Eli Lilly and Company (LLY) has released positive topline results from its QWINT-1 and QWINT-3 Phase 3 trials, evaluating the efficacy and safety of its once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes.
The QWINT-1 trial compared efsitora to once-daily insulin glargine in insulin-naïve patients over 52 weeks. It met its primary endpoint, demonstrating non-inferior A1C (blood sugar) reduction with efsitora compared to insulin glargine at week 52. Efsitora achieved an A1C reduction of 1.31%, resulting in an A1C of 6.92%, while insulin glargine achieved a reduction of 1.27% with an A1C of 6.96%.
The QWINT-3 trial compared efsitora to once-daily insulin degludec in patients already receiving basal insulin therapy over 78 weeks. This trial also met its primary endpoint, showing non-inferior A1C reduction with efsitora compared to insulin degludec at week 26. Efsitora demonstrated an A1C reduction of 0.86% (A1C of 6.93%), while insulin degludec achieved a reduction of 0.75% (A1C of 7.03%).
Both trials also revealed that participants taking efsitora spent more time in range (glucose levels between 70-180 mg/dL), indicating improved glucose control compared to baseline.
These promising results suggest that efsitora has the potential to become a valuable treatment option for managing type 2 diabetes, offering a convenient once-weekly dosing schedule and demonstrating non-inferior efficacy to existing insulin therapies. Further research and regulatory approval are necessary before efsitora becomes widely available.
