NCT00621868已完成2 期
ASP1941 Phase II Clinical Study - A Double-blind, Placebo-controlled, Parallel-group, Dose-response Study in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 361
- 主要终点
- HbA1c level
研究概览
简要总结
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of type 2 diabetes mellitus
- •Fasting serum C-peptide level > 0.6 ng/mL
- •HbA1c between 7.0 and 10.0%
- •Body Mass Index between 20 and 45 kg/m2
排除标准
- •Serum creatinine > upper limit of normal
- •Proteinuria (albumin/creatinine ratio > 300 mg/g)
- •Dysuria and/or urinary tract infection
- •Significant renal, hepatic or cardiovascular diseases
- •Hypertension
- •Severe gastrointestinal diseases
研究组 & 干预措施
1
Experimental
Lowest dose
干预措施: ipragliflozin (Drug)
2
Experimental
Low-middle dose
干预措施: ipragliflozin (Drug)
3
Experimental
High-middle dose
干预措施: ipragliflozin (Drug)
4
Experimental
Highest dose
干预措施: ipragliflozin (Drug)
5
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c level
时间窗: 12 weeks
次要结局
- Blood glucose level(12 Weeks)
- Safety(12 Weeks)
研究者
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