Degludec insulin versus efsitora insulin in diabetes mellitus management: A systematic review and meta-analysis

Purpose: To compare the efficacy and safety of next-generation basal insulin efsitora versus insulin degludec in managing type 1 and type 2 diabetes. Methods: We systematically searched PubMed, Embase, and CENTRAL databases until October 2024. This study followed PRISMA guidelines. Statistical analyses were performed using R version 4.4.1. The risk of bias was assessed using the RoB2 tool, and the quality of evidence was evaluated using the GRADE approach. This study was registered in PROSPERO under protocol CRD42024597806. Results: Six randomized controlled trials involving 2590 patients were included in the analysis. Of these, 1376 (53.13 %) received efsitora insulin. No significant differences were observed between efsitora and degludec in glycemic efficacy outcomes, including HbA1c reduction, fasting blood glucose, weight change, and proportion of patients achieving HbA1c <7 %. Regarding safety outcomes, most endpoints, such as adverse events, injection site reactions, hypersensitivity, severe hypoglycemia, and mortality, were comparable between groups, with no significant subgroup effects. However, subgroup analysis revealed a lower incidence of nocturnal hypoglycemia with efsitora in patients with type 2 diabetes, and a higher rate of serious adverse events in patients with type 1 diabetes, suggesting potential population-specific differences in safety profiles. Conclusion: Efsitora and degludec insulins show similar overall efficacy and safety in the management of diabetes. However, subgroup analyses indicate that patient-specific factors, such as diabetes type, may influence the risk of certain adverse events. These findings support the importance of individualized insulin selection based on patient characteristics and risk profiles.