Eli Lilly and Co. (LLY) announced detailed results from the QWINT-2 phase 3 trial evaluating once-weekly insulin efsitora alfa (efsitora) compared to once-daily insulin degludec in adults with type 2 diabetes using insulin for the first time (insulin naive).
In the trial, efsitora met the primary endpoint of non-inferior A1C reduction. 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 at 52 weeks, the company said in a statement.
In addition, participants taking efsitora achieved 45 minutes more time in range4 per day, a key secondary endpoint, without additional time in hypoglycemia (glucose less than 54 mg/dL) in comparison to insulin degludec for the efficacy estimand.
In the trial, efsitora demonstrated a safety profile similar to daily insulins. There were no severe hypoglycemic events reported during treatment with efsitora compared to six reported with insulin degludec. Overall hypoglycemia rates in the study were low, with estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure of 0.58 with efsitora vs. 0.45 with insulin degludec.
The company noted that estimated combined rates of severe or clinically significant nocturnal hypoglycemic events per patient-year of exposure were 0.08 with both efsitora and insulin degludec. Additionally, rates of hypoglycemia were similar among people currently using GLP-1s and those not using GLP-1s. Adverse events were similar between treatment groups in the trial.
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