## Protocol Section
### Identification Module
**NCT ID:** NCT02738879

**Brief Title:** Randomized Sitagliptin Withdrawal Study (MK-0431-845)

**Official Title:** A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of the Continuation of Sitagliptin Compared With the Withdrawal of Sitagliptin During Initiation and Titration of Insulin Glargine (LANTUS®) in Subjects With Type 2 Diabetes Mellitus

#### Organization Study ID Info
**ID:** 0431-845
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**ID:** 2015-004990-34
**Type:** EUDRACT_NUMBER
**Domain:** Merck Protocol Number
**ID:** MK-0431-845
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2018-01-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-02-25

**Type:** ACTUAL

**Last Update Submit Date:** 2019-02-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-01-22

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-02-25

**Type:** ACTUAL

**Results First Submit Date:** 2019-01-18

**Results First Submit QC Date:** 2019-02-22

#### Start Date
**Date:** 2016-05-09

**Type:** ACTUAL

**Status Verified Date:** 2019-02

#### Study First Post Date
**Date:** 2016-04-14
**Type:** ESTIMATED
**Study First Submit Date:** 2016-04-11
**Study First Submit QC Date:** 2016-04-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a trial of continuing sitagliptin versus withdrawing sitagliptin in participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control who initiate and titrate insulin glargine (LANTUS®) based on a treat-to-target algorithm to achieve fasting glucose levels of 72-100 mg/dL (4-5.6 mmol/L). A primary hypothesis of this trial is that after 30 weeks, continuing sitagliptin results in a greater reduction of hemoglobin A1C (A1C) relative to withdrawing sitagliptin.

### Conditions Module

**Conditions:**

- Type 2 Diabetes Mellitus

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 746

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks

**Intervention Names:**

- Drug: Sitagliptin

- Drug: Metformin

- Drug: Metformin XR

- Drug: Insulin glargine

**Label:** Sitagliptin

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks

**Intervention Names:**

- Drug: Placebo to sitagliptin

- Drug: Metformin

- Drug: Metformin XR

- Drug: Insulin glargine

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sitagliptin

**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks

**Name:** Sitagliptin

**Other Names:**

- Januvia®

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks

**Name:** Placebo to sitagliptin

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Placebo

- Sitagliptin

**Description:** At least 1500 mg/day, oral, twice daily for participants entering the study on immediate-release metformin + sitagliptin or a fixed dose combination (FDC).

**Name:** Metformin

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Placebo

- Sitagliptin

**Description:** At least 1500 mg/day, oral, once daily for participants entering the study on extended-release metformin + sitagliptin or a FDC.

**Name:** Metformin XR

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- Placebo

- Sitagliptin

**Description:** Insulin glargine (LANTUS®) initiated at 10 units and titrated based on a treat-to-target algorithm to achieve fasting glucose levels of 72-100 mg/dL (4-5.6 mmol/L); administered once daily subcutaneously.

**Name:** Insulin glargine

**Other Names:**

- LANTUS®)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 30 A1C minus the Week 0 A1C.

**Measure:** Change From Baseline in A1C at Week 30

**Time Frame:** Baseline and Week 30

**Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.

**Measure:** Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)

**Time Frame:** Up to 30 weeks

**Description:** An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

**Measure:** Percentage of Participants Who Discontinued Study Drug Due to an AE

**Time Frame:** Up to 30 weeks

**Description:** An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

**Measure:** Percentage of Participants Who Experienced One or More Adverse Events (AEs)

**Time Frame:** Up to 32 weeks

#### Secondary Outcomes

**Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The incidence (number of participants with ≥1 event divided by number of participants) of documented symptomatic hypoglycemia was determined.

**Measure:** Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)

**Time Frame:** Up to 30 weeks

**Description:** Change from baseline reflects the Week 30 total daily insulin dose minus the Week 0 total daily insulin dose. The Week 0 total daily insulin dose was 0, by definition, because insulin was not administered at baseline.

