A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006)

Summary

The purpose of this study is to assess the hypothesis that treatment with study medication (omarigliptin; MK-3102) provides greater reduction in A1C Hemoglobin (a marker of diabetic severity) compared with placebo, after 12 weeks of treatment. The study will evaluate 5 different doses of omarigliptin to identify which dose is the most effective in the treatment of type 2 diabetes.

Timeline

Start

2010-10-08

Primary completion

2012-01-03

Completion

2013-04-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); Omarigliptin 25 mg (Base) vs Placebo (Base); p <0.001; Difference in least squares mean -0.71 (95% CI -0.93 to -0.50) NCT01217073 ↗

paper The placebo-adjusted least-squares mean reductions from baseline in HbA1c, 2-h PMG, and FPG were -0.72% (-7.8 mmol/mol), -2.5, and -1.3 mmol/L, respectively (all P < 0.001). PMID 26310692 ↗

Publications

• Results Sheu WH, Gantz I, Chen M, Suryawanshi S, Mirza A, Goldstein BJ, Kaufman KD, Engel SS. Safety and Efficacy of Omarigliptin (MK-3102), a Novel Once-Weekly DPP-4 Inhibitor for the Treatment of Patients With Type 2 Diabetes. Diabetes Care. 2015 Nov;38(11):2106-14. doi: 10.2337/dc15-0109. Epub 2015 Aug 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omarigliptin	Small molecule	0.25 mg	Oral
Subject	Omarigliptin	Small molecule	1 mg	Oral
Subject	Omarigliptin	Small molecule	3 mg	Oral
Subject	Omarigliptin	Small molecule	10 mg	Oral
Subject	Omarigliptin	Small molecule	25 mg	Oral
Comparator	Metformin	Small molecule	500 mg	Oral
Comparator	Pioglitazone	Small molecule	15 mg	Oral

Indications