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Clinical Trial Details

Trial ID: L4401
Source ID: NCT05109949
Associated Drug: Dapagliflozin 10mg Tab
Title: Acute Effect of Empagliflozin vs Dapagliflozin Over Pulse Wave Velocity in Type Two Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2 Without Complication
Interventions: DRUG: Dapagliflozin 10Mg Tab|DRUG: Empagliflozin 25 MG|OTHER: Placebo
Outcome Measures: Primary: Pulse wave velocity, Change from baseline carotid-femoral pulse wave velocity at 7 days. Using a PulsePen tonometer by DiaTechne., 7 days | Secondary: Fasting plasma glucose, Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit; in an automated clinical chemistry analysis equipment brand XL-100Erba, 7 days|Total cholesterol, Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit., 7 days|Triglycerides, Change from baseline, using the BioSystems® Glycerol phosphate Oxidase / Peroxidase kit., 7 days|High-density lipoprotein cholesterol, Change from baseline, using the BioSystems® Direct / Detergent HDL kit, 7 days|Low-density lipoprotein cholesterol, Change from baseline, using the BioSystems® Cholesterol Oxidase / Peroxidase kit, 7 days|Creatinine, Change from baseline, using the BioSystems® kit Modified Jaffe's no deproteinization, 7 days|Blood pressure, Change from baseline, using an OMRON calibrated electronic digital sphygmomanometer model HEM 907 XL. The patient will remain seated in a chair resting his back on the backrest, with a minimum rest of 5 minutes, The average of 3 measurements such as BP will be taken, 7 days
Sponsor/Collaborators: Sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 72
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2020-03-30
Completion Date: 2022-08-01
Results First Posted:
Last Update Posted: 2021-11-19
Locations: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara, Guadalajara, Jalisco, 44340, Mexico
URL: https://clinicaltrials.gov/show/NCT05109949