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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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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
Online Access: Check full text

URI: https://cronfa.swan.ac.uk/Record/cronfa69630
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.
Keywords: Hospitalisation; Hypoglycaemia; Insulin icodec; Type 1 diabetes; Type 2 diabetes
College: Faculty of Medicine, Health and Life Sciences
Funders: This study was funded by Novo Nordisk A/S, Søborg, Denmark. The journal’s Rapid Service Fee was funded by Novo Nordisk A/S.
Issue: 8
Start Page: 1615
End Page: 1631