NCT00497198已完成2 期
An Exploratory Study of MCI-196 for Treatment of Type 2 Diabetes in Randomized, Double-Blind, Parallel-Assignment, Placebo-Controlled Manner
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
- 183
- 主要终点
- Fasting Plasma Glucose at Baseline
研究概览
简要总结
The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2 Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner. And in addition, the changes in lipid-related parameters are examined.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose fasting blood glucose levels during the observation period are between 130mg/dL and 200mg/dL.
- •Patients whose HbA1c is 7.0% or above during the observation period.
排除标准
- •Patients with serious cardiac, hepatic or renal complications.
- •Patients with serious diabetic complications.
- •Patients with complete biliary obstruction or ileus.
- •Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception.
研究组 & 干预措施
MCI-196
Experimental
干预措施: MCI-196 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo of MCI-196 Tablet (Drug)
结局指标
主要结局
Fasting Plasma Glucose at Baseline
时间窗: 0 weeks
Change From Baseline in Blood Glucose at Week 12
时间窗: 12 weeks (baseline to week 12)
Hemoglobin A1c (HbA1c) at Baseline
时间窗: 0 weeks
Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12
时间窗: 12 weeks (baseline to week 12)
次要结局
- Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12(12 weeks (baseline to week 12))
研究者
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