Efsitora Demonstrates Non-Inferiority vs. Insulin Glargine, Degludec for Type 2 Diabetes

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Eli Lilly has announced promising results from the QWINT-1 and QWINT-3 trials, which evaluated once-weekly insulin efsitora alfa (efsitora) for type 2 diabetes. The trial included patients who were using basal insulin for the first time (insulin-naïve) and patients who have switched from daily basal insulin injections. Results found that efsitora showed non-inferior A1C reduction compared to the most frequently used daily basal insulins.¹

"Once weekly insulins, like efsitora, have the potential to transform diabetes care as we know it," said Jeff Emmick, MD, PhD, SVP, product development, Lilly, in a press release. "Many patients are reluctant to start insulin because of the burden it places on them. With a simple fixed-dose regimen, once-weekly efsitora could make it easier for people with diabetes to start and manage insulin therapy, while reducing the impact it has on their day-to-day lives."

QWINT-1 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 using a fixed dose compared to insulin glargine for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial consisted of 796 patients from the United States, Mexico, Argentina, and Puerto Rico, who were randomly assigned to receive efsitora once weekly or insulin glargine once daily administered subcutaneously, starting with a dose of 100 units followed by a fixed dose escalation to achieve a target fasting blood glucose of 80-130 mg/dL. The primary endpoint of this study was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to insulin glargine.

QWINT-3 was a multicenter, randomized, parallel-design, open-label trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 78 weeks after a three-week lead-in period and followed by a five-week safety follow-up period in adults with type 2 diabetes currently treated with basal insulin. In this trial, 986 patients were randomly assigned across the United States, Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain, and Taiwan to receive efsitora once weekly or insulin degludec once daily administered subcutaneously. Similar to the QWINT-1 study, the primary endpoint was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin degludec.

Both trials demonstrated non-inferiority with efsitora compared to other insulin treatments. In QWINT-1, this was achieved over 52 weeks, while in QWINT-3, it was achieved over 78 weeks. In QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec resulting in an A1C of 6.93% and 7.03%, respectively. For QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine, resulting in an A1C of 6.92% and 6.96%, respectively.

In both studies, the safety and tolerability of efsitora was similar to that of daily basal insulin therapies for the treatment of type 2 diabetes. In the QWINT-1 study, estimated combined rates of severe or clinically significant hypoglycemic adverse events (AEs) were found to be 40% lower than insulin glargine. In QWINT-3, instances of the same AE from weeks 0-78 were 0.84 with efsitora vs. 0.74 with insulin degludec.

Results are expected to be revealed in full detail at an upcoming congress and will be published in a peer reviewed journal. To date, the QWINT clinical trial program has enrolled more than 4,000 people living with type 1 or type 2 diabetes across five global studies.¹

Reference

1. In a first-of-its-kind fixed dose study, once weekly insulin efsitora alfa leads to A1C reduction similar to daily insulin. Lilly. September 5, 2024. Accessed September 5, 2024. https://investor.lilly.com/news-releases/news-release-details/first-its-kind-fixed-dose-study-once-weekly-insulin-efsitora