Insulin Degludec/Liraglutide combination bioavailability compared to separate injections in healthy Chinese subjects

Type 2 Diabetes (T2D) management often requires combination therapies to achieve optimal glycemic control, frequently involving both basal insulin and GLP-1 receptor agonists. Fixed-dose combination products, such as insulin degludec/liraglutide (IDegLira), offer the advantage of simplified dosing regimens, potentially improving patient adherence and outcomes. However, before clinical use, it is crucial to demonstrate that the pharmacokinetic profile and bioavailability of each component in the combination product are comparable to those administered as separate injections. This ensures that the combined formulation delivers the expected drug exposure without altering the individual drug's absorption or metabolism.

This randomized, open-label, three-period crossover trial investigated the single-dose pharmacokinetics of insulin degludec/liraglutide (IDegLira) compared to co-administration of separate injections of insulin degludec and liraglutide in healthy Chinese subjects. Participants received all three test substances, with the administration order allocated by chance. Serial blood samples were collected at predefined time points across three dosing periods to determine the plasma concentrations of both insulin degludec and liraglutide using specific analytical methods. The total blood volume drawn throughout the entire study period was kept below 400 mL.