AIMS: In the QWINT-1 phase 3 Trial, once-weekly insulin efsitora alfa (efsitora) administered using an innovative fixed-dose regimen demonstrated noninferior HbA1c reduction versus once-daily insulin glargine U100 (glargine) over 52 weeks in insulin-naïve adults with type 2 diabetes. This report focuses on baseline characteristics and clinical outcomes of efsitora-treated participants based on their insulin dose at Week 52 (N = 303). METHODS: Efsitora was dosed using a fixed-dose titration regimen with 100, 150, 250 and 400 U fixed-doses titrated as needed every 4 weeks to achieve fasting blood glucose (FBG) of 80-130 mg/dL (4.4-7.2 mmol/L). Participants not at target FBG on the 400 U fixed-dose after ≥ 4 weeks transitioned to flexible dosing using an efsitora multi-dose pen. Glargine was administered using a multi-dose pen and titrated weekly to the same target. Analyses assessed clinical characteristics and glycaemic outcomes by efsitora dose at Week 52, and hypoglycaemia after fixed-dose increases. RESULTS: Participants requiring higher Week 52 efsitora doses had greater baseline weight, HbA1c and fasting glucose, and more were male. Most participants (76%) remained on a fixed efsitora dose, and the majority established their final dose by Week 16. All efsitora fixed-doses resulted in robust HbA1c lowering, with mean final HbA1c < 7.0%. Based on events within 4-week periods after an efsitora fixed-dose increase, estimated rates of combined Level 2 and 3 hypoglycaemia were < 0.5 events/year. CONCLUSIONS: In QWINT-1, the innovative fixed-dose efsitora simple titration resulted in effective HbA1c lowering for all fixed doses. Rates of clinically meaningful hypoglycaemia were low after fixed-dose increases.
Connery et al. (2026) studied this question.