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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-24

Study Completion Date

2014-04-25

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.

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Omarigliptin 25 mg (Phase A+B)

Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)

Group Type EXPERIMENTAL

Omarigliptin

Intervention Type DRUG

Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly

Placebo to sitagliptin

Intervention Type DRUG

Placebo to sitagliptin 50 mg tablet administered orally once daily

Sitagliptin (Phase A) switching to Omarigliptin (Phase B)

Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)

Group Type ACTIVE_COMPARATOR

Omarigliptin

Intervention Type DRUG

Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly

Sitagliptin

Intervention Type DRUG

Sitagliptin 50 mg tablet administered orally once daily

Placebo to omarigliptin

Intervention Type DRUG

Placebo to omarigliptin 25 mg capsule administered orally once weekly

Placebo (Phase A) switching to Omarigliptin (Phase B)

Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)

Group Type PLACEBO_COMPARATOR

Omarigliptin

Intervention Type DRUG

Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly

Placebo to omarigliptin

Intervention Type DRUG

Placebo to omarigliptin 25 mg capsule administered orally once weekly

Placebo to sitagliptin

Intervention Type DRUG

Placebo to sitagliptin 50 mg tablet administered orally once daily

Interventions

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Omarigliptin

Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly

Intervention Type DRUG

Sitagliptin

Sitagliptin 50 mg tablet administered orally once daily

Intervention Type DRUG

Placebo to omarigliptin

Placebo to omarigliptin 25 mg capsule administered orally once weekly

Intervention Type DRUG

Placebo to sitagliptin

Placebo to sitagliptin 50 mg tablet administered orally once daily

Intervention Type DRUG

Other Intervention Names

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Januvia®

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No