A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)

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).

Timeline

Start

2012-12-05

Primary completion

2015-06-19

Completion

2015-06-19

Outcome

Met primary endpoint

registry Omarigliptin vs Placebo to Omarigliptin; p <0.001; Difference in the least squares means -0.39 (95% CI -0.59 to -0.19) NCT01717313 ↗

Publications

• Results Home P, Shankar RR, Gantz I, Iredale C, O'Neill EA, Jain L, Pong A, Suryawanshi S, Engel SS, Kaufman KD, Lai E. A randomized, double-blind trial evaluating the efficacy and safety of monotherapy with the once-weekly dipeptidyl peptidase-4 inhibitor omarigliptin in people with type 2 diabetes. Diabetes Res Clin Pract. 2018 Apr;138:253-261. doi: 10.1016/j.diabres.2017.10.018. Epub 2017 Oct 24.

Drugs

Indications