Once‐weekly insulin icodec compared with daily basal insulin analogues in type 2 diabetes: Participant‐level meta‐analysis of the ONWARDS 1–5 trials
Authors' conclusion
Icodec was associated with a similar incidence but higher rates of clinically significant hypoglycaemia (equating to one additional hypoglycaemic episode every 6 years) and fewer severe hypoglycaemic episodes versus comparators. Our findings also confirmed the greater efficacy of icodec that was demonstrated in the ONWARDS trial programme.
Study context
- Population
- Participants with T2D randomised in ONWARDS 1–5, pooled as overall T2D, insulin-naive and insulin-experienced subgroups, and by trial comparatorONWARDS 1–5 pooled
- Participants
- 3,765 participants
- Comparison
- Once-weekly insulin icodec vs once-daily basal insulin analogues
- Icodecn = 1,882
- Comparatorsn = 1,883reference
- Outcome
- Incidence and rates of clinically significant and severe hypoglycaemia
Methodological detailspooled analysis
- Pooled analysis
Pooled result
As reported in the abstract
Clinically significant hypoglycaemia (overall T2D pool)
Icodec vs ComparatorsEstimate (95% CI)
Incidence similar
OR (incidence) 1.14(0.94–1.38)
Rates low but significantly higher with icodec
estimated rate ratio 1.51(1.24–1.85)
- Severe hypoglycaemic episodes, icodec vs comparators
- 8 vs. 18
Further pooled results
| Outcome | Estimate | P value |
|---|---|---|
| Change in HbA1c from baseline, all subgroupsGreater reduction with icodec, irrespective of subgroup | estimated treatment difference range −0.10 to −0.29 % | all p < 0.05 |
| HbA1c <53 mmol/mol (7.0%) without clinically significant or severe hypoglycaemia, subgroups except insulin-experiencedGreater odds with icodec · not greater in the insulin-experienced subgroup | OR range 1.30-1.55 | all p < 0.05 |
Safety
Hypoglycaemia (see key findings)
- Severe hypoglycaemic episodes, icodec vs comparators
- 8 vs. 18
- Clinically significant hypoglycaemia rate ratio, icodec vs comparators
- 1.51
Original publication
Once‐weekly insulin icodec compared with daily basal insulin analogues in type 2 diabetes: Participant‐level meta‐analysis of the ONWARDS 1–5 trials. Diabetes Obes Metab. Published 1 July 2024. doi:10. 1111/ dom. 15726
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