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临床试验/EUCTR2005-000959-15-SE
EUCTR2005-000959-15-SE进行中(未招募)不适用

A multicenter clinical trial to evaluate quality of life in patients with Type 2 diabetes before and after changing therapy to a combination of insulin glargine and oral antidiabetic drugs in a real life situation

sanofi-aventis0 个研究点开始时间: 2005年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)

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

  • Patients with Type 2 diabetes inadequately controlled on a combination of highest tolerable dose of OAD + NPH insulin for more than 3 months
  • HbA1c >7.0 %
  • Age >18 years
  • Willingness to participate
  • Ability to perform QoL assessment
  • Body Mass Index (BMI = weight [kg] / height [m] x height [m]): < or equal to 35 kg/m2
  • Has been given written and verbal information and has had opportunity to ask questions about the study
  • Signed consent (written) to participate in the study
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Autoimmune diabetes, as defined by the World Health Organization (WHO)
  • Ongoing treatment with tiazolidindion (TZD) drug
  • Inability to comply with study procedures
  • Retinopathy with surgical treatment (laser photocoagulation or vitrectomy) during the preceding 3 months of study entry or requiring treatment within 3 months after the study entry
  • Drug abuse
  • Hypersensitivity to insulin glargine or any excipients

研究者

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