Thursday, Eli Lilly and Co (NYSE: LLY) released topline results from the QWINT-1 and QWINT-3 phase 3 trials evaluating once weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes.
QWINT-1 evaluated the efficacy and safety of once-weekly efsitora compared to once-daily insulin glargine for 52 weeks in insulin naïve patients.
- The trial met its primary endpoint of non-inferior A1C (blood sugar) reduction with efsitora compared to insulin glargine at week 52.
- For the efficacy estimand, 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 estimand, efsitora reduced A1C by 1.19% compared to 1.16% for insulin glargine, resulting in an A1C of 7.05% and 7.08%, respectively.
- The QWINT-3 trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 26. For the efficacy estimand, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec resulting in an A1C of 6.93% and 7.03%, respectively.
- For the treatment-regimen estimand, efsitora reduced A1C by 0.81% compared to 0.72% for insulin degludec resulting in an A1C of 6.99% and 7.08%, respectively.
- For the efficacy estimand, participants taking efsitora spent 62.8% of time in range compared to 61.3% for insulin degludec for weeks 22-2612.
- For the treatment-regimen estimand, participants taking efsitora spent 61.4% of time in range compared to 61% for insulin degludec14.
- Further, for the efficacy estimand, participants taking efsitora spent 38.3% of time in tight range (glucose 70-140 mg/dL) compared to 36.8% for insulin degludec for weeks 22-2615.