NCT02354235已完成3 期
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin in Patients With Inadequate Glycemic Control on Teneligliptin)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 3
- 主要终点
- Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.
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
- •Men or women who are 20 - 75 years old
- •HbA1c of ≥7.0% and <10.5%
- •FPG of ≤ 270 mg/dL
- •Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before run-in period
排除标准
- •Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
- •Patients with serious diabetic complications
- •Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
- •Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
- •Patients with severe hepatic disorder or severe renal disorder.
研究组 & 干预措施
Canagliflozin + Teneligliptin
Experimental
Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin.
Placebo + Teneligliptin
Placebo Comparator
Patients receive placebo for 24 weeks in combination with Teneligliptin.
结局指标
主要结局
Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
时间窗: Baseline, 24 Weeks
The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24.
次要结局
- Change From Baseline in Fasting Plasma Glucose Level(Baseline, 24 Weeks)
- Percentage Change in Body Weight From Baseline(Baseline, 24 Weeks)
- Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)(0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks)
- Change From Baseline in 2-hour Postprandial Plasma Glucose Level(2 Hours Postprandial, at Baseline and 24 Weeks)
研究者
研究点 (3)
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