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

NCT00479986 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2015-04-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

pioglitazone

DRUG

placebo

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • Heidelberg University

    collaborator OTHER

  • IKFE Institute for Clinical Research and Development

    lead OTHER

Principal Investigators

  • Thomas Forst, MD · IKFE - Institute for Clinical Research and Development, Mainz

  • Andreas Pfützner, MD, PhD · IKFE - Institute for Clinical Research and Development, Mainz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Completion
2006-11-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00479986 on ClinicalTrials.gov