyperglycemia or hypoglycemia)
* Subject has any significant disease or disorder, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate in the study
* Any clinically relevant abnormal findings, which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study.
* Pregnancy confirmed by a positive pregnancy test, or otherwise verified.
* Breast feeding
* Positive hepatitis C virus antibody (HCV Ab), hepatitis B virus surface antigen (HBsAg), hepatitis B virus core antibody (anti-Hbc), or human immunodeficiency virus 1/2 antibody (HIV-1/2 Ab) at Screening
* History of, or current alcohol or drug abuse
* Has donated blood within 2 months of Visit 1 (Screening) or is planning to donate blood during the study
* Has had a major surgery or a blood transfusion within 2 months before Visit 1 (screening)
* Participation in any clinical study with an investigational drug or new formulation of a marketed drug during the last 1 month prior to Visit 1

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chula Vista

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 91911

**Location 2:**

**City:** Portland

**Country:** United States

**Facility:** Research Site

**State:** Oregon

**Zip:** 97239

**Location 3:**

**City:** Chattanooga

**Country:** United States

**Facility:** Research Site

**State:** Tennessee

**Zip:** 37411

#### Overall Officials

**Official 1:**

**Affiliation:** Medical Director AstraZeneca

**Name:** Peter Ohman, MD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Riddle MC, Nahra R, Han J, Castle J, Hanavan K, Hompesch M, Huffman D, Strange P, Ohman P. Control of Postprandial Hyperglycemia in Type 1 Diabetes by 24-Hour Fixed-Dose Coadministration of Pramlintide and Regular Human Insulin: A Randomized, Two-Way Crossover Study. Diabetes Care. 2018 Nov;41(11):2346-2352. doi: 10.2337/dc18-1091. Epub 2018 Sep 13.

**PMID:** 30213882

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune 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

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Type 1 Diabetes Mellitus

- 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

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000001067

- Term: Appetite Depressants

- ID: D000019440

- Term: Anti-Obesity Agents

- ID: D000065091

- Term: Amylin Receptor Agonists

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: AnObAg

- Name: Anti-Obesity Agents

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: HIGH

- As Found: Day 1

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: HIGH

- As Found: Day 1

- ID: M250016

- Name: Pramlintide

- Relevance: HIGH

- As Found: Step 1

- ID: M29802

- Name: Insulin Lispro

- Relevance: HIGH

- As Found: Diary

- ID: M17768

- Name: Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M29005

- Name: Islet Amyloid Polypeptide

- Relevance: HIGH

- As Found: Step 1

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4379

- Name: Appetite Depressants

- Relevance: LOW

- As Found: Unknown

- ID: M21396

- Name: Anti-Obesity Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007328

- Term: Insulin

- ID: C000557859

- Term: Insulin, Globin Zinc

- ID: D000061268

- Term: Insulin Lispro

- ID: C000105254

- Term: Pramlintide

- ID: D000058228

- Term: Islet Amyloid Polypeptide

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** This was a crossover study.

#### Event Groups

**Group ID:** EG000

**Title:** Placebo & Regular Insulin

**Description:** Placebo was similar sterile solution without pramlintide

**ID:** EG000

**Other Num Affected:** 9

**Other Num at Risk:** 28

**Serious Number At Risk:** 28

**Title:** Placebo & Regular Insulin

**Group ID:** EG001

**Title:** Pramlintide & Regular Insulin

**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml

**ID:** EG001

**Other Num Affected:** 22

**Other Num at Risk:** 32

**Serious Number At Risk:** 32

**Title:** Pramlintide & Regular Insulin

**Frequency Threshold:** 1

#### Other Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Cardiovascular disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Vitreous Detachment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Abdominal discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v.19.0

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v.19.0

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v.19.0

**Term:** Contusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA v.19.0

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Hypoglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA v.19.0

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Irritability

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA v.19.0

**Term:** Sinus congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA v.19.0

**Term:** Ecchymosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA v.19.0

**Term:** Hyperhidrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA v.19.0

**Term:** Photosensitivity reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA v.19.0

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA v.19.0

**Term:** Pruritus allergic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA v.19.0

**Term:** Scab

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA v.19.0

**Term:** Phlebitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA v.19.0

**Time Frame:** Over two 24-hour treatment periods with a 2-week washout period between periods.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Units:** Participants