**Measure:** Change From Baseline in Total Daily Insulin Dose (Units) at Week 30

**Time Frame:** Baseline and Week 30

**Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.

**Measure:** Event Rate of Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)

**Time Frame:** Up to 30 weeks

**Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.

**Measure:** Event Rate of Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)

**Time Frame:** Up to 30 weeks

**Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L).

**Measure:** Percentage of Participants With Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)

**Time Frame:** Up to 30 weeks

**Description:** A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.

**Measure:** Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol) at Week 30

**Time Frame:** Week 30

**Description:** Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at Week 0).

**Measure:** Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30

**Time Frame:** Baseline and Week 30

**Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.

**Measure:** Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)

**Time Frame:** Up to 30 weeks

**Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L).

**Measure:** Percentage of Participants With Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)

**Time Frame:** Up to 30 weeks

**Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L).

**Measure:** Percentage of Participants With Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)

**Time Frame:** Up to 30 weeks

**Description:** A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.

**Measure:** Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol at Week 30 and No Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) up to Week 30

**Time Frame:** Week 30

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Have T2DM based on American Diabetes Association guidelines
* Be on one of the following treatment regimens:

  1. Stable dose of sitagliptin (100 mg/day) and metformin IR or XR (metformin) (≥1500 mg/day) either co-administered or as a fixed dose combination (FDC) for ≥12 weeks with A1C between 7.5% and 11.0%, inclusive.

     OR
  2. Stable dose of metformin (≥1500 mg/day) and another dipeptidyl peptidase-4 (DPP-4) inhibitor (at maximum labeled dose, other than sitagliptin, either co-administered or as a FDC, for ≥12 weeks with A1C between 7.5% and 11.0%, inclusive.

     OR
  3. Stable dose of sitagliptin (100 mg/day) and metformin (≥1500 mg/day) either co administered or as a FDC, and a sulfonylurea for ≥12 weeks OR stable dose of metformin (≥1500 mg/day) and a sulfonylurea administered as a FDC and sitagliptin (100 mg/day) with A1C between 7.0% and 10.0%, inclusive.

     OR
  4. Stable dose of metformin (≥1500 mg/day) and another DPP-4 inhibitor (at maximum labeled dose), other than sitagliptin, either co-administered or as a FDC, and a sulfonylurea for ≥12 weeks OR stable dose of metformin (≥1500 mg/day) and a sulfonylurea administered as a FDC and another DPP-4 inhibitor other than sitagliptin with A1C between 7.0% and 10.0%, inclusive OR
  5. Stable dose of metformin (≥1500 mg/day) and a sulfonylurea either co-administered or as a FDC for ≥12 weeks with A1C between 7.5% and 11.0%, inclusive.
* Meet one of the following categories:

  1. The participant is a male
  2. The participant is a female who is not of reproductive potential
  3. The participant is a female who is of reproductive potential and agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by practicing abstinence from heterosexual activity OR use (or have her partner use) acceptable contraception during heterosexual activity

Exclusion Criteria:

* Has been treated with any anti-hyperglycemic agent (AHA) other than protocol-specified agents (i.e., other than metformin, DPP-4 inhibitor, or sulfonylurea agent) within the prior 12 weeks.
* Has a history of 2 or more episodes of hypoglycemia resulting in seizure, coma, or loss of consciousness, OR has had recurrent (≥3 times per week) episodes of hypoglycemia over the past 8 weeks.
* Has a history of type 1 diabetes mellitus (T1DM) or ketoacidosis, or has a history of latent autoimmune diabetes of adults (LADA), is assessed by the investigator as possibly having T1DM or LADA confirmed with a C-peptide \<0.7 ng/mL (\<0.23 nmol/L), or has a history of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, or post-organ transplant).
* Is assessed by the investigator to be not appropriate for, or does not agree to target, a fasting glucose of 72-100 mg/dL (4.0-5.6 mmol/L).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Merck Sharp & Dohme LLC

**Name:** Medical Director

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

**IPD Sharing:** YES

**URL:** http://engagezone.msd.com/ds_documentation.php

### References Module

#### References

**Citation:** Roussel R, Duran-Garcia S, Zhang Y, Shah S, Darmiento C, Shankar RR, Golm GT, Lam RLH, O'Neill EA, Gantz I, Kaufman KD, Engel SS. Double-blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase-4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT-I Study. Diabetes Obes Metab. 2019 Apr;21(4):781-790. doi: 10.1111/dom.13574. Epub 2018 Dec 9.

