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

March 31, 2015 updated by: IKFE Institute for Clinical Research and Development

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany
        • Dr. Michael Morcos
      • Mainz, Germany, 55116
        • Ikfe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: placebo
Drug: placebo
Experimental: Pioglitazone
Drug: pioglitazone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: 4 weeks
4 weeks
Metabolic control (HbA1c, Glucose)
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IKFE Institute for Clinical Research and Development

Collaborators

Takeda
Heidelberg University
Johannes Gutenberg University Mainz

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

May 29, 2007

First Submitted That Met QC Criteria

May 29, 2007

First Posted (Estimate)

May 30, 2007

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATS-K-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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