NCT01057628已完成3 期
Phase III Study of ASP1941 -A Phase III, Randomized, Double-Blind, Placebo-controlled, Monotherapy Study to Assess the Efficacy, Safety, and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
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
- 130
- 主要终点
- change from baseline in HbA1c
研究概览
简要总结
This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients for at least 12 weeks
- •HbA1c value between 7.0 and 10.0%
- •Body Mass Index (BMI) 20.0 - 45.0 kg/m2
- •Investigator adjudicates that a subject is able to discontinue currently taking hypoglycemic agents safely during treatment
排除标准
- •Type 1 diabetes mellitus patients
- •Serum creatinine > upper limit of normal
- •Proteinuria (albumin/creatinine ratio > 300mg/g)
- •Dysuria and/or urinary tract infection, genital infection
- •Significant renal, hepatic or cardiovascular diseases
- •Severe gastrointestinal diseases
研究组 & 干预措施
ASP1941 group
Experimental
oral
干预措施: ipragliflozin (Drug)
placebo group
Placebo Comparator
oral
干预措施: placebo (Drug)
结局指标
主要结局
change from baseline in HbA1c
时间窗: 16 weeks
次要结局
- change from baseline in fasting plasma glucose(16 weeks)
- change from baseline in fasting serum insulin(16 weeks)
- safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)(During treatment)
研究者
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