NCT01634282已完成3 期
A Long-term Clinical Study of OPC-262 in Patients With Type 2 Diabetes on Study (Extension From Study 262-09-001)
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
- 222
- 主要终点
- Change in HBA1c form baseline
研究概览
简要总结
The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate the efficacy of OPC-262
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who completed Study 262-09-001 (namely, patients who visited the hospital at visit Week 24）
- •Patients who are capable of giving informed consent prior to participating in this clinical study
- •Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)
排除标准
- •Patients who withdrew from Study 262-09-001
- •Patients who experienced serious adverse events that the relationship with the study drug was not denied in Study 262-09-001
- •Patients who experienced serious adverse events that the relationship with the study drug are denied in Study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study
- •Patients who met the exclusion criteria of Study 262-09-001 during the study period of Study 262-09-001
- •Female patients who wish to become pregnant during the study period of Study 262-09-002 or within 4 weeks after the study
- •Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
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
Change in HBA1c form baseline
时间窗: 52 Weeks
Incidence and severity of adverse events
时间窗: 52 Weeks
次要结局
未报告次要终点
研究者
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