Once-daily prandial lixisenatide versus once-daily rapid-acting insulin in patients with type 2 diabetes mellitus insufficiently controlled with basal insulin: analysis of data from five randomized, controlled trials

J Diabetes Complications. 2014 Jan-Feb;28(1):40-4. doi: 10.1016/j.jdiacomp.2013.10.003. Epub 2013 Oct 14.

Abstract

Aims: To compare the efficacy and safety of lixisenatide (LIXI), a once-daily prandial glucagon-like peptide-1 (GLP-1) receptor agonist, as add-on to basal insulin (Basal+LIXI) versus once-daily rapid-acting insulin (Basal+RAI) in patients with type 2 diabetes mellitus (T2DM).

Methods: Data were extracted from five randomized controlled trials assessing the efficacy and safety of basal insulin+insulin glulisine (n=3) or basal insulin+LIXI (n=2). Patients in the Basal+LIXI cohort were matched to patients in the Basal+RAI cohort using propensity score matching.

Results: In the matched population, Basal+LIXI was twice as likely to reach composite outcomes of glycated haemoglobin (HbA1c) <7% and no symptomatic hypoglycaemia compared with the Basal+RAI group (odds ratio [OR]: 1.90; 95% confidence interval [CI]: 1.01, 3.55; P=0.0455), as well as HbA1c <7% and no severe hypoglycaemia (OR: 1.97; 95 CI: 1.06, 3.66; P=0.0311). Furthermore, Basal+LIXI was more than twice as likely to reach HbA1c <7%, no weight gain and no symptomatic hypoglycaemia (OR: 2.58; 95% CI: 1.23, 5.40; P=0.0119).

Conclusions: Both basal+LIXI and Basal+RAI improved glycaemic control in patients with T2DM with inadequate glycaemic control on basal insulin. Basal+LIXI offers an effective therapeutic option to advance basal insulin therapy, improving glucose control without weight gain and with less risk of hypoglycaemia than prandial insulin.

Keywords: Basal insulin; Basal+RAI; GLP-1 receptor agonist; Lixisenatide.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Case-Control Studies
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / epidemiology
  • Drug Administration Schedule
  • Female
  • Glycated Hemoglobin / metabolism
  • Humans
  • Insulin Detemir
  • Insulin, Long-Acting / therapeutic use*
  • Insulin, Short-Acting / administration & dosage*
  • Male
  • Meals
  • Middle Aged
  • Peptides / administration & dosage*
  • Randomized Controlled Trials as Topic
  • Treatment Failure

Substances

  • Glycated Hemoglobin A
  • Insulin, Long-Acting
  • Insulin, Short-Acting
  • Peptides
  • hemoglobin A1c protein, human
  • Insulin Detemir
  • lixisenatide