Pharmacokinetic properties of insulin degludec in healthy Chinese subjects

Objective: The objective of this study was to investigate the pharmacokinetic properties ofinsulin degludec in healthy Chinese subjects and to compare those properties with resultsfrom previous trials in Caucasian and Japanese subjects. Methods: Twenty-four healthy Chinesesubjects received a single dose of 0.4 U/kg body weight insulin degludec. Blood samples weretaken for pharmacokinetic analysis pre-dose and until 120 hours post-dose. A populationpharmacokinetic 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 seruminsulin degludec concentration was higher. This was expected since steady-state for insulindegludec is reached after 2-3 days of once-daily dosing due to its long half-life. The simulatedsteady-state pharmacokinetic profile of insulin degludec in healthy Chinese subjects showeda close to even distribution of exposure across a 24-hour dosing interval, comparable to thatin 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 thesame range in Chinese subjects compared with Caucasian and Japanese subjects. Conclusion:The pharmacokinetic properties of insulin degludec in Chinese subjects are consistent withthose in Caucasian and Japanese subjects. ClinicalTrials.gov identifier: NCT01437592.