Eli Lilly: QWING-2 ph3 trial met primary endpoint of non-inferior A1C reduction

Eli Lilly and Company announced detailed results from the QWINT-2 phase 3 trial evaluating once-weekly insulin efsitora alfa compared to once-daily insulin degludec in adults with type 2 diabetes using insulin for the first time. The data were published in The New England Journal of Medicine and simultaneously presented today at the European Association for the Study of Diabetes Annual Meeting 2024. In the trial, efsitora met the primary endpoint of non-inferior A1C reduction. For the efficacy estimand1,2, efsitora reduced A1C by 1.34% compared to 1.26% for insulin degludec resulting in an A1C of 6.87% and 6.95% respectively3 at 52 weeks. Additionally, participants taking efsitora achieved 45 minutes more time in range4 per day, a key secondary endpoint, without additional time in hypoglycemia in comparison to insulin degludec for the efficacy estimand. “Traditionally, basal insulins are dosed once a day – a treatment schedule that can make compliance difficult for a significant portion of people living with type 2 diabetes,” said Carol Wysham, M.D., clinical professor of medicine at the University of Washington School of Medicine. “Efsitora has the potential to address treatment burden and improve adherence – all while lowering A1C. These results can make a significant impact for people living with type 2 diabetes looking for a once-weekly option that provides similar outcomes as daily insulins.” QWINT-2 was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 52 weeks in insulin-naive adults with type 2 diabetes. The trial randomized 928 participants across the U.S., Brazil, Canada, China, Czechia, Germany, Greece, Japan, Korea, Mexico and Puerto Rico to receive efsitora once weekly or insulin degludec once daily administered subcutaneously. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to insulin degludec. The trial was also designed to assess efficacy and safety for patients using and not using GLP-1 receptor agonists.