Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used

Paul Norwood, Roger Chen, Elmar Jaeckel, Ildiko Lingvay, Henrik Jarlov, Lucine Lehmann, Simon Heller

The rates of hypoglycaemia reported in clinical trials are affected by the definitions of hypoglycaemia used. This post-hoc analysis took data from two trials comparing the once-daily, fixed ratio combination of insulin degludec/liraglutide (IDegLira) with basal insulin regimens, and re-analysed these data using alternative hypoglycaemia definitions and stratified outcomes by dosing time and baseline characteristics. Post hoc analyses of the DUAL I (patients uncontrolled on oral antidiabetic drugs) and DUAL V (patients uncontrolled on insulin glargine (IGlar) U100) trials were carried out using different definitions of hypoglycaemia and by whether treatments were administered in the AM or PM. Rates of hypoglycaemia for the definitions of confirmed and ADA-documented symptomatic hypoglycaemia were compared according to age, gender and BMI. Although hypoglycaemia rates differed with the alternative hypoglycaemia definitions, rates were consistently lower with IDegLira versus IDeg and IGlar U100. Despite HbA1c being lower with IDegLira at end of treatment, confirmed and nocturnal-confirmed hypoglycaemia rates were lower for IDegLira versus IDeg and IGlar U100, irrespective of dosing time. The definitions of confirmed and ADA documented symptomatic hypoglycaemia did not have a significant effect on the treatment difference between IDegLira and IDeg, liraglutide or IGlar U100 when further assessed by baseline age, gender and BMI. Treatment with IDegLira, versus IDeg and IGlar U100, resulted in lower rates of hypoglycaemia regardless of dosing time and definition of hypoglycaemia used. The choice of hypoglycaemia definition did not influence the results of analyses when stratified by age, sex and BMI.