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Effects of Vildagliptin on Glucose Control Over 24 Weeks in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

¹ Diabetes and Endocrinology Unit, Department of General Medicine, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy
² Novartis Pharma, Basel, Switzerland
³ Baylor College of Medicine, Houston, Texas

Address correspondence and reprint requests to Alan J. Garber, MD, PhD, Baylor College of Medicine, 6550 Fannin St., Suite 1045, Houston, TX 77030. E-mail: agarber{at}bcm.tmc.edu

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 (1,500 mg/day) but achieving inadequate glycemic control (A1C 7.5–11%).

RESULTS—The between-treatment difference (vildagliptin – placebo) in adjusted mean change (AM) ± 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 AM 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.

Abbreviations: AM, adjusted mean change • AE, adverse event • AUC, area under the curve • DPP-4, dipeptidyl peptidase-4 • FPG, fasting plasma glucose • ISR, insulin secretory rate • ITT, intent-to-treat • PPG, postprandial glucose • SAE, serious adverse event

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