Aim: To investigate the efficacy and tolerability of vildagliptin as add-on therapy to metformin in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.
Methods: This was a 24-week, randomized, double-blind, placebo-controlled study. Patients with T2DM (N = 438) with haemoglobin A1c (HbA1c) of 7.0-10.0% and fasting plasma glucose (FPG) <15 mmol/l (<270 mg/dl) were randomized (1 : 1 : 1) to vildagliptin 50 mg bid, vildagliptin 50 mg qd or placebo in addition to metformin.
Results: The treatment groups were well balanced at baseline [mean HbA1c, 8.0%, FPG, 8.8 mmol/l (158 mg/dl); body mass index, 25.5 kg/m(2) ]. The adjusted mean change (AMΔ) in HbA1c at endpoint was -1.05 ± 0.08%, -0.92 ± 0.08% and -0.54 ± 0.08% in patients receiving vildagliptin 50 mg bid, 50 mg qd and placebo, respectively. The between-treatment difference (vildagliptin 50 mg bid-placebo) was -0.51 ± 0.11%, p < 0.001. A greater proportion of vildagliptin-treated patients met at least one responder criterion (82.1 and 70.7%) compared to placebo-treated patients (60.4%). The AMΔ at endpoint for FPG with vildagliptin 50 mg bid, -0.95 mmol/l (-17.1 mg/dl); 50 mg qd, -0.84 mmol/l (-15.1 mg/dl) was significantly different compared with the placebo -0.26 mmol/l (-4.68 mg/dl) (p ≤ 0.001). Adverse events (AEs) were reported as 34.2, 36.5 and 37.5% for patients receiving vildagliptin 50 mg bid, 50 mg qd or placebo, respectively. Two patients in the vildagliptin 50 mg qd and one in the placebo group reported serious AEs, which were not considered to be related to the study drug; one incidence of hypoglycaemic event was reported in the vildagliptin 50 mg bid group.
Conclusion: Vildagliptin as add-on therapy to metformin improved glycaemic control and was well tolerated in Chinese patients who were inadequately controlled by metformin only.
© 2012 Blackwell Publishing Ltd.