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Lixisenatide as add‐on to oral anti‐diabetic therapy: an effective treatment for glycaemic control with body weight benefits in type 2 diabetes
Author(s) -
Raccah Denis,
Gourdy Pierre,
Sagnard Luc,
Ceriello Antonio
Publication year - 2014
Publication title -
diabetes/metabolism research and reviews
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.307
H-Index - 110
eISSN - 1520-7560
pISSN - 1520-7552
DOI - 10.1002/dmrr.2548
Subject(s) - lixisenatide , medicine , placebo , type 2 diabetes , clinical endpoint , diabetes mellitus , type 2 diabetes mellitus , meta analysis , odds ratio , randomized controlled trial , endocrinology , exenatide , alternative medicine , pathology
Background Achieving recommended glycated haemoglobin (HbA 1c ) targets in patients with type 2 diabetes mellitus (T2DM) requires effective control of fasting and post‐prandial plasma glucose. As T2DM progresses, oral anti‐diabetics are no longer sufficient to maintain glycaemic control. Five phase III studies in the GetGoal clinical trial programme assessed the efficacy of lixisenatide, a once‐daily prandial glucagon‐like peptide‐1 receptor agonist, in combination with oral anti‐diabetics in patients with T2DM insufficiently controlled using oral anti‐diabetics. Methods A meta‐analysis was performed of the results of five 24‐week clinical trials (comprising 2760 patients) concerning lixisenatide or placebo plus oral anti‐diabetic therapy. The primary endpoint of these studies was change in HbA 1c at week 24. Changes in fasting and post‐prandial plasma glucose, and weight were also established as were the odds ratios for hypoglycaemia and composite safety and efficacy endpoints. Meta‐analysis outcomes were assessed using a random effects model. All meta‐analyses were performed using RevMan, version 5.1. Results Lixisenatide was significantly better than placebo in terms of achieving all endpoints in this meta‐analysis, including the primary endpoint change in HbA 1c at week 24, with p < 0.0001 for all endpoints. The mean number of symptomatic hypoglycaemic events per patient year was increased for patients in the lixisenatide versus placebo groups ( p = 0.04). However, compared with patients in the placebo group, patients treated with lixisenatide were more likely to achieve composite efficacy and safety endpoints. Conclusions This meta‐analysis demonstrates that lixisenatide in combination with oral anti‐diabetic therapy significantly improves outcomes combining efficacy and safety parameters in patients with T2DM. © 2014 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons, Ltd.