FDA Approves Merck's Janumet for Type 2 Diabetes

Merck announced that the FDA has approved Janumet, a tablet combining a Januvia, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin for the treatment of Type 2 diabetes.

Janumet has been approved as an adjunct to diet and exercise for improving blood sugar control in adult patients with Type 2 diabetes who are not adequately controlled on metformin or Januvia (sitagliptin) alone, or in patients already being treated with the combination of Januvia and metformin.

"With Janumet and Januvia, Merck now has a growing family of products that provides physicians with important treatment options for patients with Type 2 diabetes," Adam Schechter, president of U.S. Human Health at Merck, said. The FDA approved Januvia in October 2006.

A 24-week, randomized, double-blind, placebo-controlled study of 701 patients with mildly to moderately elevated A1C levels inadequately controlled on metformin showed that patients taking Janumet experienced significant additional mean placebo-subtracted reductions in A1C of 0.7 percent beyond that achieved by patients who continued on metformin alone. In the study, more than twice as many patients on Janumet reached the American Diabetes Association's A1C goal of less than 7 percent compared with patients on metformin alone.