Once-Weekly Insulin Icodec: Safety Profile in Type 2 and Type 1 Diabetes Based on a Pooled Analysis of ONWARDS 1-6

IF 4.4 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice Pub Date : 2026-10-01 Epub Date: 2026-05-12 DOI:10.1016/j.eprac.2026.05.003

Harpreet S. Bajaj MD, Sofie Bech Andersen PhD, Boryana Hristova MD, Satish Hulkund MSc, Monika Kellerer MD PhD, Yiming Mu MD, Siri Vinther PhD, Ildiko Lingvay MD

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引用次数: 0

Abstract

Objective

To describe the safety profile of once-weekly insulin icodec (icodec), focusing on aspects beyond hypoglycemia, in a pooled population from the ONWARDS phase 3a trials.

Methods

ONWARDS 1-6 investigated the efficacy and safety of icodec versus once-daily basal insulin comparators in insulin-naive and insulin-experienced adults with type 2 diabetes, and insulin-experienced adults with type 1 diabetes. Adverse event (AE) data from all trial periods were pooled. Hypersensitivity, injection-site reactions, and medication errors, as well as microvascular and macrovascular (including time to first major adverse cardiovascular event [MACE]) complications, were among the safety areas evaluated.

Results

Total treatment exposure was 2118.70 and 2127.76 patient-years of exposure (PYE) in the icodec (n = 2170) and comparator groups (n = 2170), respectively. Adjusted rates (events/100 PYE) were similar for icodec and comparators for all AEs (248.49 vs 242.53), serious AEs (14.51 vs 14.03), and severe AEs (7.92 vs 7.50), respectively. Adjusted rates of hypersensitivity were 5.88 and 6.74 events/100 PYE in the icodec and comparator groups, respectively. Most injection-site reactions were mild; adjusted rates: 5.86 and 3.66 events/100 PYE, respectively. Medication error rates were 2.47 and 2.53 events/100 PYE, respectively. Time to first MACE was similar between groups (hazard ratio [95% confidence interval]: 0.93 [0.56-1.56]). Adjusted rates for other AEs were broadly similar between groups.

Conclusion

Based on a detailed evaluation of safety focus areas across the ONWARDS 1-6 trials, the safety profile of once-weekly icodec was generally similar to that of once-daily basal insulin comparators in individuals with type 2 diabetes or type 1 diabetes.

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每周一次胰岛素Icodec: 2型和1型糖尿病的安全性：基于1-6的汇总分析

目的：描述每周一次的胰岛素icodec （icodec）的安全性，重点关注低血糖以外的方面，在来自a3期临床试验的汇总人群中。方法：1-6研究了icodec与每日一次基础胰岛素比较剂在胰岛素初始和胰岛素经验成人2型糖尿病（T2D）以及胰岛素经验成人1型糖尿病（T1D）中的疗效和安全性。汇总所有试验期间的不良事件（AE）数据。超敏反应、注射部位反应、用药错误以及微血管和大血管（包括首次主要心血管不良事件[MACE]发生的时间）并发症均在安全性评估范围之内。结果：icodec组（n=2170）和比较组（n=2170）的总治疗暴露量分别为2118.70和2127.76患者年暴露量（PYE）。所有ae （248.49 vs 242.53）、严重ae （14.51 vs 14.03）和严重ae （7.92 vs 7.50）的icodec和比较物的调整率（事件/100 PYE）相似。icodec组和比较组的调整超敏率分别为5.88和6.74事件/100 PYE。大多数注射部位的反应是轻微的；调整率：分别为5.86和3.66事件/100年。用药错误率分别为2.47和2.53事件/100 PYE。两组间至首次MACE的时间相似（风险比[95%可信区间（CI）]: 0.93[0.56-1.56]）。其他不良事件的调整率在两组之间大致相似。结论：基于对1-6个试验中安全性重点领域的详细评估，在T2D或T1D患者中，每周一次的icodec的安全性与每天一次的基础胰岛素比较剂的安全性大致相似。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Endocrine Practice ENDOCRINOLOGY & METABOLISM-

CiteScore

7.60

自引率

2.40%

发文量

546

审稿时长

41 days

期刊介绍： Endocrine Practice (ISSN: 1530-891X), a peer-reviewed journal published twelve times a year, is the official journal of the American Association of Clinical Endocrinologists (AACE). The primary mission of Endocrine Practice is to enhance the health care of patients with endocrine diseases through continuing education of practicing endocrinologists.