EffectS of PiogLitazone on ENDOthelial progenitoR cells in type 2 diabetic patients with vascular complications - The SPLENDOR Study - SPLENDOR
- Conditions
- MedDRA version: 9.1Level: HLTClassification code 10012654Term: Diabetic complications cardiovascularType 2 diabetes
- Registration Number
- EUCTR2007-003077-44-IT
- Lead Sponsor
- TAKEDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
HbA1c>7,5% and <10%; age at onset of type 2 diabetes >35 years; metfomine monotherapy up to the maximum tolerated daily dose; one or more cardiovascular comorbidity.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
insulin therapy; severe obesity; evidence of systemic deseases; cardiovascular deseases as unstable angina, myocardial infarction, bypass or PTCA within 3 months of study entry, heart failure.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate whether treatment with pioglitazone influences the number circulating endothelial progenitor cells;Secondary Objective: To evaluate the effects of piolitazone on glucose metabolism, lipid metabolism, insulin sentitivity, markers of inflammation and adipokines. Tolerability and safety will also be evaluated.;Primary end point(s): To evaluate whether treatment with pioglitazone influences the number circulating endothelial progenitor cells
- Secondary Outcome Measures
Name Time Method