Efficacy and safety of switching to insulin icodec, a once-weekly basal insulin, vs insulin glargine U100 in patients with type 2 diabetes inadequately controlled on OADs and basal insulin

Background Insulin icodec (icodec) is a novel basal insulin analogue in development as the first once-weekly insulin. Methods This 16-week phase 2 trial compared the efficacy and safety of once-weekly icodec with and without a loading dose (LD) vs once-daily IGlar U100 in patients with T2D insufficiently controlled (HbA1c 7.0-10.0%) with oral antidiabetic drugs and once/twice-daily insulin. Insulin doses were titrated weekly to a target of 4.4-7.2 mmol/L The primary endpoint was time in range (TIR) 3.9-10.0 mmol/L (based on continuous glucose monitoring (Dexcom G6®​) during weeks 15 and 16. Secondary endpoints included HbA1c and hypoglycaemic episodes. Results Patients (N=154) were randomized 1:1:1 to icodec + LD (n=54), icodec (n=50) or IGlar U100 (n=50). TIR (weeks 15 and 16) was statistically significantly greater for icodec + LD than for IGlar U100 (72.9 vs 65.0%, estimated treatment difference [ETD]: 7.88%; p=0.01) and similar between icodec and IGlar U100. For icodec + LD, icodec and IGlar U100, respectively, the estimated mean changes from baseline in HbA1c were: -0.77, -0.47 and -0.54%-points. Observed rates of combined level 2 (<3 mmol/L or < 54 mg/dL) and 3 (severe) hypoglycaemia were similar between icodec + LD and IGlar, and numerically lower for icodec. Conclusion Switching to once-weekly insulin icodec was well tolerated and efficacious. Switching to icodec with a loading dose resulted in significantly more “time in range” without an increased risk of clinically significant hypoglycaemia vs IGlar U100. Publication History Article published online: 26 May 2022 © 2022. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany