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临床试验/EUCTR2016-000370-38-DK
EUCTR2016-000370-38-DK进行中(未招募)1 期

A randomized, double-blinded, placebo-controlled trial that evaluates the effect of empagliflozin on oxidative stress in patients with type 2 diabetes - EMPOX

Rigshospitalet, Klinisk Farmakologisk Afd. Q76420 个研究点目标入组 35 人开始时间: 2016年2月10日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
35

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
Male

入选标准

  • - Male individuals with type 2 diabetes
  • - Age = 18 years and = 75 years
  • - HbA1c > 6.5 %
  • - Capable of understanding oral- and written information
  • 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 14
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • - eGFR < 60 ml/hour/1.73 m2
  • - Currently in insulin treatment
  • - Coronary artery bypass grafting, percutan coronary intervention, acute coronary syndrome, apoplexy, lung embolism, deep vein thrombosis or transitory cerebral ischemia < 6 months.
  • - Genital infection < 14 days
  • - p-alanin-aminotransferase =3 x upper limit
  • - Psychiatric disorder
  • - Intolerance to empagliflozin or other agents relevant to study
  • - Non-compliance

研究者

发起方
Rigshospitalet, Klinisk Farmakologisk Afd. Q7642

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