Bosi_2007_Diabetes.Care_30_890

OBJECTIVE: We sought to evaluate the efficacy and safety of vildagliptin, a new dipeptidyl peptidase-4 inhibitor, added to metformin during 24 weeks of treatment in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: This was a double-blind, randomized, multicenter, parallel group study of a 24-week treatment with 50 mg vildagliptin daily (n = 177), 100 mg vildagliptin daily (n = 185), or placebo (n = 182) in patients continuing a stable metformin dose regimen (> or =1,500 mg/day) but achieving inadequate glycemic control (A1C 7.5-11%). RESULTS: The between-treatment difference (vildagliptin-placebo) in adjusted mean change (AMDelta) +/- SE in A1C from baseline to end point was -0.7 +/- 0.1% (P < 0.001) and -1.1 +/- 0.1% (P < 0.001) in patients receiving 50 or 100 mg vildagliptin daily, respectively. The between-treatment difference in the AMDelta fasting plasma glucose (FPG) was -0.8 +/- 0.3 mmol/l (P = 0.003) and -1.7 +/- 0.3 mmol/l (P < 0.001) in patients receiving 50 or 100 mg vildagliptin daily, respectively. Adverse events (AEs) were reported by 63.3, 65.0, and 63.5% of patients receiving 50 mg vildagliptin daily, 100 mg vildagliptin daily, or placebo, respectively. Gastrointestinal AEs were reported by 9.6 (P = 0.022 vs. placebo), 14.8, and 18.2% of patients receiving 50 mg vildagliptin daily, 100 mg vildagliptin daily, or placebo, respectively. One patient in each treatment group experienced one mild hypoglycemic event. CONCLUSIONS: Vildagliptin is well tolerated and produces clinically meaningful, dose-related decreases in A1C and FPG as add-on therapy in patients with type 2 diabetes inadequately controlled by metformin.