NCT02586168已完成2 期
The Effect of Gemcabene (CI-1027) on Insulin Sensitivity in Nondiabetic Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 主要终点
- Insulin sensitivity
研究概览
简要总结
The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good health, as determined by medical history, physical examination, EKG and clinical laboratory assessments
- •Males; and females of non-reproductive potential
- •Non-diabetic
排除标准
- •Use of any medication considered unacceptable by the clinical investigators during the 14-day period before the start of Day
- •Hormone Replacement Therapy is acceptable.
- •Use of a lipid-lowering agent (niacin, fibrates, statin) during the 8 weeks before screening
- •Use of any anti-diabetic medications
- •Use of any steroid medications
- •Donation of any blood or plasma product or participation in another study in the 30 days prior to Day 1
- •If female, pregnant, lactating or of childbearing potential; and
- •History of significant reaction to any fibrate lipid-lowering agent
研究组 & 干预措施
Gemcabene 900 mg
Experimental
Gemcabene 900 mg
干预措施: Gemcabene 900 mg (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Insulin sensitivity
时间窗: 4 weeks
次要结局
- Clinical Laboratory - hematology, chemistry(4 weeks)
- Adverse Events(4 weeks)
- ECG(4 weeks)
研究者
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