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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.
Diabetes Metab Res Rev. 2014 Nov; 30(8):742-8.DM

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+Show Affiliations

Department of Diabetology, University Hospital Sainte-Marguerite, Marseille, France.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24687427

Citation

Raccah, Denis, et al. "Lixisenatide as Add-on to Oral Anti-diabetic Therapy: an Effective Treatment for Glycaemic Control With Body Weight Benefits in Type 2 Diabetes." Diabetes/metabolism Research and Reviews, vol. 30, no. 8, 2014, pp. 742-8.
Raccah D, Gourdy P, Sagnard L, et al. Lixisenatide as add-on to oral anti-diabetic therapy: an effective treatment for glycaemic control with body weight benefits in type 2 diabetes. Diabetes Metab Res Rev. 2014;30(8):742-8.
Raccah, D., Gourdy, P., Sagnard, L., & Ceriello, A. (2014). Lixisenatide as add-on to oral anti-diabetic therapy: an effective treatment for glycaemic control with body weight benefits in type 2 diabetes. Diabetes/metabolism Research and Reviews, 30(8), 742-8. https://doi.org/10.1002/dmrr.2548
Raccah D, et al. Lixisenatide as Add-on to Oral Anti-diabetic Therapy: an Effective Treatment for Glycaemic Control With Body Weight Benefits in Type 2 Diabetes. Diabetes Metab Res Rev. 2014;30(8):742-8. PubMed PMID: 24687427.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lixisenatide as add-on to oral anti-diabetic therapy: an effective treatment for glycaemic control with body weight benefits in type 2 diabetes. AU - Raccah,Denis, AU - Gourdy,Pierre, AU - Sagnard,Luc, AU - Ceriello,Antonio, PY - 2013/12/27/received PY - 2014/02/18/revised PY - 2014/03/19/accepted PY - 2014/4/2/entrez PY - 2014/4/2/pubmed PY - 2015/7/15/medline KW - glycaemic control KW - lixisenatide KW - oral anti-diabetics KW - prandial KW - type 2 diabetes mellitus SP - 742 EP - 8 JF - Diabetes/metabolism research and reviews JO - Diabetes Metab. Res. Rev. VL - 30 IS - 8 N2 - 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. SN - 1520-7560 UR - https://www.unboundmedicine.com/medline/citation/24687427/Lixisenatide_as_add_on_to_oral_anti_diabetic_therapy:_an_effective_treatment_for_glycaemic_control_with_body_weight_benefits_in_type_2_diabetes_ L2 - https://doi.org/10.1002/dmrr.2548 DB - PRIME DP - Unbound Medicine ER -