A randomized controlled trial of the efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes and inadequate glycaemic control on metformin plus a sulphonylurea

Aims To evaluate the efficacy and safety of saxagliptin as add‐on therapy in adults with type 2 diabetes with inadequate glycaemic control on metformin plus a sulphonylurea. Methods In this 24‐week, multicentre, randomized, parallel‐group, double‐blind study, outpatients aged ≥18 years with type 2 diabetes, body mass index ≤40 kg/m2 and inadequate glycaemic control, received saxagliptin 5 mg or placebo once‐daily added to background medication consisting of a stable maximum tolerated dose of metformin plus a sulphonylurea. The primary end point was change in glycated haemoglobin (HbA1c) from baseline to week 24. Safety and tolerability assessments included adverse events (AEs), hypoglycaemia and body weight. Results A total of 257 patients were randomized, treated and included in the safety analysis (saxagliptin, n = 129; placebo, n = 128); 255 were included in the efficacy analysis (saxagliptin, n = 127; placebo, n = 128). HbA1c reduction was greater with saxagliptin versus placebo [between‐group difference in adjusted mean change from baseline, −0.66%; 95% confidence interval (CI), −0.86 to −0.47 (7 mmol/mol, −9.4 to −5.1); p