Pilot trial studying the Effects of Pioglitazone in Comparison to Placebo on Myocardial Function and Oxidative Stress in Patients with Type II Diabetes and Insulin Resistance undergoing elective PTCA

• Conditions: Type 2 diabetic patients treated with oral agents except PPAR gamma agonists and / or patients with insulin resistance measured by IRIS score > 50 with stable coronary artery disease and supposed elective Stent-PCI will be included

• Registration Number: EUCTR2006-002237-20-DE
• Lead Sponsor: Takeda Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-29
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with stable coronary artery disease with planned Stent-PCI
and
2. Patients with type II diabetes and / or IRIS score > 50
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

PCI within less than 15 days after acreening visit, use of systemic corticosteroids, Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures, history of esvere multiple allergies, have had more than one unexplained episode of severe hypoglycaemia within 6 months prior to screening visit, progressive fatal disease, pre-treatment with PPar gamma agonists within the 3 months prior to screening, if insulin therapy applicable: initiation of insulin treament within the last 3 months, a history of significant cardiovascular (NYHA stage II-IV), respiratory, gastrointestinal, hepatic (ALAT > 2.5 times normal ref. range), renal (creatinine >1.2 in women and >1.5 mg/dl in men and/or GFR < 45), neurological, psychiatric and or haematological disease as judged by the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified