Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5)) : A Randomized Trial
An erratum to this article was published (Ann Intern Med, Dec 2023 ↗)
Primary result · Change in HbA1cResult — go to the resultEstimated treatment difference −0.38 percentage points 95% CI −0.66 to −0.09Authors' conclusion
Compared with OD analogues, icodec with app showed superior HbA1c reduction and improved treatment satisfaction and compliance with similarly low hypoglycemia rates.
Study context
- Population
- Insulin-naive adults with T2D, 176 sites in 7 countries
- Participants
- 1,085 adults
- Comparison
- Once-weekly insulin icodec with dosing guide app vs once-daily basal insulin analogues
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 52
Methodological detailsopen-label, parallel-group, phase 3a, real-world elements, prespecified hierarchical testing, multinational
- Open-label
- Parallel-group
- Phase 3a
- Real-world elements
- Prespecified hierarchical testing
- Multinational
Primary result
Change in HbA1c · baseline to week 52
Estimated treatment difference
−0.38 percentage points
95% CI −0.66 to −0.09
P < 0.001 for noninferiority; P = 0.009 for superiority
Icodec with appvs OD analogues
estimated treatment difference −0.38 percentage points (95% CI −0.66 to −0.09); P < 0.001 for noninferiority; P = 0.009 for superiority
As reported in the abstract
Secondary outcomes
| Outcome | ETD (CI) | |
|---|---|---|
| TRIM-D compliance domain score · week 52More favorable with icodec with app | 3.04 (1.28–4.81) | |
| Change in DTSQ total treatment satisfaction score · week 52More favorable with icodec with app | 0.78 (0.10–1.47) | |
| −20246Difference (linear scale) |
Safety
Clinically significant or severe hypoglycemia
- Rates low and similar with both treatments
Original publication
Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5)) : A Randomized Trial. Ann Intern Med. Published 26 September 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →