A once-weekly insulin therapy showed similar blood sugar control and safety to a once-daily insulin in adults with type 2 diabetes already using basal insulin, based on findings from a large, multinational clinical trial.
The study enrolled 986 adults from 127 sites across 9 countries and followed them for 78 weeks. Participants were randomly assigned to receive either once-weekly efsitora (655 patients) or once-daily degludec (331 patients). All had been using basal insulin without prandial insulin and were permitted up to three non-insulin glucose-lowering medications.
The primary objective was to determine whether efsitora could match degludec in lowering glycated hemoglobin (HbA1c), a marker of long-term glucose control. At 26 weeks, patients receiving efsitora showed a least-squares mean HbA1c reduction of 0.81 percentage points, compared with 0.72 in the degludec group. The difference fell within the prespecified margin for noninferiority, meeting the trial’s main endpoint.
Both groups demonstrated similar improvements in fasting blood glucose levels. Time in the target glucose range (70–180 mg/dL), measured via continuous glucose monitoring, increased by nearly 2 hours per day in both groups, with no significant differences at 26 weeks.
Hypoglycemia was closely monitored. Approximately 41% of patients on efsitora and 37% on degludec experienced level 2 (clinically significant) or level 3 (severe) hypoglycemia. Event rates were 0.84 and 0.74 per patient-year, respectively, with no statistically significant difference.
Adverse events were reported in 75% of patients on efsitora and 66% on degludec, most of which were mild or moderate. Serious adverse events occurred in 16% of the efsitora group and 11% of the degludec group, most commonly cardiovascular in nature. Nine deaths occurred during the study—seven in the efsitora group and two in the degludec group—but none were attributed to the treatments.
Insulin doses were lower in the efsitora group at all measured points. Despite the lower dose and less frequent administration, both groups maintained similar blood glucose control throughout the trial.
Patient satisfaction was higher with weekly dosing, as measured by standardized questionnaires at 26, 52, and 78 weeks. The reduction in injection frequency—from 365 to 52 annually—likely contributed to this preference.
Participants had a median age of 62 years and a median diabetes duration of 14.5 years. The study included a diverse population by age, ethnicity, and treatment background.
The findings support once-weekly insulin as a viable alternative to daily injections for adults with type 2 diabetes already using basal insulin, providing comparable effectiveness and safety with a reduced treatment burden.
Full disclosures can be found in the published study.
Source: The Lancet