Efficacy and Safety of Intensifying Once‐Weekly Insulin Icodec Treatment With Once‐Weekly Semaglutide in Adults With Type 2 Diabetes: A Single‐Arm, Open‐Label, Treat‐to‐Target, Phase 3b Trial ( ONWARDS 8)
Main finding · Change in HbA1cResult — go to the resultEstimated mean change −1.23 %-points 95% CI −1.39 to −1.07Authors' conclusion
Intensification of icodec with semaglutide was feasible, with low rates of clinically significant or severe hypoglycaemia.
Study context
- Population
- Adults with T2D (HbA1c 7.5%-10.5%) on daily basal insulin, not on a GLP-1 RA; eligible for intensification if HbA1c >7.0% and ≤10.5% after icodec run-in94 initiated semaglutide
- Participants
- 148 adults
- Comparison
- Intensification of once-weekly insulin icodec with once-weekly semaglutide
- Icodec + semaglutiden = 94
- Outcome
- Change in HbA1c
- Follow-up
- Week 26 (baseline) to Week 52
Methodological detailsopen-label, treat-to-target, phase 3b, 26-week icodec run-in period
- Open-label
- Treat-to-target
- Phase 3b
- 26-week icodec run-in period
Main finding
As reported in the abstract
baseline to Week 52
Estimated mean change
−1.23 %-points
95% CI −1.39 to −1.07
P < 0.0001
Week 52vs baseline
estimated mean change −1.23 %-points (95% CI −1.39 to −1.07); P < 0.0001
Further findings
Changes from baseline to Week 52
- 7-point SMBG profile change
- −1.72 mmol/L
- Postprandial glucose increment change
- −1.31 mmol/L
- Body weight change
- −3.85 kg
- All p < 0.0001
Relative decrease in mean weekly icodec dose · Week 25 to Week 52
- Relative decrease in mean weekly icodec dose
- 24%
- Participants with icodec dose reduced by 20% at Week 26, per protocol
- 69.1%
Safety
Combined clinically significant or severe hypoglycaemia · baseline to Week 57 (end of trial)
- Rate of combined clinically significant or severe hypoglycaemia
- 0.24 episodes per person-year of exposure
Original publication
Efficacy and Safety of Intensifying Once‐Weekly Insulin Icodec Treatment With Once‐Weekly Semaglutide in Adults With Type 2 Diabetes: A Single‐Arm, Open‐Label, Treat‐to‐Target, Phase 3b Trial ( ONWARDS 8). Diabetes Obes Metab. Published 1 July 2026. doi:10.
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