Eli Lilly has shared promising phase 3 results for its once-weekly insulin candidate efsitora alfa in adults with type 2 diabetes (T2D).
All three studies met their primary endpoint of non-inferior A1C reduction compared to daily basal insulin, according to data presented at this year’s American Diabetes Association Scientific Sessions.
More than 4.3 million people in the UK have diabetes, with T2D accounting for around 90% of all cases. Current treatment options focus on disease management and include diet and exercise, diabetes medications and insulin therapy.
It is hoped that an insulin option specifically designed for once-weekly subcutaneous administration could improve adherence rates and quality of life for patients with the chronic condition.
QWINT-1, which evaluated efsitora alfa in patients using insulin for the first time, showed that Lilly’s candidate reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52. In the trial, efsitora was titrated across four fixed doses at four-week intervals, as needed for blood glucose control.
In QWINT-3 and QWINT-4, which enrolled patients who had previously used daily basal insulin, and those who had previously used daily basal insulin and mealtime insulin, respectively, efsitora was given using traditional insulin dosing, with adjustments based on each patient’s glucose level.
At week 26 in QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec. At the same time point in QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine.
Efsitora also demonstrated an overall safety profile similar to two of the most commonly used daily basal insulin therapies for T2D across all three studies.
Jeff Emmick, senior vice president of product development at Lilly, said: “These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach.”
Lilly said it is planning to submit global regulatory applications for efsitora as a treatment for adults with T2D by the end of this year.
“We look forward to working with regulatory agencies to bring this innovation to patients around the world,” Emmick said.