**PMID:** 30393950

## Document Section

### Large Document Module

#### Large Docs

- Date: 2016-07-14

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 3838059

- Type Abbrev: Prot_SAP

- Upload Date: 2019-01-18T10:19

## 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 Mellitus

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Type 2 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

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000054795

- Term: Incretins

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000054873

- Term: Dipeptidyl-Peptidase IV Inhibitors

- ID: D000011480

- Term: Protease Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- 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: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M11667

- Name: Metformin

- Relevance: HIGH

- As Found: Assessment

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M347

- Name: Insulin Glargine

- Relevance: HIGH

- As Found: Gait

- ID: M335

- Name: Sitagliptin Phosphate

- Relevance: HIGH

- As Found: Anesthetic

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27905

- Name: Incretins

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M27957

- Name: Dipeptidyl-Peptidase IV Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19609

- Name: HIV Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M14343

- Name: Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008687

- Term: Metformin

- ID: D000069036

- Term: Insulin Glargine

- ID: D000068900

- Term: Sitagliptin Phosphate

### Misc Info Module

#### Removed Countries

- Country: Argentina

- Country: Australia

- Country: Canada

- Country: Czech Republic

- Country: Czechia

- Country: Denmark

- Country: Estonia

- Country: France

- Country: Germany

- Country: Guatemala

- Country: Hungary

- Country: Israel

- Country: Korea, Republic of

- Country: Latvia

- Country: Mexico

- Country: New Zealand

- Country: Philippines

- Country: Poland

- Country: Puerto Rico

- Country: Romania

- Country: Russian Federation

- Country: Spain

- Country: Turkey

- Country: United Kingdom

- Country: United States

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.

#### Event Groups

**Group ID:** EG000

**Title:** Sitagliptin

**Deaths Num At Risk:** 373

**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks

**ID:** EG000

**Other Num Affected:** 79

**Other Num at Risk:** 373

**Serious Number Affected:** 14

**Serious Number At Risk:** 373

**Title:** Sitagliptin

**Group ID:** EG001

**Title:** Placebo

**Deaths Num Affected:** 2

**Deaths Num At Risk:** 370

**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks

**ID:** EG001

**Other Num Affected:** 72

**Other Num at Risk:** 370

**Serious Number Affected:** 18

**Serious Number At Risk:** 370

**Title:** Placebo

**Frequency Threshold:** 5

#### Other Events

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.1

**Term:** Hypoglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 20.1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.1

#### Serious Events

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Coronary artery disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Phimosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Congenital, familial and genetic disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Strangulated umbilical hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Cholecystitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Groin abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Pyelonephritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Sialoadenitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Tracheitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Fibula fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Ligament rupture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Heart rate irregular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Endometrial adenocarcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Gastrointestinal tract adenoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Non-Hodgkin's lymphoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Prostate cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Carotid artery stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Cerebral ischaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Cerebrovascular accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 370

**Num Events:** 2

**Term:** Ischaemic stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 370

**Num Events:** 2

**Term:** Lumbar radiculopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Neuralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Term:** Sciatica

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Acute respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 373

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 370

**Term:** Diabetic foot

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 373

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 370

**Num Events:** 1

**Time Frame:** Up to 32 weeks

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 374

**Group ID:** BG001

**Value:** 372

**Group ID:** BG002

**Value:** 746

**Units:** Participants

### Group

**ID:** BG000

**Title:** Sitagliptin

**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Placebo to sitagliptin 100 mg, oral, once daily for 30 weeks

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.5

**Value:** 58.5

#### Measurement

**Group ID:** BG001

**Spread:** 9.7

**Value:** 58.1

#### Measurement

**Group ID:** BG002

**Spread:** 9.6

**Value:** 58.3

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 374

**Group ID:** BG001

**Value:** 372

**Group ID:** BG002

**Value:** 746

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** In utero

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Preterm newborn infants (gestational age < 37 wks)

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Newborns (0-27 days)

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Infants and toddlers (28 days-23 months)

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Children (2-11 years)

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Adolescents (12-17 years)

