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An Open-Label, Parallel Group Study Investigating the Effects of Age and Gender on the Pharmacokinetics of the Once-Daily Glucagon-Like Peptide-1 Analogue Liraglutide

From Clinical Pharmacology (Dr Damholt), Biostatistics (Mr Pedersen), and Medical & Science-Liraglutide (Dr Ekblom, Dr Zdravkovic), Novo Nordisk A/S, Bagsværd, Denmark, and Parexel International GmbH, Berlin, Germany (Dr Golor, Dr Wierich).

Liraglutide is a once-daily glucagon-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 male and 8 female subjects were recruited from an 18- to 45-year-old group and an 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 last 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.

Key Words: Liraglutide • NN2211 • diabetes type 2 • glucagon-like peptide-1 analogue • human subjects

Address for reprints: Milan Zdravkovic, MD, PhD, Novo Nordisk A/S, Medical & Science-Liraglutide, 2880, Bagsværd, Denmark; e-mail: mzd{at}novonordisk.com.

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