Once Weekly Efsitora Shows Non-Inferiority in A1c Reductions Compared With Daily Basal Insulin

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Topline results of QWINT-2 and QWINT-4 met the primary end point of change in hemoglobin A1c compared to degludec and glargine, respectively, for those with type 2 diabetes.

Once weekly insulin efsitora alfa (efsitora; Eli Lilly and Company) demonstrated non-inferiority in A1c reduction when compared to commonly used daily basal insulins, according to results from the QWINT-2 (NCT05362058) and QWINT-4 (NCT05462756) phase 3 clinical trials. The company announced topline results from both studies, which evaluated the medication in adults with type 2 diabetes (T2D) using insulin for the first time and for those who require multiple daily insulin injections.1

Senior woman using a flash glucose monitor to manage her diabetes at home | Image Credit: (JLco) Julia Amaral - stock.adobe.com

Image Credit: (JLco) Julia Amaral - stock.adobe.com

"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, product development at Eli Lilly, said in a press release. "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."1

According to a review published in Diabetologia, the QWINT program is made up of 5 open-label phase 3 randomized control trials, including for individuals who are insulin-naïve (QWINT-1 and QWINT-2) and insulin-experienced (QWINT-3 and QWINT-4) who have T2D as well as individuals with type 1 diabetes (QWINT-5). For all trials, the primary end point is change in hemoglobin (Hb) A1c levels compared to the active comparators of either degludec or glargine U100, either alone or in basal-bolus scheme.2

For QWINT-2, there were 912 individuals evaluated who received either efsitora or degludec for 52 weeks, and QWINT-4 consisted of 670 individuals who received either efsitora or glargine U100 for 26 weeks.2

Both trials met the primary end point of non-inferior A1c reduction with efsitora. For QWINT-2, efsitora reduced A1c by approximately 1.34% compared to 1.25% for insulin degludec, with A1c of 6.87% and 6.95%, respectively. For QWINT-4, efsitora and insulin glargine reduced A1c by 1.07%, with A1c of 7.12% and 7.11%, respectively.1

Efsitora also demonstrated that it was non-inferior to degludec in A1c change in individuals, regardless of whether they were using or not using glucagon-like peptide-1 (GLP-1) receptor agonists in the QWINT-2 trial. Furthermore, individuals who took glucagon-like peptide-1 (GLP-1) spent approximately 45 minutes more time in range and 37 minutes more in tight range without additional time in hypoglycemia in comparison to degludec.1

Secondary outcomes for QWINT-2 included change from baseline HbA1c of efsitora compared to insulin degludec for individuals using GLP-1 receptor agonists and for those not using GLP-1 receptor agonists. Further, investigators will also determine time in glucose range, change from baseline in fasting glucose, weekly insulin dose, level 2 or level 3 nocturnal hypoglycemia events, change from baseline in body weight, time in hypoglycemia range with glucose less than 54 mg/dL, time in hyperglycemia range with glucose greater than 180 mg/dL, change from baseline in Treatment Related Impact Measures-Diabetes, change from baseline in Short Form-36 Version 2 Health Survey Acute Form, and change from baseline in EuroQol-5 Dimension-5 level.3

The secondary endpoints for QWINT-4 included the percentage of individuals achieving HbA1c­­­ of less than 7% without nocturnal hypoglycemia; nocturnal hypoglycemia event rate; change from baseline in fasting glucose; time in glucose range; time in hypoglycemia range; glucose variability; hypoglycemia event rate; change from baseline in body weight; and treatment experience in the Diabetes Injection Device Experience Questionnaire at week 26.4

Detailed results from the QWINT-2 study will be presented at the European Association for the Study of Diabetes Annual Meeting 2024, and topline results from QWINT-1, QWINT-3 and QWINT-5 are expected to be announced later this year.1

REFERENCES
  1. With Once-a-Week Dosing, Insulin Efsitora Alfa Delivers A1C Reduction and Safety Profile Consistent with Daily Insulin. Nres release. Eli Lilly. May 16, 2024. Accessed May 17, 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
  3. A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2). Eli Lilly and Company. ClinicalTrials.gov Identification: NCT05362058. April 16, 2024. Accessed May 17, 2024. https://clinicaltrials.gov/study/NCT05362058
  4. A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (QWINT-4). Eli Lilly and Company. ClinicalTrials.gov Identification: NCT05462756. March 8, 2024. Accessed May 17, 2024. https://clinicaltrials.gov/study/NCT05462756
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