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速效门冬胰岛素和 1 型和 2 型糖尿病患者对新型餐时胰岛素类似物的需求:加拿大视角。

Fast-Acting Insulin Aspart and the Need for New Mealtime Insulin Analogues in Adults With Type 1 and Type 2 Diabetes: A Canadian Perspective.

机构信息

Division of Endocrinology and Metabolism, University of Alberta, Edmonton, Alberta, Canada.

Division of Endocrinology and Metabolism, Western University, London, Ontario, Canada.

出版信息

Can J Diabetes. 2019 Oct;43(7):515-523. doi: 10.1016/j.jcjd.2019.01.004. Epub 2019 Jan 24.

Abstract

Limiting postprandial glucose (PPG) excursions is an important aspect of overall glycemic control. Rapid-acting insulin analogues (RAIAs) aim to mimic the physiologic action of endogenous insulin observed in individuals without diabetes and prevent excessive PPG excursions. However, many people with type 1 diabetes and type 2 diabetes treated with RAIAs do not achieve glycated hemoglobin (A1C) targets, and there is an unmet need for further improvements in PPG control. Current RAIAs have a delayed onset and a longer duration of action compared with endogenous insulin secreted in response to meals. Approaches to developing new mealtime insulins with accelerated absorption kinetics include changing the route of administration (i.e. via inhalation) and changing the insulin formulation. Fast-acting insulin aspart (faster aspart) is a novel formulation of insulin aspart (IAsp) containing the excipients niacinamide and L-arginine. Faster aspart has an earlier onset of insulin exposure and a greater early glucose-lowering effect than IAsp. In large clinical trials, mealtime faster aspart demonstrated noninferiority to IAsp with respect to A1C reduction and provided superior PPG control with no increase in overall severe or blood glucose-confirmed hyperglycemia. In addition, faster aspart administered up to 20 min after the start of a meal was noninferior to mealtime IAsp in terms of A1C control, highlighting the opportunity for postmeal dosing. Faster aspart is the first of a new generation of mealtime insulins to be approved in Canada for the treatment of adults with type 1 diabetes and type 2 diabetes, and it is included in the 2018 Diabetes Canada clinical practice guidelines.

摘要

控制餐后血糖(PPG)波动是整体血糖控制的重要方面。速效胰岛素类似物(RAIAs)旨在模拟无糖尿病个体内源性胰岛素的生理作用,防止 PPG 过度波动。然而,许多使用 RAIAs 治疗的 1 型和 2 型糖尿病患者并未达到糖化血红蛋白(A1C)目标,因此需要进一步改善 PPG 控制。与餐时内源性胰岛素分泌相比,目前的 RAIAs 具有延迟起效和较长的作用持续时间。开发吸收动力学更快的新型餐时胰岛素的方法包括改变给药途径(即通过吸入)和改变胰岛素配方。速效胰岛素天门冬氨酸(速秀霖)是天门冬胰岛素(IAsp)的一种新型制剂,含有烟酰胺和 L-精氨酸赋形剂。速秀霖具有更早的胰岛素暴露起始时间和更大的早期降血糖作用。在大型临床试验中,餐时速秀霖在降低 A1C 方面与 IAsp 相比具有非劣效性,并提供了更好的 PPG 控制,而不会增加总体严重或血糖确认的高血糖。此外,在进餐开始后 20 分钟内给予速秀霖与餐时 IAsp 相比在 A1C 控制方面具有非劣效性,突出了餐后给药的机会。速秀霖是新一代餐时胰岛素中的第一种在加拿大获得批准用于治疗 1 型和 2 型糖尿病成人的胰岛素,它被纳入了 2018 年加拿大糖尿病临床实践指南。

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