NCT01072331已完成3 期
Pharmacokinetic/Pharmacodynamic Study of MP-513 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
- 99
- 主要终点
- Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)
研究概览
简要总结
The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration.
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
- •Patients who are 20 - 75 years old
- •Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before administration of investigational drug
- •Patients whose HbA1c is ≥6.5% and <10.0%
- •Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 8 weeks before administration of investigational drug.
排除标准
- •Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
- •Patients who are accepting treatments of arrhythmias
- •Patients with serious diabetic complications
- •Patients who are the excessive alcohol addicts
- •Patients with severe hepatic disorder or severe renal disorder.
- •Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
研究组 & 干预措施
MP-513 10 mg, once a day, for 4 weeks
Experimental
干预措施: MP-513 (Drug)
MP-513 20 mg, once a day, for 4 weeks
Experimental
干预措施: MP-513 (Drug)
Placebo of MP-513
Placebo Comparator
干预措施: Placebo of MP-513 (Drug)
结局指标
主要结局
Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)
时间窗: 4 weeks
Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)
时间窗: 4 weeks
次要结局
- Change From Baseline in 24-h Mean Glucose(4 weeks)
- Change From Baseline in Fasting Plasma Glucose(4 weeks)
研究者
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