Eli Lilly (NYSE:LLY) today announced positive results from phase 3 clinical trials evaluating its once-weekly insulin efsitora alfa.
The Indianapolis-based pharmaceutical giant evaluated its once-weekly insulin in insulin-naïve adults in the QWINT-1 study. These adults have type 2 diabetes and are using basal insulin for the first time. Additionally, Eli Lilly’s QWINT-3 trial looked at those who switched from daily basal insulin injections.
In these long-term, treat-to-target trials, the insulin showed non-inferior A1C reduction compared to the most frequently used daily basal insulins.
“Once weekly insulins, like efsitora, have the potential to transform diabetes care as we know it,” said Dr. Jeff Emmick, SVP, product development, Eli Lilly. “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 pitted once-weekly efsitora to once-daily insulin glargine for 52 weeks. It randomized insulin-naïve adults to receive either efsitora once per week in a single-use autoinjector or insulin glargine once daily. Investigators titrated efsitora across four fixed doses at four-week intervals, as needed for blood glucose control. The study had a goal of providing data supporting real-life applications of fixed-dose regimens.
Eli Lilly says the trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin glargine at week 52. For efficacy, Efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine, resulting in an A1C of 6.92% and 6.96%, respectively. For the treatment regimen, it reduced A1C by 1.19% compared to 1.16% for insulin glargine, leading to A1C of 7.05% and 7.08%, respectively.
QWINT-3 evaluated efficacy and safety for 78 weeks in adults with type 2 diabetes currently treated with basal insulin. The study randomized participants 2:1 to receive either efsitora once per week or insulin degludec once per day.
Eli Lilly said the study met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin deguldec at week 26. For efficacy, efsitora reduced A1C by 0.86%, compared to 0.75% in the other group. That led to an A1C of 6.93% and 7.03%, respectively. For the treatment regimen, it reduced A1C by 0.81% compared to 0.72% for insulin degludec. That resulted in an A1C of 6.99% and 7.08%, respectively.
In both studies, investigators found a similar safety and tolerability profile for efsitora compared to daily basal insulin therapies.
