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临床试验/EUCTR2010-021922-36-DK
EUCTR2010-021922-36-DK进行中(未招募)1 期

Safety and effect of liraglutide in patients with type 2 diabetes and severe renal insufficiency.

Department of Nephrology, Rigshospitalet, University of Copenhagen0 个研究点开始时间: 2011年5月2日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • · Male or female; aged 18-85 years
  • · Chronic severely impaired kidney function treated with chronic maintenance
  • · Type 2 Diabetes
  • · Male or female; aged 18-85 years
  • · Normal kidney fuction
  • · Type 2 Diabetes
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 35
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 5

排除标准

  • Group 1 and 2
  • · Type 1 diabetes mellitus
  • ·Chronic pancreatitis / previous acute pancreatitis
  • ·Known or suspected hypersensitivity to trial product(s) or related products
  • ·Treatment with oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors or other drugs, which in the Investigator’s opinion could interfere with glucose or lipid metabolism 90 days prior to screening
  • ·Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder which in the investigators’ opinion could interfere with the results of the trial
  • ·Inflammatory bowel disease
  • ·Cardiac disease defined as: decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
  • ·Body mass index = 18.5 kg/m2 or = 50.0 kg/m2
  • ·Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
  • ·Clinical signs of diabetic gastroparesis
  • ·Impaired liver function (transaminases >two times upper reference levels)
  • ·Receipt of any investigational product 90 days prior to this trial
  • ·Known or suspected abuse of alcohol or narcotics
  • ·Screening calcitonin =50 ng/l
  • ·Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2

研究者

发起方
Department of Nephrology, Rigshospitalet, University of Copenhagen

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