Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3516
Source ID: NCT03423355
Associated Drug: Dapagliflozin (Forxiga®)
Title: Dapagliflozin Effect on Erythropoiesis and Physical Fitness
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG: Dapagliflozin (Forxiga®)|DRUG: Hydrochlorothiazide 25 mg|DRUG: Placebo matching Dapagliflozin
Outcome Measures: Primary: Change in blood EPO levels, The primary objective is to investigate the change in erythropoietin (EPO) levels after 2 weeks of treatment with dapagliflozin in comparison to treatment with placebo., 2 weeks of treatment | Secondary: Change in physical fitness, Change in physical fitness between baseline and EoT as assessed by spiroergometry (VO2max, heart rate and blood pressure) with dapagliflozin in comparison to treatment with placebo, 4 weeks of treatment|Change in reticulocyte concentration, hematocrit and red blood cells, Change in reticulocyte concentration, hematocrit and red blood cells between baseline and after 2 and 4 weeks of treatment with dapagliflozin in comparison to treatment with placebo, baseline, 2 weeks and 4 weeks of treatment|Change in hepcidin, Change in hepcidin between baseline and EoT with dapagliflozin in comparison to treatment with placebo, baseline and 4 weeks of treatment|Change in blood EPO levels, Change in blood EPO levels between baseline and EoT (comparison dapagliflozin vs HCT vs placebo), baseline, 4 weeks of treatment|Change in iron status (Fe), Change in iron status between baseline and EoT as measured by Fe with dapagliflozin in comparison to treatment with placebo, baseline and 4 weeks of treatment|Change in iron status (Ferritin), Change in iron status between baseline and EoT as measured by ferritin with dapagliflozin in comparison to treatment with placebo, baseline and 4 weeks of treatment|Change in iron status (Transferrin), Change in iron status between baseline and EoT as measured by transferrin with dapagliflozin in comparison to treatment with placebo, baseline and 4 weeks of treatment|Change in catecholamine (adrenalin), Change in adrenalin concentrations between baseline and EoT with dapagliflozin in comparison to treatment with placebo, baseline and 4 weeks of treatment|Change in catecholamine (noradrenalin), Change in noradrenalin concentrations between baseline and EoT with dapagliflozin in comparison to treatment with placebo, baseline and 4 weeks of treatment|Change in catecholamine (metabolites metanephrine), Change in metabolites metanephrine concentrations between baseline and EoT with dapagliflozin in comparison to treatment with placebo, baseline and 4 weeks of treatment|Change in catecholamine (normetanephrine), Change in normetanephrine concentrations between baseline and EoT with dapagliflozin in comparison to treatment with placebo, baseline and 4 weeks of treatment|Change in steroid hormone, Change in steroid hormone concentrations between baseline and EoT with dapagliflozin in comparison to treatment with placebo, baseline and 4 weeks of treatment|Change of ejection fraction, Change of ejection fraction measured by echocardiography, between baseline and EoT with dapagliflozin in comparison to treatment with placebo, baseline and 4 weeks of treatment|Change of diastolic function parameters, Change of diastolic function parameters measured by echocardiography, between baseline and EoT with dapagliflozin in comparison to treatment with placebo, baseline and 4 weeks of treatment
Sponsor/Collaborators: Sponsor: University Hospital Tuebingen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-09
Completion Date: 2023-12
Results First Posted:
Last Update Posted: 2021-12-15
Locations: University Hospital Tuebingen, Otfried-Mueller Str. 10, Tuebingen, 72076, Germany
URL: https://clinicaltrials.gov/show/NCT03423355