NCT02220907已完成3 期
Long-term Administration Study of MT-2412 in 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
- 153
- 试验地点
- 6
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women age ≥20 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 12 weeks before treatment 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
Teneligliptin/Canagliflozin
Experimental
Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks.
干预措施: Teneligliptin/Canagliflozin (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 52 Weeks
次要结局
- Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)(Baseline, 52 Weeks)
- Change From Baseline in Fasting Plasma Glucose Level(Baseline, 52 Weeks)
- Percentage Change in Body Weight From Baseline(Baseline, 52 Weeks)
研究者
研究点 (6)
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