NCT02314637已完成3 期
Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese 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
- 240
- 试验地点
- 1
- 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 Sulfonylurea (glimepiride) in Japanese 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In case of combination therapy with Sulfonylurea, patients who has been receiving a stable dose and regimen of sulfonylurea 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
- •HbA1c criteria:
- •monotherapy: 6.9% - 10.5%
- •combination therapy with Sulfonylurea: 7.4 - 10.5%
- •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 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
Teneligliptin
Experimental
Teneligliptin for 52 weeks
干预措施: Teneligliptin (Drug)
Teneligliptin + Sulfonylurea
Experimental
Teneligliptin for 52 weeks in combination with sulfonylurea
干预措施: Teneligliptin + Sulfonylurea (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 Week 52)
- Change From Baseline in HbA1c at Week 52(Baseline and Week 52)
研究者
研究点 (1)
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