This paper presents a summary of the Evidence Review Group (ERG) report into the clinical
effectiveness and cost-effectiveness of liraglutide in the treatment of type 2 diabetes mellitus,
based upon the manufacturer’s submission to the National Institute for Health and Clinical
Excellence (NICE) as part of the single technology appraisal (STA) process. The manufacturer
proposed the use of liraglutide as a second or third drug in patients with type 2 diabetes whose
glycaemic control was unsatisfactory with metformin, with or without a second oral glucoselowering
drug. The submission included six manufacturer-sponsored trials that compared the
efficacy of liraglutide against other glucose-lowering agents. Not all of the trials were relevant to the decision problem. The most relevant were Liraglutide Effects and Actions in Diabetes 5
(LEAD-5) (liraglutide used as part of triple therapy and compared against insulin glargine) and
LEAD-6 [liraglutide in triple therapy compared against another glucagon like peptide-1 (GLP-1)
agonist, exenatide]. Five of the six trials were published in full and one was then unpublished.
Two doses of liraglutide, 1.2 and 1.8 mg, were used in some trials but in the two comparisons
in triple therapy, against glargine and exenatide, only the 1.8-mg dose was used. Liraglutide
in both doses was found to be clinically effective in lowering blood glucose concentration
[glycated haemoglobin (HbA1c)], reducing weight (unlike other glucose-lowering agents, such
as sulphonylureas, glitazones and insulins, which cause weight gain) and also reducing systolic
blood pressure (SBP). Hypoglycaemia was uncommon. The ERG carried out meta-analyses
comparing the 1.2- and 1.8-mg doses of liraglutide, which suggested that there was no difference
in control of diabetes, and only a slight difference in weight loss, insufficient to justify the extra
cost
