跳至主要内容
临床试验/NCT01394341
NCT01394341已完成4 期

Safety and Effect of Liraglutide in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Bo Feldt-Rasmussen3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年9月最近更新:
适应症
干预措施

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

T2D, Dialysis, Liraglutide

Active Comparator

Daily liraglutide treatment Chronic dialysis treatment

干预措施: Liraglutide (Drug)

T2D, Dialysis, Placebo

Placebo Comparator

Daily placebo Chronic dialysis treatment

干预措施: Liraglutide (Drug)

T2D, Normal kidney function, Liraglutide

Active Comparator

Daily Liraglutide treatment Normal kidney function

干预措施: Liraglutide (Drug)

T2D, Normal kidney function, Placebo

Placebo Comparator

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

发起方
Bo Feldt-Rasmussen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bo Feldt-Rasmussen

Professor, DMSc, Head of Department

Rigshospitalet, Denmark

研究点 (3)

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