高级检索
当前位置: 首页 > 详情页

Liraglutide pharmacokinetics and dose-exposure response in Asian subjects with Type 2 diabetes from China, India and South Korea

文献详情

资源类型:
WOS体系:

收录情况: ◇ SCIE

单位: [1]Novo Nordisk AS, DK-2860 Soborg, Denmark [2]All India Inst Med Sci, New Delhi, India [3]Catholic Univ Korea, Catholic Med Ctr, Seoul, South Korea [4]Wuhan Union Hosp, Dept Endocrinol, Wuhan, Hubei, Peoples R China [5]Royal Liverpool Univ Hosp, Liverpool, Merseyside, England [6]China Japan Friendship Hosp, Dept Endocrinol, Beijing, Peoples R China
出处:
ISSN:

关键词: Liraglutide Population pharmacokinetics Type 2 diabetes Exposure-response

摘要:
Aims: To investigate the population pharmacokinetics and exposure-response relationship of liraglutide, a human glucagon-like peptide-1 (GLP-1) analogue, in Asian subjects with Type 2 diabetes mellitus. Methods: Data were derived from a published 16-week, randomized, double-blind, double-dummy, active-controlled, parallel-group trial of liraglutide in China, India and South Korea. The analysis utilized 2061 pharmacokinetic (PK) samples from 605 subjects exposed to liraglutide 0.6, 1.2 or 1.8 mg once daily. Demographic factors (body weight, age, gender, country) of importance for liraglutide clearance were evaluated. An exploratory exposure-response analysis was conducted to investigate effects on glycated haemoglobin (HbA(1c)) and body weight. Results: Estimated liraglutide exposure (area under the curve; AUC) appeared to increase proportionally with increasing liraglutide dose (0.6-1.8 mg). The covariate analysis confirmed previous findings in a global clinical trial. Body weight was a predictor of liraglutide exposure; compared to a reference subject of 67 kg, exposure was 32% lower for maximum (115 kg) and 54% higher for minimum (37 kg) observed body weights. Gender, age and country had no relevant effect on exposure. Exposure-response analysis supported the use of 1.2 mg as maintenance dose with the option of individual dose escalation to 1.8 mg to optimize treatment outcomes. Conclusions: Exposure appeared to increase proportionally with increasing liraglutide dose in Asian subjects with Type 2 diabetes mellitus. The only PK relevant predictor of exposure was body weight. The exposure-response relationships for HbA(1c) and body weight in Asian subjects were similar to observations in global populations. (C) 2015 The Authors. Published by Elsevier Ireland Ltd.

基金:
语种:
被引次数:
WOS:
中科院(CAS)分区:
出版当年[2014]版:
大类 | 3 区 医学
小类 | 4 区 内分泌学与代谢
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 内分泌学与代谢
JCR分区:
出版当年[2013]版:
Q3 ENDOCRINOLOGY & METABOLISM
最新[2023]版:
Q1 ENDOCRINOLOGY & METABOLISM

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2013版] 出版当年五年平均[2009-2013] 出版前一年[2012版] 出版后一年[2014版]

第一作者:
第一作者单位: [1]Novo Nordisk AS, DK-2860 Soborg, Denmark [*1]Novo Nordisk AS, Quantitat Clin Pharmacol, Vandtarnsvej 108-110, DK-2860 Soborg, Denmark
通讯作者:
通讯机构: [1]Novo Nordisk AS, DK-2860 Soborg, Denmark [*1]Novo Nordisk AS, Quantitat Clin Pharmacol, Vandtarnsvej 108-110, DK-2860 Soborg, Denmark
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:1320 今日访问量:0 总访问量:816 更新日期:2025-04-01 建议使用谷歌、火狐浏览器 常见问题

版权所有:重庆聚合科技有限公司 渝ICP备12007440号-3 地址:重庆市两江新区泰山大道西段8号坤恩国际商务中心16层(401121)