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学科主题: 临床医学
题名:
Efficacy and safety of exenatide once-weekly vs exenatide twice-daily in Asian patients with type 2 diabetes mellitus
作者: Ji, Linong1; Onishi, Yukiko2; Ahn, Chul Woo3; Agarwal, Pankaj4; Chou, Chien-Wen5; Haber, Harry6; Guerrettaz, Kelly7; Boardman, Marilyn K.8
关键词: Asian ; Exenatide ; Type 2 diabetes
刊名: JOURNAL OF DIABETES INVESTIGATION
发表日期: 2013
DOI: 10.1111/j.2040-1124.2012.00238.x
卷: 4, 期:1, 页:53-61
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]: CROSS-SECTIONAL SURVEY ; BLOOD-GLUCOSE CONTROL ; BETA-CELL FUNCTION ; BODY-MASS INDEX ; GLYCEMIC CONTROL ; INSULIN SENSITIVITY ; RANDOMIZED-TRIAL ; JAPANESE PATIENTS ; TREATED PATIENTS ; OPEN-LABEL
英文摘要:

Aims/Introduction To compare safety and efficacy of the extended-release formulation exenatide once weekly (EQW) vs exenatide twice daily (EBID) for 26weeks in type 2 diabetes patients from China, India, Japan, South Korea and Taiwan. Materials and Methods A randomized, comparator-controlled, open-label study included 681 patients with type 2 diabetes inadequately controlled (hemoglobin A1c [HbA1c] 7 and 11%) with oral antihyperglycemic medications (OAMs). Patients added 2mg EQW or 10g EBID to current OAMs. Safety was re-evaluated 10weeks after last treatment. Results EQW was superior to EBID on HbA1c measures at week 26 (Least-squares mean treatment difference: 0.31% [95% confidence interval 0.49, 0.14%]). More EQW-treated patients achieved target HbA1c 7.0% (P=0.003), 6.5% (P<0.001), or 6.0% (P=0.003). Fasting serum glucose reductions were greater among EQW-treated patients (P<0.001). Bloodglucose profiles improved in both treatment groups (P<0.001). Weight loss occurred with both treatments, but was greater with EBID. Adverse events (10%, either group) were nausea, injection-site induration, dyslipidemia and vomiting. Injection-site induration was more frequent with EQW, whereas nausea, vomiting and hypoglycemia were less frequent. One episode each of major hypoglycemia (EBID) and pancreatitis (EQW) were reported. Conclusion In this population, EQW and EBID showed efficacious glucose and weight control; safety and tolerability were consistent with observations in non-Asian patients. This trial was registered with ClinicalTrials.gov (no. NCT00917267).

语种: 英语
项目资助者: Eli Lilly and Company
WOS记录号: WOS:000314242900009
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/64127
Appears in Collections:北京大学第二临床医学院_期刊论文

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作者单位: 1.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
2.Asahi Life Fdn, Inst Adult Dis, Tokyo, Japan
3.Gangnam Severance Hosp, Seoul, South Korea
4.Eli Lilly & Co, Indianapolis, IN 46285 USA
5.Hormone Care & Res Ctr, Ghaziabad, India
6.Chi Mei Med Ctr, Tainan, Taiwan
7.PharmaNet i3, Ann Arbor, MI USA
8.PharmaNet i3, Blue Bell, PA USA

Recommended Citation:
Ji, Linong,Onishi, Yukiko,Ahn, Chul Woo,et al. Efficacy and safety of exenatide once-weekly vs exenatide twice-daily in Asian patients with type 2 diabetes mellitus[J]. JOURNAL OF DIABETES INVESTIGATION,2013,4(1):53-61.
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