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
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