Lixisenatide as add-on to oral anti-diabetic therapy: an effective treatment for glycaemic control with body weight benefits in type 2 diabetes.

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.