Once-weekly insulin icodec shows superiority to daily insulin glargine

Researchers report that patients have achieved significantly better glycemic control with once-weekly investigative insulin icodec than with with once-daily insulin glargine U100.

The findings were reported on July 27, 2027 in the NEJM/New England Journal of Medicine.

“ONWARDS 1, the longest trial in the ONWARDS development program for insulin icodec, showed that this weekly insulin regimen facilitated the initiation of basal insulin treatment and improved glycemic control and potentially treatment adherence through reducing the insulin injection burden for persons with type 2 diabetes who had not previously received insulin,” the authors said.

The researchers conducted a 78-week randomized, phase 3a trial, including a 52-week main phase and a 26-week extension phase, plus a 5-week follow-up period.

Only adult patients with type 2 diabetes (glycated hemoglobin level, 7 to 11%) who had not been treated with insulin were eligible to enroll.

Subjects were randomized in a 1:1 ratio to receive once-weekly insulin icodec or once-daily insulin glargine U100.

The primary end point was change in glycated hemoglobin from baseline to week 52.

There were 492 subjects in each cohort. Baseline characteristics were similar.

At week 52, the mean reduction in the glycated hemoglobin level was greater with icodec than with glargine U100, from 8.50% to 6.93% with icodec (a mean change of  −1.55 percentage points) and from 8.44% to 7.12% with glargine U100 ( a mean change of −1.35 percentage points.)

The 19% between-group difference in efficacy for the primary endpoint was statistically significant and confirmed the noninferiority (P<0.001) and superiority (P=0.02) of icodec.

Notably, the percentage of time spent in the glycemic range of 70 to 180 mg per deciliter was significantly higher with icodec than with glargine U100 (P< 0.001), which also confirmed superiority.

No new safety signals were found, and adverse events were similar in both cohorts.

The authors concluded, “The noninferiority and statistical superiority of once-weekly icodec to once-daily glargine U100 with respect to the change in the glycated hemoglobin level from baseline to week 52 (primary end point) was confirmed. Researchers report that patients have achieved significantly better glycemic control with once-weekly investigative insulin icodec than with once-daily insulin glargine U100.”