### Group

**ID:** BG000

**Title:** Pramlintide First, Then Placebo

**Description:** (Treatment Sequence A) - Safety Analysis Set

### Group

**ID:** BG001

**Title:** Placebo First, Then Pramlintide

**Description:** (Treatment Sequence B) - Safety Analysis Set

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 30

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** >=65 years

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 14.83

**Value:** 45.1

#### Measurement

**Group ID:** BG001

**Spread:** 12.68

**Value:** 38.9

#### Measurement

**Group ID:** BG002

**Spread:** 13.92

**Value:** 42.0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 25

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 7

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 30

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

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

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

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

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 30

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.012

**Value:** 72.03

#### Measurement

**Group ID:** BG001

**Spread:** 8.859

**Value:** 68.73

#### Measurement

**Group ID:** BG002

**Spread:** 8.949

**Value:** 70.38

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 6.966

**Value:** 168.41

#### Measurement

**Group ID:** BG001

**Spread:** 7.684

**Value:** 167.31

#### Measurement

**Group ID:** BG002

**Spread:** 7.236

**Value:** 167.86

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2.806

**Value:** 25.38

#### Measurement

**Group ID:** BG001

**Spread:** 2.341

**Value:** 24.52

#### Measurement

**Group ID:** BG002

**Spread:** 2.579

**Value:** 24.95

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13.177

**Value:** 27.81

#### Measurement

**Group ID:** BG001

**Spread:** 10.866

**Value:** 21.94

#### Measurement

**Group ID:** BG002

**Spread:** 12.249

**Value:** 24.88

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 21

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** CSII

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 9

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** MDI

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** Both

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** <30 mL/min

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** ≥30 to <60 mL/min

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 16

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** ≥60 to <90 mL/min

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 14

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** ≥90 mL/min

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2.767

**Value:** 8.57

#### Measurement

**Group ID:** BG001

**Spread:** 3.149

**Value:** 8.15

#### Measurement

**Group ID:** BG002

**Spread:** 2.928

**Value:** 8.35

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 15

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 31

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.356

**Value:** 7.84

#### Measurement

**Group ID:** BG001

**Spread:** 0.574

**Value:** 8.21

#### Measurement

**Group ID:** BG002

**Spread:** 0.506

**Value:** 8.03

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0

**Value:** 0.030

#### Measurement

**Group ID:** BG001

**Spread:** 0.0141

**Value:** 0.030

#### Measurement

**Group ID:** BG002

**Spread:** 0.0100

**Value:** 0.030

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 1

**Group ID:** BG001

**Value:** 2

**Group ID:** BG002

**Value:** 3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.525

**Value:** 38.14

#### Measurement

**Group ID:** BG001

**Spread:** 8.920

**Value:** 36.58

#### Measurement

**Group ID:** BG002

**Spread:** 10.725

**Value:** 37.36

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 16

**Group ID:** BG002

**Value:** 32

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Weight
**Unit of Measure:** kg
### Measure 7
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Height
**Unit of Measure:** cm
### Measure 8
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Body Mass Index
**Unit of Measure:** kg/m^2
### Measure 9
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Duration of Diabetes
**Unit of Measure:** Years
### Measure 10
**Description:** Subject's usual method of insulin administration - either multiple daily injections (MDI) or continuous subcutaneous infusion of insulin (CSII), or both.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Current Administration of Insulin
**Unit of Measure:** Participants
### Measure 11
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Renal Status Category
**Unit of Measure:** Participants
### Measure 12
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Baseline Fasting Glucose
**Unit of Measure:** mmol/L
### Measure 13
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Baseline A1c
**Unit of Measure:** %
### Measure 14
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Baseline C-peptide
**Unit of Measure:** nmol/L
### Measure 15
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
**Title:** Baseline Insulin
**Unit of Measure:** U/day
**Population Description:** Safety Analysis Set: All randomized subjects receiving any infused study treatment. Subjects were analyzed according to the treatment sequence they received.
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** Due to the unavailability of the pramlintide assay, no data are presented for pramlintide PK parameters, and changes in pramlintide concentration could not be related to changes in insulin, plasma glucose, glucagon, or triglycerides.
