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icodec胰岛素:一种用于治疗1型和2型糖尿病的新型每周一次制剂。

Insulin icodec: A novel once-weekly formulation for the treatment of type 1 and type 2 diabetes mellitus.

作者信息

Pham David Q, Andraos John, Ayoub Joelle

机构信息

Department of Pharmacy, College of Pharmacy, Western University of Health Sciences, Pomona, CA, 91766, USA.

Department of Pharmacy, Hoag Hospital, Mary & Dick Allen Diabetes Center, Newport Beach, CA, 92663, USA.

出版信息

Rev Endocr Metab Disord. 2025 Mar 29. doi: 10.1007/s11154-025-09960-x.

Abstract

Insulin icodec is a novel once-weekly basal insulin analog subcutaneous injection seeking approval by the United States Food and Drug Administration (FDA) for use in both type 1 and type 2 diabetes mellitus. The mission of this manuscript is to provide a thorough overview of insulin icodec's clinical trials that were involved in its approval as well as review its pharmacology, pharmacokinetics, adverse effects, drug interactions, dosage recommendations, and regulatory issues. This article includes a thorough review of insulin icodec's safety and efficacy in type 1 and type 2 diabetes mellitus including its pharmacokinetic and pharmacodynamic profile. A systematic search of the electronic database of PubMed from inception until December 2024 using MeSH keywords was completed. Keywords used were icodec, insulin, type 1 diabetes, and type 2 diabetes. Overall, 14 clinical trials were identified and reviewed. The majority of the trials reviewed showed decreases in A1C as primary endpoints and non-inferiority and superiority with insulin icodec versus the comparator. In select studies, mild hypoglycemia was more evident in subjects taking insulin icodec versus the comparator but no other concerns were identified. The reviewed literature showed similar and sometimes improved glycemic control when insulin icodec was compared to other long-acting insulins both in insulin-naive and previously insulin-treated patients. Hypoglycemia was similar or slightly increased with insulin icodec when compared to other long acting insulins. Overall, icodec is a useful, new formulation of basal insulin that allows for less injections, improved compliance, and potentially improved glycemic control providing a new tool to practitioners managing patients with diabetes who need to be on insulin.

摘要

icodec胰岛素是一种新型的基础胰岛素类似物,每周皮下注射一次,正在寻求美国食品药品监督管理局(FDA)批准用于1型和2型糖尿病。本文的目的是全面概述icodec胰岛素在获批过程中所涉及的临床试验,并回顾其药理学、药代动力学、不良反应、药物相互作用、剂量建议和监管问题。本文全面回顾了icodec胰岛素在1型和2型糖尿病中的安全性和有效性,包括其药代动力学和药效学特征。使用医学主题词(MeSH)关键词对PubMed电子数据库从建立到2024年12月进行了系统检索。使用的关键词是icodec、胰岛素、1型糖尿病和2型糖尿病。总共确定并审查了14项临床试验。大多数审查的试验显示,糖化血红蛋白(A1C)降低作为主要终点,与对照相比,icodec胰岛素具有非劣效性和优越性。在一些研究中,与对照相比,服用icodec胰岛素的受试者轻度低血糖更明显,但未发现其他问题。综述文献显示,在初治胰岛素患者和既往接受胰岛素治疗的患者中,将icodec胰岛素与其他长效胰岛素相比时,血糖控制相似,有时甚至有所改善。与其他长效胰岛素相比,icodec胰岛素导致的低血糖相似或略有增加。总体而言,icodec是一种有用的新型基础胰岛素制剂,可减少注射次数,提高依从性,并可能改善血糖控制,为治疗糖尿病患者的医生提供了一种新工具。

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