drugset / Trial / NCT01863667

A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)

NCT01863667

Phase 3 Terminated 65 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis is that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.

Timeline

Start
2013-07-08
Primary completion
2014-04-03
Completion
2014-04-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Glimepiride Small molecule 1 mg Oral
Subject Glimepiride Small molecule 2 mg Oral
Subject Glimepiride Small molecule 6 mg Oral
Subject Omarigliptin Small molecule 25 mg Oral