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德谷胰岛素的临床应用。

Clinical use of insulin degludec.

作者信息

Vora Jiten, Cariou Bertrand, Evans Marc, Gross Jorge Luiz, Harris Stewart, Landstedt-Hallin Lena, Mithal Ambrish, Rodriguez Martín Rodríguez, Meneghini Luigi

机构信息

Department of Endocrinology and Diabetes, Royal Liverpool University Hospital, Prescot Street, Liverpool L7 8XP, UK.

Clinique d'Endocrinologie, l'Institut du Thorax, CHU Nantes, Nantes, France.

出版信息

Diabetes Res Clin Pract. 2015 Jul;109(1):19-31. doi: 10.1016/j.diabres.2015.04.002. Epub 2015 Apr 14.

Abstract

The limitations of current basal insulin preparations include concerns related to their pharmacokinetic and pharmacodynamic properties, hypoglycaemia, weight gain, and perception of management complexity, including rigid dosing schedules. Insulin degludec (IDeg) is a novel basal insulin with improved pharmacokinetic and pharmacodynamic properties compared to insulin glargine (IGlar) including a long half-life of ∼25 h and a duration of action >42 h at steady state, providing a flat and stable blood glucose-lowering effect when injected once daily. Evidence from phase 3a clinical trials with a treat-to-target design in patients with type 1 and type 2 diabetes has shown that IDeg has similar efficacy to IGlar, with a 9% and 26% reduction in risk of overall and nocturnal hypoglycaemia, respectively (in the pooled population) during the entire treatment period, and a 16% and 32% reduction during the maintenance period, respectively. Given its pharmacodynamic properties, IDeg offers a broad dosing window, allowing for flexible dose administration, if required. Two different formulations of IDeg are available (100 units/mL [U100] and 200 units/mL), the latter providing the same IDeg dose as the U100 formulation in half the injection volume. The unique pharmacokinetic profile of IDeg facilitates glycaemic control while minimising the risk of nocturnal hypoglycaemia.

摘要

目前基础胰岛素制剂存在诸多局限性,包括与它们的药代动力学和药效学特性、低血糖、体重增加以及管理复杂性(包括严格的给药方案)相关的问题。德谷胰岛素(IDeg)是一种新型基础胰岛素,与甘精胰岛素(IGlar)相比,其药代动力学和药效学特性有所改善,半衰期约为25小时,稳态下作用持续时间>42小时,每日注射一次时可提供平稳、稳定的降血糖效果。在1型和2型糖尿病患者中进行的3a期临床试验(采用达标治疗设计)的证据表明,IDeg与IGlar疗效相似,在整个治疗期间,总体低血糖风险和夜间低血糖风险分别降低9%和26%(在合并人群中),在维持期分别降低16%和32%。鉴于其药效学特性,IDeg提供了较宽的给药窗,如果需要,允许灵活给药。有两种不同剂型的IDeg可供选择(100单位/毫升[U100]和200单位/毫升),后者在注射体积减半的情况下提供与U100剂型相同的IDeg剂量。IDeg独特的药代动力学特征有助于血糖控制,同时将夜间低血糖风险降至最低。

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