CTRI/2020/02/023250尚未招募3 期
Efficacy and Safety of Remogliflozin on Non-alcoholic fatty liver disease in diabetic patients on background Metformin therapy-A Randomized Controlled Clinical Trial
Kshirsagar Shivani Prakash1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Aspartate transaminase
研究概览
简要总结
Drugs of the class SGLT2 inhibitors have shown to be efficacious in improving liver profile in non-alcoholic fatty liver disease. Preclinical studies of efficacy of Remogliflozin in Non alcoholic fatty liver disesase are available.Hence this study is being done to study the efficacy and safety of Remogliflozin on Non alcoholic fatty liver disease in diabetic patients on metformin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Controlled Type 2 Diabetes Mellitus on Metformin therapy Diagnosed with Non-Alcoholic Fatty liver disease Fasting plasma glucose less than than 250 mg/dl Willing to participate in the study and comply with it procedures by signing a written informed consent.
排除标准
- •age less than 18 years and more than 75 years Uncontrolled Diabetes Mellitus Diabetic patients on Insulin therapy Fasting plasma glucose more than 250 mg/dl Viral Hepatitis Autoimmune Hepatitis Primary Billiary Cirrhosis.
结局指标
主要结局
Aspartate transaminase
时间窗: 0 week and 6 weeks | 0 week and 6 weeks
Alanine Transaminase
时间窗: 0 week and 6 weeks | 0 week and 6 weeks
次要结局
- Adverse drug reactions(6 weeks)
- Fasting blood glucose(0 week and 6 weeks)
- Body weight(0 week and 6 weeks)
研究者
研究点 (1)
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