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

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 (AUC_τ,SS) and maximum icodec concentration (C_max,SS) vs icodec dose did not differ significantly from 1, supporting dose-proportionality for both AUC_τ,SS (P = 0.40) and C_max,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.