Pharmacokinetic properties of once‐weekly insulin icodec in Chinese individuals with type 2 diabetes

Abstract

ABSTRACT Introduction Insulin icodec is a novel once‐weekly basal insulin developed for the treatment of diabetes. The aim of this study was to investigate the pharmacokinetics of icodec in Chinese individuals with type 2 diabetes. Materials and Methods In an open‐label, single‐group study, 24 Chinese individuals with type 2 diabetes (18–64 years, glycated hemoglobin ≤9.0%, body mass index 18.0–38.0 kg/m2) were treated with once‐weekly icodec for 6 weeks. The icodec dose was constant and individualized, aimed at achieving self‐measured plasma glucose of 4.4–7.0 mmol/L before breakfast. Blood samples were drawn from the first icodec dose until 35 days after last dose and were analyzed for total serum icodec concentration (i.e., the sum of albumin‐bound and unbound icodec). Results Icodec trough concentrations measured following initiation of once‐weekly icodec dosing suggested that clinical steady state for icodec was achieved after approximately 3–4 weeks of dosing. When at steady state, icodec exposure covered the full 1‐week dosing interval. The geometric mean half‐life was 159 h. The slopes of total icodec exposure (AUCτ,SS) and maximum icodec concentration (Cmax,SS) vs icodec dose did not differ significantly from 1, supporting dose‐proportionality for both AUCτ,SS (P = 0.40) and Cmax,SS (P = 0.43). Icodec was safe and well tolerated, and no new safety issues were identified in relation to icodec in this study. Discussion The pharmacokinetic properties of icodec assessed at steady state in this study demonstrated well‐distributed exposure across the 1‐week dosing interval and a half‐life that supports once‐weekly administration in Chinese individuals with type 2 diabetes.

Keywords

• China
• Insulin
• Pharmacokinetics