哪些糖尿病患者将从每周一次的基础胰岛素类似物中获益最多?特别关注 1 型糖尿病患者的综述

Chrysoula Kosmeri, Maria S Baltogianni, V. Giapros, E. Siomou, V. Tsinopoulou, Foteini Balomenou, Anastasios Serbis
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引用次数: 0

摘要

基础胰岛素类似物通常每天给药一次或两次,在过去二十年中一直是每天多次注射(MDI)胰岛素治疗 1 型糖尿病(T1D)患者的两大支柱之一。最近,每周一次的基础胰岛素类似物已经开发出来,并已进入后期临床试验阶段。其中一种类似物是胰岛素 icodec(icodec),这种胰岛素可与白蛋白可逆结合,并逐渐释放到患者的血液循环中。Icodec 主要在 2 型糖尿病成年患者的临床试验中试用。最近的一项 3a 期临床试验由成年 T1D 患者参加,旨在评估 Icodec 与一种日用基础胰岛素类似物(degludec)相比的疗效和安全性。第26周时,Icodec的糖化血红蛋白(HbA1c)降低率与每日一次的degludec相比没有劣势,在范围内时间(TIR)(70-180 mg/dL)和超过范围时间(TAR)(>180 mg/dL)方面也没有显著差异。另一方面,它与临床显著低血糖(血糖< 54 mg/dL)和严重低血糖(需要外部协助恢复)的发生率增加有关,但仍低于或接近国际推荐的低血糖目标值。另一种每周一次的胰岛素类似物--基础胰岛素 Fc(BIF)已在一项由 T1D 成年患者参加的 2 期临床试验中进行了研究,结果同样令人鼓舞。这些初步数据表明,一周一次的胰岛素类似物可用于某些 T1D 患者,例如,不定期使用胰岛素的患者或使用 MDI 但希望减少注射次数的患者。此外,由于胰岛素类似物的作用时间较长,它可以降低糖尿病酮症酸中毒的风险和住院治疗的需要。此外,因费用或皮肤问题而难以佩戴糖尿病设备/闭环胰岛素泵的 T1D 患者也可能从长效胰岛素中获益。越来越多的证据表明,胰岛素辅助疗法对 T1D 患者有益,但由于可能会增加糖尿病酮症酸中毒的风险,这些疗法尚未获得 FDA 批准。这些长效胰岛素类似物可与辅助疗法一起用于部分患者。本综述旨在介绍有关单周胰岛素类似物的作用模式、临床试验结果以及对 T1D 患者可能带来的益处的现有数据。此外,它还打算就一些重要的临床问题提出未来的研究框架,如一周一次的胰岛素类似物的使用与运动、病假或手术,以增进我们对这一胰岛素管理领域无可争议的创新的了解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Which Diabetes Patients Will Benefit the Most from Once-Weekly Basal Insulin Analogs? A Review with a Special Focus on Type 1 Diabetes Patients
Basal insulin analogs, typically administered once or twice daily, have been one of the two pillars of the multiple daily injection (MDI) insulin therapy of patients with type 1 diabetes (T1D) for the last twenty years. Recently, once-weekly basal insulin analogs have been developed and are in late-phase clinical trials. One of these analogs is insulin icodec (icodec), appropriately developed to bind reversibly to albumin and to be gradually released into the patient’s circulation. Icodec has been tried mostly in clinical trials of adult patients with type 2 diabetes. A recent phase 3a clinical trial comprising adult patients with T1D was designed to evaluate icodec’s efficacy and safety compared with a daily basal insulin analog (degludec) after a 26-week main phase plus a safety extension of another 26 weeks. Icodec showed non-inferiority to once-daily degludec in glycated hemoglobin (HbA1c) reduction at week 26, and no significant differences in time in range (TIR) (70–180 mg/dL) and in time above range (TAR) (>180 mg/dL). On the other hand, it was associated with increased rates of clinically significant hypoglycemia (blood glucose < 54 mg/dL) and severe hypoglycemia (external assistance need for recovery), remaining either below or close to the internationally recommended targets for hypoglycemia. Another once-weekly insulin analog, basal insulin Fc (BIF), has been investigated in a phase 2 clinical trial comprising adult patients with T1D, with equally promising results. These preliminary data suggest that once-weekly insulin analogs could be of use for some patients with T1D, for example, patients not taking insulin regularly or those who are on MDI and wish for fewer injections. In addition, due to its prolonged mode of action, it could decrease the risk of diabetic ketoacidosis and the need for hospitalization. Additionally, patients with T1D that struggle with wearing diabetes mellitus devices/closed-loop insulin pumps either due to the cost or due to skin issues may also benefit from long-acting insulin. There is increasing evidence of the benefits of adjunctive therapies to insulin in T1D patients, but these therapies are not FDA-approved due to a possible higher risk of diabetic ketoacidosis. These long-acting insulin analogues could be used with adjunctive therapies in selected patients. This review aims to present available data on the mode of action, clinical trial results, and possible benefits of once-weekly insulin analogs for patients with T1D. In addition, it intends to suggest a future research framework for important clinical questions, such as once-weekly insulin analog use and exercise, sick days, or surgery, that will enhance our knowledge regarding this indisputable innovation in insulin management.
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