#### Measurement

**Group ID:** BG000

**Value:** 275

#### Measurement

**Group ID:** BG001

**Value:** 272

#### Measurement

**Group ID:** BG002

**Value:** 547

**Category Title:** Adults (18-64 years)

#### Measurement

**Group ID:** BG000

**Value:** 99

#### Measurement

**Group ID:** BG001

**Value:** 100

#### Measurement

**Group ID:** BG002

**Value:** 199

**Category Title:** From 65-84 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** 85 years and over

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 374

**Group ID:** BG001

**Value:** 372

**Group ID:** BG002

**Value:** 746

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 204

#### Measurement

**Group ID:** BG001

**Value:** 181

#### Measurement

**Group ID:** BG002

**Value:** 385

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 170

#### Measurement

**Group ID:** BG001

**Value:** 191

#### Measurement

**Group ID:** BG002

**Value:** 361

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 374

**Group ID:** BG001

**Value:** 372

**Group ID:** BG002

**Value:** 746

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 19

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 37

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

#### Measurement

**Group ID:** BG000

**Value:** 42

#### Measurement

**Group ID:** BG001

**Value:** 37

#### Measurement

**Group ID:** BG002

**Value:** 79

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 7

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

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 24

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 259

#### Measurement

**Group ID:** BG001

**Value:** 270

#### Measurement

**Group ID:** BG002

**Value:** 529

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 34

#### Measurement

**Group ID:** BG001

**Value:** 34

#### Measurement

**Group ID:** BG002

**Value:** 68

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 374

**Group ID:** BG001

**Value:** 372

**Group ID:** BG002

**Value:** 746

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 36

#### Measurement

**Group ID:** BG001

**Value:** 26

#### Measurement

**Group ID:** BG002

**Value:** 62

**Category Title:** Asia

#### Measurement

**Group ID:** BG000

**Value:** 158

#### Measurement

**Group ID:** BG001

**Value:** 172

#### Measurement

**Group ID:** BG002

**Value:** 330

**Category Title:** Europe

#### Measurement

**Group ID:** BG000

**Value:** 85

#### Measurement

**Group ID:** BG001

**Value:** 83

#### Measurement

**Group ID:** BG002

**Value:** 168

**Category Title:** Latin America

#### Measurement

**Group ID:** BG000

**Value:** 80

#### Measurement

**Group ID:** BG001

**Value:** 78

#### Measurement

**Group ID:** BG002

**Value:** 158

**Category Title:** North America

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 28

**Category Title:** Other

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 374

**Group ID:** BG001

**Value:** 372

**Group ID:** BG002

**Value:** 746

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.9

**Value:** 8.8

#### Measurement

**Group ID:** BG001

**Spread:** 1.0

**Value:** 8.8

#### Measurement

**Group ID:** BG002

**Spread:** 0.9

**Value:** 8.8

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 373

**Group ID:** BG001

**Value:** 370

**Group ID:** BG002

**Value:** 743

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 50.8

**Value:** 199.0

#### Measurement

**Group ID:** BG001

**Spread:** 51.8

**Value:** 201.2

#### Measurement

**Group ID:** BG002

**Spread:** 51.3

**Value:** 200.1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 373

**Group ID:** BG001

**Value:** 370

**Group ID:** BG002

**Value:** 743

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 30.3

**Value:** 103.7

#### Measurement

**Group ID:** BG001

**Spread:** 28.1

**Value:** 106.4

#### Measurement

**Group ID:** BG002

**Spread:** 29.2

**Value:** 105.1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 373

**Group ID:** BG001

**Value:** 370

**Group ID:** BG002

**Value:** 743

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 19.8

**Value:** 84.8

#### Measurement

**Group ID:** BG001

**Spread:** 18.9

**Value:** 85.6

#### Measurement

**Group ID:** BG002

**Spread:** 19.4

**Value:** 85.2

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 373

**Group ID:** BG001

**Value:** 370

**Group ID:** BG002

**Value:** 743

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 184

#### Measurement

**Group ID:** BG001

**Value:** 184

#### Measurement

**Group ID:** BG002

**Value:** 368

**Category Title:** Met + DPP-4i

#### Measurement

**Group ID:** BG000

**Value:** 87

#### Measurement

**Group ID:** BG001

**Value:** 86

#### Measurement

**Group ID:** BG002

**Value:** 173

**Category Title:** Met + DPP-4i + sulfonylurea (SU)

#### Measurement

**Group ID:** BG000

**Value:** 103

#### Measurement

**Group ID:** BG001

**Value:** 102

#### Measurement

**Group ID:** BG002

**Value:** 205

**Category Title:** Met + SU

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 374

**Group ID:** BG001

**Value:** 372

**Group ID:** BG002

**Value:** 746

**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:** Age, Customized
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Geographic Region
**Unit of Measure:** Participants
### Measure 6
**Description:** Percent A1C= Glycated hemoglobin/total hemoglobin x 100
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** All randomized and treated participants
