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Gla-100二十年——关键临床试验的思考

Two Decades of Gla-100-Reflections from the Pivotal Clinical Trials.

作者信息

Makkar Brij Mohan, Sinha Ajay Kumar, Suryanarayana K M, Chakravorty Saibal, Sidduri Srinivas Rao, Ahmad Anish, Biswas Kaushik, Roy Anjan, Mohan Viswanathan

机构信息

Senior Consultant Endocrinologist, Dr. Makkar's diabetes and obesity center, Delhi.

Associate Professor, Department of Medicine, NMCH, Patna, Bihar.

出版信息

J Assoc Physicians India. 2020 Dec;68(12[Special]):18-24.

Abstract

The progressive nature of type 2 diabetes mellitus (T2DM) renders the shifting of patients from oral drugs to insulin therapy an inevitability in most patients especially in those with long duration of diabetes. At the turn of the last millennium, neutral protamine Hagedorn (NPH) insulin was still the only long-acting insulin available for people with diabetes. The advent of the first truly long-acting basal insulin, i.e. insulin glargine 100 U/mL (Gla-100) brought to the table a remarkably long duration of action and a very minimal risk of hypoglycemia by due to less pronounced peaks in their action profile. Further, in trying to achieve fasting normoglycemia, Gla-100 has demonstrated remarkably more holistic glucose-lowering efficacy in several pivotal trials compared to other insulin formulations, such as premixed insulin and coformulations-apart from NPH insulin. This article delineates clinical data on the effectiveness of Gla-100 vs. other insulin formulations in the context of T2DM.

摘要

2型糖尿病(T2DM)的进展性使得大多数患者,尤其是糖尿病病程较长的患者,从口服药物转向胰岛素治疗成为必然。在上个千年之交,中性鱼精蛋白锌(NPH)胰岛素仍是糖尿病患者唯一可用的长效胰岛素。首款真正长效的基础胰岛素,即100 U/mL甘精胰岛素(Gla-100)的出现,带来了显著延长的作用持续时间,并且由于其作用曲线中峰值不明显,低血糖风险极低。此外,在试图实现空腹血糖正常化方面,与其他胰岛素制剂(如预混胰岛素和复方制剂——不包括NPH胰岛素)相比,Gla-100在多项关键试验中显示出显著更全面的降糖疗效。本文阐述了在2型糖尿病背景下,Gla-100与其他胰岛素制剂疗效对比的临床数据。

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