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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

on to placebo or JANUVIA. Treatment with JANUVIA at 100 mg daily provided significant improvements in A1C, FPG, and 2-hour PPG compared to placebo (Table 2). In the 18-week study, 9% of patients receiving JANUVIA 100 mg and 17% who received placebo required rescue therapy. In the 24-week study, 9% of patients receiving JANUVIA 100 mg and 21% of patients receiving placebo required rescue therapy. The improvement in A1C was not affected by gender, age, race, or baseline BMI. As is typical for trials of agents to treat type 2 diabetes, mean response to JANUVIA in A1C lowering appears to be related to the degree of A1C elevation at baseline. Overall, the 200 mg daily dose did not provide greater glycemic efficacy than the 100 mg daily dose. The effect of JANUVIA on lipid endpoints was similar to placebo. Body weight did not increase from baseline with JANUVIA therapy in either study, compared to a small reduction in patients given placebo. Table 2 Glycemic Parameters in 18- and 24-Week Placebo-Controlled Studies of JANUVIA in Patients with Type 2 Diabetes+ ---------------------------------------------------------------------- 18-Week Study 24-Week Study ----------------- ----------------- JANUVIA Placebo JANUVIA Placebo 100 mg 100 mg ------------------------------------------- -------- -------- -------- A1C (%) N = 193 N = 103 N = 229 N = 244 ------------------------------------------- -------- -------- -------- Baseline (mean) 8.0 8.1 8.0 8.0 ------------------------------------------- -------- -------- -------- Change from baseline (adjusted mean++) -0.5 0.1 -0.6 0.2 ------------------------------------------- ------
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