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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Cardiovascular Disease
Drug: pioglitazone
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Pioglitazone in Patients With Type 2 Diabetes Mellitus and Coronary Heart Disease at High Risk for Vascular Complications : A Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by IKFE Institute for Clinical Research and Development:

Primary Outcome Measures:
  • Short-term effect of Pioglitazone on Markers of vascular risk (MMP-9, hsCRP, monocyte activation) [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 4 weeks ]
  • Metabolic control (HbA1c, Glucose) [ Time Frame: 4 weeks ]

Enrollment: 92
Study Start Date: June 2005
Study Completion Date: November 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479986

Locations
Germany
Dr. Michael Morcos
Heidelberg, Germany
IKFE
Mainz, Germany, 55116
Sponsors and Collaborators
IKFE Institute for Clinical Research and Development
Takeda
Johannes Gutenberg University Mainz
Heidelberg University
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00479986     History of Changes
Other Study ID Numbers: ATS-K-016
Study First Received: May 29, 2007
Last Updated: May 29, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by IKFE Institute for Clinical Research and Development:
diabetes mellitus
monocyte activation
cardiovascular risk

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014