NCT01023945已完成1 期
A Phase 1, Randomized, Double-blind, Placebo Controlled, Monotherapy Study to Assess the Pharmacodynamics, Pharmacokinetics, 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
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change in plasma glucose levels
研究概览
简要总结
The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.
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
- •Type 2 diabetic patients for at least 12 weeks
- •HbA1c value between 7.0 and 10.0% at screening
- •Fasting plasma glucose ≥ 126mg/dL and < 240mg/dL at screening
- •Body Mass Index (BMI) 20.0 - 45.0 kg/m2.
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
- •Significant renal, hepatic or cardiovascular diseases
- •Severe gastrointestinal diseases
研究组 & 干预措施
ASP1941 high dose group
Experimental
oral
干预措施: ASP1941 (Drug)
ASP1941 low dose group
Experimental
oral
干预措施: ASP1941 (Drug)
Placebo group
Placebo Comparator
oral
干预措施: Placebo (Drug)
结局指标
主要结局
Change in plasma glucose levels
时间窗: On day 14
次要结局
- Urinary glucose excursion(On day 14)
- Pharmacokinetic parameter of ASP1941(On day 14)
- Safety by adverse events, routine safety laboratories and vital signs.(During treatment)
- Change in serum insulin levels(On day 14)
研究者
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