Author(s): Pinget M, Goldenberg R, Niemoeller E, MuehlenBartmer I, Guo H,
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Abstract AIMS: To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT00763815. © 2013 John Wiley & Sons Ltd.
This article was published in Diabetes Obes Metab
and referenced in Journal of Developing Drugs