Efficacy and tolerability of vildagliptin as an add-on to glimepiride in Japanese patients with Type 2 diabetes mellitus

Aim: To investigate the efficacy and tolerability of vildagliptin, a potent and selective dipeptidyl peptidase-4 inhibitor, as add-on to glimepiride in Japanese patients with Type 2 diabetes mellitus (T2DM) who were inadequately controlled. Methods: This 12-week, randomized, double-blind, placebo-controlled study compared vildagliptin 50 mg twice-daily (n = 102) with placebo (n = 100) when added to a stable dose of glimepiride (>= 1 mg/d). Results: Treatment groups were balanced at baseline (glycosylated hemoglobin [HbA(1c)], 7.9%; fasting plasma glucose, 163.8 mg/dL). During treatment HbA(1c) decreased progressively with vildagliptin, but remained unchanged with placebo. The adjusted mean change (AM Delta) at endpoint was -1.0 +/- 0.1 and -0.1 +/- 0.1% in vildagliptin- and placebo-treated patients (between-group Delta = -1.0 +/- 0.1%, P < 0.001). A greater proportion of vildagliptin-treated patients had HbA(1c) <= 6.5% compared to placebo-treated patients (45% vs. 3%, P < 0.001). The AM Delta FPG was -20.9 +/- 2.8 mg/dL with vildagliptin compared to 6.3 +/- 2.8 mg/dL with placebo (between-group Delta = -27.2 +/- 3.9 mg/dL, P < 0.001). Patients in vildagliptin and placebo groups reported similar incidences of adverse events (AEs) (59.8% vs. 57.0%), serious AEs (0% vs. 2.0%), suspected drug-related AEs (21.6% vs. 23.0%), and discontinuation due to AEs (1.0% vs. 3.0%). Hypogylcaemia was reported in two (vildagliptin) and one (placebo) patient. Conclusion: Vildagliptin is effective and well tolerated as an add-on to glimepiride in Japanese patients with T2DM. (C) 2010 Elsevier Ireland Ltd. All rights reserved.