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Clinical Trial Details

Trial ID: L2798
Source ID: NCT02106104
Associated Drug: Linagliptin 5 Mg Qd (N=24)
Title: Renal Effects of DPP-4 Inhibitor Linagliptin in Type 2 Diabetes
Acronym: RENALIS
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Linagliptin 5 mg QD (N=24)|DRUG: Glimepiride 1 mg QD (N=24)
Outcome Measures: Primary: Changes from baseline following 8-week treatment with linagliptin vs glimepiride on fasting and postprandial renal hemodynamics, measured as GFR / ERPF (determined by inulin/para-aminohippuric-acid clearance), 8 weeks | Secondary: Renal tubular function, 8 weeks|Renal damage, measured by urine biomarkers, 8 weeks|Blood Pressure and Heart Rate, 8 weeks | Other: Body anthropometrics: body weight, height, body mass index, waist circumference, 8 weeks|Body fat content, 8 weeks|Systemic hemodynamic variables (blood pressure, heart rate, stroke volume, cardiac output/-index, total systemic vascular resistance), Derived from non-invasive beat-to-beat finger blood pressure measurements, 8 weeks|Cardiac autonomic nervous system function, 8 weeks|Microvascular function, 8 weeks|Arterial stiffness, 8 weeks|Glycemic variables, Glycated hemoglobin (HbA1c) and fasting glucose, 8 weeks|Lipid spectrum, 8 weeks|DPP4- and ACE activity, 8 weeks
Sponsor/Collaborators: Sponsor: Amsterdam UMC, location VUmc
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-03
Completion Date: 2016-04
Results First Posted:
Last Update Posted: 2016-05-17
Locations: VU University Medical Center, Amsterdam, 1081 HV, Netherlands
URL: https://clinicaltrials.gov/show/NCT02106104