Efficacy and safety of lixisenatide in Japanese patients with type 2 diabetes mellitus inadequately controlled by sulfonylurea with or without metformin: Subanalysis of GetGoal‐S. Issue 2 (24th September 2014)

• Record Type: Journal Article
• Authors: Onishi, Yukiko; Niemoeller, Elisabeth; Ikeda, Yukio; Takagi, Hiroki; Yabe, Daisuke; Seino, Yutaka
• Is Part Of: Journal of diabetes investigation. Volume 6:Issue 2(2015:Apr.)
• Page Start: 201
• Page End: 209
• Publication Date: 2014-09-24
• Subjects: Diabetes -- Periodicals; Diabetes -- Research -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1111/jdi.12275
• Languages: English
• ISSNs: 2040-1116

Abstract

<abstract abstract-type="main" id="jdi12275-abs-0001"> <title>Abstract</title> <sec id="jdi12275-sec-0001" sec-type="section"> <title>Aims/Introduction</title> <p>This was a subanalysis of Japanese patients included in the glucagon‐like peptide‐1 receptor agonist AVE0010 in patients with type 2 diabetes mellitus for glycemic control and safety evaluation (GetGoal‐S) study – a 24‐week, randomized, placebo‐controlled study of lixisenatide in patients with type 2 diabetes mellitus inadequately controlled by sulfonylurea with or without metformin.</p> </sec> <sec id="jdi12275-sec-0002" sec-type="section"> <title>Materials and Methods</title> <p>In GetGoal‐S, 127 Japanese patients received the once‐daily prandial glucagon‐like peptide‐1 receptor agonist lixisenatide 20 μg/day or a matching placebo. The primary outcome was change in glycated hemoglobin.</p> </sec> <sec id="jdi12275-sec-0003" sec-type="section"> <title>Results</title> <p>At week 24, lixisenatide significantly reduced mean glycated hemoglobin (least squares mean difference vs the placebo −1.1% [12 mmol/mol, <italic>P </italic>< 0.0001]), and significantly more lixisenatide patients reached glycated hemoglobin targets of <7% (53 mmol/mol) and ≤6.5% (48 mmol/mol) vs the placebo. Lixisenatide produced statistically significant reductions in 2‐h postprandial plasma glucose (least squares mean difference vs the placebo −8.51 mmol/L, <italic>P </italic>< 0.0001) and glucose excursion vs the placebo, and significantly reduced fasting plasma glucose (least squares mean difference vs the placebo −0.65 mmol/L, <italic>P </italic>= 0.0454). Bodyweight decreased with both lixisenatide and the placebo (least squares mean change −1.12 kg for lixisenatide, −1.02 kg for placebo). The overall incidence of adverse events was similar for lixisenatide and the placebo (84.2 and 82.4%, respectively), the most frequent being gastrointestinal disorders (52.6% for lixisenatide vs 29.4% for placebo). The incidence of symptomatic hypoglycemia was higher with lixisenatide vs the placebo (17.1 and 9.8%, respectively), with no cases of severe symptomatic hypoglycemia in either group.</p> </sec> <sec id="jdi12275-sec-0004" sec-type="section"> <title>Conclusions</title> <p>In the Japanese subpopulation of the GetGoal‐S study, lixisenatide produced a significant and clinically relevant improvement in glycated hemoglobin, with a pronounced improvement in postprandial plasma glucose, and a good safety and tolerability profile.</p> </sec> </abstract>