A Phase IIb, Double-blind, Parallel Group, Multi-center, Dose-finding Study to Investigate the Efficacy and Safety of 4 Doses of MP-513 When Added to Ongoing Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus, With an Open Label Extension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 44
- 主要终点
- Change in HbA1c From Baseline to Week 24
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are aged ≧ 18 years old.
- •Patients whose HbA1c is ≧ 7.0 % and < 10.0%.
- •Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡.
- •Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit.
排除标准
- •Patients with type 1 diabetes or secondary form of diabetes.
- •Patients with heart failure symptoms.
- •Patients with serious diabetic complications.
- •Patients with severe hepatic disorder or severe renal disorder.
- •Patients who are the excessive alcohol addicts.
- •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 Lowest Dose and Metformin
干预措施: MP-513 Lowest Dose and Metformin (Drug)
MP-513 Low Dose and Metformin
干预措施: MP-513 Low Dose and Metformin (Drug)
MP-513 Medium Dose and Metformin
干预措施: MP-513 Medium Dose and Metformin (Drug)
MP-513 High Dose and Metformin
干预措施: MP-513 High Dose and Metformin (Drug)
Placebo and Metformin
干预措施: Placebo and Metformin (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 24
时间窗: Baseline and Week 24
The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.
次要结局
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24(Baseline and Week 24)
- Adverse Events, Laboratory Tests, Vital Signs, Etc.(Weeks 24, 52)