### Point of Contact
**Email:** Peter.Ohman@astrazeneca.com
**Organization:** AstraZeneca
**Phone:** +1 (301) 398-0120
**Title:** Dr. Peter Ohman
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -37.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -5.2
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 7.88
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0118
**P-Value Comment:** 
**Parameter Type:** Least squares mean difference
**Parameter Value:** -21.5
**Statistical Comment:** 
**Statistical Method:** Linear mixed-effects model
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -12.356
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -3.438
**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:** 0.0013
**P-Value Comment:** 
**Parameter Type:** LS mean difference (pramlintide-placebo)
**Parameter Value:** -7.897
**Statistical Comment:** 
**Statistical Method:** Linear mixed effects model
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -9.175
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -1.378
**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:** 0.0091
**P-Value Comment:** 
**Parameter Type:** LS mean difference (pramlintide-placebo)
**Parameter Value:** -5.277
**Statistical Comment:** 
**Statistical Method:** Linear mixed effects model
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -7.445
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -1.424
**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:** 0.0057
**P-Value Comment:** 
**Parameter Type:** LS mean difference (pramlintide-placebo)
**Parameter Value:** -4.435
**Statistical Comment:** 
**Statistical Method:** Linear mixed effects model
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -37326
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -20139
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 4163.6
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** Least squares mean difference
**Parameter Value:** -28733
**Statistical Comment:** 
**Statistical Method:** Linear mixed-effects model
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** -53.099
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -3.737
**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:** 0.0258
**P-Value Comment:** 
**Parameter Type:** LS mean difference
**Parameter Value:** -28.418
**Statistical Comment:** 
**Statistical Method:** Linear mixed-effects model
**Tested Non-Inferiority:** 
### Outcome Measure 7
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** 1.01
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.70
**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:** 0.0456
**P-Value Comment:** 
**Parameter Type:** LS Mean Ratio (Pramlintide/Placebo)
**Parameter Value:** 1.31
**Statistical Comment:** 
**Statistical Method:** Linear mixed-effects model
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** 0.896
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.011
**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:** 0.1015
**P-Value Comment:** 
**Parameter Type:** LS mean ratio (pramlintide/placebo)
**Parameter Value:** 0.951
**Statistical Comment:** 
**Statistical Method:** Linear mixed-effects model
**Tested Non-Inferiority:** 
### Outcome Measure 10
### Outcome Measure 11
#### Analysis
**CI Lower Limit:** 0.901
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.307
**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:** 0.3730
**P-Value Comment:** 
**Parameter Type:** LS mean ratio (pramlintide/placebo)
**Parameter Value:** 1.085
**Statistical Comment:** 
**Statistical Method:** Linear mixed effects model
**Tested Non-Inferiority:** 
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.17
- **Upper Limit:** 
- **Value:** 173.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.17
- **Upper Limit:** 
- **Value:** 152.2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 31.427
- **Spread:** 
- **Upper Limit:** 41.039
- **Value:** 36.233
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 23.487
- **Spread:** 
- **Upper Limit:** 33.185
- **Value:** 28.336
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20.472
- **Spread:** 
- **Upper Limit:** 26.021
- **Value:** 23.247
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15.231
- **Spread:** 
- **Upper Limit:** 20.709
- **Value:** 17.970
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20.817
- **Spread:** 
- **Upper Limit:** 26.253
- **Value:** 23.535
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 16.280
- **Spread:** 
- **Upper Limit:** 21.922
- **Value:** 19.101
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3379.8
- **Upper Limit:** 
- **Value:** 26243
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3379.8
- **Upper Limit:** 
- **Value:** -2489
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 220.032
- **Spread:** 
- **Upper Limit:** 267.638
- **Value:** 243.835
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 191.614
- **Spread:** 
- **Upper Limit:** 239.220
- **Value:** 215.417
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 67.6648
- **Upper Limit:** 
- **Value:** 11.181
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 70.0174
- **Upper Limit:** 
- **Value:** -12.753
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 33.6
- **Spread:** 
- **Upper Limit:** 56.9
