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学科主题: 临床医学
题名:
Pharmacokinetics, safety, and tolerability of single- and multiple-dose exenatide once weekly in Chinese patients with type 2 diabetes mellitus
作者: 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
发表日期: 2013-06-01
DOI: 10.1111/1753-0407.12020
卷: 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
项目资助者: Eli Lilly and Company
WOS记录号: WOS:000318243000006
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/65873
Appears in Collections:北京大学第一临床医学院_药剂科_期刊论文

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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

Recommended Citation:
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.
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