Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent 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
- 462
- 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 MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
- •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 6.5% - 10.0%
- •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 who are accepting treatments of arrhythmias
- •Patients with serious diabetic complications
- •Patients who are habitual excessive alcohol consumption.
- •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
teneligliptin and biguanide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
干预措施: biguanide (Drug)
teneligliptin
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
干预措施: teneligliptin (Drug)
teneligliptin and glinide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
干预措施: teneligliptin (Drug)
teneligliptin and glinide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
干预措施: glinide (Drug)
teneligliptin and biguanide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
干预措施: teneligliptin (Drug)
teneligliptin and alpha-glucosidase inhibitor
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
干预措施: teneligliptin (Drug)
teneligliptin and alpha-glucosidase inhibitor
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
干预措施: alpha-glucosidase inhibitor (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 52 Weeks
Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
次要结局
- Change From Baseline in Fasting Plasma Glucose at Week 52(Baseline and 52 weeks)
- Change From Baseline in HbA1c at Week 52(Baseline and 52 weeks)
- Change From Baseline in Fasting Glucagon at Week 52(Baseline and 52 weeks)
- Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52(Baseline and 52 weeks)