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

This study has been completed.
Sponsor:
Collaborators:
Takeda
Johannes Gutenberg University Mainz
Heidelberg University
Information provided by:
IKFE Institute for Clinical Research and Development
ClinicalTrials.gov Identifier:
NCT00479986
First received: May 29, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted

May 29, 2007
May 29, 2007
June 2005
Not Provided
Short-term effect of Pioglitazone on Markers of vascular risk (MMP-9, hsCRP, monocyte activation) [ Time Frame: 4 weeks ]
Same as current
No Changes Posted
  • Safety [ Time Frame: 4 weeks ]
  • Metabolic control (HbA1c, Glucose) [ Time Frame: 4 weeks ]
Same as current
Not Provided
Not Provided
 
Effects of Pioglitazone in Type 2 Diabetes Mellitus and Coronary Heart Disease
Effects of Pioglitazone in Patients With Type 2 Diabetes Mellitus and Coronary Heart Disease at High Risk for Vascular Complications : A Placebo-Controlled Study

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.

PPARgamma activation by pioglitazone has shown to be associated with an improvement of cardiovascular risk when measured with clinical (assessement of intima-media-thickness) or biochemical (hsCRP, MMP-9 etc.) markers. Well controlled patients (HbA1c < 8.0 %) will receive either pioglitazone or placebo (randomised, double-blind) for 4 weeks. Blood will be drawn to investigate the change in cardiovascular or metabolic markers and mRNA will be isolated from circulating mononuclear cells to investiagte the degree of activation of the immune system, which is another measure for the risk of atherosclerosis development.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Cardiovascular Disease
  • Drug: pioglitazone
  • Drug: placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
November 2006
Not Provided

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.)
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00479986
ATS-K-016
Yes
Not Provided
IKFE Institute for Clinical Research and Development
  • Takeda
  • Johannes Gutenberg University Mainz
  • Heidelberg University
Principal Investigator: Thomas Forst, MD IKFE - Institute for Clinical Research and Development, Mainz
Study Director: Andreas Pfützner, MD, PhD IKFE - Institute for Clinical Research and Development, Mainz
IKFE Institute for Clinical Research and Development
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP