Effects of Pioglitazone in Type 2 Diabetes Mellitus and Coronary Heart Disease

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone (in comparison to placebo) on biomarkers for atherosclerosis and cardiovascular risk, as well as the degree of activation of the immune system, when given on top of an anti-diabetic treatment (metformin and/or sulfonylurea drugs) that has already resulted in good glycemic control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IKFE Institute for Clinical Research and Development
• Collaborators: Heidelberg University; Johannes Gutenberg University Mainz; Takeda
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• type 2 diabetes mellitus

• stable oral treatment with metfromin and/or sulfonylurea

• age 20 - 80 years

• angiographically confirmed atherosclerosis or hsCRP > 1 mg/l

Exclusion Criteria:

• type 1 diabetes

• HbA1c > 8.5 %

• severe disease

• acute coronary syndrome

• contraindications to pioglitazone (heart failure etc.)