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

Abstract

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.

• Authors: Denis Raccah, Pierre Gourdy, Luc Sagnard, Antonio Ceriello
• Journal: Diabetes/metabolism research and reviews (Diabetes Metab Res Rev) Vol. 30 Issue 8 Pg. 742-8 (Nov 2014) ISSN: 1520-7560 [Electronic] England
• PMID: 24687427 (Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons, Ltd.

Chemical References

• GLP1R protein, human
• Glucagon-Like Peptide-1 Receptor
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Peptides
• Receptors, Glucagon
• Sulfonylurea Compounds
• Thiazolidinediones
• hemoglobin A1c protein, human
• lixisenatide
• Metformin
• Pioglitazone

Topics

• Administration, Oral
• Clinical Trials, Phase III as Topic
• Combined Modality Therapy (adverse effects)
• Diabetes Mellitus, Type 2 (blood, complications, drug therapy, metabolism)
• Drug Administration Schedule
• Drug Resistance, Multiple
• Drug Therapy, Combination (adverse effects)
• Glucagon-Like Peptide-1 Receptor
• Glycated Hemoglobin (analysis)
• Humans
• Hyperglycemia (prevention & control)
• Hypoglycemia (chemically induced)
• Hypoglycemic Agents (administration & dosage, adverse effects, therapeutic use)
• Metformin (administration & dosage, adverse effects, therapeutic use)
• Multicenter Studies as Topic
• Overweight (chemically induced, complications, prevention & control)
• Peptides (administration & dosage, adverse effects, therapeutic use)
• Pioglitazone
• Randomized Controlled Trials as Topic
• Receptors, Glucagon (agonists, metabolism)
• Sulfonylurea Compounds (administration & dosage, adverse effects, therapeutic use)
• Thiazolidinediones (administration & dosage, adverse effects, therapeutic use)