Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis.
journal contributionposted on 17.01.2017, 15:37 by B. Charbonnel, M. Bertolini, F. J. Tinahones, M. P. Domingo, Melanie Davies
AIMS: The efficacy of the once-daily prandial GLP-1 receptor agonist lixisenatide plus basal insulin in T2DM was assessed by pooling results of phase III trials. METHODS: A meta-analysis was performed of results from three trials in the GetGoal clinical program concerning lixisenatide or placebo plus basal insulin with/without OADs. The primary endpoint was change in HbA1c from baseline to week 24. Secondary endpoints were change in PPG, FPG, insulin dose, and weight from baseline to week 24. Hypoglycemia rates and several composite endpoints were assessed. RESULTS: Lixisenatide plus basal insulin was significantly more effective than basal insulin alone at reducing HbA1c at 24 weeks. Composite and secondary endpoints were improved significantly with lixisenatide plus basal insulin, with the exception of FPG, which showed no significant difference between the groups. Lixisenatide plus basal insulin was associated with an increased incidence of hypoglycemia versus basal insulin alone. CONCLUSIONS: Lixisenatide plus basal insulin resulted in significant improvement in glycemic control versus basal insulin alone, particularly in terms of controlling PPG. Prandial lixisenatide in combination with basal insulin is a suitable option for treatment intensification in patients with T2DM insufficiently controlled with basal insulin, as these agents have complementary effects on PPG and FPG, respectively.
This meta-analysis was sponsored by Sanofi. Editorial assistance was provided by Jane Bryant, PhD, of Caudex Medical and was funded by Sanofi.
CitationJournal of Diabetes and its Complications, 2014, 28 (6), pp. 880-886
Author affiliation/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Cardiovascular Sciences
VersionVoR (Version of Record)
Published inJournal of Diabetes and its Complications
NotesClinicalTrials.gov identifier: for each of the trials included in the meta-analysis: GetGoal-Duo1, NCT00975286; GetGoal-L, NCT00715624; GetGoal-L-Asia, NCT00899958.
Basal insulinCombinationLixisenatideMeta-analysisPrandialAdministration, OralAgedClinical Trials, Phase III as TopicDiabetes Mellitus, Type 2Drug Therapy, CombinationFemaleHumansHypoglycemic AgentsInsulin DetemirInsulin, Long-ActingMaleMiddle AgedPeptidesRandomized Controlled Trials as TopicTreatment Outcome