Endocrine Abstracts

Introduction: To systematically evaluate the study designs and the outcomes being analysed in the ongoing trials evaluating the efficacy and safety of Insulin Glargine 300 U/ml with insulin degludec

Methods: We reviewed contemporary protocols of trials that are currently ongoing through WHO-ICTRP (www.who.int/ictrp/search/en), www.clinicaltrials.gov trials registry database. Latest evaluation was on January 28, 2022 with key word ‘insulin galrgaine U 300’, degludec, for the trials initiated over the last two years (2019-2021). Two researchers independently extracted the protocols and analysed the outcomes.

Results: We evaluated clinical parameters to improve metabolic control and lower risk of hypoglycaemia. We analysed the protocols of the six ongoing trials including, the landmark trials namely PREMIER INSULIN (perioperative non-ICU, n=180), ULTRAFLEXI1 (T1DM) are cumulatively recruiting 1416 patients; across Japan (4 trials) and Austria (1 trial) and 1 trial as global multicentric (North America and Europe). The study designs include randomised, parallel, cross-over, designed studies. Three trials are evaluating the comparative efficacy patients in T1DM (n=110) and other three in T2DM (n=1306). Insulin glargine U300 along with insulin degludec is being compared with Insulin icodec - a novel once-weekly basal insulin analog. The comparative trials include age range from 7 to 90 years, including a dedicated trial in elderly (n=30). The mean number of participants being enrolled is 236 (SD ± 425, maximum 1096, minimum 25, 95% CI -210 to 682). The trial duration range from 1 day in post-operative non-ICU setting to 52 weeks. Trials evaluate the glycemic control (HbA1c), time spent in hypoglycaemia in post exercise regimen, mean amplitude of glycemic excursion, nocturnal glucose fluctuation index by flash glucose monitoring, and frequency of hypoglycemia.

Conclusion: We evaluated emerging outcomes based on clinical, comparative glycemic indices including CGM based precise evaluation parameters, qualitative non-glycemic and quality of life parameters, patient reported outcome comparing Insulin glargine U300 with insulin degludec.