Eli Lilly has announced positive results from its Phase 3 clinical trials, QWINT-1 and QWINT-3, for its once-weekly insulin efsitora, suggesting it could be as effective as traditional daily insulin doses for individuals with type 2 diabetes. This development offers the potential to significantly reduce the burden of daily injections for patients.
Efficacy in Insulin-Naive Patients
The QWINT-1 trial focused on type 2 diabetes patients who were initiating insulin therapy. After 52 weeks, patients on fixed-doses of efsitora experienced an average A1C level reduction of 1.31%. Comparatively, patients in the same trial receiving daily insulin saw a decrease of 1.27% in their A1C levels. These results indicate that efsitora is non-inferior to daily insulin in controlling blood sugar levels in insulin-naive patients.
Results in Patients Previously on Insulin
The QWINT-3 trial examined efsitora's effectiveness in type 2 diabetes patients already undergoing daily insulin injections. The study found that patients treated with efsitora achieved an A1C reduction of 0.86% after 26 weeks, while those on daily insulin experienced a 0.75% reduction. These findings suggest that efsitora can effectively manage blood glucose levels in patients transitioning from daily insulin regimens.
Potential Impact on Patient Adherence
According to Eli Lilly, the convenience of a once-weekly injection could significantly improve patient adherence to insulin therapy. Paul Owens, an Eli Lilly vice president, highlighted the potential for 313 fewer injections per year with efsitora, offering an innovative solution for achieving and maintaining A1C control while enhancing patients' sense of control over their disease.
Market Context and Future Plans
Eli Lilly is in competition with Novo Nordisk to introduce a long-acting insulin to the U.S. market. The FDA previously rejected Novo Nordisk’s weekly insulin, Awiqli, due to concerns related to its manufacturing process and use in type 1 diabetes. Eli Lilly has not yet made a decision regarding regulatory submission for efsitora but will continue to evaluate data to inform future development plans. Detailed results from the QWINT-1 and QWINT-3 trials are expected to be presented at a later date, following the presentation of QWINT-2 and QWINT-5 trial results at the European Association for the Study of Diabetes (EASD) Annual Meeting.
