NCT01686711已完成4 期
A Phase 4, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Study to Evaluate the Efficacy and Safety of AD-4833 When Orally Administered Once Daily as add-on to SYR-322 Versus SYR-322 Alone in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Treatment With SYR-322 in Addition to Diet and/or Exercise Therapy
Takeda0 个研究点目标入组 207 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 主要终点
- Glycosylated Hemoglobin (HbA1c)
研究概览
简要总结
To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
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
- •Those judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.
- •Those who can sign and date a written, informed consent form prior to the initiation of any study procedures.
排除标准
- •Those with concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease etc.
- •Others who are assessed to be ineligible for the study by the investigator or subinvestigator.
研究组 & 干预措施
SYR-322 25 mg , AD-4833 15 mg
Experimental
干预措施: AD-4833 15 mg (Drug)
SYR-322 25 mg , AD-4833 30 mg
Experimental
干预措施: AD-4833 30 mg (Drug)
SYR-322 25 mg , AD-4833 placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Glycosylated Hemoglobin (HbA1c)
时间窗: 16 weeks
Measurement of change in HbA1c (ratio of hemoglobin bound to glucose)
次要结局
未报告次要终点
研究者
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