Eli Lilly and Company (NYSE: LLY) announced positive topline results from the QWINT-2 and QWINT-4 phase 3 clinical trials for once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes. These trials included both insulin-naïve patients and those requiring multiple daily insulin injections. Efsitora demonstrated non-inferior A1C reduction compared to the most commonly used daily basal insulins.
Jeff Emmick, MD, Ph.D., senior vice president of product development at Lilly, stated, “The results of QWINT-2 and QWINT-4 are a significant milestone for the diabetes community. Efsitora offers an innovative once-weekly solution that safely achieves and maintains A1C control, reduces the treatment burden of daily injections, and potentially improves adherence for people with diabetes.”
QWINT-2 compared the efficacy and safety of once-weekly efsitora to once-daily insulin degludec over 52 weeks. Insulin-naïve adults with type 2 diabetes were randomized to receive either efsitora weekly or insulin degludec daily. Efsitora showed non-inferior A1C reduction, decreasing A1C by 1.34% compared to 1.26% for insulin degludec, resulting in final A1C levels of 6.87% and 6.95%, respectively. Participants on efsitora also spent more time in the target glucose range without additional hypoglycemia.
QWINT-4 evaluated efsitora against insulin glargine over 26 weeks in adults with type 2 diabetes previously treated with basal insulin and multiple daily mealtime insulin injections. Both efsitora and insulin glargine reduced A1C by 1.07%, with final A1C levels of 7.12% and 7.11%, respectively.
In both trials, efsitora was safe and well-tolerated, with comparable rates of hypoglycemic events to daily insulins. Detailed results from QWINT-2 will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024, with additional data from other QWINT trials expected later this year.
The QWINT phase 3 global clinical development program for insulin efsitora alfa began in 2022, enrolling over 4,000 participants with type 1 or type 2 diabetes across five global registration studies.
- QWINT-2 (NCT05362058): A 52-week, open-label, treat-to-target trial comparing weekly efsitora to daily insulin degludec in insulin-naïve adults with type 2 diabetes.
- QWINT-4 (NCT05462756): A 26-week, open-label, treat-to-target trial comparing weekly efsitora to daily insulin glargine in adults with type 2 diabetes previously treated with basal insulin and multiple mealtime injections.
Insulin efsitora alfa is a once-weekly basal insulin combining a novel insulin variant with a human IgG2 Fc domain. It is designed for stable glucose levels with less variability, making it a promising option for adults with type 1 and 2 diabetes.
