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Clinical Trial Details

Trial ID: L3421
Source ID: NCT02276196
Associated Drug: Lixisenatide
Title: Effect of LIXIsenatide on the Renal System
Acronym: ELIXIRS
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetic Kidney Disease|Diabetic Nephropathy|Diabetes Mellitus|Glucagon-Like Peptide 1
Interventions: DRUG: Lixisenatide|DRUG: Insulin glulisine
Outcome Measures: Primary: Changes from baseline following 8-week treatment with a glucagon-like peptide(GLP)-1 receptor agonist versus insulin glulisine on renal hemodynamics, measured as glomerular filtration rate (GFR) / effective renal plasma flow (ERPF), ml/min, 8 weeks | Secondary: Renal damage, measured by urine biomarkers, enzyme immuno assay, 8 weeks|Renal tubular function, e.g. percentage (%), 8 weeks|Blood Pressure, mmHg, 8 weeks | Other: Body anthropometrics: body weight, height, body mass index, waist circumference, kilogram, meters, centimeters, 8 weeks|Body fat content, e.g. percentage (%), 8 weeks|Glycemic variables, e.g. mmol/l, mmol/mol, 8 weeks|Lipid spectrum, e.g. mmol/l, 8 weeks|Inflammatory markers, e.g. nmol/l, 8 weeks|Systemic hemodynamic variables, e.g. ml/min, 8 weeks|Heart rate, beat per minute, 8 weeks|Microvascular function, e.g. count, 8 weeks|Arterial stiffness, e.g. augmentation index, 8 weeks
Sponsor/Collaborators: Sponsor: Amsterdam UMC, location VUmc
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-09
Completion Date: 2016-04
Results First Posted:
Last Update Posted: 2016-04-29
Locations: VU Universtiy Medical Center, Amsterdam, 1081 HV, Netherlands
URL: https://clinicaltrials.gov/show/NCT02276196