Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial
Primary result · Change in HbA1cResult — go to the resultEstimated treatment difference 0.05 percentage points 95% CI −0.13 to 0.23Authors' conclusion
In adults with type 1 diabetes, once-weekly icodec showed non-inferiority to once-daily degludec in HbA1c reduction at week 26, with statistically significantly higher rates of combined clinically significant or severe hypoglycaemia. For icodec, time below 3.0 mmol/L (<54 mg/dL) was at the threshold of the internationally recommended target (<1%) during weeks 22-26 and below target during weeks 48-52.
Study context
- Population
- Adults with T1D and HbA1c <10.0% (86 mmol/mol)randomised 1:1
- Participants
- 582 adults
- Comparison
- Once-weekly insulin icodec vs once-daily insulin degludec, both with insulin aspart
- Icodecn = 290
- Degludecn = 292reference
- Primary endpoint
- Change in HbA1c from baseline, tested for non-inferiority (0.3 percentage point margin)
- Follow-up
- Week 26
Methodological detailsopen-label, treat-to-target, phase 3a, non-inferiority, 99 sites across 12 countries, 52 weeks: 26-week main phase plus 26-week safety extension, Enrolment April 30 to Oct 15, 2021; 655 screened
- Open-label
- Treat-to-target
- Phase 3a
- Non-inferiority
- 99 sites across 12 countries
- 52 weeks: 26-week main phase plus 26-week safety extension
- Enrolment April 30 to Oct 15, 2021; 655 screened
Primary result
Change in HbA1c
Estimated treatment difference
0.05 percentage points
95% CI −0.13 to 0.23
P = 0.0065 for non-inferiority
Change by group
Icodec
−0.47
estimated mean change · percentage points
Degludec
−0.51
estimated mean change · percentage points
As reported in the abstract
Further findings
Baseline HbA1c
| Outcome | Icodec | Degludec |
|---|---|---|
| DeathJudged unlikely to be due to the trial product | 1 events | — not stated in the abstract |
— not stated in the abstract
Safety
| Outcome | Icodec | Degludec | Estimated rate ratio (95% CI) | P value | |
|---|---|---|---|---|---|
| Combined clinically significant or severe hypoglycaemia · baseline to week 26Events per patient-year of exposure | 19.9 | 10.4 | 1.9 (1.5–2.3) | P < 0.0001 | |
| 0.512Estimated rate ratio (log scale) |
Serious adverse events
Serious adverse events Icodec 39 · Degludec 25
Combined clinically significant or severe hypoglycaemia · baseline to week 26
- Rate also significantly higher with icodec over 57 weeks (52 weeks plus 5-week follow-up)
Original publication
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