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). Issue 8 (November 2014)

• Record Type: Journal Article
• Authors: Yu Pan, Chang; Han, Ping; Liu, Xiaoming; Yan, Shengli; Feng, Ping; Zhou, Zhiguang; Lv, Xiaofeng; Tian, Hui; Jin Kui, Yang; Su, Benli; Shang, Shuhua; Niemoeller, Elisabeth
• Is Part Of: Diabetes/metabolism research and reviews. Volume 30:Issue 8(2014:Nov.)
• Page Start: 726
• Page End: 735
• Publication Date: 2014-11
• Subjects: Diabetes -- Periodicals; Metabolism -- Periodicals; 616.642
• DOI: 10.1002/dmrr.2541
• Languages: English
• ISSNs: 1520-7552

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="dmrr2541-sec-0001" sec-type="section"> <title>Background</title> <p>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.</p> </sec> <sec id="dmrr2541-sec-0002" sec-type="section"> <title>Methods</title> <p>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<sub>1c</sub>) from baseline to week 24.</p> </sec> <sec id="dmrr2541-sec-0003" sec-type="section"> <title>Results</title> <p>A total of 391 patients were randomized. Lixisenatide significantly reduced HbA<sub>1c</sub> levels compared with placebo (LS mean difference: −0.36%, <italic>p</italic> = 0.0004). A significantly higher proportion of lixisenatide‐treated patients achieved HbA<sub>1c</sub> targets of <7% (<italic>p</italic> = 0.003) and ≤6.5% (<italic>p</italic> = 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, <italic>p</italic> < 0.0001) and a significant reduction in fasting plasma glucose (<italic>p</italic> = 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; <italic>p</italic> = 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 (<italic>p</italic> = 0.1321), with no severe symptomatic hypoglycaemia events reported.</p> </sec> <sec id="dmrr2541-sec-0004" sec-type="section"> <title>Conclusions</title> <p>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. <italic>Diabetes/Metabolism Research and Reviews</italic> published by John Wiley & Sons, Ltd.</p> </sec> </abstract>