Once-weekly dose of insulin efsitora alfa delivers A1C reduction consistent with the most advanced daily insulin in people with type 2 diabetes
Once-weekly dose of insulin efsitora alfa delivers A1C reduction consistent with the most advanced daily insulin in people with type 2 diabetes |
[10-September-2024] |
In QWINT-2, efsitora helped adults naïve to insulin therapy currently using and not using GLP-1 receptor agonists achieve an A1C below 7% Detailed results were published in The New England Journal of Medicine and simultaneously presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024 INDIANAPOLIS, Sept. 10, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from the QWINT-2 phase 3 trial evaluating once-weekly insulin efsitora alfa (efsitora) compared to once-daily insulin degludec in adults with type 2 diabetes using insulin for the first time (insulin naïve). The data were published in The New England Journal of Medicine (NEJM) and simultaneously presented today at the European Association for the Study of Diabetes (EASD) 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 (glucose <54 mg/dL) 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." Full Results
"For the past century, we've been searching for the next scientific breakthrough that would alleviate the complexity that comes with starting insulin treatment," said Jeff Emmick, M.D., Ph.D., senior vice president, product development, Lilly. "With these results, we believe we're headed towards a future where people with type 2 diabetes who use basal insulin can achieve their desired results with a simple treatment option like efsitora." In the trial, efsitora demonstrated a safety profile similar to daily insulins. There were no severe hypoglycemic events reported during treatment with efsitora compared to six reported with insulin degludec. Overall hypoglycemia rates in the study were low, with estimated combined rates of severe or clinically significant (blood glucose <54 mg/dL) hypoglycemic events per patient-year of exposure of 0.58 with efsitora vs. 0.45 with insulin degludec. Estimated combined rates of severe or clinically significant nocturnal hypoglycemic events per patient-year of exposure were 0.08 with both efsitora and insulin degludec. Additionally, rates of hypoglycemia were similar among people currently using GLP-1s and those not using GLP-1s. Adverse events were similar between treatment groups in the trial. Detailed results for QWINT-5 are also being presented at EASD and simultaneously published in The Lancet. About the QWINT clinical trial program QWINT-2 (NCT05362058) 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-naïve adults with type 2 diabetes. The trial randomized 928 participants across the U.S., Brazil, Canada, China, Czechia (Czech Republic), 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. About insulin efsitora alfa About Lilly Cautionary Statement Regarding Forward-Looking Statements 1 The efficacy estimand represents the treatment effect had all participants adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia.
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