EUCTR2015-003873-13-GR进行中(未招募)1 期
Evaluation of the tubular effects of dapagliflozin using 1HNMR spectroscopy.
Institute for the Study, Research and Education in Diabetes Mellitus and Metabolic Disorders0 个研究点目标入组 50 人开始时间: 2015年10月23日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provision of informed consent prior to any study specific procedures
- •2. Female and/or male aged 18-70 years. Women with childbearing potential can only be included in the study if a serological pregnancy test is negative and a safe contraception method is used throughout the study.
- •3. Uncontrolled type 2 diabetes mellitus (HbA1c > 7%) on metformin monotherapy (= 2000 mg qd or maximum tolerated dose)
- •4. Stage 1 hypertension (BP 140-159/90-99 mmHg)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. Known primary kidney disease (eGFR < 60 ml/min)
- •2. History of cardiovascular disease
- •3. Type 1 diabetes
- •4. History of heart failure
- •5. Diseases that shorten the life expectancy (cancers, degenerative neurological disorders etc.)
- •6. Pregnancy-lactation
- •7. Patients with eGFR values lower than 45 ml/min (on repeated measurements) during the study period will be excluded
研究者
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