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临床试验/EUCTR2013-004737-33-FR
EUCTR2013-004737-33-FR进行中(未招募)1 期

A prospective, multicenter, randomized, open-label study of 12 week duration to evaluate the effect of VILDagliptin added to insulin on glycaemic control in haemoDIALyzed patients with type 2 diabetes: probe analysis of CGM - VILDDIA

Hôpitaux Universitaires de Strasbourg0 个研究点目标入组 70 人开始时间: 2015年9月25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
70

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

入选标准

  • - Patients treated by haemodialysis for more than 3 months with 1g/L glucose in dialysate fluid
  • - Patients treated by stable doses of insulin (any regimen) for Type 2 diabetes without any oral antidiabetic agent
  • - Age > 18 and < 83 years
  • - HbA1c > 7%
  • 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 60
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • - Variability in EPO doses > 20% of doses (U/Kg/Month) or blood transfusion in the 2 previous months
  • - Life expectancy less than 1 year
  • - Chronic inflammatory disease
  • - Steroid treatment
  • - Cancer (evolutive or requiring chemotherapy or radiotherapy)
  • - Patient waiting for programmed surgery
  • - History of cardiovascular disease (stroke, coronary heart disease, hospitalization for heart failure) in the 4 previous months
  • - Non-compliant patients

研究者

发起方
Hôpitaux Universitaires de Strasbourg

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