Vildagliptin as add‐on therapy to insulin improves glycemic control without increasing risk of hypoglycemia in A sian, predominantly C hinese, patients with type 2 diabetes mellitus

Background The aim of the present study was to investigate the efficacy and safety of vildagliptin added onto insulin with or without metformin in an A sian, predominantly C hinese, population with type 2 diabetes mellitus ( T2DM ). Methods In this 24‐week, multicenter, double‐blind, placebo‐controlled trial, patients with T2DM inadequately controlled ( HbA1c 7.5%–11.0%) on stable therapy with long‐acting, intermediate‐acting, or premixed insulin, with or without concomitant metformin, were randomized to receive vildagliptin 50 mg b.i.d. or placebo. Results Of 293 patients randomized, 146 received vildagliptin and 147 received placebo treatment. At baseline, the overall mean age of patients was 58.1 years, mean T2DM duration was 11.3 years, and mean HbA1c was 8.7%. The adjusted mean (± SE ) change in HbA1c at Week 24 in the vildagliptin and placebo groups was −1.08 ± 0.12% and −0.38 ± 0.12%, respectively (between‐treatment difference −0.70 ± 0.16%; P  < 0.001). The between‐group difference in fasting plasma glucose was −0.43 ± 0.38 mmol/L ( P  = 0.259). Significantly, more patients achieved HbA1c <7.0% with vildagliptin than with placebo (23.6% vs 11.2%; P  = 0.006). The incidence of adverse events in the vildagliptin and placebo groups was 43.8% and 46.3%, whereas that of serious adverse events was 3.4% and 6.8%, respectively. The frequency of hypoglycemia was lower in the vildagliptin than placebo group (2.7% vs 5.4%). Conclusion The addition of vildagliptin 50 mg b.i.d. significantly improved glycemic control without an increased risk of hypoglycemia in A sian, predominantly C hinese, patients with T2DM inadequately controlled on insulin, with or without metformin.