Once‐weekly insulin efsitora alfa: Design and rationale for the QWINT phase 3 clinical development programme
Study context
- Population
- Insulin-naïve adults with T2D (QWINT-1, −2), adults with T2D previously on basal insulin (QWINT-3, −4), adults with T1D (QWINT-5)5 trials
- Planned comparison
- Once-weekly insulin efsitora alfa vs once-daily basal insulin comparators (insulin glargine U100 or insulin degludec U100)
- Primary endpoint
- Change in HbA1c from baseline, efsitora vs active comparator
- Follow-up
- Week 26 or 52
Methodological detailsfive trials (QWINT-1 to QWINT-5), multicentre, randomized, controlled, open-label, treat-to-target, Key secondary objectives: change in fasting glucose, insulin dose, CGM variables and patient-reported outcome questionnaires
- Five trials (QWINT-1 to QWINT-5)
- Multicentre
- Randomized
- Controlled
- Open-label
- Treat-to-target
- Key secondary objectives: change in fasting glucose, insulin dose, CGM variables and patient-reported outcome questionnaires
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Once‐weekly insulin efsitora alfa: Design and rationale for the QWINT phase 3 clinical development programme. Diabetes Obes Metab. Published 28 April 2024. doi:10.
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