Late Breaking Data Released at ADA Showed that the Investigational,Use of Januvia and Metformin as Initial Combination Therapy,Provided Significant Glucose Lowering Efficacy over 54 Weeks in,Patients with Type 2 Diabetes ( garcontrol said John Amatruda M.D....)

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Late Breaking Data Released at ADA Showed that the Investigational,Use of Januvia and Metformin as Initial Combination Therapy,Provided Significant Glucose Lowering Efficacy over 54 Weeks in,Patients with Type 2 Diabetes

gar control," said John Amatruda, M.D., vice president, clinical research, Merck & Co., Inc. "This study examines the clinical effect of initial combination therapy with JANUVIA and metformin, the two drugs comprising JANUMET, over one year."

An important predictive factor of the magnitude of A1C reduction in response to anti-hyperglycemic therapy is a patient's starting level of A1C. In a subgroup analysis of patients grouped by severity of starting baseline A1C, treatment with JANUVIA 50 mg/metformin 1000 mg twice daily demonstrated increasing mean A1C reductions from baseline the higher the baseline A1C. A mean reduction of 3.1 percent was seen in patients with baseline A1C of 10 percent or more (n=17), while reductions of 2.2 percent, 1.7 percent, and 1.0 percent were seen with baseline A1C values of nine to 10 percent, eight to nine percent, and less than eight percent, respectively.

Investigational study showed JANUVIA significantly improved blood sugar control when added to sulfonylurea or to sulfonylurea and metformin vs. sulfonylurea or sulfonylurea and metformin alone (Poster #535-P; Study #035)

In this study, which was designed to examine the efficacy and safety of JANUVIA in patients with type 2 diabetes whose blood glucose levels were inadequately controlled (A1C levels of 7.5 percent to 10.5 percent) on a sulfonylurea (glimepiride) alone or on a sulfonylurea (glimepiride) plus metformin, JANUVIA demonstrated a significant mean difference from placebo in A1C of 0.9 percent in patients on glimepiride and metformin and 0.6 percent in patients on glimepiride alone (p less than 0.001 for both comparisons to the addition of placebo).

After a titration/stabilization period on glimepiride (at least 4 mg/day) with or without metformin (at least 1500 mg/day) and a 2-week placebo run-in, 441 patients with a mean baseline A1C of 8.3 percent were randomized to the addition of JANUVIA 100 mg once-daily or placebo for 24 weeks. Of thes
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