RCT: Once-Weekly Insulin Efsitora Non-Inferior to Insulin Degludec for HbA1c Control but Increases Hypoglycemia in Adults with Type 1 Diabetes
12 Sep, 2024 | 13:06h | UTCStudy Design and Population: This 52-week, randomized, open-label non-inferiority trial included 692 adults with type 1 diabetes from 82 global sites. Participants were randomly assigned to receive once-weekly insulin efsitora (n=343) or once-daily insulin degludec (n=349), both in combination with insulin lispro. The primary objective was to assess the change in HbA1c from baseline to week 26, with a non-inferiority margin of 0.4%.
Main Findings: HbA1c reduction was similar between the groups at 26 weeks (–0.51% for efsitora vs. –0.56% for degludec; p=0.43). However, participants on efsitora experienced higher rates of level 2 or 3 hypoglycemia (14.03 vs. 11.59 events per patient year, p=0.016) and a greater incidence of severe hypoglycemia (10% for efsitora vs. 3% for degludec). Overall, the safety profile was similar, with no treatment-related deaths.
Implications for Practice: Once-weekly insulin efsitora offers comparable glycemic control to daily degludec, but its association with increased hypoglycemia, especially during dose titration, indicates that closer monitoring and optimization are necessary. This treatment could reduce the burden of daily injections, but its hypoglycemia risks must be managed carefully.