**Title:** Hemoglobin A1C (A1C)
**Unit of Measure:** Percent A1C
### Measure 7
**Description:** Fasting plasma glucose level after a 10-hour overnight fast.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** All randomized and treated participants
**Title:** Fasting Plasma Glucose (FPG)
**Unit of Measure:** mg/dL
### Measure 8
**Description:** Estimated Glomerular Filtration Rate (eGFR) is a test of renal function.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** All randomized and treated participants
**Title:** Estimated Glomerular Filtration Rate
**Unit of Measure:** mL/min/1.73 m^2
### Measure 9
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** All randomized and treated participants
**Title:** Body Weight
**Unit of Measure:** Kilograms
### Measure 10
**Description:** Background Anti-Hyperglycemic Agent (AHA) at Screening metformin = Met) dipeptidyl peptidase 4 inhibitor = DPP-4i
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Anti-Hyperglycemic Agent
**Unit of Measure:** Participants
**Population Description:** The overall number of baseline participants included all randomized participants.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrialsDisclosure@merck.com
**Organization:** Merck Sharp & Dohme Corp.
**Phone:** 1-800-672-6372
**Title:** Clinical Trials Disclosure
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -0.58
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.34
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** A longitudinal data analysis (LDA) model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening. Least Squares Means = LSM
**Non-Inferiority Comment:** Hypothesis A: After 30 weeks, continuing sitagliptin is non-inferior relative to withdrawing sitagliptin on the change from baseline in A1C. Non-inferiority is declared if the upper bound of the two-sided 95% CI for the difference is less than 0.3%.
**Non-Inferiority Type:** NON_INFERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Between Group Difference in the LSM
**Parameter Value:** -0.46
**Statistical Comment:** 
**Statistical Method:** LDA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.58
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.34
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** A LDA model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.
**Non-Inferiority Comment:** Hypothesis B: After 30 weeks, continuing sitagliptin results in a greater reduction of A1C relative to withdrawing sitagliptin.
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** < 0.001
**P-Value Comment:** 
**Parameter Type:** Between Group Difference in the LSM
**Parameter Value:** -0.46
**Statistical Comment:** 
**Statistical Method:** LDA
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.54
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.98
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.039
**P-Value Comment:** 
**Parameter Type:** Event Rate Ratio
**Parameter Value:** 0.73
**Statistical Comment:** 
**Statistical Method:** Negative Binomial Model
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -2.3
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.7
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 95% CI
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Between Group Difference in Percentages
**Parameter Value:** -0.3
**Statistical Comment:** 
**Statistical Method:** Miettinen & Nurminen
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -11.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.9
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.250
**P-Value Comment:** 
**Parameter Type:** Between Group Difference in Percentages
**Parameter Value:** -4.1
**Statistical Comment:** 
**Statistical Method:** Miettinen and Nurminen
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -14.6
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -1.5
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The analysis is based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.016
**P-Value Comment:** 
**Parameter Type:** Between Group Difference in the LSM
**Parameter Value:** -8.0
**Statistical Comment:** 
**Statistical Method:** LDA model
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 0.67
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.99
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.041
**P-Value Comment:** 
**Parameter Type:** Event Rate Ratio
**Parameter Value:** 0.81
**Statistical Comment:** 
**Statistical Method:** Negative Binomial Model
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 0.51
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.37
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.473
**P-Value Comment:** 
**Parameter Type:** Event Rate Ratio
**Parameter Value:** 0.83
**Statistical Comment:** 
**Statistical Method:** Negative Binomial Model
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** -6.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.7
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. Includes imputed events after participants discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.624
**P-Value Comment:** 
**Parameter Type:** Between Group Difference in Percentages
**Parameter Value:** -1.2
**Statistical Comment:** 
**Statistical Method:** Miettinen and Nurminen
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** 11.6
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 25.7
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** < 0.001
**P-Value Comment:** 
**Parameter Type:** Between Group Difference in Percentages
**Parameter Value:** 18.8
**Statistical Comment:** 
**Statistical Method:** Miettinen and Nurminen
**Tested Non-Inferiority:** 
### Outcome Measure 10
#### Analysis
**CI Lower Limit:** -11.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -1.0
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Analysis was based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.020
