Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)

Summary

The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1) Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.

Timeline

Start

2012-10-24

Primary completion

2014-04-25

Completion

2014-04-25

Outcome

Met primary endpoint

paper The difference in LS mean for omarigliptin vs placebo was -0.80% ( P  < .001). PMID 28449368 ↗

paper The difference in LS mean for omarigliptin vs sitagliptin was -0.02% (95% confidence interval -0.15, 0.12), which met the criterion for non-inferiority to sitagliptin. PMID 28449368 ↗

Publications

• Results Gantz I, Okamoto T, Ito Y, Okuyama K, O'Neill EA, Kaufman KD, Engel SS, Lai E; the Omarigliptin Study 020 Group. A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1602-1609. doi: 10.1111/dom.12988. Epub 2017 Jul 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omarigliptin	Small molecule	25 mg	Oral
Subject	Sitagliptin	Small molecule	50 mg	Oral

Indications