EUCTR2019-001987-31-DE进行中（未招募）1 期
COMBined Active Treatment in Type 2 Diabetes with NASH - COMBAT T2 NASH
Deutsche Diabetes Forschungsgesellschaft e.V.0 个研究点目标入组 192 人开始时间: 2020年6月15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
- 192
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
- •- Diagnosis of T2D and NASH with fibrosis stage F1-F3
- •- Age between 25 and 75 years
- •- HbA1c = 9.5%
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 92
排除标准
- •- Contraindications on liver biopsy
- •- Evidence of cirrhosis on liver biopsy
- •- Liver disease of other etiology
- •- History of ketoacidosis
- •- Alcohol consumption >30 g/d for males and >20 g/d for females
- •- Past (=5 years) or current history of alcohol or drug abuse and/or
- •psychiatric disease
- •- Medications that may induce steatosis
- •- Planned pregnancy, pregnant or lactating women, positive pregnancy
- •test, and woman of childbearing potential not using two adequate
- •methods of contraception
研究者
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