Benzinga - by Vandana Singh, Benzinga Editor.
Eli Lilly and Co (NYSE:LLY) released Thursday topline results from two phase 3 trials.
The drugmaker evaluated once-weekly insulin efsitora alfa (efsitora) in type 2 diabetes patients using insulin for the first time (insulin naïve) and those who require multiple daily insulin injections.
In the treat-to-target clinical trials, efsitora showed non-inferior A1C reduction compared to the most commonly used daily basal insulins globally.
QWINT-2 evaluated the efficacy and safety of once-weekly efsitora compared to once-daily insulin degludec for 52 weeks.
The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 52.
For the efficacy estimand, efsitora reduced A1C by 1.34% compared to 1.26% for insulin degludec resulting in an A1C of 6.87% and 6.95%, respectively.
In a key secondary endpoint, efsitora was non-inferior to insulin degludec in A1C change among participants using and not using GLP-1 receptor agonists.
Further, participants taking efsitora spent 45 minutes more time in range and 37 minutes more in tight range without additional time in hypoglycemia (blood glucose
QWINT-4 evaluated the efficacy and safety of efsitora compared to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin.
For the efficacy estimand, efsitora and insulin glargine reduced A1C by 1.07% resulting in an A1C of 7.12% and 7.11%, respectively.
In QWINT-2 and QWINT-4, efsitora was safe and well-tolerated.
The estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure were 0.58 with efsitora vs. 0.45 with insulin degludec (QWINT-2) and 6.6 with efsitora vs. 5.9 with insulin glargine (QWINT-4).
Topline readouts from QWINT-1, QWINT-3, and QWINT-5 are anticipated later this year.
Price Action: LLY shares are down 0.43% at $783.65 at last check Thursday.
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