NCT03332836终止1 期
A Phase 1, Multiple Ascending Dose, Glucose Clamp Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM12460A Compared to Insulin Glargine in Subjects With Type 2 Diabetes Mellitus
Hanmi Pharmaceutical Company Limited2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年10月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 2 Diabetes Mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Female subjects must be non-pregnant and non-lactating
排除标准
- •Recurrent severe hypoglycemia or hypoglycemic unawareness or recent severe ketoacidosis, as judged by the Investigator
- •Pregnant or lactating women
- •Participation in an investigational study within 30 days prior to dosing
结局指标
主要结局
Number of participants with adverse events
时间窗: 1 month
An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products.
次要结局
- Cmax of HM12460A(1 month)
- AUC of HM12460A(1 month)
研究者
研究点 (2)
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