Phase IIb Data Show Investigational Once-Weekly DPP-4 Inhibitor MK-3102 Significantly Lowers Blood Sugar In Patients With Type 2 Diabetes
New data announced at the 48th European Association for the Study of Diabetes (EASD) annual meeting show Merck Sharp & Dohme’s (MSD) investigational once-weekly DPP-4 inhibitor significantly lowers blood sugar compared with placebo in patients with type 2 diabetes. The 12 week study also shows that treatment with MK-3102 is associated with an incidence of symptomatic hypoglycaemia similar to placebo, in patients with type 2 diabetes.1
“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, M.D., Clinical Research, Metabolism, Merck Research Laboratories.
The findings are from a multicentre, randomised, 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 glycaemic control on diet and exercise.1
A total of 685 patients with a mean baseline HbA1c of approximately 8 percent were randomised: 571 patients received MK-3102 at one of the five once-weekly doses and 114 patients received placebo for 12 weeks.1 The primary endpoint was change in HbA1c from baseline at 12 weeks compared to placebo across doses. The secondary endpoints were two-hour post-meal glucose and fasting plasma glucose.1
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 with 1 mg; and 0.28 percent with 0.25 mg.1
In the study, MK-3102 was generally well tolerated with a safety profile that was generally similar to placebo.1 Treatment with MK-3102 was associated with a low incidence of hypoglycaemia (0 to 2%) that was similar to placebo (1%).1
“Since the discovery of the DPP-4 inhibitor class, MSD 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 III studies to move MK-3102 forward in the development process,” said Nancy Thornberry, Senior Vice President and Franchise Head, Diabetes and Endocrinology, MSD Research Laboratories.
I. Gantz, M. Chen, A. Mirza, S. Suryawanshi, M.J. Davies, B.J. Goldstein. Effect of MK-3102, a novel once-weekly DPP-4 inhibitor, over 12 weeks in patients with type 2 diabetes mellitus. Presented at EASD Wednesday, Oct 03, 2012, 2:45 PM – 3:00 PM
Merck Sharp & Dohme Limited