A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)

Summary

This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study 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

2012-09-10

Primary completion

2015-01-26

Completion

2015-01-26

Outcome

Mixed primary results

paper which met the pre-specified criterion for declaring non-inferiority. PMID 28548024 ↗

registry Difference in percentages -6.9 (95% CI -13.9 to 0.1) NCT01682759 ↗

registry Difference in percentages 1.1 (95% CI -1.6 to 3.8) NCT01682759 ↗

Publications

• Results Handelsman Y, Lauring B, Gantz I, Iredale C, O'Neill EA, Wei Z, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of omarigliptin, a once-weekly DPP-4 inhibitor, or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Curr Med Res Opin. 2017 Oct;33(10):1861-1868. doi: 10.1080/03007995.2017.1335638. Epub 2017 Jun 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Glimepiride	Small molecule	6 mg	—
Subject	Omarigliptin	Small molecule	25 mg	—
Background	Metformin	Small molecule	1500 mg	—
Background	insulin glargine	Protein / enzyme biologic	—	—

Indications