来自每周一次胰岛素icodec 3a期及后续1-6期试验的住院情况洞察
Insights on Hospitalisations from the Phase 3a ONWARDS 1-6 Trials of Once-Weekly Insulin Icodec.
作者信息
Philis-Tsimikas Athena, Krogsdahl Bache Julie, Fu Ariel, Kellerer Monika, Salvesen-Sykes Karen, Bain Stephen C
机构信息
Scripps Whittier Diabetes Institute, San Diego, CA, USA.
, 9834 Genesee Ave, Suite 300, La Jolla, CA, 92037, USA.
出版信息
Diabetes Ther. 2025 Jun 4. doi: 10.1007/s13300-025-01745-4.
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) 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 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).
简介
ONWARDS项目评估了每周一次的icodec胰岛素与每日一次的基础胰岛素对照药物在2型糖尿病（T2D）或1型糖尿病（T1D）患者中的疗效和安全性。这项对ONWARDS 1 - 6进行的事后探索性分析评估了icodec在住院期间及前后的影响。
方法
ONWARDS 1 - 6是随机、双臂、3a期试验（ClinicalTrials.gov：NCT04460885；NCT04770532；NCT04795531；NCT04880850；NCT04760626；NCT04848480）。患有T2D（ONWARDS 1 - 5；n = 3765）和T1D（ONWARDS 6；n = 582）的成年人接受了icodec或每日一次的对照药物（德谷胰岛素、甘精胰岛素U100、甘精胰岛素U300）。对住院病例分析了：住院时长、icodec剂量、自我测量的血糖、糖化血红蛋白（HbA）水平以及住院前、住院期间和住院后的临床显著低血糖和严重低血糖情况。
结果
在各项试验中，接受icodec治疗的住院参与者数量（n = 152/2172）与接受每日一次对照药物治疗的住院参与者数量（n = 156/2175）相近。各治疗组的中位住院天数相似（icodec组为5.0天；每日一次对照药物组为6.0天）；icodec剂量在住院期间保持相当稳定。大多数住院参与者完成了试验，没有永久停止治疗（icodec组为84.9%；每日一次对照药物组为90.4%）。在评估的时间点上，两个治疗组的平均HbA水平均保持相对稳定。6名接受icodec治疗的参与者（1名T2D患者；5名T1D患者）和3名接受每日一次对照药物治疗的参与者（1名T2D患者；2名T1D患者）报告在住院期间发生了临床显著或严重低血糖。
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接受icodec治疗，且icodec似乎对血糖管理或低血糖没有影响。该分析表明，在住院期间，每周一次的icodec可以与每日一次的基础胰岛素类似物以相似的方式进行管理。
试验注册
ClinicalTrials.gov标识符，NCT04460885（ONWARDS 1）、NCT04770532（ONWARDS 2）、NCT04795531（ONWARDS 3）、NCT04880850（ONWARDS 4）、NCT04760626（ONWARDS 5）、NCT04848480（ONWARDS 6）。
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