Background: Achieving recommended glycated haemoglobin (HbA1c ) 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 HbA1c 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 HbA1c 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.
Keywords: glycaemic control; lixisenatide; oral anti-diabetics; prandial; type 2 diabetes mellitus.
© 2014 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons, Ltd.