Effects of Pioglitazone in Type 2 Diabetes Mellitus and Coronary Heart Disease - Full Text View

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

This study has been completed.

First Received: May 29, 2007 No Changes Posted

Sponsor:	IKFE Institute for Clinical Research and Development
Collaborators:	Takeda Global Research & Development Center, Inc. Johannes Gutenberg University Mainz University of Heidelberg
Information provided by:	IKFE Institute for Clinical Research and Development
ClinicalTrials.gov Identifier:	NCT00479986

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Coronary Artery Disease Diabetes Heart Diseases

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

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

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 Global Research & Development Center, Inc.

Johannes Gutenberg University Mainz

University of Heidelberg

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

Study ID Numbers:	ATS-K-016
Study First Received:	May 29, 2007
Last Updated:	May 29, 2007
ClinicalTrials.gov Identifier:	NCT00479986 History of Changes
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:

Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Pioglitazone
Myocardial Ischemia
Physiological Effects of Drugs
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Arteriosclerosis
Pharmacologic Actions
Coronary Disease
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010