Phase 2b Trial Update of MK-3102 for Type 2 Diabetes
Merck announced Phase 2b data for MK-3102 for the treatment of type 2 diabetes.
The findings reported were from a multicenter, randomized, double-blind, placebo-controlled dose-ranging study designed to evaluate five doses of MK-3102 (0.25mg, 1mg, 3mg, 10mg and 25mg) in patients with type 2 diabetes who had inadequate glycemic control on diet and exercise. A total of 685 patients with a mean baseline HbA1c of approximately 8% were randomized: 571 patients received MK-3102 at one of the five once-weekly doses (0.25mg, n=113; 1mg, n=115; 3mg, n=114; 10mg, n=115; 25mg, n=114) and 114 patients received placebo for 12 weeks. The primary endpoint was change in HbA1c from baseline at 12 weeks compared to placebo across doses. The secondary endpoints were 2-hour post-meal glucose and fasting plasma glucose.
MK-3102 significantly reduced HbA1c compared to placebo (P<0.001) from a mean baseline of approximately 8% across all doses. In the full study population at 12 weeks, the placebo-adjusted reduction from baseline in HbA1c was 0.71% with MK-3102 25mg; 0.67% with 10mg; 0.49% with 3mg; 0.50% with 1mg; and 0.28% with 0.25mg.
A statistically significant (P<0.001) trend was observed across doses studied for the secondary endpoints of 2-hour post-meal glucose (PMG) and fasting blood glucose (FPG). For 2-hour PMG placebo-adjusted reductions from baseline at Week 12 were: MK-3102 25mg=2.5mmol/L; 10mg=2.3mmol/L; 3mg=1.9mmol/L; 1mg=1.9mmol/L; 0.25mg=1mmol/L. For FPG, placebo-adjusted reductions from baseline at Week 12 were MK-3102 25mg=1.2mmol/L; 10mg=0.7mmol/L; 3mg=0.8mmol/L; 1mg=1.1mmol/L; 0.25mg=0.1mmol/L.
MK-3102 is an investigational once-weekly DPP-4 inhibitor.
For more information call (800) 672-6372 or visit www.merck.com.