NCT01431807已完成3 期
An Open-label, Multicenter, Long-term Phase 3 Study to Evaluate the Safety and Efficacy of Long-term Treatment With SYR-472 in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Diet and/or Exercise Therapies or Treatment With an Existing Oral Anti-diabetic Drug Added to Diet and/or Exercise Therapies
Takeda0 个研究点目标入组 680 人开始时间: 2011年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 680
- 主要终点
- Adverse events
研究概览
简要总结
To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.
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
- •The participant is an outpatient.
- •The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- •Diabetes Mellitus
排除标准
- •The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
- •The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.
研究组 & 干预措施
SYR-472 group
Experimental
(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
干预措施: SYR-472 (Drug)
结局指标
主要结局
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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