**P-Value Comment:** 
**Parameter Type:** Between Group Difference in the LSM
**Parameter Value:** -6.5
**Statistical Comment:** 
**Statistical Method:** LDA
**Tested Non-Inferiority:** 
### Outcome Measure 11
#### Analysis
**CI Lower Limit:** -9.1
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.0
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 95% CI
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Between Group Difference in Percentages
**Parameter Value:** -2.1
**Statistical Comment:** 
**Statistical Method:** Miettinen & Nurminen
**Tested Non-Inferiority:** 
### Outcome Measure 12
#### Analysis
**CI Lower Limit:** 0.40
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.44
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The analysis was calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.394
**P-Value Comment:** 
**Parameter Type:** Event Rate Ratio
**Parameter Value:** 0.76
**Statistical Comment:** 
**Statistical Method:** Negative Binomial Model
**Tested Non-Inferiority:** 
### Outcome Measure 13
#### Analysis
**CI Lower Limit:** -8.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.8
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The analysis included imputed events after participants discontinued from the study medication, using a Gamma frailty model. Proportions and difference in proportions were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The bootstrap method was used to obtain the CI and p-value.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.740
**P-Value Comment:** 
**Parameter Type:** Between Group Difference in Percentages
**Parameter Value:** -1.2
**Statistical Comment:** 
**Statistical Method:** Miettinen and Nurminen
**Tested Non-Inferiority:** 
### Outcome Measure 14
#### Analysis
**CI Lower Limit:** -4.7
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.2
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The analysis included imputed events after subjects discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.712
**P-Value Comment:** 
**Parameter Type:** Between Group Difference in Percentages
**Parameter Value:** -0.7
**Statistical Comment:** 
**Statistical Method:** Miettinen and Nurminen
**Tested Non-Inferiority:** 
### Outcome Measure 15
#### Analysis
**CI Lower Limit:** 0.5
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 10.1
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.030
**P-Value Comment:** 
**Parameter Type:** Between Group Difference in Percentages
**Parameter Value:** 5.3
**Statistical Comment:** 
**Statistical Method:** Miettinen and Nurminen
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.98
- **Spread:** -1.98
- **Upper Limit:** -1.78
- **Value:** -1.88
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.52
- **Spread:** -1.52
- **Upper Limit:** -1.32
- **Value:** -1.42
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.22
- **Spread:** 1.22
- **Upper Limit:** 1.96
- **Value:** 1.55
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.70
- **Spread:** 1.70
- **Upper Limit:** 2.66
- **Value:** 2.12
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.6
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 28.5
- **Spread:** 28.5
- **Upper Limit:** 38.6
- **Value:** 33.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 32.7
- **Spread:** 32.7
- **Upper Limit:** 42.6
- **Value:** 37.7
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 48.5
- **Spread:** 48.5
- **Upper Limit:** 58.0
- **Value:** 53.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 56.5
- **Spread:** 56.5
- **Upper Limit:** 66.0
- **Value:** 61.3
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.34
- **Spread:** 4.34
- **Upper Limit:** 5.88
- **Value:** 5.05
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.33
- **Spread:** 5.33
- **Upper Limit:** 7.24
- **Value:** 6.21
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.20
- **Spread:** 0.20
- **Upper Limit:** 0.45
- **Value:** 0.30
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.25
- **Spread:** 0.25
- **Upper Limit:** 0.53
- **Value:** 0.36
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8.9
- **Spread:** 8.9
- **Upper Limit:** 15.8
- **Value:** 12.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 10.0
- **Spread:** 10.0
- **Upper Limit:** 17.2
- **Value:** 13.6
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 54.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35.4
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -90.0
- **Spread:** -90.0
- **Upper Limit:** -79.6
- **Value:** -84.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -83.5
- **Spread:** -83.5
- **Upper Limit:** -73.1
- **Value:** -78.3
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 60.0
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.10
- **Spread:** 0.10
- **Upper Limit:** 0.28
- **Value:** 0.17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.14
- **Spread:** 0.14
- **Upper Limit:** 0.36
- **Value:** 0.22
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 61.9
- **Spread:** 61.9
- **Upper Limit:** 71.7
- **Value:** 66.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 63.2
- **Spread:** 63.2
- **Upper Limit:** 72.9
- **Value:** 68.0
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.9
- **Spread:** 4.9
- **Upper Limit:** 10.3
- **Value:** 7.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.4
- **Spread:** 5.4
- **Upper Limit:** 11.2
- **Value:** 8.3
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10.0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 30 A1C minus the Week 0 A1C.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline).
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 30
**Title:** Change From Baseline in A1C at Week 30
**Type:** PRIMARY
**Unit of Measure:** Percent A1C
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study treatment. Two participants in the sitagliptin group were not included in the primary analysis due to a missing value of a model covariate (race).
