Randomized, double‐blind, placebo‐controlled trial of the once‐daily GLP ‐1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea ( GetGoal ‐L‐Asia)

Aims To assess the efficacy and safety of once‐daily lixisenatide versus placebo in Asian patients with type 2 diabetes insufficiently controlled on basal insulin ± sulfonylurea. Methods In this 24‐week, randomized, double‐blind, placebo‐controlled, parallel‐group, multicentre study, participants (mean baseline HbA 1c 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily. The primary endpoint was HbA 1c change from baseline to week 24. Results Once‐daily lixisenatide significantly improved HbA 1c versus placebo ( LS mean difference vs. placebo = −0.88% [95% CI = −1.116, −0.650]; p < 0.0001), and allowed more patients to achieve HbA 1c <7.0% (35.6 vs. 5.2%) and ≤6.5% (17.8 vs. 1.3%). Lixisenatide also significantly improved 2‐h postprandial plasma glucose and glucose excursion, average 7‐point self‐monitored blood glucose and fasting plasma glucose. Lixisenatide was well tolerated; 86% of patients on lixisenatide completed the study versus 92% on placebo. Ten (6.5%) lixisenatide and 9 (5.7%) placebo patients experienced serious adverse events. More lixisenatide patients [14 (9.1%)] discontinued for adverse events versus placebo [5 (3.2%)], mainly with gastrointestinal causes. Nausea and vomiting were reported in 39.6 and 18.2% of patients on lixisenatide versus 4.5 and 1.9% on placebo. Symptomatic hypoglycaemia was more frequent with lixisenatide (42.9%) versus placebo (23.6%), but was similar between groups (32.6 vs. 28.3%, respectively), in those not receiving sulfonylureas. No severe hypoglycaemia was reported. Conclusions In an Asian type 2 diabetes population insufficiently controlled by basal insulin ± sulfonylurea, once‐daily lixisenatide significantly improved glycaemic control, with a pronounced postprandial effect, and was well tolerated.