Safety and Effect of Liraglutide in Patients With Type 2 Diabetes and Severe Renal Insufficiency
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Plasma liraglutide concentration (pmol/L)
研究概览
简要总结
Incretin-based therapy for the treatment of patients with type 2 diabetes mellitus (T2D) is new and fundamentally different from the classical treatments with oral antidiabetic agents and insulin. The novel and original aspect of this investigator-initiated study is the focus on treatment with an incretin-based agent (the GLP-1 analogue liraglutide) in T2D patients with severely reduced kidney function. At present there is virtually no knowledge of the physiology and clinical implications of the role of incretin hormones and incretin-based therapy in this group of diabetic patients.The aim of the study is to establish an evidence-based rationale for introducing a GLP-1 analogue to the limited armamentarium of antidiabetic drugs for patients with type T2D and severe renal insufficiency. The overall hypothesis is that patients with T2D and severe renal insufficiency will tolerate and benefit from treatment with the GLP-1 analogue liraglutide, hereby improving glycaemic control and reducing risk factors of cardiovascular disease
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
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
T2D, Dialysis, Liraglutide
Daily liraglutide treatment Chronic dialysis treatment
干预措施: Liraglutide (Drug)
T2D, Dialysis, Placebo
Daily placebo Chronic dialysis treatment
干预措施: Liraglutide (Drug)
T2D, Normal kidney function, Liraglutide
Daily Liraglutide treatment Normal kidney function
干预措施: Liraglutide (Drug)
T2D, Normal kidney function, Placebo
Daily placebo treatment Normal kidney function
干预措施: Liraglutide (Drug)
结局指标
主要结局
Plasma liraglutide concentration (pmol/L)
时间窗: 12 weeks
Plasma liraglutide concentration evaluated over time during continuous intervention
次要结局
- Pancreatic beta-cell function(12 weeks)
- Hypoglycaemia; minor or major(12 weeks)
- Glycaemic control(12 weeka)
- Cardiovascular risk factors (lipids and blood pressure)(12 weeks)
研究者
Bo Feldt-Rasmussen
Professor, DMSc, Head of Department
Rigshospitalet, Denmark
