NCT01521962已完成3 期
A Phase 3 Study to Investigate the Efficacy and Safety of SYR-322 When Used in Combination With Insulin Preparation in Subjects With Type 2 Diabetes in Japan
Takeda0 个研究点目标入组 67 人开始时间: 2012年2月最近更新:
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
- 67
- 主要终点
- Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value)
研究概览
简要总结
To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
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 subject is an outpatient.
- •The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
排除标准
- •The subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
- •The subject is considered ineligible for the study for any other reason by the investigator or subinvestigator.
研究组 & 干预措施
SYR-322 (Alogliptin) QD
Experimental
SYR-322 25 mg, orally.
干预措施: Alogliptin (Drug)
Insulin
Placebo Comparator
injection
干预措施: Insulin (Drug)
结局指标
主要结局
Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value)
时间窗: Baseline and Week 12
次要结局
未报告次要终点
研究者
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