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临床试验/EUCTR2007-002448-10-SK
EUCTR2007-002448-10-SK进行中(未招募)1 期

A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 1356 (5 mg administered orally once daily) over 24 weeks, in drug naive or previously treated (6 weeks washout) type 2 diabetic patients with insufficient glycaemic control

未提供0 个研究点目标入组 450 人开始时间: 2008年5月7日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
450

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

  • Signed and dated informed consent
  • Type 2 diabetes mellitus, treated with a maximum of 1 antidiabetic drug.
  • HbA1c >=6.5 and =<9% at start of wash-out of current medication and >=7%, =<10% after wash-out
  • 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

  • Myocardial infarction, stoke or TIA wihtin 6 months prior to consent
  • Impaired hepatic function
  • Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to consent
  • Treatment with more than 1 antidiabetic drug within 10 weeks prior to consent

研究者

发起方
未提供

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A randomised, double-blind, placebo-controlled... | 临床试验