**Reporting Status:** POSTED
**Time Frame:** Up to 30 weeks
**Title:** Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)
**Type:** PRIMARY
**Unit of Measure:** Events/Participant-Years
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Description:** An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study treatment.
**Reporting Status:** POSTED
**Time Frame:** Up to 30 weeks
**Title:** Percentage of Participants Who Discontinued Study Drug Due to an AE
**Type:** PRIMARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The incidence (number of participants with ≥1 event divided by number of participants) of documented symptomatic hypoglycemia was determined.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study treatment.
**Reporting Status:** POSTED
**Time Frame:** Up to 30 weeks
**Title:** Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Description:** Change from baseline reflects the Week 30 total daily insulin dose minus the Week 0 total daily insulin dose. The Week 0 total daily insulin dose was 0, by definition, because insulin was not administered at baseline.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline).
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 30
**Title:** Change From Baseline in Total Daily Insulin Dose (Units) at Week 30
**Type:** SECONDARY
**Unit of Measure:** Insulin Units
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). Two participants (both in the sitagliptin group) were not included in the analysis due to a missing value of a model covariate (race).
**Reporting Status:** POSTED
**Time Frame:** Up to 30 weeks
**Title:** Event Rate of Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)
**Type:** SECONDARY
**Unit of Measure:** Events/Participant-Years
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). Two participants (both in the sitagliptin group) were not included in the analysis due to a missing value of a model covariate (race).
**Reporting Status:** POSTED
**Time Frame:** Up to 30 weeks
**Title:** Event Rate of Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)
**Type:** SECONDARY
**Unit of Measure:** Events/Participant-Years
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 8
**Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study treatment.
**Reporting Status:** POSTED
**Time Frame:** Up to 30 weeks
**Title:** Percentage of Participants With Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 9
**Description:** A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study treatment.
**Reporting Status:** POSTED
**Time Frame:** Week 30
**Title:** Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol) at Week 30
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 10
**Description:** Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at Week 0).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline).
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 30
**Title:** Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 11
**Description:** An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study treatment.
**Reporting Status:** POSTED
**Time Frame:** Up to 32 weeks
**Title:** Percentage of Participants Who Experienced One or More Adverse Events (AEs)
**Type:** PRIMARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 12
**Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study treatment. Two participants in the sitagliptin group were not included in the primary analysis due to a missing value of a model covariate (race).
**Reporting Status:** POSTED
**Time Frame:** Up to 30 weeks
**Title:** Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)
**Type:** SECONDARY
**Unit of Measure:** Events/Participant-Years
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 13
**Description:** Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study treatment.
**Reporting Status:** POSTED
**Time Frame:** Up to 30 weeks
**Title:** Percentage of Participants With Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 14
**Description:** Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study treatment.
**Reporting Status:** POSTED
**Time Frame:** Up to 30 weeks
**Title:** Percentage of Participants With Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 15
**Description:** A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study treatment.
**Reporting Status:** POSTED
**Time Frame:** Week 30
**Title:** Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol at Week 30 and No Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) up to Week 30
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** OG000
**Title:** Sitagliptin
##### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Sitagliptin 100 mg, oral, once daily for 30 weeks
**ID:** FG000
**Title:** Sitagliptin
#### Group
**Description:** Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Withdraw
**Type:** Pregnancy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Screen Failure
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Site Discontinued Study Participation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 374
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 372
##### Milestone
**Type:** Treated
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 373
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 370
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 361
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 347
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 25
**Pre-Assignment Details:** Male and female participants with Type 2 diabetes mellitus (T2DM) ≥18 years of age were enrolled in this trial.
**Recruitment Details:** A total of 746 participants were randomized across 149 study sites in 22 countries.
**Has Results:** True