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EASD
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But higher severe hypoglycemia risk with efsitora in type 1 diabetes likely precludes its use
by
Kristen Monaco, Senior Staff Writer, MedPage Today
September 10, 2024
An investigational once-weekly insulin was noninferior to a daily option for patients with type 2 diabetes, but proved risky for those with type 1 diabetes, the phase III QWINT-2 and -5 trials showed.
In insulin-naive patients with type 2 diabetes enrolled in QWINT-2, average HbA1c levels decreased from 8.21% at baseline to 6.97% at week 52 with once-weekly insulin efsitora, and from 8.24% to 7.05% with once-daily insulin degludec (estimated treatment difference -0.09 percentage points, 95% CI -0.22 to 0.04), reported Carol Wysham, MD, of the MultiCare Rockwood Center for Diabetes and Endocrinology in Spokane, Washington, at the European Association for the Study of Diabetes (EASD) annual meeting in Madrid.
In addition, time in target range was slightly higher with the once-weekly option. The efsitora group spent 64.3% of time with a glucose level between 70 and 180 mg/dL compared with 61.2% of time for those in the degludec group (estimated treatment difference 3.1 percentage points, 95% CI 0.1-6.1), according to the study that was simultaneously published in the New England Journal of Medicine.
Efsitora is a basal insulin comprised of a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain designed to provide stable glucose levels over 7 days.
“Traditionally, basal insulins are dosed once a day — a treatment schedule that can make compliance difficult for a significant portion of people living with type 2 diabetes,” said Wysham. “Efsitora has the potential to address treatment burden and improve adherence, all while lowering A1C.”
Melanie Davies, MD, of the University of Leicester in England, noted that “patients liked this insulin,” referencing the significant improvement in Treatment-Related Impact Measure-Diabetes total score with efsitora over degludec.
There were no severe hypoglycemia events reported with insulin efsitora compared with six episodes reported with degludec. The rate of combined clinically significant or severe hypoglycemia was 0.58 events per participant-year of exposure with efsitora versus 0.45 events per participant-year of exposure with degludec (estimated rate ratio 1.30, 95% CI 0.94-1.78).
Currently, all basal insulin products on the market are designed for daily dosing. Safety concerns with a once-weekly formulation, particularly hypoglycemia, have historically been a barrier to their adoption, though this is a greater concern for type 1 diabetes.
“It was important that efsitora did not induce an excess of clinically significant hypoglycemia episodes, given the recent report from the ONWARDS 6 trial involving persons with type 1 diabetes that another once-weekly insulin, icodec, resulted in disproportionate rates of hypoglycemia as compared with degludec,” wrote Irwin Brodsky, MD, MPH, of the MaineHealth Endocrinology and Diabetes Center in Scarborough, in an accompanying editorial.
In May, an FDA advisory committee voted against approval of investigational once-weekly icodec for patients with type 1 diabetes due to risks of hypoglycemia. (The product is still under review for adults with type 2 diabetes.)
QWINT-5 tested efsitora in patients with type 1 diabetes, showing noninferiority to degludec, with average HbA1c levels dropping from 7.88% at baseline to 7.41% at week 26 with efsitora and from 7.94% to 7.36% with degludec (estimated treatment difference 0.052%, 95% CI -0.077 to 0.181, P=0.43), reported Richard Bergenstal, MD, of the University of Minnesota in Minneapolis, at EASD and in The Lancet .
However, like with icodec, safety was a concern. Rates of combined level 2 (
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