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

Author(s): Bosi E, Camisasca RP, Collober C, Rochotte E, Garber AJ

Affiliation(s): General Medicine, Diabetes & Endocrinology Unit, San Raffaele Scientific Institute, and Vita-Salute San Raffaele University, Milan, Italy.

Publication date & source: 2007-02-02, Diabetes Care., [Epub ahead of print]

Publication type:

Objective: To evaluate the efficacy and safety of vildagliptin, a new dipeptidyl peptidase-4 inhibitor, added to metformin during 24-week treatment in patients with type 2 diabetes. Research Design and Methods: Double-blind, randomized, multicenter, parallel group study of 24-week treatment with vildagliptin 50 mg daily (n = 177), 100 mg daily (n = 185), or placebo (n = 182) in patients continuing a stable metformin dose regimen (>/=1500 mg/day) but achieving inadequate glycemic control (HbA(1c) = 7.5%-11%). Results: The between-treatment difference (vildagliptin -- placebo) in adjusted mean change (AMDelta) in HbA(1c) from baseline to endpoint was -0.7 +/- 0.1% (P < .001) and -1.1 +/- 0.1% (P < .001) in patients receiving vildagliptin 50 mg or 100 mg daily, respectively. The between-treatment difference in the AMDelta fasting glucose (FPG) was -0.8 +/- 0.3 mmol/L (P = .003) and -1.7 +/- 0.3 mmol/L (P < .001) in patients receiving vildagliptin 50 mg or 100 mg daily, respectively. Adverse events (AEs) were reported by 63.3%, 65.0%, and 63.5% of patients receiving vildagliptin 50 mg daily, 100 mg daily, or placebo, respectively. Gastrointestinal AEs were reported by 9.6% (P = .022 vs placebo), 14.8%, and 18.2% of patients receiving vildagliptin 50 mg daily, 100 mg 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 HbA(1c) and FPG as add-on therapy in patients with type 2 diabetes inadequately controlled by metformin. This trial (NCT00099892) is registered with ClinicalTrials.gov.