Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double‐blind, placebo‐controlled, 24‐week trial (GetGoal‐M‐Asia)

Background This study assessed the efficacy and safety of the once‐daily glucagon‐like peptide‐1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea. Methods In this 24‐week, double‐blind, placebo‐controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo. The primary endpoint was absolute change in glycated haemoglobin (HbA 1c ) from baseline to week 24. Results A total of 391 patients were randomized. Lixisenatide significantly reduced HbA 1c levels compared with placebo (LS mean difference: −0.36%, p  = 0.0004). A significantly higher proportion of lixisenatide‐treated patients achieved HbA 1c targets of <7% ( p  = 0.003) and ≤6.5% ( p  = 0.001) versus placebo. Lixisenatide was associated with a statistically significant reduction in 2‐h postprandial plasma glucose after a standardized breakfast versus placebo (LS mean difference: −4.28 mmol/L, p  < 0.0001) and a significant reduction in fasting plasma glucose ( p  = 0.0109). There was no difference in weight loss versus placebo, with a modest reduction in body weight reported for both groups (lixisenatide: −1.50 kg, placebo: −1.24 kg; p  = 0.296). The incidence of treatment‐emergent adverse events (TEAEs) was 64.3% with lixisenatide versus 47.4% with placebo, with serious TEAEs reported in 1.5% versus 2.1% of patients, respectively. The most common TEAE in the lixisenatide group was nausea (16.3% vs 2.6% with placebo). The incidence of symptomatic hypoglycaemia was 5.6% with lixisenatide treatment and 2.6% with placebo ( p  = 0.1321), with no severe symptomatic hypoglycaemia events reported. Conclusions In Asian patients with type 2 diabetes mellitus insufficiently controlled on metformin ± sulfonylurea, lixisenatide significantly improved glycaemic control and was well tolerated during the 24‐week study. © 2014 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons, Ltd.