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Clinical Trial Details

Trial ID: L7256
Source ID: NCT02728453
Associated Drug: Empagliflozin
Title: SGLT2 Inhibition and Left Ventricular Mass
Acronym: EMPATROPHY
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: Empagliflozin|DRUG: Glimepiride
Outcome Measures: Primary: change in left ventricular mass, change in left ventricular mass determined by cardiac MRI as the difference between 24 weeks and baseline, baseline and 24 weeks | Secondary: change in left ventricular end-systolic volume, change in left ventricular end-systolic volume (cMRI, 24 weeks - baseline), baseline and 24 weeks|change in left ventricular function, change in left ventricular function (cMRI, 24 weeks - baseline), baseline and 24 weeks|change in intramyocardial lipid content, change in intramyocardial lipid content (cMR spectroscopy, 24 weeks - baseline), baseline and 24 weeks|change in diastolic function, change in diastolic function (echocardiography, 24 weeks - baseline), baseline and 24 weeks|change in HbA1c, change in HbA1c (24 weeks - baseline), baseline and 24 weeks|change in fasting plasma glucose concentration, change in fasting plasma glucose concentration (24 weeks - baseline), baseline and 24 weeks|change in body weight, change in body weight (24 weeks - baseline), baseline and 24 weeks|change ambulatory blood pressure, change in ambulatory blood pressure (24 weeks - baseline), baseline and 24 weeks|change in left ventricular end-diastolic volume, change in left ventricular end-diastolic volume (cMRI, 24 weeks - baseline), baseline and 24 weeks|change in fasting serum insulin concentration, change in fasting serum insulin concentration (24 weeks - baseline), baseline and 24 weeks|change in waist circumference, change in waist circumference (24 weeks - baseline), baseline and 24 weeks|change in body fat mass, change in body fat mass (24 weeks - baseline), baseline and 24 weeks | Other: change in cardiac fibrosis, change in cardiac fibrosis (cMRI, 24 weeks - baseline), baseline and 24 weeks|change in global long strain, change in global long strain (echocardiography, 24 weeks - baseline), baseline and 24 weeks|number of participants with abnormal laboratory values in the blood, To determine this number, blood electrolytes, blood count, hematocrit, liver function tests, blood urea and creatinine will be measured at baseline and every 4 weeks thereafter., baseline and 4, 8, 12, 16, 20, 24 weeks|number of participants with abnormal laboratory values in the urine, To determine this number, dip stick urine analysis will be performed at baseline and every 4 weeks thereafter (glucose will be measured but not reported to investigators to ensure blinding)., baseline and 4, 8, 12, 16, 20, 24 weeks|number of participants with lower urinary tract infections or genital fungal infections, To determine this number, signs and symptoms of lower urinary tract infections or genital fungal infections will be recorded at baseline and every 4 weeks thereafter., baseline and 24 weeks
Sponsor/Collaborators: Sponsor: Hannover Medical School | Collaborators: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 7
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-04-27
Completion Date: 2017-09-27
Results First Posted:
Last Update Posted: 2019-03-22
Locations: Hannover Medical School, Hannover, 30625, Germany
URL: https://clinicaltrials.gov/show/NCT02728453