Saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin with or without metformin: Results from the SUPER study, a randomized, double-blind, placebo-controlled trial

This prospective, multicentre, phase III study (NCT02104804) evaluated the efficacy and safety of saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin +/- metformin. Patients with glycated haemoglobin (HbA1c) 7.5% to 10.5% and fasting plasma glucose (FPG) <15 mmol/L (270mg/dL) on stable insulin therapy (20-150U/d) were randomized (1:1) to saxagliptin 5 mg once daily (N=232) or placebo (N=230) for 24weeks, stratified by metformin use. The primary efficacy measure was change in HbA1c. Saxagliptin treatment resulted in a greater adjusted mean change in HbA1c from baseline to week 24 than placebo (-0.58%; P<.001), irrespective of metformin use, and a greater mean change in FPG (0.9 mmol/L [-15.9 mg/dL]; P<.001). More patients achieved HbA1c <7% with saxagliptin (11.4%) than with placebo (3.5%, P=.002). Adverse events and incidence of hypoglycaemia were similar in both groups. Overall, add-on saxagliptin 5 mg once daily significantly improved glycaemic control without increasing hypoglycaemia risk and was well tolerated in Chinese patients with type 2 diabetes inadequately controlled by insulin (+/- metformin).