A Phase III Study of MP-513 in Combination With Sulfonylurea in Japanese Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 194
- 主要终点
- Change From Baseline in HbA1c at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea 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
- 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 12 weeks before administration of investigational drug
- •Patients whose HbA1c is between 7.0% and 10.0%
- •Patients who took Sulfonylurea for diabetes over 12 weeks before administration of investigational drug
- •Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 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 with Class III/IV heart failure symptoms according to NYHA functional classification
- •Patients who are gastrointestinal disorder (diarrhea, vomiting)
- •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
Placebo / Teneli + SU
干预措施: Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea) (Drug)
Teneli / Teneli + SU
干预措施: Teneli / Teneli + SU (Drug)
结局指标
主要结局
Change From Baseline in HbA1c at Week 12
时间窗: at Week 0 and Week 12
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.
次要结局
- Change From Baseline in Fasting Plasma Glucose at Week 12(at Week 0 and Week 12)
- Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12(0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12)
- Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12(at Week 0 and Week 12)