Weekly fixed-dosed efsitora as good as daily glargine in T2D

For adult patients with type 2 diabetes (T2D) who are naïve to insulin, a once-weekly fixed-dose efsitora regimen is noninferior to once-daily glargine at reducing blood glucose levels, according to the phase III treat-to-target QWINT-1 trial.

A total of 795 T2D patients who had not previously received insulin therapy were randomly assigned to a once-weekly, fixed-dose efsitora regimen or a once-daily insulin glargine U100 regimen. Treatment with efsitora was administered as a single dose of 100 U once a week, with dose adjustments made every 4 weeks, as needed, at fixed doses of 150, 250, and 400 U to achieve fasting blood glucose levels of 80–130 mg/dL. Glargine doses were adjusted weekly or more often according to a standard algorithm to reach the same glycaemic goals.

The primary endpoint was the change in the glycated haemoglobin level at 52 weeks, with the noninferiority margin set at 0.4 percentage points.

At week 52, mean glycated haemoglobin levels dropped from 8.20 percent at baseline to 7.05 percent with efsitora (least-squares mean change, −1.19 percentage points) and from 8.28 percent to 7.08 percent with glargine (least-squares mean change, −1.16 percentage points). The estimated between-group difference of −0.03 percentage points established the noninferiority of efsitora to glargine.

Clinically significant hypoglycaemia (<54 mg/dL) or severe hypoglycaemia (level 3; requiring assistance for treatment) occurred less frequently with efsitora vs glargine (0.50 vs 0.88 events per participant-year of exposure; estimated rate ratio, 0.57, 95 percent confidence interval [CI], 0.39–0.84).

At week 52, the mean total weekly insulin dose was 289.1 U with efsitora and 332.8 U with glargine (estimated between-group difference, −43.7 U per week, 95 percent CI, −62.4 to −25.0). The median number of dose adjustments required was two and eight, respectively.