Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec versus once-daily basal insulin in individuals with type 2 diabetes by kidney function: A post hoc participant-level analysis of the ONWARDS 1–5 trials

IF 5.7 2区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes, Obesity & Metabolism Pub Date : 2025-02-10 DOI:10.1111/dom.16231

Peter Rossing MD, Malik Benamar MD, Alice Y. Y. Cheng MD, Bharath Kumar MSc, Christian Laugesen MD, Harpreet S. Bajaj MD

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Abstract

Aim

This post hoc analysis of ONWARDS 1–5 assessed the efficacy and hypoglycaemia outcomes with once-weekly insulin icodec (icodec) versus once-daily basal insulin comparators (degludec, glargine U100 or glargine U300) in insulin-naive (ONWARDS 1, 3 and 5) and insulin-experienced (ONWARDS 2 and 4) adults (aged ≥18 years) with type 2 diabetes (T2D) by kidney function subgroup.

Materials and Methods

Treatment outcomes were analysed by trial according to kidney function subgroup (estimated glomerular filtration rate [eGFR] ≥90; eGFR 60–<90; eGFR 30–<60; eGFR <30; all mL/min/1.73m²). Severe kidney function impairment (eGFR <30) at screening was an exclusion criterion for ONWARDS 1–4, but not ONWARDS 5.

Results

ONWARDS 1–5 included 3765 participants; 3763 were included in this analysis. In ONWARDS 1, 3 and 5, there were no statistically significant treatment interactions by kidney function subgroup for change in glycated haemoglobin (HbA1c) from baseline to end of treatment (EOT); there were statistically significant subgroup interactions in ONWARDS 2 and 4 (both p-interaction <0.05). Change in body weight (baseline to EOT) across kidney function subgroups was comparable between treatment arms. Across trials, there was no consistent trend by kidney function subgroup for mean weekly insulin dose during the last 2 weeks of treatment or rates of combined clinically significant or severe hypoglycaemia. There were no statistically significant treatment interactions by kidney function subgroup for the achievement of HbA1c <7% without clinically significant or severe hypoglycaemia; all p-interaction >0.05.

Conclusions

Efficacy and hypoglycaemia outcomes of icodec versus once-daily comparators were generally consistent among adults with T2D, regardless of kidney function.

Abstract Image

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根据肾功能，2型糖尿病患者使用每周一次胰岛素icodec与每天一次基础胰岛素的疗效和低血糖结局：一项对1-5试验的事后参与者水平分析

目的：这项对向前看1-5的事后分析评估了每周一次胰岛素icodec （icodec）与每天一次基础胰岛素比较物（degludec、甘精U100或甘精U300）在胰岛素初始（向前看1、3和5）和胰岛素经验（向前看2和4）成人（年龄≥18岁）2型糖尿病（T2D）患者中的疗效和低血糖结局。材料与方法：根据肾功能亚组(估计肾小球滤过率[eGFR]≥90；表皮生长因子受体60-2)。严重肾功能损害（eGFR）结果：1-5包括3765名参与者；3763例纳入本分析。在第1、3和5阶段，肾功能亚组对糖化血红蛋白（HbA1c）从基线到治疗结束（EOT）的变化没有统计学意义；两组间亚组间相互作用有统计学意义（p-相互作用均为0.05）。结论：在成人T2D患者中，无论肾功能如何，icodec的疗效和低血糖结局与每日一次的比较物总体上是一致的。

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

Diabetes, Obesity & Metabolism 医学-内分泌学与代谢

CiteScore

10.90

自引率

6.90%

发文量

319

审稿时长

3-8 weeks

期刊介绍： Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.