Type 2 diabetes MedDRA version: 9.1 Level: HLT Classification code 10012654 Term: Diabetic complications cardiovascular
Conditions
Interventions
Trade Name: ACTOS
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pioglitazone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Trade Name: DAONIL
Pharm
Sponsors
TAKEDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HbA1c>7,5% and 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed