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【ChiCTR-TRC-11001613】甲福明二甲双胍治疗糖尿病合并慢性心力衰的效果研究

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基本信息

登记号

ChiCTR-TRC-11001613

试验状态

结束

药物名称

盐酸二甲双胍

药物类型

化药

规范名称

盐酸二甲双胍

首次公示信息日的期

2011-11-05

临床申请受理号

靶点

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适应症

II型糖尿病

试验通俗题目

甲福明二甲双胍治疗糖尿病合并慢性心力衰的效果研究

试验专业题目

甲福明二甲双胍治疗糖尿病合并慢性心力衰的效果研究：随机对照试验

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

400038

联系人通讯地址

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临床试验信息

试验目的

The efficacy of metformin in patients with diabetes and chronic heart failure

试验分类

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试验类型

随机平行对照

试验分期

Ⅳ期

随机化

完全随机

盲法

statistician: Bliding patients: Bliding observer: Bliding investigators: Bliding

试验项目经费来源

重庆市科技厅、西南医院

试验范围

目标入组人数

100

实际入组人数

第一例入组时间

2011-11-01

试验终止时间

1990-01-01

是否属于一致性

入选标准

1) Volunteers who can compliance the treatment and have signed the informed consent form prior to performance of study-related procedures; 2) Age from 18 years to 80 years; 3) A diagnosis of type 2 diabetes defined as: a previous physician diagnosis of type 2 diabetes as documented in the subject's clinical record or a new diagnosis of type 2 diabetes ( fasting blood glucose >=7.0 mmol/L or random blood glucose >=11.1 mmol/L accompanied by acute metabolic decompensation or 2 hour plasma glucose in a 75 gram oral glucose tolerance test >=11.1 mmol/L); 4) All the patient also have been diagnosed as chronic heart failure.；

排除标准

Patients who meet any of the following exclusion criteria will be excluded from the study: 1) acute diabetic complications, acute cardiovascular diseases, or acute cerebrovascular diseases; 2) subjects who are intolerance to metformin therapy, or are using metformin currently; 3) type 1 diabetes mellitus; 4) subjects who have been given reasonable treatment, but their heart failure still can be relieve; 5) subjects who have been or intend to do coronary artery bypass grafting, percutaneous coronary intervention or cardiac transplantation in 4 months; 6) severe comorbidities, such as HIV infection, cancer, serious infection, mezzo or severe anemia, severe renal or liver insufficiency; 7) those participating in another clinical trial.；

研究者信息

研究负责人姓名

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试验机构

第三军医大学西南医院

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

400038

联系人通讯地址