Merck, known as MSD outside the United States and Canada, announced Phase 2b data for MK-3102, the company’s investigational once-weekly DPP-4 inhibitor in development for the treatment of type 2 diabetes. MK-3102 significantly lowered blood sugar in this 12-week study compared with placebo, with an incidence of symptomatic hypoglycemia that was similar to placebo, in patients with type 2 diabetes. These data were presented today at the 48th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Berlin.
“If approved, MK-3102 would provide a novel, once-weekly treatment option to help reduce blood sugar levels in patients with type 2 diabetes,” said lead study author Ira Gantz, MD, Clinical Research, Metabolism, Merck Research Laboratories.
The findings reported are from a multicenter, randomized, double-blind, placebo-controlled dose-ranging study designed to evaluate five doses of MK-3102 (0.25, 1, 3, 10 and 25 mg) 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 percent were randomized: 571 patients received MK-3102 at one of the five once-weekly doses (0.25 mg, n=113; 1 mg, n=115; 3 mg, n=114; 10 mg, n=115; 25 mg, 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 percent across all doses. In the full study population at 12 weeks, the placebo-adjusted reduction from baseline in HbA1c was 0.71 percent with MK-3102 25 mg; 0.67 percent with 10 mg; 0.49 percent with 3 mg; 0.50 percent with 1 mg; and 0.28 percent with 0.25 mg.
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 25 mg=2.5 mmol/L; 10 mg=2.3 mmol/L; 3 mg=1.9 mmol/L; 1 mg=1.9 mmol/L; 0.25 mg=1.0 mmol/L. For FPG, placebo-adjusted reductions from baseline at week 12 were MK-3102 25 mg=1.2 mmol/L; 10 mg= 0.7 mmol/L; 3 mg=0.8 mmol/L; 1 mg=1.1 mmol/L; 0.25 mg=0.1 mmol/L.
In the study, MK-3102 was generally well tolerated with a safety profile that was generally similar to placebo.
Diabetes is a chronic, progressive disease that affects 366 million people globally, including nearly 26 million people in the U.S., however, based on National Health and Nutrition Examination Survey (NHANES) data from 1999-2006, more than 40 percent of patients are not at the American Diabetes Association (ADA) goal of less than 7.0 percent for HbA1c.
“Since the discovery of the DPP-4 inhibitor class, Merck has been actively committed to advancing the science of how to treat type 2 diabetes. We are encouraged by these Phase IIb results in patients with type 2 diabetes, and we are initiating Phase 3 studies to move MK-3102 forward in the development process,” said Nancy Thornberry, Senior Vice President and Franchise Head, Diabetes and Endocrinology, Merck Research Laboratories.
Date: October 3, 2012