title: Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis.
abstract: OBJECTIVE
  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.
authors.affiliation: Centre Hospitalier Universitaire de Nantes, Nantes, France. Electronic address: Bernard.charbonnel@univ-nantes.fr.
authors.forename: Bernard
authors.initials: B
authors.lastname: Charbonnel
authors.affiliation: Sanofi, Paris, France.
authors.forename: Monica
authors.initials: M
authors.lastname: Bertolini
authors.affiliation: CIBER de Fisiopatalogía de la Obesidad y Nutrición (CIBEROBN), Insituto de Salud Carlos III, and Hospital Virgen de la Victoria, Malaga, Spain.
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Tinahones
authors.affiliation: Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.
authors.forename: Manuel Puig
authors.initials: MP
authors.lastname: Domingo
authors.affiliation: Diabetes Research Centre, University of Leicester, Leicester, UK.
authors.forename: Melanie
authors.initials: M
authors.lastname: Davies
mesh_terms: D000284:Administration, Oral; D000368:Aged; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D016896:Treatment Outcome; D000067758:Glucagon-Like Peptide-2 Receptor
chemical_list: D007004:Hypoglycemic Agents; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting; D010455:Peptides; C479460:lixisenatide; D000067758:Glucagon-Like Peptide-2 Receptor
keywords: Basal insulin; Combination; Lixisenatide; Meta-analysis; Prandial