Once-Weekly Insulin Icodec: Safety Profile in Type 2 and Type 1 Diabetes Based on a Pooled Analysis of ONWARDS 1-6
Authors' conclusion
Based on a detailed evaluation of safety focus areas across the ONWARDS 1-6 trials, the safety profile of once-weekly icodec was generally similar to that of once-daily basal insulin comparators in individuals with type 2 diabetes or type 1 diabetes.
Study context
- Population
- Insulin-naive and insulin-experienced adults with T2D, and insulin-experienced adults with T1D
- Participants
- 2,170 vs 2,170
- Comparison
- Once-weekly insulin icodec vs once-daily basal insulin comparators
- Icodecn = 2,170
- Comparatorsn = 2,170reference
- Outcome
- Adjusted AE rates (events/100 PYE)
- Follow-up
- All trial periods
Pooled result
As reported in the abstract
All adverse event (AEs), Icodec vs Comparators
248.49 vs 242.53
Serious AEs, Icodec vs Comparators
14.51 vs 14.03
Severe AEs, Icodec vs Comparators
7.92 vs 7.50
Further pooled results
Treatment exposure (patient-years of exposure)
Safety
Hypersensitivity, adjusted rate (events/100 PYE)
Injection-site reactions, adjusted rate (events/100 PYE) · Most injection-site reactions were mild
Medication errors
- Medication error rates reported (events/100 patient-years of exposure (PYE)); the sentence does not name the groups
Time to first MACE
- Time to first MACE similar between groups; HR
- 0.93 (0.56-1.56) (95% CI)
Other AEs
- Adjusted rates for other AEs were broadly similar between groups
Original publication
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