Prediabetes and dialysis dependent end-stage renal disease MedDRA version: 17.0 Level: LLT Classification code 10014646 Term: End stage renal disease (ESRD) System Organ Class: 100000004857 MedDRA version: 17.0 Level: LLT Classification code 10065542 Term: Prediabetes System Organ Class: 100000004861 MedDRA version: 17.0 Level: LLT Classification code 10012347 Term: Dependence on renal dialysis System Organ Class: 100000004869
Conditions
Sponsors
Bo Feldt-Rasmussen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial will examine the effects of liraglutide treatment on several cardiovascular risk factors in patients with prediabetes and end-stage renal disease. 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 Objective: Secondary objectives include various clinical and biochemical cardiovascular and safety parameters.;Primary end point(s): Difference between the two treatment arms in area under the curve for the plasma glucose concentrations during a 3h 75g-OGTT on the trial visit of week 26.;Timepoint(s) of evaluation of this end point: The trial visit of week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • hypoglycaemia (safety parameter) • fasting plasma glucose, proinsulin, insulin and glucagon • insulin resistance (evaluated by HOMA-IR) • beta-cell function (evaluated by HOMA-ß) • change in glycaemic state following oral glucose tolerance test (normal glucose tolerance (NGT, fasting plasma glucose < 6.1 mmol/l and 2h plasma glucose < 7.8 mmol/l), IFG (fasting plasma glucose = 6.1 and < 7.0 mmol/l), IGT (2h plasma glucose = 7,8 and < 11.1 mmol/l) and DM (fasting plasma glucose = 7 mmol/l or 2h plasma glucose = 11.1 mmol/l)) • blood pressure • pulse • weight • body composition by DXA scan • cardiac function and perfusion(r-PET/CT) • cardiac autonomic function (heart rate variability by ECG) • Arterial stiffness: Augmentation index from Pulse wave analysis (PWA) • cardiovascular and endothelial risk markers (TnT, TnI, CK-MB, hsCRP, PAI-1, tPA, urat, vWF, VCAM, ICAM, TNFalpha, proBNP, E-selectin and asymmetric dimethylarginin) • Prothrombotic state (fibrinogen, activated partial thromboplastin time (APTT) and thromboelastography (TEG)) • lipid profile • plasma liraglutide;Timepoint(s) of evaluation of this end point: The trial visit of week 26 | — |
Countries
Denmark
Contacts
Public ContactAfd. 2132 att Bo Feldt-Rasmussen
Department of Nephrology, Rigshospitalet
Outcome results
None listed