Abstrato

Pharmacokinetic properties of insulin degludec in healthy Chinese subjects

Pei Hu, Ji Jiang, Lars Bardtrum & Hanne L Haahr*

Objective: The objective of this study was to investigate the pharmacokinetic properties of insulin degludec in healthy Chinese subjects and to compare those properties with results from previous trials in Caucasian and Japanese subjects. Methods: Twenty-four healthy Chinese subjects received a single dose of 0.4 U/kg body weight insulin degludec. Blood samples were taken for pharmacokinetic analysis pre-dose and until 120 hours post-dose. A population pharmacokinetic model was applied to the single-dose data to simulate steady-state profiles. Results: Compared with the observed single-dose 24-hour serum insulin degludec profile, corresponding to the first dosing interval in a once-daily regimen, the simulated steady-state serum insulin degludec concentration was higher. This was expected since steady-state for insulin degludec is reached after 2-3 days of once-daily dosing due to its long half-life. The simulated steady-state pharmacokinetic profile of insulin degludec in healthy Chinese subjects showed a close to even distribution of exposure across a 24-hour dosing interval, comparable to that in healthy Caucasian subjects and in Caucasian and Japanese subjects with type 1 diabetes. Steady-state total exposure and maximum concentration of insulin degludec were within the same range in Chinese subjects compared with Caucasian and Japanese subjects. Conclusion: The pharmacokinetic properties of insulin degludec in Chinese subjects are consistent with those in Caucasian and Japanese subjects. ClinicalTrials.gov identifier: NCT01437592.