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Clinical Trial Details

Trial ID: L0948
Source ID: NCT02284230
Associated Drug: Liraglutide
Title: The Effect of Liraglutide in Patients With Prediabetes and Kidney Failure
Acronym: LiRA2
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic|Prediabetic State
Interventions: DRUG: Liraglutide|DRUG: Placebo
Outcome Measures: Primary: Plasma glucose during oral glucose tolerance test at week 26, Difference between the two treatment arms in plasma glucose concentrations during a 3h 75g-OGTT on the trial visit of week 26, The trial visit of week 26 | Secondary: Hypoglycemic incidents, Total hypoglycemic episodes during intervention, From the randomisation to trial visit of week 26|Fasting values of glucometabolic hormones, Fasting plasma glucose, proinsulin, insulin and glucagon, The trial visit of week 26|Insulin resistance, Insulin resistance evaluated by homeostasis model assessment (HOMA), The trial visit of week 26|Beta cell function, Beta-cell function evaluated by HOMA, The trial visit of week 26|Change in glycemic state, Change in glycemic 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), impaired fasting glucose (IFG, fasting plasma glucose ≥ 6.1 and \< 7.0 mmol/l), impaired glucose tolerance (IGT, 2h plasma glucose ≥ 7,8 and \< 11.1 mmol/l) and diabetes mellitus (DM, fasting plasma glucose ≥ 7 mmol/l or 2h plasma glucose ≥ 11.1 mmol/l)), The trial visit of week 26|Blood pressure, Blood Pressure, The trial visit of week 26|Pulse, Resting pulse, The trial visit of week 26|Weight, Weight, The trial visit of week 26|Body composition, Body composition by dual energy x-ray absorptiometry (DXA) scan, The trial visit of week 26|Cardiac function and perfusion, Cardiac function and perfusion evaluated by Rb-PET/CT scan, The trial visit of week 26|Cardiac autonomic function, Cardiac autonomic function evaluated by heart rate variability, The trial visit of week 26|Arterial stiffness, Arterial stiffness evaluated by Augmentation index from Pulse wave analysis, The trial visit of week 26|Cardiovascular and endothelial risk markers, Cardiovascular and endothelial risk markers (troponin T, troponin I, creatine kinase-MB, high-sensitivity C-reactive protein (hsCRP), plasminogen activator inhibitor 1 (PAI-1), Tissue plasminogen activator (tPA), urat, von Willebrand factor (vWF), vascular endothelial cell adhesion molecule (VCAM), intercellular adhesion molecule (ICAM), TNFalpha, proBNP, E-selectin and asymmetric dimethylarginine), The trial visit of week 26|Prothrombotic state, Prothrombotic state (fibrinogen, activated partial thromboplastin time (APTT) and thromboelastography (TEG)), The trial visit of week 26|Lipid profile, Lipid profile, The trial visit of week 26|Plasma liraglutide, Plasma liraglutide, The trial visit of week 26
Sponsor/Collaborators: Sponsor: Bo Feldt-Rasmussen | Collaborators: Novo Nordisk A/S|The GCP unit at Copenhagen University Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-12
Completion Date: 2015-08
Results First Posted:
Last Update Posted: 2015-08-24
Locations: Department of Nephrology, Rigshospitalet, Copenhagen, 2100, Denmark
URL: https://clinicaltrials.gov/show/NCT02284230