Insights on Hospitalisations from the Phase 3a ONWARDS 1-6 Trials of Once-Weekly Insulin Icodec.

IF 2.6 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2025-06-04 DOI:10.1007/s13300-025-01745-4

Athena Philis-Tsimikas, Julie Krogsdahl Bache, Ariel Fu, Monika Kellerer, Karen Salvesen-Sykes, Stephen C Bain

{"title":"Insights on Hospitalisations from the Phase 3a ONWARDS 1-6 Trials of Once-Weekly Insulin Icodec.","authors":"Athena Philis-Tsimikas, Julie Krogsdahl Bache, Ariel Fu, Monika Kellerer, Karen Salvesen-Sykes, Stephen C Bain","doi":"10.1007/s13300-025-01745-4","DOIUrl":null,"url":null,"abstract":"Introduction: The ONWARDS programme assessed the efficacy and safety of once-weekly insulin icodec (icodec) versus once-daily basal insulin comparators in type 2 diabetes (T2D) or type 1 diabetes (T1D). This post hoc exploratory analysis of ONWARDS 1-6 assessed the impact of icodec during and around hospitalisation.Methods: ONWARDS 1-6 were randomised, two-arm, phase 3a trials (ClinicalTrials.gov: NCT04460885; NCT04770532; NCT04795531; NCT04880850; NCT04760626; NCT04848480). Adults with T2D (ONWARDS 1-5; n = 3765) and T1D (ONWARDS 6; n = 582) received icodec or once-daily comparators (insulin degludec, insulin glargine U100, insulin glargine U300). Hospitalised cases were analysed for: hospitalisation duration, icodec dose, self-measured blood glucose, glycated haemoglobin (HbA1c) levels, and clinically significant and severe hypoglycaemia before, during, and after hospitalisation.Results: Across trials, a similar number of participants receiving icodec (n = 152/2172) and once-daily comparators (n = 156/2175) were hospitalised. Median duration of hospital stay was similar between treatment groups (icodec, 5.0 days; once-daily comparators, 6.0 days); icodec dose remained fairly stable around hospitalisation. Most hospitalised participants completed the trial without permanently discontinuing treatment (icodec, 84.9%; once-daily comparators, 90.4%). Mean HbA1c levels remained relatively stable over assessed time points for both treatment groups. Six participants receiving icodec (one with T2D; five with T1D) and three receiving once-daily comparators (one with T2D; two with T1D) reported clinically significant or severe hypoglycaemia during hospitalisation.Conclusions: Similar numbers of hospitalisations were reported in both treatment arms. Icodec treatment was continued during hospitalisation in most participants and did not appear to have an impact on glycaemic management or hypoglycaemia. This analysis suggests that once-weekly icodec could be managed in a similar way to once-daily basal insulin analogues during hospitalisation.Trial registration: ClinicalTrials.gov identifiers, NCT04460885 (ONWARDS 1), NCT04770532 (ONWARDS 2), NCT04795531 (ONWARDS 3), NCT04880850 (ONWARDS 4), NCT04760626 (ONWARDS 5), NCT04848480 (ONWARDS 6).","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":2.6000,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13300-025-01745-4","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction: The ONWARDS programme assessed the efficacy and safety of once-weekly insulin icodec (icodec) versus once-daily basal insulin comparators in type 2 diabetes (T2D) or type 1 diabetes (T1D). This post hoc exploratory analysis of ONWARDS 1-6 assessed the impact of icodec during and around hospitalisation.

Methods: ONWARDS 1-6 were randomised, two-arm, phase 3a trials (ClinicalTrials.gov: NCT04460885; NCT04770532; NCT04795531; NCT04880850; NCT04760626; NCT04848480). Adults with T2D (ONWARDS 1-5; n = 3765) and T1D (ONWARDS 6; n = 582) received icodec or once-daily comparators (insulin degludec, insulin glargine U100, insulin glargine U300). Hospitalised cases were analysed for: hospitalisation duration, icodec dose, self-measured blood glucose, glycated haemoglobin (HbA_1c) levels, and clinically significant and severe hypoglycaemia before, during, and after hospitalisation.

Results: Across trials, a similar number of participants receiving icodec (n = 152/2172) and once-daily comparators (n = 156/2175) were hospitalised. Median duration of hospital stay was similar between treatment groups (icodec, 5.0 days; once-daily comparators, 6.0 days); icodec dose remained fairly stable around hospitalisation. Most hospitalised participants completed the trial without permanently discontinuing treatment (icodec, 84.9%; once-daily comparators, 90.4%). Mean HbA_1c levels remained relatively stable over assessed time points for both treatment groups. Six participants receiving icodec (one with T2D; five with T1D) and three receiving once-daily comparators (one with T2D; two with T1D) reported clinically significant or severe hypoglycaemia during hospitalisation.

Conclusions: Similar numbers of hospitalisations were reported in both treatment arms. Icodec treatment was continued during hospitalisation in most participants and did not appear to have an impact on glycaemic management or hypoglycaemia. This analysis suggests that once-weekly icodec could be managed in a similar way to once-daily basal insulin analogues during hospitalisation.

Trial registration: ClinicalTrials.gov identifiers, NCT04460885 (ONWARDS 1), NCT04770532 (ONWARDS 2), NCT04795531 (ONWARDS 3), NCT04880850 (ONWARDS 4), NCT04760626 (ONWARDS 5), NCT04848480 (ONWARDS 6).

查看原文本刊更多论文

每周一次胰岛素Icodec的3a期1-6期临床试验对住院患者的影响

在2型糖尿病（T2D）或1型糖尿病（T1D）患者中，研究人员评估了每周一次的胰岛素icodec （icodec）与每天一次的基础胰岛素比较物的疗效和安全性。该事后探索性分析评估了住院期间和住院前后icodec的影响。方法：1-6项随机、双组、3a期试验(ClinicalTrials.gov: NCT04460885；NCT04770532;NCT04795531;NCT04880850;NCT04760626;NCT04848480)。成人t2dm患者(1-5岁；n = 3765)和T1D (onward 6；n = 582)接受icodec或每日1次比较药物（去葡萄糖胰岛素、甘精胰岛素U100、甘精胰岛素U300）。对住院病例进行分析：住院时间、icodec剂量、自测血糖、糖化血红蛋白（HbA1c）水平，以及住院前、住院期间和住院后的临床显著和严重低血糖。结果：在所有试验中，接受icodec （n = 152/2172）和每日一次比较剂（n = 156/2175）的参与者住院人数相似。治疗组间的中位住院时间相似(icodec， 5.0天；每天一次比较，6.0天)；Icodec的剂量在住院前后保持相当稳定。大多数住院患者完成试验后没有永久停止治疗(icodec, 84.9%；每日一次比较，90.4%)。两个治疗组的平均HbA1c水平在评估时间点上保持相对稳定。6名参与者接受icodec(1名T2D；5名T1D患者)和3名接受每日一次比较者(1名T2D患者；2例T1D患者在住院期间报告了临床显著或严重的低血糖。结论：两个治疗组报告的住院人数相似。大多数参与者在住院期间继续使用Icodec治疗，似乎对血糖管理或低血糖没有影响。这一分析表明，在住院期间，每周一次的icodec可以以类似于每天一次的基础胰岛素类似物的方式管理。试验注册：ClinicalTrials.gov标识符，NCT04460885 (onward 1), NCT04770532 (onward 2), NCT04795531 (onward 3), NCT04880850 (onward 4), NCT04760626 (onward 5), NCT04848480 （onward 6）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.