Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal‐P). Issue 11 (26th May 2013)

• Record Type: Journal Article
• Authors: Pinget, M.; Goldenberg, R.; Niemoeller, E.; Muehlen‐Bartmer, I.; Guo, H.; Aronson, R.
• Is Part Of: Diabetes, obesity & metabolism. Volume 15:Issue 11(2013:Nov.)
• Page Start: 1000
• Page End: 1007
• Publication Date: 2013-05-26
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12121
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12121-sec-0001" sec-type="section"> <title>Aims</title> <p>To compare the efficacy and safety of once‐daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin.</p> </sec> <sec id="dom12121-sec-0002" sec-type="section"> <title>Methods</title> <p>This randomized, double‐blind study included a 24‐week main treatment period and a ≥52‐week variable extension period. Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) at week 24.</p> </sec> <sec id="dom12121-sec-0003" sec-type="section"> <title>Results</title> <p>In total, 484 patients were randomized: 323 to lixisenatide; 161 to placebo. After 24 weeks, lixisenatide once daily significantly improved HbA1c (−0.56% vs. placebo; p < 0.0001) and increased the proportion of patients achieving HbA1c <7% compared with placebo (52.3% vs. 26.4%, respectively; p < 0.0001) and significantly improved fasting plasma glucose (−0.84 mmol/l vs. placebo; p < 0.0001). There was a small decrease in body weight with lixisenatide once daily and a small increase with placebo, with no statistically significant difference between the two groups. Overall, lixisenatide once daily was well tolerated, with a similar proportion of treatment‐emergent adverse events (TEAEs) and serious TEAEs between groups (lixisenatide: 72.4% and 2.5%; placebo: 72.7% and 1.9%). Symptomatic hypoglycaemia rates were also relatively low in both groups (lixisenatide 3.4% and placebo 1.2%), with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable extension period.</p> </sec> <sec id="dom12121-sec-0004" sec-type="section"> <title>Conclusions</title> <p>Lixisenatide once daily significantly improved glycaemic control with a low risk of hypoglycaemia, and was well tolerated over 24 weeks and during the long‐term, double‐blind extension period in patients with T2DM insufficiently controlled on pioglitazone ± metformin.</p> </sec> </abstract>