NCT03011177已完成4 期
A Randomized, Open Label, Parallel-group, Non-inferiority, Active-controlled, Phase Ⅳ Study to Evaluate the Efficacy and Safety of Teneligliptin Versus Linagliptin in Type 2 Diabetes Mellitus Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes Mellitus patients.
详细描述
A randomized, open label, parallel-group, non-inferiority, active-controlled, phase IV study
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 19 years or older on screening
- •Patients with type 2 diabetes mellitus
- •Patients with 7.0% ≤ HbA1c ≤ 11.0% at the screening visit
- •Patients with Fasting Plasma Glucose <15mmol/L(270mg/dL) on screening
排除标准
- 未提供
研究组 & 干预措施
teneligliptin
Experimental
teneligliptin 20mg qd
干预措施: Teneligliptin (Drug)
linagliptin
Active Comparator
linagliptin 5mg qd
干预措施: Linagliptin (Drug)
结局指标
主要结局
HbA1c
时间窗: 12week
次要结局
未报告次要终点
研究者
研究点 (1)
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