Photo Credit: Jeniffer Fontan

The following is a summary of “Insulin Efsitora versus Degludec in type 2 diabetes without previous insulin treatment,” published in the September issue of Emergency Medicine by Wysham et al.

Insulin efsitora alfa (efsitora) is a new basal insulin meant to be taken once a week. So far, safety and effectiveness data come from small phase 1 and 2 trials.

Researchers conducted a prospective study to evaluate the safety and effectiveness of efsitora in patients with type 2 diabetes compared to existing insulin treatments.

They conducted a 52-week phase 3 trial with adults who had type 2 diabetes but had not used insulin before. Participants were randomly assigned 1:1 to receive either efsitora or degludec. The primary endpoint was to determine changes in glycated hemoglobin levels from baseline to week 52, with a margin of 0.4 percentage points. Secondary endpoints included changes in glycated hemoglobin for those using and not using GLP-1 receptor agonists, glucose levels in the target range (70-180 mg/dL) from weeks 48 to 52, and hypoglycemic episodes.

The results showed that about 928 participants were randomized (466 to efsitora and 462 to degludec) for this study. With efsitora, glycated hemoglobin dropped from 8.21% to 6.97% (least-squares mean change, −1.26 percentage points), while with degludec it dropped from 8.24% to 7.05% (least-squares mean change, −1.17 percentage points) (estimated treatment difference, −0.09 percentage points; 95% CI, −0.22 to 0.04), showing noninferiority. Efsitora was non-inferior to degludec for glycated hemoglobin changes in GLP-1 receptor agonist users and non-users. Glucose levels were within the target range 64.3% of the time with efsitora and 61.2% with degludec (estimated treatment difference, 3.1 percentage points; 95% CI, 0.1 to 6.1). Efsitora had a combined rate of clinically significant or severe hypoglycemia of 0.58 events per participant-year, compared to 0.45 with degludec (estimated rate ratio, 1.30; 95% CI, 0.94 to 1.78), with no severe hypoglycemia reported for efsitora and 6 episodes for degludec. Adverse event rates were similar between the groups.

Investigators concluded that for adults with type 2 diabetes new to insulin, once-weekly efsitora was just as effective as once-daily degludec in lowering glycated hemoglobin levels.

Source: nejm.org/doi/full/10.1056/NEJMoa2403953