Vildagliptin added to sulfonylurea improves glycemic control without hypoglycemia and weight gain in Chinese patients with type 2 diabetes mellitus 中国2型糖尿病患者使用磺脲类药物联合维格列汀可改善血糖控制且无低血糖及体重增加

Objective The aim of the present study was to assess the efficacy and safety of vildagliptin as add-on to sulfonylurea therapy in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy. Methods The 24-week randomized double-blind placebo-controlled study compared vildagliptin 50 mg, q.d., with placebo as add-on to glimepiride in T2DM patients who were inadequately controlled (HbA1c 7.5%–11.0% [58–97 mmol/mol]) on a stable dose of sulfonylurea for ≥12 weeks before study entry. Results In all, 279 patients were randomized to receive either vildagliptin (n = 143) or placebo (n = 136). At baseline, overall mean age was 58.5 years, body weight 68.1 kg, duration of diabetes 6.9 years and daily glimepiride dose 3.3 mg. After 24 weeks, the adjusted mean change (AMΔ) in HbA1c was −0.7% (−8 mmol/mol; baseline 8.6%, 70 mmol/mol) in the vildagliptin group and −0.2% (−2 mmol/mol; baseline 8.7%, 72 mmol/mol) in the placebo group, with a treatment difference of −0.5% (−5 mmol/mol; P < 0.001). The between-group difference in AMΔ in fasting plasma glucose was −0.4 mmol/L (P = 0.160). There was a slight, but not significant, decrease in body weight in both groups. No hypoglycemic events were reported in either group, including those patients reaching HbA1c <7.0%. Patients in the vildagliptin and placebo groups reported low and comparable incidences of adverse events (14.0% vs 17.8%) and serious adverse events (0.7% in each group). Conclusion Vildagliptin 50 mg, q.d., added to sulfonylurea monotherapy is effective in Chinese patients with T2DM, without increasing the risk of hypoglycemia and weight gain.