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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

++ Least squares means adjusted for prior antihyperglycemic therapy status and baseline value. ss. pless than0.001 compared to placebo. % Data not available. Additional Monotherapy Study A multinational, randomized, double-blind, placebo-controlled study was also conducted to assess the safety and tolerability of JANUVIA in 91 patients with type 2 diabetes and chronic renal insufficiency (creatinine clearance less than 50 mL/min). Patients with moderate renal insufficiency received 50 mg daily of JANUVIA and those with severe renal insufficiency or with ESRD on hemodialysis or peritoneal dialysis received 25 mg daily. In this study, the safety and tolerability of JANUVIA were generally similar to placebo. A small increase in serum creatinine was reported in patients with moderate renal insufficiency treated with JANUVIA relative to those on placebo. In addition, the reductions in A1C and FPG with JANUVIA compared to placebo were generally similar to those observed in other monotherapy studies. (See Clinical Pharmacology (12.3).) 14.2 Combination Therapy Combination Therapy with Metformin A total of 701 patients with type 2 diabetes participated in a 24-week, randomized, double-blind, placebo-controlled study designed to assess the efficacy of JANUVIA in combination with metformin. Patients already on metformin (N=431) at a dose of at least 1500 mg per day were randomized after completing a 2-week single-blind placebo run-in period. Patients on metformin and another antihyperglycemic agent (N = 229) and patients not on any antihyperglycemic agents (off therapy for at least 8 weeks, N = 41) were randomized after a run-in period of approximately 10 weeks on metformin (at a dose of at least 1500 mg per day) in monotherapy. Patients were randomized to the addition of either 100 mg of JANUVIA or placebo, administered once daily. Patients who failed to meet specific glycemic goals during the studies were
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