Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial
Primary result · HbA1cResult — go to the resultEstimated treatment difference −0.2 percentage points 95% CI −0.3 to −0.1Authors' conclusion
Among people with insulin-naive type 2 diabetes, once-weekly icodec demonstrated superior HbA1c reduction to once-daily degludec after 26 weeks of treatment, with no difference in weight change and a higher rate of combined level 2 or 3 hypoglycemic events in the context of less than 1 event per patient-year exposure in both groups.
Study context
- Population
- Adults with insulin-naive T2D on any noninsulin glucose-lowering agents, hemoglobin A1c (HbA1c) 7%-11% (53–97 mmol/mol); mean age 58 years, 37% women564 completed
- Participants
- 588 adults
- Comparison
- Once-weekly icodec vs once-daily degludec
- Icodecn = 294
- Degludecn = 294reference
- Primary endpoint
- Change in HbA1c from baseline (noninferiority margin, 0.3% percentage points)
- Follow-up
- Week 26
Methodological detailsdouble-masked, noninferiority, treat-to-target, phase 3a, 92 sites in 11 countries, Conducted March 2021 to June 2022
- Double-masked
- Noninferiority
- Treat-to-target
- Phase 3a
- 92 sites in 11 countries
- Conducted March 2021 to June 2022
Primary result
HbA1c · 26 weeks
Estimated treatment difference
−0.2 percentage points
95% CI −0.3 to −0.1
P < 0.001 for noninferiority
By group
As reported in the abstract
Secondary outcomes
| Outcome | ETD (mg/dL) (95% CI) | P value | |
|---|---|---|---|
| FPG change · baseline to week 26 | 0 (−6 to 5) | P = 0.90 | |
| −10−50510Difference, mg/dL (linear scale) |
kg
| Outcome | Icodec | Degludec | ETD (kg) (95% CI) | P value | |
|---|---|---|---|---|---|
| Body weight change · baseline to week 26 | 2.8 | 2.3 | 0.46 (−0.19 to 1.10) | P = 0.17 | |
| −0.500.511.5Difference, kg (linear scale) |
Mean weekly insulin dose · last 2 weeks of treatment
- No significant difference between icodec and degludec
Safety
Combined level 2 or 3 hypoglycemia · week 0 to 31 · numerically higher with icodec
P = 0.11
Combined level 2 or 3 hypoglycemia · week 0 to 26 · statistically higher with icodec
P = 0.01
Original publication
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