One basal insulin noninferior to another in type 2 diabetes

In the management of type 2 diabetes (T2D) in adults who are naïve to insulin, once-weekly efsitora alfa compares favourably with once-daily degludec in terms of lowering glycated haemoglobin levels, according to an open-label phase III study.

In the study, 928 adults with T2D were randomly assigned to receive efsitora (n=466) or degludec (n=462). The primary endpoint was the change in glycated haemoglobin levels at week 52. Secondary and safety endpoints included the change in the glycated haemoglobin level in the subgroups of participants who were using and not using glucagon-like peptide-1 (GLP-1) receptor agonists, the percentage of time that the glucose level was in the target range of 70–180 mg/dL in weeks 48 through 52, and hypoglycaemic episodes.

The mean glycated haemoglobin level dropped from 8.21 percent at baseline to 6.97 percent at week 52 for efsitora-treated participants (least-squares mean change, −1.26 percentage points) and from 8.24 percent to 7.05 percent for those treated with degludec (least-squares mean change, −1.17 percentage points). The estimated treatment difference of −0.09 percentage points (95 percent confidence interval [CI], −0.22 to 0.04) established the noninferiority of efsitora.

Furthermore, efsitora showed noninferiority to degludec with respect to the change in glycated haemoglobin levels regardless of the use of GLP-1 receptor agonists. The same was true for the percentage of time that the glucose level was within the target range (64.3 percent and 61.2 percent, respectively; estimated treatment difference, 3.1 percentage points, 95 percent CI, 0.1–6.1).

The rate of combined clinically significant or severe hypoglycaemia was 0.58 events per participant-year of exposure with efsitora and 0.45 events per participant-year of exposure with degludec (estimated rate ratio, 1.30, 95 percent CI, 0.94–1.78).

None of the efsitora-treated participants experienced severe hypoglycaemia as opposed to six episodes among those who received degludec.

The incidence of adverse events was comparable between the two treatment groups.