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Once-Weekly Insulin Icodec: Safety Profile in Type 2 and Type 1 Diabetes Based on a Pooled Analysis of ONWARDS 1-6
Harpreet S Bajaj1, Sofie Bech Andersen2, Boryana Hristova2
1LMC Diabetes and Endocrinology, Brampton, Ontario, Canada.
Summary
The safety profile of once-weekly insulin icodec is similar to daily basal insulins in type 1 and type 2 diabetes patients. This analysis of ONWARDS trials found comparable rates of adverse events and cardiovascular outcomes.
Area of Science:
- Endocrinology
- Pharmacology
- Clinical Trials
Background:
- Once-weekly insulin icodec offers a novel dosing regimen for diabetes management.
- Understanding its safety profile beyond hypoglycemia is crucial for clinical adoption.
- The ONWARDS phase 3a trials provide a robust dataset for safety evaluation.
Purpose of the Study:
- To assess the safety profile of once-weekly insulin icodec.
- To compare safety aspects, excluding hypoglycemia, with once-daily basal insulins.
- To analyze adverse events, hypersensitivity, injection-site reactions, and cardiovascular outcomes.
Main Methods:
- Pooled safety data from ONWARDS 1-6 phase 3a trials.
- Inclusion of insulin-naive and insulin-experienced adults with type 2 diabetes (T2D) and type 1 diabetes (T1D).
- Evaluation of adverse events (AEs), hypersensitivity, injection-site reactions, medication errors, and time to major adverse cardiovascular event (MACE).
Main Results:
- Similar overall, serious, and severe AE rates between icodec and comparator groups (events/100 patient-years).
- Comparable rates of hypersensitivity and injection-site reactions.
- Similar time to first MACE between treatment groups (HR: 0.93 [95% CI: 0.56-1.56]).
Conclusions:
- Once-weekly insulin icodec demonstrates a safety profile generally similar to once-daily basal insulins.
- The safety findings support the use of icodec in adults with T1D and T2D.
- Further analysis confirms the safety of icodec beyond hypoglycemia in large-scale trials.
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