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Clinical Trial Details

Trial ID: L3436
Source ID: NCT02682563
Associated Drug: Dapagliflozin 10mg Qd
Title: Renoprotective Effects of Dapagliflozin in Type 2 Diabetes
Acronym: RED
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02682563/results
Conditions: Diabetes Mellitus, Type 2|Diabetic Nephropathies
Interventions: DRUG: Dapagliflozin 10mg QD|DRUG: Gliclazide 30mg QD
Outcome Measures: Primary: Glomerular Filtration Rate (GFR) in ml/Min, Calculated from urinary and plasma inulin concentrations, GFR in ml/min, 12 weeks|Effective Renal Plasma Flow (ERPF) in ml/Min, Calculated from urinary and plasma para-aminohippurate concentrations, ERPF in ml/min, 12 weeks | Secondary: Fractional Excretion of Sodium in % of Filtered Sodium, Calculated fractional excretions with measured GFR (see above) and urinary and plasma concentrations of sodium. Fractional excretion in % of filtered sodium, 12 weeks|Fractional Excretion of Potassium in % of Filtered Potassium, Calculated fractional excretions with measured GFR (see above) and urinary and plasma concentrations of potassium. Fractional excretion in % of filtered potassium, 12 weeks|Fractional Excretion of Glucose in % of Filtered Glucose, Calculated fractional excretions with measured GFR (see above) and urinary and plasma concentrations of glucose. Fractional excretion in % of filtered glucose, 12 weeks|Urinary Albumin-Creatinine Ratio in mg/mmol, Calculated from measured urinary albumin and creatinin concentrations, in mg/mmol, 12 weeks|Neutrophil Gelatinase-associated Lipocalin (NGAL), NGAL (ng/mmoll) measured in urine as a marker of renal damage, 12 weeks|Kidney Injury Molecule-1 (KIM-1) in ng/mmol, KIM-1 (ng/mmol) measured in urine as a marker of renal damage, 12 weeks | Other: Body Weight, Measured in kilograms, 12 weeks|Systolic Blood Pressure, Blood pressure will be measured using an automated oscillometric blood pressure device (DinamapĀ®) in mmHg, 12 weeks
Sponsor/Collaborators: Sponsor: M.H.H. Kramer | Collaborators: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 44
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2016-02
Completion Date: 2018-09
Results First Posted: 2020-07-07
Last Update Posted: 2020-07-07
Locations: VU University Medical Center, Amsterdam, Noord-Holland, 1081 HV, Netherlands
URL: https://clinicaltrials.gov/show/NCT02682563