NCT00924534已完成2 期
A Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV337 in Patients With Type 2 Diabetes on Metformin Monotherapy
Abbott Products12 个研究点 分布在 3 个国家目标入组 61 人开始时间: 2009年12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
- 61
- 试验地点
- 12
- 主要终点
- Change from Baseline in alanine amino transferase level to Day 35
研究概览
简要总结
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 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
1
Placebo Comparator
干预措施: Placebo (Drug)
2
Experimental
干预措施: SLV337 (Drug)
3
Experimental
干预措施: SLV337 (Drug)
4
Experimental
干预措施: SLV337 (Drug)
结局指标
主要结局
Change from Baseline in alanine amino transferase level to Day 35
时间窗: 35 days
Change from baseline in Creatinine level to Day 35
时间窗: 35 days
Change from baseline in the count of Red blood cells to Day 35
时间窗: 35 days
Change from baseline in White blood cells count to Day 35
时间窗: 35 days
Change from baseline in Creatinine kinase level to Day 35
时间窗: 35 days
次要结局
- Change from baseline in Fasting plasma glucose level to Day 28(28 days)
- Change from baseline in Adiponectin level to Day 28(28 days)
- Change from baseline in Triglycerides level to Day 28(28 days)
- Change from baseline in High density lipoprotein cholesterol level to Day 28(28 days)
研究者
研究点 (12)
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