对长效类似胰岛素的PK/PD曲线的解释的实用指南。第二部分:去糖精胰岛素与甘精胰岛素U300

IF 0.6 Q4 ENDOCRINOLOGY & METABOLISM
O. Greeff, J. J. van Tonder, Kershlin Naidu, A. McMaster, A. van Tonder, R. Mothilal
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引用次数: 0

摘要

葡萄糖钳研究是胰岛素治疗早期发展的一个组成部分。这些研究中产生的数据用于建立药物的药代动力学(PK)和药效学(PD)谱,但方法上的差异混淆了不同葡萄糖钳研究结果的比较。葡萄糖钳研究系列的第一部分讨论了葡萄糖钳研究解释的实用技巧。该系列的第二部分比较了长效基础类似胰岛素,去葡萄糖糖胰岛素(IDeg)和甘精胰岛素U300 (Gla-300)的PK/PD谱。葡萄糖钳夹研究的患者群体与这些类似胰岛素不同,因此数据的直接比较并不总是可能的。据报道,IDeg的最大作用时间为42小时,Gla-300的最大作用时间为36小时,覆盖时间为24小时。IDeg血浆胰岛素浓度是Gla-300的56倍。这些类似胰岛素的III期临床试验结果证实了葡萄糖钳夹研究中观察到的可预测性和低受试者变异性。深入了解长效基础类似胰岛素的PK/PD特征,使治疗医师能够利用这些特征来优化糖尿病患者的治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A practical guide to the interpretation of PK/PD profiles of longer-acting analogue insulins. Part two: Insulin degludec vs. insulin glargine U300
Glucose clamp studies form an integral part of the early development of insulin therapies. Data generated in these studies are used to establish pharmacokinetic (PK) and pharmacodynamic (PD) profiles of the agents, but methodological differences confound comparison of results from different glucose clamp studies. The first part of this series on glucose clamp studies discussed practical tips for the interpretation of glucose clamp studies. The second part of the series compares the PK/PD profiles of longer-acting basal analogue insulins, insulin degludec (IDeg) and insulin glargine U300 (Gla-300). The patient populations for glucose clamp studies with these analogue insulins differ, and therefore direct comparison of the data is not always possible. The maximum duration of action of IDeg is reported as 42 h and that of Gla-300 as 36 h, translating to 24 h coverage. The plasma insulin concentration of IDeg is 56 times that of Gla-300. Results from phase III clinical trials for these analogue insulins confirm the predictability and low within-subject variability observed in glucose clamp studies. Insight into the PK/PD profiles of longer-acting basal analogue insulins allows the treating physician to utilise these characteristics to optimise the treatment of their patients with diabetes.
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