期刊
JOURNAL OF CLINICAL PHARMACOLOGY
卷 46, 期 6, 页码 635-641出版社
WILEY
DOI: 10.1177/0091270006288215
关键词
liraglutide; NN2211; diabetes type 2; glucagon-like peptide-1 analogue; human subjects
Liraglutide is a once-doily glucogon-like peptide-1 analogue being developed for the treatment of type 2 diabetes. The aim of this study was to investigate the effect of age and gender on the pharmacokinetics of liraglutide. Eight mole and 8 female subjects were recruited from an 18- to 45-year old group and on over-65-year-old group, respectively. All Subjects received a single subcutaneous dose of 1.0 mg liraglutide. The area under the liraglutide plasma concentration curve from time 0 to lost quantifiable concentration adjusted for body weight (significant covariate; P = .001) was found to be equivalent in young and elderly subjects (primary end point), with an estimated ratio of 0.94 (90% confidence interval, 0.84-1.06; P = .39). No significant impact of gender was observed (P = .38; estimated ratio, 1.08; 90% confidence interval, 0.93-1.26). Adverse events were Of mild or moderate severity. The most frequently reported events were headache, vomiting and nausea. When adjusted for body weight, no effect of gender or age Was found on the pharmacokinetics of liraglutide.
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