Lixisenatide is a novel glucagon-like peptide 1 receptor agonist (GLP-1RA) recently licensed in the UK for use in adults with type 2 diabetes, in combination with oral glucose-lowering drugs and /or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. The approval was based on results from the GetGoal clinical programme, which included 11 clinical trials involving more than 5000 patients with type 2 diabetes. Although two other GLP-1RAs are also currently licensed in the UK (exenatide and liraglutide), neither is currently licensed for use in addition to insulin therapy.
The purpose of the current double-blind, placebo-controlled study (n=495) was to examine the efficacy and safety of adding once-daily lixisenatide (20mcg) to established basal insulin therapy ± metformin in people with long-standing type 2 diabetes and inadequate glycaemic control (mean baseline HbA1c of 8.4%). The placebo-corrected change in HbA1c from randomisation to week 24 (primary endpoint) was –0.4% (95% CI –0.6 to –0.2; P=0.0002).
The study addressed a challenging population for which improving glycaemic control may be expected to be difficult. The authors comment that their findings are consistent with those seen for exenatide and liraglutide, and that collectively the studies support the efficacy and safety of combining a GLP-1RA with basal insulin.
The authors acknowledge that the study was limited by the lack of comparison of lixisenatide with other possible ways of intensifying treatment with basal insulin and metformin (e.g. prandial insulin), and that longer-term follow-up of this treatment approach is required. They say that further studies are needed to directly compare lixisenatide with exenatide or liraglutide in combination with basal insulin.
NICE recently published a new medicines evidence summary on lixisenatide – please click on link for information.