Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5359
Source ID: NCT02919059
Associated Drug: Dapagliflozin 10 Mg
Title: Study to Asses the Effect of Dapagliflozin on Central Blood Pressure Reduction.
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Dapagliflozin 10 mg|DRUG: Glimepiride 4 mg
Outcome Measures: Primary: Effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period regarding central systolic blood pressure, To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding central systolic blood pressure estimated by applanation tonometry, 24 weeks | Secondary: Effect of dapagliflozin relative to glimepiride at 24 weeks regarding central systolic/diastolic blood pressure, To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding central systolic/diastolic blood pressure estimated by applanation tonometry., 24 weeks|Effect of dapagliflozin relative to glimepiride at 24 weeks regarding central pulse pressure, To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding central pulse pressure estimated by applanation tonometry., 24 weeks|Effect of dapagliflozin relative to glimepiride at 24 weeks of treatment with inadequate glycemic control regarding 24 hours ambulatory systolic/diastolic blood pressure, To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding 24 hours ambulatory systolic/diastolic blood pressure., 24 weeks|Type and number of Adverse events in patienteSafety and tolerability of dapagliflozin relative to glimepiride., Type and number of Adverse events to assess the safety and tolerability of dapagliflozin relative to glimepiride., 28 weeks|Effect of dapagliflozin relative to glimepiride at 24 weeks with inadequate glycemic control regarding augmentation pressure, To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding augmentation pressure estimated by applanation tonometry., 24 weeks|Effect of dapagliflozin relative to glimepiride at 24 weeks with inadequate glycemic control regarding augmentation index, o assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding augmentation index estimated by applanation tonometry., 24 weeks
Sponsor/Collaborators: Sponsor: IInstituto Gallego de Medicina Vascular
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 159
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2016-12-13
Completion Date: 2019-08
Results First Posted:
Last Update Posted: 2017-03-29
Locations: Hospital Nuestra SeƱora de la Esperanza, Santiago de Compostela, Galicia, 15705, Spain
URL: https://clinicaltrials.gov/show/NCT02919059