A Phase 4 interventional study of Pioglitazone and Metformin and Glibenclamide and Metformin in Diabetes Mellitus, sponsored by Takeda. Completed at 2 sites in Italy. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-07-12.
Sponsored by Takeda · Phase 4, Interventional, and Treatment
The purpose of this study is to determine the efficacy of pioglitazone compared to glibenclamide, once daily (QD), taken together with metformin and lifestyle modification in type 2 diabetic subjects with cardiovascular disease.
Diabetes is one of the most common chronic diseases worldwide, affecting nearly 200 million people, almost all suffering from Type 2 Diabetes. It is the fourth leading cause of death in developed countries due to the negative impact of the disease on the cardiovascular system. Treatment, aimed to the reduction of this intrinsic cardiovascular risk, is based on tight control of glucose and all coexisting metabolic abnormalities as well as of biomarkers of inflammation and atherogenesis.
Macrovascular complications account for the vast majority of morbidity and mortality in diabetic patients, and there is growing evidence that pathophysiologic mechanisms other than hyperglycemia are responsible. The condition of the vascular endothelium in particular has been shown to effect the health and disease of the cardiovascular system.
The number and function of endothelial progenitor cells correlate inversely with cardiovascular risk factors and may be a surrogate biologic marker for vascular function and cumulative cardiovascular risk.
Pioglitazone is an orally active thiazolidinedione derivative. It is a ligand for peroxisome proliferator-activated receptor-gamma activation that alters transcription of various genes regulating carbohydrate and lipid metabolism.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 39 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Has one or more cardiovascular comorbidities as follows:
and/or two or more of the following major cardiovascular risk factors:
Exclusion Criteria:
Is unable to remain on a stable dose of the following class of medications 30 days prior to randomization and throughout the six months of the study:
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Other drugs that are highly protein bound, including:
(along with lifestyle modification)
Drug: Pioglitazone and Metformin
(along with lifestyle modification)
Drug: Glibenclamide and Metformin
Pioglitazone 30 mg, tablets, orally, once daily, metformin stable dose and lifestyle modification for up to 24 weeks.
Also known as: ACTOS®, AD-4833
Glibenclamide 10 mg, tablets, orally, once daily and metformin stable dose and lifestyle modification for up to 24 weeks.
Also known as: Diabeta, Glynase, Micronase, Daonil, Semi-Daonil, Euglucon
Increase from Baseline in the number of Endothelial Progenitor Cells (CD34+KDR+).
Time frame: Baseline and Final Visit.
Change from Baseline in Circulating Progenitor Cells Integrated Markers of cardiovascular risk (CD34+).
Time frame: Baseline and Weeks 12 and 24.
Change from Baseline in Flow Mediated Dilation Integrated Markers of cardiovascular risk.
Time frame: Baseline and Final Visit.
Modulation of Endothelial Progenitor Cell recruitment (vascular endothelial growth factor, erythropoietin and stromal cell-derived factor-1).
Time frame: Weeks: 4, 12 and 24.
Measure of Glucose Control (glycosylated hemoglobin and fasting plasma glucose).
Time frame: 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).
Time frame: Weeks: 4, 12 and 24.
Change from Baseline in lipid parameters (free fatty acids and oxidized low-density lipoprotein).
Time frame: 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).
Time frame: 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).
Time frame: Baseline and Weeks 12 and 24.
Change from Baseline in Adipokines (adiponectin).
Time frame: Baseline and Weeks 12 and 24.
Change from Baseline in Oxidative Stress (maleic dialdehyde, ferric reducing antioxidant power and lipid hydroperoxide.
Time frame: Baseline and Weeks 12 and 24.
Urinary albumin excretion.
Time frame: Weeks: 12 and 24.
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Takeda