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

IF 3.2 3区 医学
Yijun Li, Ariel Fu, Shan Jiang, Ann-Katrine Kjærsgaard Jøns, Beibei Liang, Qi Ni, Rasmus Ribel-Madsen, Lisbet Westergaard
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引用次数: 0

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.

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来源期刊
Journal of Diabetes Investigation
Journal of Diabetes Investigation Medicine-Internal Medicine
自引率
9.40%
发文量
218
期刊介绍: Journal of Diabetes Investigation is your core diabetes journal from Asia; the official journal of the Asian Association for the Study of Diabetes (AASD). The journal publishes original research, country reports, commentaries, reviews, mini-reviews, case reports, letters, as well as editorials and news. Embracing clinical and experimental research in diabetes and related areas, the Journal of Diabetes Investigation includes aspects of prevention, treatment, as well as molecular aspects and pathophysiology. Translational research focused on the exchange of ideas between clinicians and researchers is also welcome. Journal of Diabetes Investigation is indexed by Science Citation Index Expanded (SCIE).
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