- **Value:** 43.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 44.0
- **Spread:** 
- **Upper Limit:** 74.4
- **Value:** 57.2
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 459.096
- **Spread:** 
- **Upper Limit:** 558.280
- **Value:** 506.265
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 436.759
- **Spread:** 
- **Upper Limit:** 531.118
- **Value:** 481.633
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 58.9024
- **Upper Limit:** 
- **Value:** -14.954
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 69.2684
- **Upper Limit:** 
- **Value:** -16.055
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.631
- **Spread:** 
- **Upper Limit:** 9.162
- **Value:** 7.794
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.196
- **Spread:** 
- **Upper Limit:** 9.943
- **Value:** 8.459
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 178.2360
- **Upper Limit:** 
- **Value:** 380.525
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 176.7569
- **Upper Limit:** 
- **Value:** 377.324
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.4265
- **Upper Limit:** 
- **Value:** 15.855
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.3649
- **Upper Limit:** 
- **Value:** 15.722
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 17.0950
- **Upper Limit:** 
- **Value:** 33.144
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 16.2315
- **Upper Limit:** 
- **Value:** 32.838
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.3466
- **Upper Limit:** 
- **Value:** 10.556
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.6175
- **Upper Limit:** 
- **Value:** 11.653
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 24-hour MWG mg/dL, defined as total area under the 24-hour tissue glucose curve obtained with CGM, divided by actual time span in the 24-hour period.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Full Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) had at least 1 efficacy assessment available from each of the 2 crossover periods and were included in the Full Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 24 h
**Title:** Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM)
**Type:** PRIMARY
**Unit of Measure:** mg/dL
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 2
**Description:** Absolute postprandial plasma glucose AUC was measured for the first 3 hours (AUC0-3h) following lunch based on sample availability. (Sample times: 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 3 hours
**Title:** Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch
**Type:** SECONDARY
**Unit of Measure:** mmol/L*h
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 3
**Description:** Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following dinner based on sample availability. (Sample times: 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 2 hours
**Title:** Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner
**Type:** SECONDARY
**Unit of Measure:** mmol/L*h
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 4
**Description:** Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following breakfast based on sample availability. (Sample times: 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 2 hours
**Title:** Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast
**Type:** SECONDARY
**Unit of Measure:** mmol/L*h
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 5
**Description:** Incremental (i.e., baseline-corrected) area under the 24-hour tissue glucose concentration curve (AUC0-24h) measured by continuous glucose monitoring (CGM) with a pre-test, non-fasting tissue glucose value as baseline. (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Full Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) had at least 1 efficacy assessment available from each of the 2 crossover periods and were included in the Full Analysis Set,
**Reporting Status:** POSTED
**Time Frame:** 24 h
**Title:** Efficacy of Pramlintide by Measurement of Incremental 24-hour Tissue Glucose Area Under the Plasma Concentration-time Curve (AUC) Obtained With Continuous Glucose Monitoring (CGM)
**Type:** SECONDARY
**Unit of Measure:** mg/dL*min
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 6
**Description:** Absolute mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 24 h
**Title:** Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)
**Type:** SECONDARY
**Unit of Measure:** mmol/L*h
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 7
**Description:** Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 24 hours
**Title:** Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)
**Type:** SECONDARY
**Unit of Measure:** mmol/L*h
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 8
**Description:** Percent time spent in the normoglycemic range of tissue glucose concentrations between \>70 mg/dL and \<180 mg/dL, measured by CGM. (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Full Analysis Set:Of the 33 correctly randomized subjects, 26 (76.5%) had at least 1 efficacy assessment available from each of the 2 crossover periods and were included in the Full Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 24 h
**Title:** Efficacy of Pramlintide Measured by Percent Time Spent in the Range of >70 mg/dL to <180 mg/dL Tissue Glucose Obtained With Continuous Glucose Monitoring (CGM)
**Type:** SECONDARY
**Unit of Measure:** Percentage of time
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 9
