CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 585 enrolled
Drug / intervention
Omarigliptin +1 moredrug
Likely dose
Omarigliptin 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01697592
NCT01697592Phase 3Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Oct 2, 2012·Updated Sep 10, 2018

In Brief

A Phase 3 clinical trial evaluating Omarigliptin and Matching placebo to omarigliptin for Type 2 Diabetes Mellitus. Completed, enrolled 585 participants.

Detailed Summary

This study will examine the safety and efficacy of the addition of omarigliptin in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2, 2012
Enrollment StartOct 24, 2012
Primary CompletionMay 8, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.8 years ago

Interventions

Omarigliptindrug

Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).

Matching placebo to omarigliptindrug

Matching placebo to omarigliptin 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).