Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
Randomized, double blind, placebo-controlled clinical trial examining the efficacy and safety of mifepristone 600 mg daily in male subjects with type 2 diabetes mellitus, not associated with Cushing's syndrome
详细描述
Randomized, double blind, placebo-controlled clinical trial examining the efficacy and safety of mifepristone 600 mg daily in male subjects with type 2 diabetes mellitus, not associated with Cushing's syndrome, and sub-optimally controlled on basal insulin, with or without prandial insulin and/or maximally-tolerated doses of metformin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks
干预措施: Placebo (Drug)
Mifepristone 600 mg daily
Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks
干预措施: Mifepristone 600 mg daily (Drug)
结局指标
主要结局
Hemoglobin A1c
时间窗: Baseline to 3 months
Glycemic lowering
次要结局
- Basal Insulin Dose(Baseline to 3 months)
- Weight(Baseline to 3 months)
- Body Mass Index(Baseline to 3 months)
- Systolic BP(Baseline to 3 months)
- Diastolic BP(Baseline to 3 months)
- LDL-cholesterol(Baseline to 3 months)
- Cortisol(Baseline to 3 months)
- ACTH(Baseline to 3 months)
- Uric Acid(Baseline to 3 months)
- PSA(Baseline to 3 months)
- Hypoglycemic Events(Baseline to 3 months)
- Adverse Events(Baseline to 3 months)
研究者
Stanley Hsia
Associate Professor of Medicine
Charles Drew University of Medicine and Science