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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Omarigliptin; Drug: Placebo to sitagliptin; Drug: Sitagliptin; Drug: Placebo to omarigliptin

• Registration Number: NCT01703221
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-10-05
• Study First Posted: 2012-10-10
• Study Start: 2012-10-24
• Primary Completion: 2014-04-25
• Study Completion: 2014-04-25
• Results First Submitted: 2015-09-29
• Results First Submitted QC: 2015-09-29
• Results First Posted: 2015-10-29
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-15
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

Inclusion Criteria

• Has type 2 diabetes mellitus

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omarigliptin 25 mg (Phase A+B)	Omarigliptin	Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
Omarigliptin 25 mg (Phase A+B)	Placebo to sitagliptin	Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
Placebo (Phase A) switching to Omarigliptin (Phase B)	Placebo to sitagliptin	Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
Sitagliptin (Phase A) switching to Omarigliptin (Phase B)	Placebo to omarigliptin	Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
Placebo (Phase A) switching to Omarigliptin (Phase B)	Placebo to omarigliptin	Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
Sitagliptin (Phase A) switching to Omarigliptin (Phase B)	Omarigliptin	Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
Sitagliptin (Phase A) switching to Omarigliptin (Phase B)	Sitagliptin	Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
Placebo (Phase A) switching to Omarigliptin (Phase B)	Omarigliptin	Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study	Up to 52 weeks	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.
Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24	Baseline and 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).
Percentage of Participants Who Experienced at Least One Adverse Event During Phase A	Up to 24 weeks	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.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A	Up to 24 weeks	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.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study	Up to 52 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24	Baseline and 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).
Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24	Baseline and Week 24	Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.