Pharmacokinetic Properties of Once‐Weekly Insulin Icodec in Children and Adolescents With Type 2 Diabetes

Background: Young people with type 2 diabetes (T2D) often need basal insulin for diabetes management. Insulin icodec is a novel basal insulin designed for once‐weekly administration. Methods: This study investigated the pharmacokinetic properties of icodec in children and adolescents with T2D aged 10 to < 18 years. Eighteen insulin‐treated (daily basal insulin dose ≥ 0.2 U/kg) participants (11 females/7 males; mean ± standard deviation body mass index 38.5 ± 7.1 kg/m 2 , HbA 1c 7.5 ± 1.3%) received a single subcutaneous injection of icodec (5.6 U/kg). Blood samples for pharmacokinetic analysis were drawn frequently until 35 days postinjection. Observed single‐dose pharmacokinetic profiles were extrapolated to steady state using pharmacokinetic modeling. Results: One‐week icodec pharmacokinetic profiles observed after a single dose and extrapolated to steady state suggest that icodec exposure covers the full weekly dosing interval in children and adolescents with T2D. After a single dose, geometric mean total exposure was 819∙10 5 pmol∙h/L [coefficient of variation (CV) 28.2%] and maximum concentration ( C max ) was 4.22∙10 5 pmol/L (CV 25.8%). Median time to maximum concentration ( t max ) was 21 h (range 12–27 h). When extrapolated to steady state, geometric mean total exposure was 771∙10 5 pmol∙h/L (CV 29.9%) and maximum concentration was 6.35∙10 5 pmol/L (CV 27.3%). Median t max was 15 h (range 13–19 h). In total, six adverse events (AEs) were reported in two participants. All AEs were mild and recovered/resolved. No serious or severe AEs, hypersensitivity or injection site reactions, or hyperglycemic episodes (plasma glucose > 14.0 mmol/L and blood ketones > 1.5 mmol/L) were reported. One level 1 hypoglycemic episode (plasma glucose < 3.9 and ≥ 3.0 mmol/L) was reported. Conclusion: Icodec was safe and well‐tolerated in the current study in children and adolescents with T2D. The pharmacokinetic properties of icodec support its potential for once‐weekly administration in children and adolescents with T2D. Trial Registration: ClinicalTrials.gov identifier: NCT05790681