EUCTR2014-001778-32-DK进行中（未招募）不适用
Glycaemic and cardiovascular efficacy of liraglutide in prediabetic patients with end-stage renal disease - The LiRA2 study
Bo Feldt-Rasmussen0 个研究点开始时间: 2014年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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; age: 18 - 85 years
- •End-stage renal diasease treated with chronic maintenance dialysis (haemodialysis or peritoneal dialysis)
- •Impaired glucose tolerance (2h plasma glucose = 7,8 and < 11.1 mmol/l following a 75g-OGTT) and/or impaired fasting glucose (fasting plasma glucose = 6.1 and < 7.0 mmol/l) evaluated at the screening visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Diabetes mellitus type 1 or type 2 (diagnose according to WHO criteria)
- •Chronic pancreatitis / previous acute pancreatitis
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Treatment with oral glucocorticoids, calcineurin inhibitors or incretin-based therapy 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 investigator’s opinion could interfere with the results of the trial
- •Clinical suspicion of cardiac disease currently investigated
- •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 (BMI) <20 kg/m2 and/or >50 kg/m2
- •Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods*
- •Impaired liver function (transaminases > two times upper reference levels)
- •The 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
- •Lawfully detained, institutionalised and patients who are unable to give informed consent due to physical or mental conditions will not be included.
- •* Intrauterine devices and hormonal contraceptives (oral pills, patches, implants, vaginal rings, and injections) are considered as adequate contraceptives. Females of childbearing potential must use one of these contraceptives throughout the entire study plus 1 week after last injection with study medication. Surgical sterile (by bilateral vasectomy, tubectomy, hysterectomy or oophorectomy) or postmenopausal (defined as amenorrheic for at least one year) female participants are not considered as having a childbearing potential and are not required to use contraception.
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