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Janumet

Generic name: metformin and sitagliptin
Treatment for: Diabetes, Type 2

Update: Janumet Now FDA Approved - March 30, 2007

Merck Announces Janumet, the Trademark for its Investigational Combination Therapy of Sitagliptin Phosphate and Metformin for Type 2 Diabetes

WHITEHOUSE STATION, N.J., December 1, 2006 - Merck & Co., Inc. today announced the trademark Janumet for MK-0431A, the Company's investigational oral medicine combining sitagliptin phosphate with metformin for type 2 diabetes. Janumet is designed to provide an additional treatment option for patients who need more than one oral agent to help control their blood sugar and is currently under standard review by the U.S. Food and Drug Administration (FDA). Merck expects FDA action on the New Drug Application (NDA) by the end of March 2007. The Company is also moving forward as planned with regulatory filings in countries outside the United States.

Data supporting Janumet were previously disclosed 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, sitagliptin phosphate 100 mg once daily added to patients inadequately controlled on metformin led to a significant additional mean reduction in A1C of 0.7 percent compared with placebo (pgreater than or equal to 0.001). The concurrent administration of sitagliptin phosphate with metformin was generally well tolerated, with no increased incidence of hypoglycemia or gastrointestinal adverse events compared with the placebo arm of the study. Body weight changes were similar between the treatment groups.

Data presented at the EASD meeting demonstrated a significant mean placebo-subtracted reduction in A1C of 2.1 percent from a mean baseline A1C of 8.8 percent (primary analysis of all patients treated, p less than 0.001) with sitagliptin phosphate 50 mg twice daily and metformin 1,000 mg twice daily in patients as initial therapy. This study included another arm with sitagliptin phosphate and a lower dose of metformin and also monotherapy and placebo arms. Full results from this study for Janumet plus other data supporting sitagliptin phosphate will be presented next week at the 19th World Diabetes Congress in Cape Town, South Africa.

In the study presented at EASD, simultaneous treatment with sitagliptin phosphate and metformin was generally well tolerated and showed no meaningful differences in tolerability compared to metformin alone. Side effects of simultaneous treatment with sitagliptin phosphate 50 mg twice daily and metformin 1,000 mg twice daily compared to metformin 1,000 mg twice daily alone included diarrhea (9 percent vs. 10 percent, respectively), nausea (6 percent vs. 8 percent, respectively), abdominal pain/discomfort (3 percent vs. 5 percent, respectively) and vomiting (3 percent vs. 1 percent, respectively).

In studies of sitagliptin phosphate administered in combination with metformin, the most common side effects reported include nasopharyngitis, back pain, arthralgia and cough.

Selected cautionary information for Januvia (sitagliptin phosphate), a component of Janumet

One of the components of Janumet is sitagliptin phosphate, marketed under the trademark Januvia. Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

To achieve plasma concentrations of Januvia similar to patients with normal renal function, lower doses are recommended in patients with moderate renal insufficiency and in patients with severe renal insufficiency or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis. Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter. Safety and effectiveness of Januvia in pediatric patients have not been established. There are no adequate and well-controlled studies in pregnant women. Januvia should be used during pregnancy only if clearly needed. Caution should be exercised when Januvia is administered to a nursing woman.

In clinical trials, Januvia demonstrated an overall incidence of side effects comparable to placebo. The most common side effects reported with Januvia (greater than or equal to 5 percent and higher than placebo) were stuffy or runny nose and sore throat, upper respiratory infection and headache.

Posted: December 2006

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