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Completed

NCT Number: NCT00479986

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Michael Morcos, Heidelberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

pioglitazone

Drug

Placebo

Drug

Primary outcomes

  1. Short-term effect of Pioglitazone on Markers of vascular risk (MMP-9, hsCRP, monocyte activation)

    Time frame: 4 weeks

Secondary outcomes

  1. Safety

    Time frame: 4 weeks

  2. Metabolic control (HbA1c, Glucose)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

IKFE Institute for Clinical Research and Development

Other

Collaborators

  • Heidelberg University
  • Johannes Gutenberg University Mainz
  • Takeda

Registry information

Official study 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

Acronym: PIOcard

Important dates

Study start
2005
Study completion
2006
First posted
May 30, 2007
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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