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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

diet and exercise, to improve glycemic control in adult patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with the combination of sitagliptin and metformin. Consistent with the labeling for metformin alone, JANUMET is contraindicated in patients with renal disease, renal dysfunction, or abnormal creatinine clearance; and acute or chronic metabolic acidosis, including diabetic ketoacidosis. JANUMET should not be used in patients with type 1 diabetes. Consistent with the labeling for metformin alone, the labeling for JANUMET contains a boxed warning for lactic acidosis, a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with JANUMET.

Initial combination therapy with JANUVIA and metformin significantly improved blood sugar control compared with metformin alone over one year (LB-04; Study #036)

This study demonstrated a mean A1C reduction from baseline of 1.8 percent in patients treated with JANUVIA 50 mg/metformin 1000 mg twice daily for up to 54 weeks (n=153). Additionally, mean A1C reductions from baseline were 1.4 percent in patients treated with JANUVIA 50 mg/metformin 500 mg twice daily (n=147), 1.3 percent in patients treated with metformin 1000 mg twice daily (n=134), 1.0 percent in patients treated with metformin 500 mg twice daily (n=117), and 0.8 percent in patients treated with JANUVIA 100 mg once daily (n=106).

After completing an initial 24-week placebo-controlled phase (n=1091) ("Phase A"), 762 patients with a mean baseline A1C of 8.7 percent continued in a 30-week, double-blind, active-controlled phase ("Phase B") on their previous active treatments: JANUVIA 50 mg/metformin 1000 mg twice daily (n=161); JANUVIA 50 mg/metformin 500 mg twice daily (n=160); metformin 1000 mg twice daily (n=153); metformin 500 mg twice daily (n=147); and JANUVIA 100 mg once-daily (n=141).

Two-thirds (67 percent
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