Eli Lilly Efistora has showed positive outcomes from QWINT-2 and QWINT-4 phase 3 clinical trials. The trials discerned impact of the once weekly insulin efsitora in patients with T2 diabetes using insulin for the first time. The trials compared results with patients requiring multiple daily insulin injections. Although results of efsitora consumption are not superior to the commonly used insulin.
Jeff Emmick, MD, Ph.D. senior vice president, product development said that “the results of QWINT-2 and QWINT-4 are a significant milestone for the T2 diabetic community. The results demonstrated that efsitora weekly subcutaneous injection provides blood sugar control equivalent to daily dose of insulin. Efsitora gives an opportunity to individual with T2 diabetes to administer insulin once a weekly hence serving a reasonable substitute for daily injection for insulin. These results will alleviate treatment burden of daily injections, which is huge considering the multiple doses of insulin the patients need to receive to have a proper functional life.
QWINT-2 estimated the efficacy and safety of once -weekly efsitora compared to once-daily insulin degludec for 52 weeks. The trial segregated the patients with T2 diabetes to receive efsitora once weekly or insulin degludec per daily. In addition, the trail also incorporated patients using and not using GLP-1 receptor agonists. The trial showed non-inferior A1C reduction with efsitora compared to insulin degludec. The results showed reduction in A1C by 1.34% compared to 1.26% for daily dose of insulin (degludec).
The secondary end point showed efsitora as a non-inferior to insulin degludec in A1C change among patients using and not using GLP-1 agonists. Efsitora consumption also reduced additional time in hypoglycemia in comparison to patients taking degludec.
QWINT-4 trials compared the efficacy of efsitora to insulin glargine for 26 weeks in patients with T2 diabetes who previously received basal insulin and at least two injections per day of mealtime insulin. Patients received efsitora once weekly or insulin glargine once daily.
The trial end point suggested the reduction in A1C by efsitora and insulin by 7.12% and 7.11% respectively. In both clinical trails (QWINT-2 and QWINT-4) efsitora was tolerated well.
Insulin efsitora alfla (efsitora) is a fusion protein. It’s a combination of novel single-chain variant of insulin with a human IgG2 Fc domain. Its once-a-week subcutaneous administration provides less glucose fluctuations. Currently, Efsitora is in phase 3 for patients with type 1 and 2 diabetes.
Dr. Isha Sharma, Ph.D.
Reference:
- Eli Lilly. (2024, May 16). With Once-a-Week Dosing, Insulin Efsitora Alfa Delivers A1C Reduction and Safety Profile Consistent with Daily Insulin.
