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Pharmacokinetics, safety, and tolerability of single- and multiple-dose exenatide once weekly in Chinese patients with type 2 diabetes mellitus
Cui, Yi Min1; Guo, Xiao Hui2; Zhang, Dong Mei1; Tham, Lai San3; Tang, Cheng Cai3; Mace, Kenneth4; Linnebjerg, Helle4
关键词Chinese diabetes exenatide glucagon-like peptide-1 pharmacokinetics
刊名JOURNAL OF DIABETES
2013-06-01
DOI10.1111/1753-0407.12020
5期:2页:127-135
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Endocrinology & Metabolism
研究领域[WOS]Endocrinology & Metabolism
关键词[WOS]SYNTHETIC EXENDIN-4 ; JAPANESE PATIENTS ; RANDOMIZED-TRIAL ; GLUCOSE CONTROL ; OPEN-LABEL ; PHARMACODYNAMICS ; COMPLICATIONS ; EFFICACY ; RELEASE
英文摘要

Background: This open-label, single-period study assessed the pharmacokinetics, safety, tolerability, and pharmacodynamics of exenatide once weekly (q.w.), following single and multiple weekly subcutaneous (s.c.) injections in native Chinese patients with type 2 diabetes (T2D).

Methods: Patients (n = 25; mean [+/- SD] age 51.3 +/- 8.2 years; body mass index 25.6 +/- 2.4 kg/m(2); HbA1c 7.4 +/- 1.2%; duration of diabetes 3.1 +/- 3.1 years) previously treated with diet modification and exercise alone or incombination with stable metformin doses were enrolled in the study. Twenty-five patients received weekly doses of 2 mg, s.c., exenatide q.w. for 10 weeks, followed by 10 weeks observation. Pharmacokinetic parameters of exenatide, fasting plasma glucose (FPG), HbA1c, and body weight were summarized using descriptive statistics.

Results: Steady state plasma exenatide concentrations (299 pg/mL) were attained within 8 weeks. Exenatide q.w. was generally well tolerated, and the majority of adverse events reported were mild in severity. The most frequent study drug-related adverse events were diarrhea and vomiting. Decreases were observed from baseline to 10 weeks in FPG (similar to 3.0 mmol/L), HbA1c (similar to 1.0%), and body weight (similar to 3.8 kg).

Conclusions: This is the first clinical trial of exenatide q.w. in native Chinese patients with T2D. The results suggest that exenatide q.w. has a pharmacokinetic profile in this patient population similar to that observed in other ethnic and racial populations, and appears to be safe and generally well tolerated, with the potential to improve glycemic control and decrease body weight without increasing the risk of hypoglycemia.

语种英语
WOS记录号WOS:000318243000006
资助机构Eli Lilly and Company
引用统计
被引频次:13[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/65873
专题北京大学第一临床医学院_药剂科
作者单位1.Peking Univ, Dept Endocrinol, Hosp 1, Beijing 100034, Peoples R China
2.Lilly NUS Ctr Clin Pharmacol, Global Pharmacokinet Pharmacodynam & Pharmacometr, Singapore, Singapore
3.Eli Lilly & Co, Lilly Res Labs, Indianapolis, IN 46285 USA
4.Peking Univ, Dept Pharm, Hosp 1, Beijing 100034, Peoples R China
推荐引用方式
GB/T 7714
Cui, Yi Min,Guo, Xiao Hui,Zhang, Dong Mei,et al. Pharmacokinetics, safety, and tolerability of single- and multiple-dose exenatide once weekly in Chinese patients with type 2 diabetes mellitus[J]. JOURNAL OF DIABETES,2013,5(2):127-135.
APA Cui, Yi Min.,Guo, Xiao Hui.,Zhang, Dong Mei.,Tham, Lai San.,Tang, Cheng Cai.,...&Linnebjerg, Helle.(2013).Pharmacokinetics, safety, and tolerability of single- and multiple-dose exenatide once weekly in Chinese patients with type 2 diabetes mellitus.JOURNAL OF DIABETES,5(2),127-135.
MLA Cui, Yi Min,et al."Pharmacokinetics, safety, and tolerability of single- and multiple-dose exenatide once weekly in Chinese patients with type 2 diabetes mellitus".JOURNAL OF DIABETES 5.2(2013):127-135.
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