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Clinical Trial Details

Trial ID: L6776
Source ID: NCT02919345
Associated Drug: Dapagliflozin 10 Mg
Title: Assessment of Dapagliflozin Effect on Diabetic Endothelial Dysfunction of Brachial Artery
Acronym: ADDENDA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Coronary Artery Disease|Carotid Artery Diseases
Interventions: DRUG: Dapagliflozin 10 mg|DRUG: Glibenclamide 5 mg
Outcome Measures: Primary: Change in flow mediated dilation (FMD) and its related endpoint (FMD post reperfusion lesion), 12 weeks | Secondary: Change in plasma nitric oxide, 12 weeks|Change in plasma isoprostane, 12 weeks|Change in plasma nitric oxide after reperfusion injury., 12 weeks|Change in plasma isoprostane after reperfusion injury., 12 weeks|Change in plasma Intercellular Adhesion Molecule 1(ICAM-1), 12 weeks|Change in plasma Vascular Cell Adhesion Molecule 1 (VCAM-1), 12 weeks|Change in plasma Endothelin-1 (ET-1), 12 weeks|Change in plasma Leptin, 12 weeks|Change in plasma Adiponectin, 12 weeks|Change in plasma C-reactive protein (CRP), 12 weeks|Change in plasma Tumor Necrosis Factor alpha (TNF-α), 12 weeks|Change in plasma interleukin-6, 12 weeks|Change in plasma interleukin-2, 12 weeks|Change in weight, 12 weeks|Change in body composition (% of fat mass and % free fat mass), 12 weeks | Other: Change in Glycated Hemoglobin, 12 weeks|Change in Systolic Blood Pressure, 12 weeks|Change in Mean Arterial Blood Pressure, 12 weeks|Change in Waist Circumference, 12 weeks
Sponsor/Collaborators: Sponsor: University of Campinas, Brazil | Collaborators: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 98
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-01
Completion Date: 2019-03
Results First Posted:
Last Update Posted: 2023-03-10
Locations: State University of Campinas, Campinas, Sao Paulo, 13083-887, Brazil
URL: https://clinicaltrials.gov/show/NCT02919345