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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
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
2013-08-19
DOI10.1186/1475-2840-12-118
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
WOS记录号WOS:000324139500001
资助机构Novartis Pharma Co. Ltd, Beijing, China
引用统计
被引频次:7[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/400002259/55193
专题北京大学第二临床医学院
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
推荐引用方式
GB/T 7714
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.
APA Ji, Li-Nong.,Pan, Chang-Yu.,Lu, Ju-Ming.,Li, Hong.,Li, Qiang.,...&VISION Study Grp.(2013).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.CARDIOVASCULAR DIABETOLOGY,12.
MLA Ji, Li-Nong,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".CARDIOVASCULAR DIABETOLOGY 12(2013).
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