**Description:** Absolute mean area under the 24-hour plasma glucagon concentration curve, measured as total area under the curve (total AUC0-24). (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 24 h
**Title:** Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)
**Type:** SECONDARY
**Unit of Measure:** h*pmol/L
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 10
**Description:** Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucagon concentration curve with a pre-test, non-fasting plasma glucagon value as baseline. (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 24 h
**Title:** Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)
**Type:** SECONDARY
**Unit of Measure:** pmol/L*h
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 11
**Description:** Fasting plasma glucose concentration at 0600 hours (6:00 AM)
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 12 hours after dinner meal
**Title:** Fasting Plasma Glucose Concentration
**Type:** SECONDARY
**Unit of Measure:** mmol/L
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 12
**Description:** Mean areas under the plasma insulin concentration curves for the 24-hour periods of pramlintide and placebo administration (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours \[dinner\], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours \[breakfast\], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours \[lunch\], 24 hours).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 24 hours
**Title:** Pharmacokinetics of Insulin as Demonstrated by 24-hour Plasma Insulin Area Under the Plasma Concentration-time Curve (AUC)
**Type:** SECONDARY
**Unit of Measure:** mU/L*h
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 13
**Description:** Mean values of the average plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours \[dinner\], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours \[breakfast\], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours \[lunch\], 24 hours).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 24 hours
**Title:** Pharmacokinetics of Insulin as Demonstrated by 24-hour Average Plasma Insulin Concentration.
**Type:** SECONDARY
**Unit of Measure:** mIU/L
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 14
**Description:** Mean maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours \[dinner\], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours \[breakfast\], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours \[lunch\], 24 hours).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 24 hours
**Title:** Pharmacokinetics of Insulin as Demonstrated by Maximum Plasma Insulin Concentration
**Type:** SECONDARY
**Unit of Measure:** mIU/L
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
#### Outcome Measure 15
**Description:** Mean time to maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours \[dinner\], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours \[breakfast\], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours \[lunch\], 24 hours).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** 24 hours
**Title:** Pharmacokinetics of Insulin as Demonstrated by the Time to the Maximum Plasma Insulin Concentration
**Type:** SECONDARY
**Unit of Measure:** h
##### Group
**Description:** Placebo was similar sterile solution without pramlintide
**ID:** OG000
**Title:** Placebo & Regular Insulin
##### Group
**Description:** Pramlintide was administered by sc infusion at a concentration of 1000ug/ml
**ID:** OG001
**Title:** Pramlintide & Regular Insulin
### Participant Flow Module
#### Group
**Description:** (Treatment Sequence A)
**ID:** FG000
**Title:** Pramlintide First, Then Placebo
#### Group
**Description:** (Treatment Sequence B)
**ID:** FG001
**Title:** Placebo First, Then Pramlintide
#### Period
**Title:** Period 1
##### Withdraw
**Type:** Hyperglycemia
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Severe non-compliance to protocol
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Subject decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
**Comment:** (Randomized Analysis Set)
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 16
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 17
##### Milestone
**Type:** COMPLETED
**Comment:** Number of subjects that entered Period 2
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 16
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
#### Period
**Title:** Period 2
##### Withdraw
**Type:** Change in risk
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
**Comment:** (Randomized Analysis Set)
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 16
##### Milestone
**Type:** COMPLETED
**Comment:** Completed Period 2
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 11
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 16
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Pre-Assignment Details:** Eligible study subjects were males and females, aged ≥18 years and ≤70 years at the time of screening with a prior diagnosis of type 1 diabetes mellitus (T1DM) and an HbA1c value of ≥7.2% and ≤9.0% at screening.
**Recruitment Details:** The first subject was enrolled in the study (at Visit 2) on 27 August 2015. A total of 79 subjects were screened and 34 subjects were randomized at 3 sites in the United States. One additional subject was randomized in error and was discontinued prior to receiving any study medication. The last subject completed the study on 05 August 2016.
**Has Results:** True