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

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 (HbA(1c)) <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 HbA(1c) <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 HbA(1c) <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. (C) 2014 Published by Elsevier Inc.