Vildagliptin dose-dependently improves glycemic control in Japanese patients with type 2 diabetes mellitus

ObjectiveTo assess the efficacy and tolerability of vildagliptin (10, 25 or 50 mg bid) in Japanese patients with type 2 diabetes mellitus (T2DM).MethodsThis 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study was performed in 291 patients. The primary assessment was change from baseline to endpoint in HbA1c.ResultsBaseline HbA1c averaged 7.4%, and the between-treatment difference (vildagliptin–placebo) in the HbA1c adjusted mean change was −0.8%, −1.0% and −1.2% with vildagliptin 10, 25 and 50 mg bid, respectively (p < 0.001). Relative to baseline, body weight did not change significantly in vildagliptin groups. There was no increase in incidence of adverse events in the vildagliptin groups (62.0%, 62.5% and 61.8%, 10, 25 and 50 mg bid, respectively) compared to placebo (73.6%). No deaths or drug-related serious adverse events were reported. Seven hypoglycemic events were observed (four events (n = 3), two events (n = 2), and one event (n = 1) in the vildagliptin 10 and 50 mg bid, and placebo, respectively) and none of them were severe or dose related.ConclusionVildagliptin 50 mg bid was considered to be the most effective and well-tolerated dose, and therefore can be considered the recommended clinical dose for Japanese patients with T2DM.