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

AimTo 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.MethodsThis 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).ResultsTreatment groups were balanced at baseline (glycosylated hemoglobin [HbA1c], 7.9%; fasting plasma glucose, 163.8 mg/dL). During treatment HbA1c decreased progressively with vildagliptin, but remained unchanged with placebo. The adjusted mean change (AMΔ) at endpoint was −1.0 ± 0.1 and −0.1 ± 0.1% in vildagliptin- and placebo-treated patients (between-group Δ = −1.0 ± 0.1%, P < 0.001). A greater proportion of vildagliptin-treated patients had HbA1c ≤6.5% compared to placebo-treated patients (45% vs. 3%, P < 0.001). The AMΔ FPG was −20.9 ± 2.8 mg/dL with vildagliptin compared to 6.3 ± 2.8 mg/dL with placebo (between-group Δ = −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.ConclusionVildagliptin is effective and well tolerated as an add-on to glimepiride in Japanese patients with T2DM.