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

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ClinicalTrials.gov Identifier: NCT00479986
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : April 1, 2015
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Cardiovascular Disease Drug: pioglitazone Drug: placebo Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2005
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pioglitazone Drug: pioglitazone
Active Comparator: placebo Drug: placebo

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479986

Dr. Michael Morcos
Heidelberg, Germany
Mainz, Germany, 55116
Sponsors and Collaborators
IKFE Institute for Clinical Research and Development
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
More Information

ClinicalTrials.gov Identifier: NCT00479986     History of Changes
Other Study ID Numbers: ATS-K-016
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: May 2007

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

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