Rate of combined clinically significant or severe hypoglycemia significantly lower with efsitora versus glargine
FRIDAY, June 27, 2025 (HealthDay News) — Once-weekly insulin efsitora alpha (efsitora) is noninferior to once-daily insulin glargine (glargine) for reducing glycated hemoglobin (HbA1c) among adults with type 2 diabetes, according to a study published online June 25 in the New England Journal of Medicine to coincide with the annual meeting of the American Diabetes Association, held from June 20 to 23 in Chicago.
Julio Rosenstock, M.D., from Velocity Clinical Research at Medical City in Dallas, and colleagues conducted a 52-week, phase 3 trial involving adults with type 2 diabetes who had not previously received insulin. A total of 795 participants were randomly assigned to receive once-weekly efsitora, initiated at 100 U, with dose adjustments made every four weeks as needed, or once-daily insulin glargine, with doses adjusted weekly or more often to reach the same glycemic goals.
The researchers observed a decrease in mean HbA1c from baseline to week 52 from 8.20 to 7.05 percent with efsitora and from 8.28 to 7.08 percent with glargine (least-squares mean change, −1.19 and −1.16 percentage points, respectively), confirming the noninferiority of efsitora to glargine. Superiority was not achieved (P = 0.68). The rate of combined clinically significant hypoglycemia or severe hypoglycemia was lower with efsitora than glargine (0.50 versus 0.88 events per participant-year of exposure; estimated rate ratio, 0.57). The mean total weekly insulin dose was 289.1 and 332.8 U/week with efsitora and glargine, respectively, at week 52.
“Once-weekly efsitora administered in a fixed-dose regimen was noninferior to once-daily glargine in reducing glycated hemoglobin levels at 52 weeks,” the authors write.
Several authors disclosed ties to pharmaceutical companies, including Eli Lilly, which is developing efsitora and funded the study.
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