Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial
Primary result · Change in HbA1cResult — go to the resultEstimated treatment difference 0.02 percentage points 95% CI −0.11 to 0.15Authors' conclusion
In people with long-standing type 2 diabetes on a basal-bolus regimen, once-weekly icodec showed similar improvements in glycaemic control, with fewer basal insulin injections, lower bolus insulin dose, and with no increase in hypoglycaemic rates compared with once-daily glargine U100. Key strengths of this trial include the use of masked continous glucose monitoring; the high trial completion rate; and the inclusion of a large, diverse, and multinational population. Limitations include the relatively short trial duration and the open-label design.
Study context
- Population
- Adults with long-standing T2D on a basal-bolus regimen (HbA1c 7.0–10.0%), 80 sites in nine countries; mean diabetes duration 17.1 years (SD 8.4)randomised 1:1
- Participants
- 582 adults
- Comparison
- Once-weekly icodec vs once-daily glargine U100, both with bolus insulin aspart
- Icodecn = 291
- Glargine U100n = 291reference
- Primary endpoint
- Change in HbA1c from baseline (non-inferiority margin 0.3 percentage points)
- Follow-up
- Week 26
Methodological detailsphase 3a, open-label, multicentre, treat-to-target, non-inferiority, Between May 14 and Oct 29, 2021; 746 screened
- Phase 3a
- Open-label
- Multicentre
- Treat-to-target
- Non-inferiority
- Between May 14 and Oct 29, 2021; 746 screened
Primary result
Change in HbA1c
Estimated treatment difference
0.02 percentage points
95% CI −0.11 to 0.15
P < 0.0001
Change by group
Icodec
−1.16
estimated mean change · percentage points
Glargine U100
−1.18
estimated mean change · percentage points
As reported in the abstract
Safety
Adverse events · safety analysis set
Serious adverse events
Serious adverse events reported Icodec 35 · Glargine U100 33
Combined level 2 and level 3 hypoglycaemia
- Rates similar between treatment groups
- No new safety concerns identified for icodec
Original publication
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