At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 203 enrolled

Drug / intervention

Omarigliptin +2 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/NCT01814748

NCT01814748Phase 3Completed

Compare CT.gov

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-3102 in ≥18 and <45 Year-Old Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control

Merck Sharp & Dohme LLC·interventional·Posted Mar 20, 2013·Updated Sep 10, 2018

In Brief

A Phase 3 clinical trial evaluating Omarigliptin, Placebo to omarigliptin, and 1 other intervention for Diabetes Mellitus. Completed, enrolled 203 participants.

Detailed Summary

This study will examine the safety and efficacy of once-weekly omarigliptin in participants 18 to \<45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The study hypothesis is that treatment with omarigliptin compared with placebo provides greater reduction in hemoglobin A1c (A1C) in participants after 24 weeks.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDiabetes Mellitus

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedMar 2013

Enrollment StartMay 2013

Primary CompletionSep 2015

TodayJul 2026

First PostedMar 20, 2013

Enrollment StartMay 3, 2013

Primary CompletionSep 14, 2015

TodayJul 2, 2026

Enrollment to primary: 2.4 yearsPosted 13.3 years ago

Interventions

Omarigliptindrug

Omarigliptin 25 mg capsule administered orally once weekly

Placebo to omarigliptindrug

Matching placebo to omarigliptin 25 mg capsule administered orally once weekly

Metformindrug

Open-label metformin (dosed daily according to the country-specific product label) was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.