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Aim  The broadly used combination of metformin and sulphonylurea (SU) often fails to bring patients to glycaemic goal. This study assessed the efficacy and safety of vildagliptin as add‐on therapy to metformin plus glimepiride combination in patients with type 2 diabetes mellitus ( T2DM ) who had inadequate glycaemic control.    Methods  A multicentre, double‐blind, placebo‐controlled study randomized patients to receive treatment with vildagliptin 50 mg bid (n = 158) or placebo (n = 160) for 24 weeks.    Results  After 24 weeks, the adjusted mean change in haemoglobin A1c ( HbA1c ) was −1.01% with vildagliptin (baseline 8.75%) and −0.25% with placebo (baseline 8.80%), with a between‐treatment difference of −0.76% (p < 0.001). Significantly more patients on vildagliptin achieved the  HbA1c  target <7% (28.3% vs. 5.6%; p < 0.001). The difference in fasting plasma glucose reduction between vildagliptin and placebo was −1.13 mmol/l (p < 0.001). In subgroup of patients with baseline  HbA1c  ≤8%, vildagliptin reduced  HbA1c  by 0.74% from baseline 7.82% (between‐treatment difference: –0.97%; p < 0.001) with significantly more patients achieving the  HbA1c  target <7% (38.6% vs. 13.9%; p = 0.014). Vildagliptin was well tolerated with low incidence of hypoglycaemia, slightly higher than with placebo (5.1% vs. 1.9%) and no clinically relevant weight gain.    Conclusions  Vildagliptin significantly improved glycaemic control in patients with  T2DM  inadequately controlled with metformin plus glimepiride combination. The addition of vildagliptin was well tolerated with low risk of hypoglycaemia and weight gain. This makes vildagliptin an attractive treatment option for patients failing on metformin plus SU particularly in patients with baseline  HbA1c  ≤8%.

diabetes, obesity and metabolism

Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea