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临床试验/EUCTR2015-003873-13-GR
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

发起方
Institute for the Study, Research and Education in Diabetes Mellitus and Metabolic Disorders

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