Merck’s diabetes drug: effective in phase 2 clinical trials

Hannah Blake

pharmaphorum

Merck &amp, Co has announced that phase 2 clinical trials of its investigational once-weekly DPP-4 inhibitor, in development for the treatment of type 2 diabetes, have been effective.

The drug, MK-3102, significantly lowered blood sugar levels in this 12-week study, compared with placebo, in patients with type 2 diabetes who had inadequate glycemic control on diet and excercise. A total of 685 patients with a mean baseline HbA1c of approximately 8% were randomized with a number of different doses of MK-3102. The primary endpoint was change in HbA1c from baseline at 12 weeks compared to placebo across placebo.

At 12 weeks, the placebo-adjusted reduction from baseline in HbA1c was statistically significant, according to Merck – 0.71% with MK-3102 25 mg, 0.67% with 10 mg, 0.49% with 3 mg, 0.50% with 1 mg, and 0.28% with 0.25 mg.

Merck has chosen to advance only the 25mg dose for phase 3 clinical trials, which will test MK-3102 against, and in combination with, a variety of diabetes treatments.

“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.”

Nancy Thornberry, Senior Vice President and Franchise Head, Diabetes and Endocrinology, Merck Research Laboratories.

Diabetes affects 347 million people globally, according to the World Health Organisation.

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