当前位置： SCI文献检索 > CLINICAL DRUG INVESTIGATION期刊下所有文献 > Insulin degludec: pharmacokinetic properties in subjects with hepatic impairment.

Insulin degludec: pharmacokinetic properties in subjects with hepatic impairment.

Abstract：

BACKGROUND AND OBJECTIVE:Insulin degludec is a basal insulin with a slow and distinct absorption mechanism resulting in an ultra-long, flat, and stable pharmacokinetic profile in patients with diabetes mellitus. The aim of this study was to examine the effect of hepatic impairment on the single-dose pharmacokinetics of insulin degludec. METHODS:Twenty-four subjects, allocated to one of four groups (n=6 per group) based on level of hepatic impairment (normal hepatic function, Child-Pugh grade A, B, or C), were administered a single subcutaneous dose of 0.4 U/kg insulin degludec. Blood samples up to 120 h post-dose and fractionated urine samples were collected to measure pharmacokinetic parameters. RESULTS:No difference was observed in pharmacokinetic parameters [area under the 120-h serum insulin degludec concentration-time curve (AUC120 h), maximum insulin degludec concentration (C max), and apparent clearance (CL/F)] for subjects with impaired versus normal hepatic function after a single dose of insulin degludec. The geometric mean [coefficient of variation (CV) %] AUC120 h values were 89,092 (16), 83,327 (15), 88,944 (23), and 79,846 (19) pmol·h/L for normal hepatic function and mild, moderate, and severe hepatic impairment, respectively. Simulated steady-state insulin degludec pharmacokinetic profiles showed an even distribution of exposure across a 24-h dosing interval regardless of hepatic function status. CONCLUSIONS:The ultra-long pharmacokinetic properties of insulin degludec were preserved in subjects with hepatic impairment and there were no statistically significant differences in absorption or clearance compared with subjects with normal hepatic function.

journal_name

Clin Drug Investig

journal_title

Clinical drug investigation

authors

Kupčová V,Arold G,Roepstorff C,Højbjerre M,Klim S,Haahr H

doi

10.1007/s40261-013-0154-1

subject

Has Abstract

pub_date

2014-02-01 00:00:00

pages

127-33

issue

2

eissn

1173-2563

issn

1179-1918

journal_volume

34

pub_type

杂志文章

相关文献

CLINICAL DRUG INVESTIGATION文献大全