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
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