NCT03508323已完成4 期
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase IV Study to Evaluate the Efficacy and Safety of Tenelia® in Patients Aged 65 and Older With Inadequately Controlled Type 2 Diabetes
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
- 65
- 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 in Patients aged 65 and Older with inadequately controlled type 2 diabetes.
详细描述
To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 65 years or older on screening
- •Patients with type 2 diabetes mellitus
- •Patients with 7.0% ≤ HbA1c ≤ 9.0% at the screening visit
- •Patients with FPG < 270mg/dL on screening visit
排除标准
- 未提供
研究组 & 干预措施
Teneligliptin
Experimental
干预措施: Teneligliptin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c
时间窗: after 12wks on baseline
Change of HbA1c
次要结局
未报告次要终点
研究者
研究点 (1)
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