NCT00760578已完成2 期
A Phase 2A, Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Two Dose Levels of Mitoglitazone™ in Type 2 Diabetic Patients
Metabolic Solutions Development Company0 个研究点目标入组 86 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 主要终点
- Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test
研究概览
简要总结
The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type 2 diabetes.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Type 2 Diabetes naive or on metformin
- •Male and female (postmenopausal or surgically sterilized), 18 to 70 years of age.
排除标准
- •Use of diabetes medications other than metformin.
- •History of heart failure or previous myocardial infarction.
- •Blood pressure great than 160/100 mmHg.
研究组 & 干预措施
Placebo
Placebo Comparator
Microcrystaline cellulose once daily
干预措施: Placebo (Drug)
Pioglitazone
Active Comparator
Pioglitazone 45 mg once daily
干预措施: Pioglitazone (Drug)
MSDC-0160 90 mg
Experimental
MSDC-0160 90 mg once daily
干预措施: MSDC-0160 90 mg (Drug)
MSDC-0160 220 mg
Experimental
MSDC-0160 220 mg once daily
干预措施: MSDC-0160 220 mg (Drug)
结局指标
主要结局
Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test
时间窗: 28 days
Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test.
次要结局
- Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test(After four weeks of active therapy)
- Change From Baseline in FFAs(After 28 days of active therapy)
- Change From Baseline in Triglycerides(28 days)
- Change From Baseline in HDL(28 days)
研究者
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