Merck & Co., Inc. today announced it planned to a type 2 diabetes drug awaiting FDA approval that combines Januvia and metformin under the trade name Janumet.

The combination drug is designed to provide an additional treatment option for patients who need more than one drug to help control their blood sugar. Merck said it expects FDA action on approval of Janumet by the end of March 2007.

Data supporting JANUMET were presented earlier this year at the 66th annual meeting of the American Diabetes Association (ADA) as well as the 42nd annual meeting of the European Association for the Study of Diabetes (EASD).

Data presented at the ADA included a 24-week, double-blind study of patients who had inadequate glycemic control with metformin (at least 1,500 mg daily). In this study, Januvia 100 mg once daily added to patients inadequately controlled on metformin led to a significant additional mean reduction in A1C -- a measure of glycemic control -- of 0.7 percent.

Data presented at the EASD meeting demonstrated a significant mean lowering of the A1C of 2.1 percent from a mean baseline A1C of 8.8 percent with Januvia 50 mg twice daily and metformin 1,000 mg twice daily in patients as initial therapy.