Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 1 diabetes (QWINT-5): a phase 3 randomised non-inferiority trial
Primary result · Mean HbA1c change from baselineResult — go to the resultEstimated treatment difference 0.052 % 95% CI −0.077 to 0.181Authors' conclusion
In adults with type 1 diabetes, once-weekly efsitora showed non-inferior HbA1c reduction compared with daily insulin degludec. Higher rates of combined level 2 or level 3 hypoglycaemia and greater incidence of severe hypoglycaemia in participants treated with efsitora compared with participants treated with degludec might suggest the need for additional evaluation of efsitora dose initiation and optimisation in people with type 1 diabetes.
Study context
- Population
- Adults aged ≥18 years with T1D and haemoglobin A1c (HbA1c) 7.0–10.0% (53.0–85.8 mmol/mol)623 completed
- Participants
- 692 adults
- Comparison
- Once-weekly efsitora vs once-daily degludec, both with insulin lispro
- Efsitoran = 343
- Degludecn = 349reference
- Primary endpoint
- Change in HbA1c from baseline (non-inferiority margin 0.4%)
- Follow-up
- Week 26
Methodological detailsphase 3, parallel-design, open-label, treat-to-target, non-inferiority, multicentre (82 global health-care centres), Enrolled Aug 12, 2022 to May 7, 2024; 893 enrolled, 692 (77%) randomised 1:1, 623 (90%) completed; 52-week study
- Phase 3
- Parallel-design
- Open-label
- Treat-to-target
- Non-inferiority
- Multicentre (82 global health-care centres)
- Enrolled Aug 12, 2022 to May 7, 2024; 893 enrolled, 692 (77%) randomised 1:1, 623 (90%) completed; 52-week study
Primary result
Mean HbA1c change from baseline
Estimated treatment difference
0.052 %
95% CI −0.077 to 0.181
P = 0.43
Change by group
Efsitora
−0.51
mean · %
Degludec
−0.56
mean · %
As reported in the abstract
Further findings
| Outcome | Efsitora | Degludec |
|---|---|---|
| Mean HbA1c · baseline to week 26 | mean 7.88% at baseline to 7.41% at week 26 | mean 7.94% at baseline to 7.36% at week 26 |
Safety
| Outcome | Efsitora | Degludec | Estimated rate ratio (95% CI) | P value | |
|---|---|---|---|---|---|
| Combined level 2 (<54 mg/dL [3.0 mmol/L]) or level 3 severe hypoglycaemia rate · weeks 0-52Events per patient year of exposure | 14.03 | 11.59 | 1.21 (1.04–1.41) | P = 0.016 | |
| 0.512Estimated rate ratio (log scale) |
Severe hypoglycaemia incidence · weeks 0-52
- Combined level 2 (<54 mg/dL [3.0 mmol/L]) or level 3 severe hypoglycaemia rate: highest rates during weeks 0-12
Treatment-emergent adverse events and deaths
- Death not related to study treatment, degludec
- 1
- Overall incidence of treatment-emergent adverse events was similar across groups
Original publication
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