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

Abstract

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 (AMΔ) 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 AMΔ 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.

Conclusions: This trial (NCT00099892) is registered with ClinicalTrials.gov.