NCT01193179已完成3 期
Long-term Co-administration Study of OPC-262 in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 450
- 主要终点
- Adverse events, clinical laboratory tests
研究概览
简要总结
The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 who are capable of giving informed consent
- •Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner
排除标准
- •Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
研究组 & 干预措施
OPC-262
Experimental
干预措施: OPC-262 (Drug)
结局指标
主要结局
Adverse events, clinical laboratory tests
时间窗: 52 weeks
次要结局
- Secondary Outcome HbA1c(52 weeks)
研究者
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