A Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy (MK-3102-024)

Phase 3 Completed 402 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to assess the safety and efficacy of omarigliptin compared to placebo in participants with inadequate glycemic control on metformin monotherapy. The primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin provides greater reduction in hemoglobin A1c (A1C) than placebo.

Timeline

Start: 2013-01-11
Primary completion: 2016-03-16
Completion: 2016-03-16

Outcome

Met primary endpoint

registry Omarigliptin (Phase A) vs Placebo to Omarigliptin (Phase A); p <0.001; Difference in least squares means -0.55 (95% CI -0.75 to -0.34) NCT01755156 ↗

Publications

Results Shankar RR, Inzucchi SE, Scarabello V, Gantz I, Kaufman KD, Lai E, Ceesay P, Suryawanshi S, Engel SS. A randomized clinical trial evaluating the efficacy and safety of the once-weekly dipeptidyl peptidase-4 inhibitor omarigliptin in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Curr Med Res Opin. 2017 Oct;33(10):1853-1860. doi: 10.1080/03007995.2017.1335637. Epub 2017 Jun 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Glimepiride	Small molecule	6 mg	Oral
Subject	Omarigliptin	Small molecule	25 mg	Oral
Background	Metformin	Small molecule	—	Oral
Background	insulin glargine	Protein / enzyme biologic	—	—