Effects of Pioglitazone in Patients with Type 2 Diabetes Mellitus and Coronary Heart Disease at High Risk for Cardiovascular Complications

• Conditions: Type 2 Diabetes mellitus

• Registration Number: EUCTR2004-004226-28-DE
• Lead Sponsor: Takeda Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-12
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

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

Inclusion Criteria

1. Type 2 Diabetes mellitus

2. Angiographically proven CHD (diagnosed within the last 6 months)

3. hs CRP > 1 mg/l

4. Age 20-80 years
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

1.Chronic inflammatory diseases (rheumatic diseases, pyelonephritis,
osteomyelitis or others.)
2.Acute infections
3.Treatment or pre-treatment with insulin for more than 6 consecutive days
4.Invasive cardiovascular intervention within the last 4 weeks
5.Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
6.History of severe or multiple allergies
7.Treatment with any other investigational drug within 3 months before trial entry.
8.Progressive fatal disease
9.Drug or alcohol abuse within the last 5 years
10.A history of symptomatic cardiac insufficiency (NYHA stage II - IV), respiratory, or hepatic insufficiency
11.Relevant anaemia (as judged by investigator)
12.Blood donation within the last 30 days or intended blood donation (during the study or 30 days after participation?)
13.Pregnancy or breast feeding
14.Sexually active woman of childbearing age not practicing birth control by using contraceptive medication, condoms or intrauterine devices (IUD).
15.Lack of compliance or other similar reason, that, the investigator believes, precludes satisfactory participation in the study
16.Pre-treatment with thiazolidinediones
17.Systemic glucocorticoid therapy
18.Have had more than one unexplained episode of severe hypoglycaemia (defined as requiring assistance of another person due to disabling hypoglycaemia) within 6 month prior to entering the study

Study & Design

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