Efficacy and Safety of Vildagliptin Monotherapy during 2-Year Treatment of Drug-naïve Patients with Type 2 Diabetes: Comparison with Metformin

Abstract

The present study was a 52-week extension of a previously published, multi-center, randomized, parallel-group study. The aim of this extension study was to compare the efficacy and tolerability of vildagliptin and metformin in drug-naïve patients with type 2 diabetes over 104 weeks. The extension population comprised 305 patients randomized to vildagliptin (100 mg daily) and 158 patients randomized to metformin (2 000 mg daily). Pioglitazone was added as rescue medication if fasting glucose was >10 mmol/l; data from patients receiving rescue medication were excluded from the primary analysis. Baseline HbA_1c averaged 8.4±0.1% in patients randomized to vildagliptin and 8.8±0.1% in those randomized to metformin. The adjusted mean change from baseline to study endpoint was −1.0±0.1% in vildagliptin-treated patients and −1.5±0.1% in those receiving metformin (p1c over 2 years in drug-naïve patients with type 2 diabetes. Vildagliptin was weight neutral, while weight loss was observed with metformin; however, metformin was associated with significantly worse gastrointestinal tolerability.