Eli Lilly (NYSE:LLY) on Thursday announced that its QWINT-1 and QWINT-3 Phase 3 clinical trials for once-weekly insulin efsitora alfa reached the primary endpoints against daily basal insulins, indicating a more convenient treatment regimen for adults with type 2 diabetes.
52-week QWINT-1 enrolled adults with type 2 diabetes who were using basal insulin for the first time. 78-week QWINT-3 enrolled those currently treated with basal insulin.
QWINT-1 met the main goal as the reduction of blood glucose biomarker A1C stood at 1.31% for efsitora compared to 1.27% for insulin glargine at Week 52, indicating non-inferiority.
Meanwhile, at Week 26, the A1C reduction for QWINT-3 reached 0.86%, compared to 0.75% for insulin degludec, as that trial also reached the primary endpoint, indicating non-inferiority.
LLY said the overall safety and tolerability of efsitora were consistent with daily basal insulin in both studies. The company plans to share the detailed results at a future medical event and submit them for publication in a peer-reviewed journal.
“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,” said Jeff Emmick, LLY’s senior vice president of product development.