Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial
An erratum to this article was published (Lancet Diabetes Endocrinol, Jul 2023 ↗)
Authors' conclusion
Among adults with basal insulin-treated type 2 diabetes, treatment with once-weekly icodec versus once-daily degludec demonstrated non-inferiority and statistical superiority in HbA1c reduction after 26 weeks, associated with modest weight gain. Overall rates of hypoglycaemia were low, with numerically but not statistically significantly higher event rates of level 2 or level 3 hypoglycaemia with icodec versus degludec.
Study context
- Population
- Adults with T2D inadequately controlled on once-daily or twice-daily basal insulin, with or without non-insulin glucose-lowering agents; 71 sites in nine countriesrandomized 1:1
- Participants
- 526 adults
- Comparison
- Once-weekly insulin icodec vs once-daily insulin degludec
- Icodecn = 263
- Degludecn = 263reference
- Primary endpoint
- Change from baseline in HbA1c; non-inferiority margin 0.3 percentage points
- Follow-up
- Week 26
Methodological detailsphase 3a, open-label, active-controlled, multicentre, treat-to-target, non-inferiority
- Phase 3a
- Open-label
- Active-controlled
- Multicentre
- Treat-to-target
- Non-inferiority
Primary result
As reported in the abstract
Non-inferiority margin 0.3 as printed, not drawn
Further findings
HbA1c at baseline · mean baseline
Estimated mean, kg
| Outcome | Icodec | Degludec | ETD (95% CI) | |
|---|---|---|---|---|
| Change in bodyweight · baseline to week 26 | +1.40 | −0.30 | 1.70 (0.76–2.63) | |
| −2024Difference (linear scale) |
Safety
Events per patient-year
| Outcome | Icodec | Degludec | Estimated rate ratio (95% CI) | |
|---|---|---|---|---|
| Combined level 2 or level 3 hypoglycaemia (events per patient-year of exposure) | 0.73 | 0.27 | 1.93 (0.93–4.02) | |
| 0.20.5125Estimated rate ratio (log scale) |
Adverse events
n receiving Icodec 262 · Degludec 263
Serious adverse events
- Serious adverse events — Serious AE possibly related to treatment (degludec)
- 1
Serious adverse events
- No new safety issues identified with icodec vs degludec
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →