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)
Diabetes, Obesity and Metabolism, 09/28/2012
Seino Y et al. – 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.
- In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline
HbA1c8.53%) 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
HbA1cchange from baseline to week 24.
- Once-daily lixisenatide significantly improved
HbA1cversus placebo ( LSmean difference vs. placebo = -0.88% [95% CI= -1.116, -0.650]; p < 0.0001), and allowed more patients to achieve HbA1c<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.