Merck & Co. on Wednesday presented data from a Phase IIb study at the EASD meeting suggesting that its once-weekly DPP-4 inhibitor MK-3102 significantly lowered HbA1c levels compared to placebo in patients with type 2 diabetes. Based on the results, Merck indicated that it is initiating Phase III studies of the experimental therapy.
The study randomised 685 patients with type 2 diabetes who had inadequate glycaemic control on diet and exercise to receive one of five weekly doses of MK-3102 or placebo. After 12 weeks of treatment with Merck’s drug, HbA1c was reduced by between 0.71 percent with the highest dose to 0.28 percent with the lowest dose, with all reductions deemed to be statistically significant compared to placebo. A statistically significant trend was also observed across doses studied for the secondary endpoints of 2-hour post-meal glucose and fasting HbA1c.
The company noted that the 0.71 percent reduction in the primary endpoint observed with the 25 milligram dose of MK-3102 is similar to the glucose reduction attained by Januvia (sitagliptin). As such, Merck has chosen to advance only the 25 milligram dose into late-stage trials, where it will be tested against and in combination with a variety of diabetes therapies. "We do anticipate the efficacy, safety and tolerability of this will be comparable to [Januvia]," remarked Nancy Thornberry, Merck's head of diabetes and endocrinology, but she stressed that MK-3102 was a new compound and not simply a new formulation of Januvia.
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