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

Athena Philis-Tsimikas Orcid Logo, Julie Krogsdahl Bache Orcid Logo, Ariel Fu Orcid Logo, Monika Kellerer Orcid Logo, Karen Salvesen-Sykes Orcid Logo, Steve Bain Orcid Logo

Diabetes Therapy, Volume: 16, Issue: 8, Pages: 1615 - 1631

Swansea University Author: Steve Bain Orcid Logo

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DOI (Published version): 10.1007/s13300-025-01745-4

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...

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Published in: Diabetes Therapy
ISSN: 1869-6953 1869-6961
Published: Springer Nature 2025
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URI: https://cronfa.swan.ac.uk/Record/cronfa69630
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Methods: ONWARDS 1&#x2013;6 were randomised, two-arm, phase 3a trials (ClinicalTrials.gov: NCT04460885; NCT04770532; NCT04795531; NCT04880850; NCT04760626; NCT04848480). Adults with T2D (ONWARDS 1&#x2013;5; n&#x2009;=&#x2009;3765) and T1D (ONWARDS 6; n&#x2009;=&#x2009;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&#x2009;=&#x2009;152/2172) and once-daily comparators (n&#x2009;=&#x2009;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. 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spelling 2025-10-17T11:14:16.5782632 v2 69630 2025-06-05 Insights on Hospitalisations from the Phase 3a ONWARDS 1–6 Trials of Once-Weekly Insulin Icodec 5399f4c6e6a70f3608a084ddb938511a 0000-0001-8519-4964 Steve Bain Steve Bain true false 2025-06-05 MEDS 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. Journal Article Diabetes Therapy 16 8 1615 1631 Springer Nature 1869-6953 1869-6961 Hospitalisation; Hypoglycaemia; Insulin icodec; Type 1 diabetes; Type 2 diabetes 1 8 2025 2025-08-01 10.1007/s13300-025-01745-4 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Other This study was funded by Novo Nordisk A/S, Søborg, Denmark. The journal’s Rapid Service Fee was funded by Novo Nordisk A/S. 2025-10-17T11:14:16.5782632 2025-06-05T13:25:49.4099153 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Biomedical Science Athena Philis-Tsimikas 0000-0002-3986-9630 1 Julie Krogsdahl Bache 0000-0001-5764-1966 2 Ariel Fu 0009-0007-0220-5877 3 Monika Kellerer 0000-0002-9834-5976 4 Karen Salvesen-Sykes 0009-0000-1247-5650 5 Steve Bain 0000-0001-8519-4964 6 69630__34478__c71d9f2f6eef4d55934003ecb61a0321.pdf 69630.VoR.pdf 2025-06-13T14:12:45.3043154 Output 1852066 application/pdf Version of Record true This article is licensed under a Creative Commons Attribution-Non Commercial 4.0 International License. true eng http://creativecommons.org/licenses/by-nc/4.0/
title Insights on Hospitalisations from the Phase 3a ONWARDS 1–6 Trials of Once-Weekly Insulin Icodec
spellingShingle Insights on Hospitalisations from the Phase 3a ONWARDS 1–6 Trials of Once-Weekly Insulin Icodec
Steve Bain
title_short Insights on Hospitalisations from the Phase 3a ONWARDS 1–6 Trials of Once-Weekly Insulin Icodec
title_full Insights on Hospitalisations from the Phase 3a ONWARDS 1–6 Trials of Once-Weekly Insulin Icodec
title_fullStr Insights on Hospitalisations from the Phase 3a ONWARDS 1–6 Trials of Once-Weekly Insulin Icodec
title_full_unstemmed Insights on Hospitalisations from the Phase 3a ONWARDS 1–6 Trials of Once-Weekly Insulin Icodec
title_sort Insights on Hospitalisations from the Phase 3a ONWARDS 1–6 Trials of Once-Weekly Insulin Icodec
author_id_str_mv 5399f4c6e6a70f3608a084ddb938511a
author_id_fullname_str_mv 5399f4c6e6a70f3608a084ddb938511a_***_Steve Bain
author Steve Bain
author2 Athena Philis-Tsimikas
Julie Krogsdahl Bache
Ariel Fu
Monika Kellerer
Karen Salvesen-Sykes
Steve Bain
format Journal article
container_title Diabetes Therapy
container_volume 16
container_issue 8
container_start_page 1615
publishDate 2025
institution Swansea University
issn 1869-6953
1869-6961
doi_str_mv 10.1007/s13300-025-01745-4
publisher Springer Nature
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Biomedical Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Biomedical Science
document_store_str 1
active_str 0
description 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.
published_date 2025-08-01T05:25:51Z
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