Phase IIb Data Showed Merck’s Investigational Once-Weekly DPP-4 Inhibitor MK-3102 Significantly Lowered Blood Sugar in Patients with Type 2 Diabetes


October 3, 2012 7:46 am ET

Phase III Trials of MK-3102 Underway

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced Phase IIb 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, M.D., Clinical Research,
Metabolism, Merck Research Laboratories.

Study Design

The findings reported today 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.

Study Results

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 III studies to move MK-3102
forward in the development process,” said Nancy Thornberry, Senior Vice
President and Franchise Head, Diabetes and Endocrinology, Merck Research

About Merck

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well. Merck is known as MSD outside the United States and Canada.
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