Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3284
Source ID: NCT00770835
Associated Drug: Pioglitazone And Metformin
Title: Efficacy and Safety of Pioglitazone in Treating Subjects With Vascular Complications Associated With Type 2 Diabetes Mellitus.
Acronym: SPLENDOR
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: Pioglitazone and Metformin|DRUG: Glibenclamide and Metformin
Outcome Measures: Primary: Increase from Baseline in the number of Endothelial Progenitor Cells (CD34+KDR+)., Baseline and Final Visit. | Secondary: Change from Baseline in Circulating Progenitor Cells Integrated Markers of cardiovascular risk (CD34+)., Baseline and Weeks 12 and 24.|Change from Baseline in Flow Mediated Dilation Integrated Markers of cardiovascular risk., Baseline and Final Visit.|Modulation of Endothelial Progenitor Cell recruitment (vascular endothelial growth factor, erythropoietin and stromal cell-derived factor-1)., Weeks: 4, 12 and 24.|Measure of Glucose Control (glycosylated hemoglobin and fasting plasma glucose)., Weeks: 4, 12 and 24.|Measure of Lipid Parameters (total lipids, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein B and apolipoprotein A1)., Weeks: 4, 12 and 24.|Change from Baseline in lipid parameters (free fatty acids and oxidized low-density lipoprotein)., Baseline and Weeks 12 and 24.|Change from Baseline in insulin sensitivity (insulin indexes by 2 hour oral glucose tolerance test with glucose, insulin and C-peptide estimation)., Baseline and Final Visit.|Change from Baseline in Inflammation Markers (high-sensitivity C-reactive protein, IL-6, vascular adhesion molecules (E-selectin, vascular cell adhesion molecule-1), monocyte chemotactic protein-1 and tumor necrosis factor-alpha)., Baseline and Weeks 12 and 24.|Change from Baseline in Adipokines (adiponectin)., Baseline and Weeks 12 and 24.|Change from Baseline in Oxidative Stress (maleic dialdehyde, ferric reducing antioxidant power and lipid hydroperoxide., Baseline and Weeks 12 and 24.|Urinary albumin excretion., Weeks: 12 and 24.
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 39
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-03
Completion Date: 2011-05
Results First Posted:
Last Update Posted: 2011-07-12
Locations: Padova, Italy|Pisa, Italy
URL: https://clinicaltrials.gov/show/NCT00770835