Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial
An erratum to this article was published (Lancet, 4 Oct 2025 ↗)
Authors' conclusion
Efsitora showed non-inferior HbA1c reductions and similar rates of combined clinically significant or severe hypoglycaemia versus glargine U100 in participants with type 2 diabetes treated with basal and prandial insulin. These findings show that efsitora is a well tolerated and efficacious once-weekly alternative to daily basal insulin, with a reduced injection frequency, for the treatment of adults with type 2 diabetes.
Study context
- Population
- Adults with T2D (HbA1c 7.0–10.0%) treated with basal and prandial insulin and up to three non-insulin glucose-lowering agents; 78 outpatient clinics and hospitals in 7 countries; mean age 58.9 years, 51% femalerandomised 1:1
- Participants
- 730 adults
- Comparison
- Once-weekly efsitora vs once-daily glargine U100, both with prandial insulin lispro
- Efsitoran = 365
- Glargine U100n = 365reference
- Primary endpoint
- HbA1c change from baseline (non-inferiority margin 0.4%)
- Follow-up
- Week 26
Methodological detailsphase 3, 26-week, parallel-design, open-label, treat-to-target, non-inferiority, multicentre
- Phase 3
- 26-week
- Parallel-design
- Open-label
- Treat-to-target
- Non-inferiority
- Multicentre
Primary result
As reported in the abstract
Efsitora
−1.01
percentage points
Glargine U100
−1.00
percentage points
Further findings
LS mean HbA1c at baseline · treatment regimen estimand
LS mean HbA1c · week 26
Safety
| Outcome | Efsitora | Glargine U100 | Estimated rate ratio (95% CI) | P value | |
|---|---|---|---|---|---|
| Overall level 2 or level 3 (severe) hypoglycaemia · treatment periodEvents per patient-year of exposure | 6.6 | 5.9 | 1.11 (0.85–1.44) | P = 0.44 | |
| Nocturnal level 2 or level 3 (severe) hypoglycaemia · treatment periodEvents per patient-year of exposure | 0.67 | 1.00 | 0.67 (0.44–1.01) | P = 0.058 | |
| 0.512Estimated rate ratio (log scale) |
Serious adverse events
Serious adverse events
- Adverse event occurrence was similar between groups
Original publication
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