NCT00036192已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 36
研究概览
简要总结
The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea (SU) monotherapy.
详细描述
This is a prospective randomized, double-blind, placebo controlled, parallel group, Phase 2 study. Subjects meeting selection criteria will be randomly assigned to receive 12 weeks twice daily (BID) dosing with FK614 or placebo. Enrollment for this study will be approximately 200 patients.
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
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has history of type 2 diabetes mellitus for at least 1 year
- •Has been taking current sulfonylurea (SU) for at least 3 months. Subjects currently taking metformin may be eligible to be switched.
- •Has not received any oral antidiabetic medication other than an SU or taken regularly prescribed insulin for at least 3 months
排除标准
- •Has type 1 diabetes mellitus
- •Has uncontrolled hypertension, i.e., systolic BP >170 or diastolic BP > 95 mm Hg.
- •History of congestive heart failure
研究者
研究点 (36)
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