Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1) Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.

Detailed Description
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The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). Participants will receive in Phase A: omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo and in Phase B: omarigliptin 25 mg once weekly.

Official Title
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A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Omarigliptin
* Drug: Sitagliptin
* Drug: Placebo to omarigliptin
* Drug: Placebo to sitagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has type 2 diabetes mellitus Exclusion Criteria: History of type 1 diabetes mellitus or a history of ketoacidosis History of any of the following medications: thiazolidinediones and/or insulin within 12 weeks prior to study participation, omarigliptin and/or sitagliptin anytime

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omarigliptin 25 mg (Phase A+B)<br>Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B) | Drug: Omarigliptin<br>* Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly<br>Drug: Placebo to sitagliptin<br>* Placebo to sitagliptin 50 mg tablet administered orally once daily<br>|
| Active Comparator: Sitagliptin (Phase A) switching to Omarigliptin (Phase B)<br>Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B) | Drug: Omarigliptin<br>* Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly<br>Drug: Sitagliptin<br>* Sitagliptin 50 mg tablet administered orally once daily<br>* Other names: Januvia®;Drug: Placebo to omarigliptin<br>* Placebo to omarigliptin 25 mg capsule administered orally once weekly<br>|
| Placebo Comparator: Placebo (Phase A) switching to Omarigliptin (Phase B)<br>Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B) | Drug: Omarigliptin<br>* Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly<br>Drug: Placebo to omarigliptin<br>* Placebo to omarigliptin 25 mg capsule administered orally once weekly<br>Drug: Placebo to sitagliptin<br>* Placebo to sitagliptin 50 mg tablet administered orally once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24 | HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline). | Baseline and Week 24 | 
| Percentage of Participants Who Experienced at Least One Adverse Event During Phase A | An adverse event (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. | Up to 24 weeks | 
| Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study | 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. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only. | Up to 52 weeks | 
| Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A | 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. | Up to 24 weeks | 
| Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study | 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. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only. | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24 | Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0. | Baseline and Week 24 | 
| Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24 | Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline). | Baseline and Week 24 |