Weekly Insulin Efsitora Alfa Matches Daily Insulin in A1C Reduction for Type 2 Diabetes

INDIANAPOLIS, Sept. 10, 2024. Eli Lilly and Company has unveiled detailed findings from the QWINT-2 phase 3 trial, which assessed the effectiveness of once-weekly insulin efsitora alfa (efsitora) against the once-daily insulin degludec in adults newly initiating insulin therapy for type 2 diabetes. These results were published in The New England Journal of Medicine (NEJM) and concurrently presented at the 2024 European Association for the Study of Diabetes (EASD) Annual Meeting.

The trial demonstrated that efsitora met its primary goal by showing non-inferior reduction in A1C levels. Specifically, efsitora reduced A1C by 1.34%, compared to insulin degludec's reduction of 1.26%, resulting in final A1C levels of 6.87% and 6.95%, respectively, after 52 weeks. Participants using efsitora also experienced an additional 45 minutes per day within the target blood glucose range, a significant secondary endpoint, without an increase in hypoglycemic episodes (glucose <54 mg/dL) compared to those using insulin degludec.

Dr. Carol Wysham, clinical professor of medicine at the University of Washington School of Medicine, emphasized the potential of efsitora to simplify insulin therapy and improve adherence, a common challenge for patients with type 2 diabetes. She highlighted that efsitora could significantly impact the lives of patients seeking a once-weekly insulin regimen that delivers comparable results to daily treatments.

Dr. Jeff Emmick, senior vice president of product development at Lilly, expressed optimism about the trial results, indicating that efsitora could represent a breakthrough in simplifying basal insulin therapy for people with type 2 diabetes. He noted that this new treatment could help patients achieve their desired outcomes with a less complex regimen.

The safety profile of efsitora was comparable to that of daily insulins. No severe hypoglycemic events were recorded with efsitora, whereas six such events were noted with insulin degludec. The overall rates of hypoglycemia were low, with a combined rate of severe or clinically significant hypoglycemic episodes per patient-year of exposure being 0.58 for efsitora versus 0.45 for insulin degludec. Additionally, the rates of nocturnal hypoglycemia were identical for both treatments. The study also found that hypoglycemia rates were similar among participants, regardless of their use of GLP-1 receptor agonists. Adverse events were evenly distributed across both treatment groups.

Detailed findings from the QWINT-5 study were also shared at the EASD meeting and published in The Lancet.

The QWINT clinical trial program commenced in 2022 and involves over 4,000 individuals with type 1 or type 2 diabetes across five global studies. The QWINT-2 trial was a randomized, controlled study where 928 insulin-naïve adults with type 2 diabetes from various countries, including the U.S., Brazil, and China, were assigned to receive either once-weekly efsitora or daily insulin degludec. The primary aim was to verify the non-inferiority of efsitora in reducing A1C levels over 52 weeks compared to insulin degludec. The trial also evaluated the safety and efficacy for patients using and not using GLP-1 receptor agonists.

Insulin efsitora alfa is a novel once-weekly basal insulin designed to maintain stable glucose levels throughout the week due to its low peak-to-trough ratio. It is currently in phase 3 development for adults with type 1 and 2 diabetes.

Eli Lilly and Company, a leading medicine firm, has been at the forefront of medical innovation for nearly 150 years. Their research spans various health challenges, including diabetes, obesity, Alzheimer's disease, immune disorders, and cancer. Their commitment extends to delivering diverse, inclusive clinical trials and ensuring accessible and affordable medicines.

 

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