Once-weekly insulin efsitora showed similar efficacy to daily insulin degludec in reducing glycated hemoglobin levels in adults with type 2 diabetes who had not previously received insulin, according to a recent study published in The New England Journal of Medicine.

In a 52-week, phase 3 trial, researchers evaluated the efficacy and safety of insulin efsitora alfa (efsitora), a once-weekly basal insulin, compared to insulin degludec, administered daily, in adults with type 2 diabetes (T2D) who had not previously received insulin. A total of 1,267 patients were screened, and 928 were randomly assigned (466 to efsitora and 462 to degludec). The efficacy analysis included 463 patients in the efsitora group and 458 in the degludec group. The study aimed to determine whether efsitora was noninferior to degludec in reducing glycated hemoglobin (HbA1c) levels after 52 weeks.

Results indicated that efsitora decreased HbA1c levels from 8.21% at baseline to 6.97%, while degludec reduced levels from 8.24% to 7.05%. The estimated treatment difference of −0.09 percentage points confirmed noninferiority. In both groups, a mean HbA1c level of less than 7% was achieved and sustained after 16 weeks of treatment. Efsitora also resulted in a greater percentage of time within the target glucose range (64.3%) compared to degludec (61.2%).

No severe hypoglycemia occurred in the efsitora group, while six episodes occurred in the degludec group. The rate of combined clinically significant or severe hypoglycemia was 0.58 events per patient-year for efsitora and 0.45 events per patient-year for degludec (rate ratio, 1.30; 95% confidence interval, 0.94 to 1.78). The average change in body weight from baseline to week 52 was comparable between the efsitora group and the degludec group, with changes of 3.6 kg and 3.5 kg, respectively.

In the efsitora group, 338 out of 466 patients (72.5%) experienced adverse events, compared to 341 out of 462 (73.8%) in the degludec group. Serious adverse events were reported in 8.8% of the efsitora group and 8.2% of the degludec group. No significant differences were observed between the groups regarding these safety outcomes.

Secondary endpoints, including fasting blood glucose levels and insulin dose, were also analyzed. The mean fasting blood glucose level decreased similarly in both groups, while the weekly insulin dose at week 52 was slightly lower with efsitora (314.7 U vs. 334.4 U for degludec).

These findings demonstrate that once-weekly efsitora is a viable alternative to daily insulin degludec for managing T2D in insulin-naive patients. Full disclosures are available in the published study.

Full disclosures can be found in the published study.