OBJECTIVE: This study was conducted to determine the optimal dose of omarigliptin, a once-weekly (q.w.) @entity5735 ( @entity5735 ) inhibitor, for the treatment of @entity1 with @entity164 2 @entity6 and evaluate the long-term safety of that dose. RESEARCH DESIGN AND METHODS: In a multicenter, double-blind, 12-week, dose-range finding study, 685 oral antihyperglycemic agent-na  ve or washed-out subjects with @entity164 2 @entity6 were randomized to one of five once-weekly doses of omarigliptin (0.25 mg, 1 mg, 3 mg, 10 mg, or 25 mg) or placebo. The primary efficacy end point was change from baseline in HbA1c, and secondary end points were 2-h postmeal glucose (PMG) and fasting plasma glucose (FPG). Analysis included all @entity1 who received at least one dose of the study medication. Subjects who completed the base study were eligible to enter a 66-week extension study. RESULTS: Once-weekly treatment for 12 weeks with omarigliptin provided dose-related reductions in HbA1c, 2-h PMG, and FPG. At week 12, the omarigliptin 25-mg dose provided the greatest glycemic efficacy. 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). The incidence of adverse events was similar across dose groups, with a low incidence of symptomatic @entity4053 and no effect on body weight. Omarigliptin was generally well-tolerated throughout the base and extension studies. CONCLUSIONS: Omarigliptin 25 mg q.w., compared with placebo, provided significant glucose lowering and was generally well tolerated for up to 78 weeks in @entity1 with @entity164 2 @entity6 .

Safety and Efficacy of Omarigliptin (MK-3102), a Novel Once-Weekly XXXX Inhibitor for the Treatment of @entity1 With Type 2 Diabetes.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity5735 :: ('1803', 'Gene') :: ['DPP-4', 'dipeptidyl peptidase IV'] @entity6 :: ('MESH:D003920', 'Disease') :: ['diabetes'] @entity4053 :: ('MESH:D007003', 'Disease') :: ['hypoglycemia'] @entity164 :: ('MESH:D017827', 'Disease') :: ['type']
@entity5735 :: (1803,Gene) :: ['DPP-4']
