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学科主题: 临床医学
题名:
Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin up-titration in Chinese patients with type 2 diabetes mellitus: study design and rationale of the vision study
作者: Ji, Li-Nong1; Pan, Chang-Yu2; Lu, Ju-Ming2; Li, Hong3; Li, Qiang4; Li, Qi-Fu5; Peng, Yong-De6; Tian, Hao-Ming7; Yao, Chen8; Zhao, Zhi-Gang9; Zhang, Ru-Ya10; Wang, Xiang-Ling10; Wang, Lei10; VISION Study Grp
关键词: VISION study ; Vildagliptin ; Type 2 diabetes ; Study design ; DPP-IV inhibitors
刊名: CARDIOVASCULAR DIABETOLOGY
发表日期: 2013-08-19
DOI: 10.1186/1475-2840-12-118
卷: 12
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Cardiac & Cardiovascular Systems ; Endocrinology & Metabolism
研究领域[WOS]: Cardiovascular System & Cardiology ; Endocrinology & Metabolism
关键词[WOS]: PEPTIDASE-IV INHIBITOR ; BETA-CELL FUNCTION ; GLUCAGON-LIKE PEPTIDE-1 ; BLOOD-GLUCOSE CONTROL ; GLYCEMIC CONTROL ; TREATED PATIENTS ; NAIVE PATIENTS ; ADD-ON ; INSULIN ; MONOTHERAPY
英文摘要:

Background and aim: Limitations of the currently recommended stepwise treatment pathway for type 2 diabetes mellitus (T2DM), especially the failure of monotherapies to maintain good glycemic control, have prompted use of early, more aggressive combination therapies.

The VISION study is designed to explore the efficacy and safety of vildagliptin as an add-on to metformin therapy compared with up-titration of metformin monotherapy in Chinese patients with T2DM.

Methods: VISION, a 24-week, phase 4, prospective, randomized, multicenter, open-label, parallel-group study, will include 3312 Chinese T2DM patients aged >= 18 years who are inadequately controlled (6.5% >HbA1c <= 9%) by metformin (750-1000 mg/day). Eligible patients will be randomized to receive either vildagliptin plus metformin or up-titration of metformin monotherapy (5: 1). Patients will also be subgrouped (1: 1: 1: 1) based on their age and body mass index (BMI): <60 years and <24 kg/m(2); <60 years and >= 24 kg/m(2); >= 60 years and <24 kg/m(2); and >= 60 years and >= 24 kg/m(2).

Conclusion: The VISION study will test the hypothesis that early use of combination therapy with vildagliptin and metformin will provide good glycemic control and will be better tolerated than up-titration of metformin monotherapy. The study will also correlate these benefits with age and BMI.

语种: 英语
项目资助者: Novartis Pharma Co. Ltd, Beijing, China
WOS记录号: WOS:000324139500001
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/55193
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.Shanghai First Peoples Hosp, Shanghai, Peoples R China
2.Sichuan Univ, West China Hosp, Chengdu 610064, Peoples R China
3.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
4.Henan Prov Peoples Hosp, Zhengzhou, Peoples R China
5.Beijing Novartis Pharma Co Ltd, Beijing, Peoples R China
6.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
7.Harbin Med Univ, Affiliated Hosp 2, Harbin, Peoples R China
8.Chinese Peoples Liberat Army Gen Hosp, Beijing 100853, Peoples R China
9.Zhejiang Univ, Coll Med, Sir Run Run Shaw Hosp, Hangzhou 310003, Zhejiang, Peoples R China
10.Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China

Recommended Citation:
Ji, Li-Nong,Pan, Chang-Yu,Lu, Ju-Ming,et al. Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin up-titration in Chinese patients with type 2 diabetes mellitus: study design and rationale of the vision study[J]. CARDIOVASCULAR DIABETOLOGY,2013,12.
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