NCT01903070已完成4 期
EFFECTS OF LINAGLIPTIN ON ACTIVE GLP-1 CONCENTRATIONS IN SUBJECTS WITH RENAL IMPAIRMENT
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- ΔAUCGLP-1-OGTT(0-240)
研究概览
简要总结
This is a bi-centric, prospective, open study comparing the effects of linagliptin on active GLP-1 concentrations in subjects with renal impairment compared to subjects with normal renal function.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have Type 2 diabetes mellitus based on the disease diagnostic criteria (WHO) classification
排除标准
- •Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis.
研究组 & 干预措施
Linagliptin in TD2 subjects
Experimental
Linagliptin in TD2 subjects with normal renal function
干预措施: Linagliptin (Drug)
Linagliptin in TD2 subjects with impaired renal function
Experimental
Linagliptin in TD2 subjects with impaired renal function
干预措施: Linagliptin (Drug)
结局指标
主要结局
ΔAUCGLP-1-OGTT(0-240)
时间窗: Glucose tolerance test following 7 days of therapy
ΔAUCGLP-1-OGTT(0-240) Change in active GLP-1 concentrations after oral glucose ingestion after linagliptin Treatment compared between Groups.
次要结局
未报告次要终点
研究者
研究点 (1)
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