At a glance
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A Multicenter, Phase III, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of MK-3102 Monotherapy in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
In Brief
A Phase 3 clinical trial evaluating Omarigliptin, Placebo to Omarigliptin, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 329 participants.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of omarigliptin (MK-3102), dosed once-weekly in participants with T2DM who have inadequate glycemic control on diet and exercise. The primary hypothesis is that after 24 weeks, treatment with omarigliptin compared with placebo provides greater reduction in hemoglobin A1c (A1C).
Study Details
Timeline
Interventions
Omarigliptin 25 mg capsule administered orally once a week.
Placebo to omarigliptin capsule administered orally once a week
If necessary, participants may have glycemic rescue therapy initiated with open-label metformin during Phase A of the study. Participants in the placebo treatment group who were not rescued with open-label metformin during Phase A will receive blinded metformin (starting at 500 mg orally twice daily with up-titration to 1000 mg orally twice daily) in Phase B. Participants in the omarigliptin treatment group who were rescued with open-label metformin in Phase A will continue open-label metformin during Phase B of the study.
During Phase B of the study, participants in the omarigliptin treatment group who did not initiate glycemic rescue therapy during Phase A will receive placebo to metformin for 30 weeks (Phase B of the study).
If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic rescue therapy