Once-Weekly Insulin for T2D Shows Positive Topline Results in Phase 3 Clinical Trial Program

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Efsitora (efsitora alfa) from Eli Lilly met its primary endpoint of non-inferior A1C reduction compared to insulin degludec and insulin glargine in 2 phase 3 studies.

A once-weekly insulin injection to treat type 2 diabetes (T2D) in insulin naïve adults and those who require multiple daily insulin injections has shown positive topline results in a phase 3 clinical trial program evaluating its efficacy and safety, Eli Lilly announced in a news release.1

Once-Weekly Insulin for T2D Shows Positive Topline Results in Phase 3 Clinical Trial Program / Davizro Photography - stock.adobe.com

Once-Weekly Insulin for T2D Shows Positive Topline Results in Phase 3 Clinical Trial Program / Davizro Photography - stock.adobe.com

The clinical program evaluating efsitora (efsitora alfa) consisted of 2 separate treat-to-target phase 3 studies: QWINT-2 (NCT05362058) and QWINT-4 (NCT05462756). In the studies, efsitora met both of its primary and key secondary endpoints, demonstrating non-inferior A1C reduction compared to commonly used daily basal insulins.

Key Takeaways

  • Eli Lilly's phase 3 clinical trial program evaluating efsitora, a once-weekly insulin injection for type 2 diabetes, showed positive results. In 2 separate studies, efsitora demonstrated non-inferior A1C reduction compared to daily basal insulins, meeting both primary and key secondary endpoints.
  • The clinical program included two phase 3 studies, QWINT-2 and QWINT-4. QWINT-2 evaluated efsitora in insulin-naïve adults with type 2 diabetes, while QWINT-4 assessed its efficacy in patients already treated with basal insulin and multiple daily injections of prandial insulin.
  • Once-weekly insulin injections like efsitora could address therapeutic challenges faced by patients with type 2 diabetes, including treatment burden and adherence issues associated with daily injections.

"The results of QWINT-2 and QWINT-4 are a significant milestone for the diabetes community and demonstrate that efsitora as a weekly insulin provides blood sugar control equivalent to daily basal insulins," Jeff Emmick, MD, PhD, senior vice president of product development at Eli Lilly, said in a release.1 "With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains A1C control, reduces treatment burden of traditional daily injections and potentially improves adherence for people with diabetes."

QWINT-2 was a parallel-design, open-label, randomized, controlled phase 3 study evaluating the efficacy and safety of efsitora compared to insulin degludec. The study included 928 insulin naïve adults with T2D who randomly received either efsitora once weekly or insulin degludec once daily for 52 weeks. It also assessed efficacy in patients using and not using GLP-1 receptor agonists.

READ MORE: Comprehensive Medication Reviews Can Help Improve Adherence in Patients With T2D

Efsitora met its primary endpoint of non-inferior A1C reduction compared to insulin degludec at week 52. The therapy reduced A1C by 1.34% compared to 1.26% for insulin degludec. Patients treated with efsitora spent 45 minutes more time in range and 37 minutes more in tight range without additional time in hypoglycemia. Additionally, efsitora met its key secondary endpoint of non-inferior A1C change compared to insulin degludec among patients using and not using GLP-1s.

QWINT-4 was a parallel-design, open-label, randomized, controlled phase 3 study evaluating the efficacy and safety of efsitora compared to insulin glargine in adults with T2D that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. Patients randomly received efsitora once weekly or insulin glargine once daily for 26 weeks. Efsitora met its primary endpoint of non-inferior A1C reduction compared to insulin glargine at week 26. Both efsitora and insulin glargine reduced A1C by 1.07%

In both trials, efsitora was safe and well-tolerated with estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure of 0.58. Eli Lilly said in the release that detailed results from the QWINT-2 study will be presented at the 2024 European Association for the Study of Diabetes (EASD) Annual Meeting.

According to research, 20% to 25% of patients with T2D require insulin therapy. However, many of these patients do not achieve adequate metabolic control following insulin initiation due to factors like therapeutic inertia, fear of hypoglycemia, poor communication, and the number of injections needed. Once-weekly insulin injections may allow patients to have better control over their diabetes due to a simplified therapy.2

“For the first time there is an opportunity to make an important breakthrough in basal insulin therapy, particularly in people with type 2 diabetes, and to improve not only the quality of life of people with diabetes, but also the practice of diabetologists,” wrote Trevisan et al in a study on once-weekly insulin injections published in Diabetologia.2

READ MORE: Diabetes Resource Center

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References
1. With Once-a-Week Dosing, Insulin Efsitora Alfa Delivers A1C Reduction and Safety Profile Consistent with Daily Insulin. News Release. Eli Lilly. May 16, 2024. Accessed May 16, 2024. https://investor.lilly.com/news-releases/news-release-details/once-week-dosing-insulin-efsitora-alfa-delivers-a1c-reduction
2. Trevisan R, Conti M, Ciardullo S. Once-weekly insulins: a promising approach to reduce the treatment burden in people with diabetes. Diabetologia. Published online April 29, 2024. doi:10.1007/s00125-024-06158-9
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