NCT02284230撤回2 期
Glycaemic and Cardiovascular Efficacy of Liraglutide in Prediabetic Patients With End-stage Renal Disease
Bo Feldt-Rasmussen1 个研究点 分布在 1 个国家开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Plasma glucose during oral glucose tolerance test at week 26
研究概览
简要总结
The present study will examine the effects of liraglutide treatment during 26 weeks on several cardiovascular risk factors in patients with prediabetes and end-stage renal disease (ESRD). The primary objective is to determine the efficacy of the treatment on glucose tolerance evaluated during a 3h 75g-oral glucose tolerance test (OGTT). Secondary objectives include various clinical and biochemical cardiovascular and safety parameters.
We hypothesise that treatment with liraglutide can improve glucose tolerance in prediabetic patients with ESRD by normalizing plasma glucose excursions during an OGTT and ameliorate other cardiovascular risk factors.
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
- Triple (Participant, Care Provider, 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
- •End-stage renal disease 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
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.
研究组 & 干预措施
Liraglutide treatment
Active Comparator
Subcutaneous, once daily injection of liraglutide, individually dosed up to 1.8 mg/day.
干预措施: Liraglutide (Drug)
Placebo treatment
Placebo Comparator
Subcutaneous, once daily injection of placebo, individually dosed up to 1.8 mg/day.
干预措施: Placebo (Drug)
结局指标
主要结局
Plasma glucose during oral glucose tolerance test at week 26
时间窗: The trial visit of week 26
Difference between the two treatment arms in plasma glucose concentrations during a 3h 75g-OGTT on the trial visit of week 26
次要结局
- Cardiac autonomic function(The trial visit of week 26)
- Lipid profile(The trial visit of week 26)
- Fasting values of glucometabolic hormones(The trial visit of week 26)
- Blood pressure(The trial visit of week 26)
- Pulse(The trial visit of week 26)
- Weight(The trial visit of week 26)
- Hypoglycemic incidents(From the randomisation to trial visit of week 26)
- Change in glycemic state(The trial visit of week 26)
- Insulin resistance(The trial visit of week 26)
- Beta cell function(The trial visit of week 26)
- Body composition(The trial visit of week 26)
- Arterial stiffness(The trial visit of week 26)
- Cardiac function and perfusion(The trial visit of week 26)
- Cardiovascular and endothelial risk markers(The trial visit of week 26)
- Prothrombotic state(The trial visit of week 26)
- Plasma liraglutide(The trial visit of week 26)
研究者
Bo Feldt-Rasmussen
Professor, MD, DMSc
Rigshospitalet, Denmark
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
The effect of liraglutide in patients with prediabetes and kidney failurePrediabetes and dialysis dependent end-stage renal diseaseMedDRA version: 17.0Level: LLTClassification code 10014646Term: End stage renal disease (ESRD)System Organ Class: 100000004857MedDRA version: 17.0Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861MedDRA version: 17.0Level: LLTClassification code 10012347Term: Dependence on renal dialysisSystem Organ Class: 100000004869EUCTR2014-001778-32-DKBo Feldt-Rasmussen
进行中（未招募）
1 期
Comparing the effects of two new therapies for diabetes on the heart, measures of fat and diabetes in young people with type 2 diabetesType 2 Diabetes MellitusEUCTR2012-002422-78-GBniversity of Leicester90
已完成
3 期
Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes MellitusDiabetes Mellitus, Type 1NCT05467514David Sanchez Garcia35
已完成
3 期
Liraglutide in Adolescents With Type 1 DiabetesType 1 DiabetesNCT02516657University at Buffalo5
已完成
3 期
Liraglutide as add-on to Insulin in Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT02092896Hvidovre University Hospital40