Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial
An erratum to this article was published (Lancet, 18 Oct 2025 ↗)
Primary result · Least-squares mean change in HbA1cResult — go to the resultEstimated treatment difference −0.09 percentage points 95% CI −0.19 to 0.01Authors' conclusion
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 (≥18 years) with T2D on basal insulin, up to three non-insulin glucose-lowering medications without prandial insulin, haemoglobin A1c (HbA1c) 6.5–10.0% (48–86 mmol/mol); median age 62.0 years, 44% femalerandomised 2:1
- Participants
- 986 adults
- Comparison
- Once-weekly efsitora vs once-daily degludec
- Efsitoran = 655
- Degludecn = 331reference
- Primary endpoint
- Change in least-squares mean HbA1c from baseline; non-inferiority margin 0.4%
- Follow-up
- Week 26
Methodological detailsphase 3, parallel-design, open-label, treat-to-target, non-inferiority, 127 sites across nine countries
- Phase 3
- Parallel-design
- Open-label
- Treat-to-target
- Non-inferiority
- 127 sites across nine countries
Primary result
Least-squares mean change in HbA1c · baseline to week 26
Estimated treatment difference
−0.09 percentage points
95% CI −0.19 to 0.01
Change by group
Efsitora
−0.81
least-squares mean · SE 0.03 · percentage points
Degludec
−0.72
least-squares mean · SE 0.04 · percentage points
As reported in the abstract
Further findings
Events
| Outcome | Efsitora | Degludec |
|---|---|---|
| Deaths | 7 | 2 |
Deaths
- None related to study treatment
Safety
| Outcome | Efsitora | Degludec | Estimated rate ratio (95% CI) | P value | |
|---|---|---|---|---|---|
| Combined level 2 or level 3 (severe) hypoglycaemia events · baseline to week 78 | 41% | 37% | 1.14 (0.83–1.56) | P = 0.43 | |
| Events per patient-year of exposure | 0.84 | 0.74 | |||
| Events | 754 | 346 | |||
| 0.512Estimated rate ratio (log scale) |
Serious adverse events
Related to treatment Efsitora 7 [1%] · Degludec 1 [<1%]
Serious adverse events
- Most frequent (at ∼1%) primarily cardiovascular-related in both groups
Original publication
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