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

Primary Purpose

Type 2 Diabetes Mellitus, Cardiovascular Disease

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
pioglitazone
placebo
Sponsored by
IKFE Institute for Clinical Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes mellitus, monocyte activation, cardiovascular risk

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Dr. Michael Morcos
  • IKFE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pioglitazone

placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety
Metabolic control (HbA1c, Glucose)

Full Information

First Posted
May 29, 2007
Last Updated
March 31, 2015
Sponsor
IKFE Institute for Clinical Research and Development
Collaborators
Takeda, Johannes Gutenberg University Mainz, Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT00479986
Brief Title
Effects of Pioglitazone in Type 2 Diabetes Mellitus and Coronary Heart Disease
Acronym
PIOcard
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 Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
IKFE Institute for Clinical Research and Development
Collaborators
Takeda, Johannes Gutenberg University Mainz, Heidelberg University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Cardiovascular Disease
Keywords
diabetes mellitus, monocyte activation, cardiovascular risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone
Arm Type
Experimental
Arm Title
placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Short-term effect of Pioglitazone on Markers of vascular risk (MMP-9, hsCRP, monocyte activation)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Safety
Time Frame
4 weeks
Title
Metabolic control (HbA1c, Glucose)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Forst, MD
Organizational Affiliation
IKFE - Institute for Clinical Research and Development, Mainz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Pfützner, MD, PhD
Organizational Affiliation
IKFE - Institute for Clinical Research and Development, Mainz
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Michael Morcos
City
Heidelberg
Country
Germany
Facility Name
IKFE
City
Mainz
ZIP/Postal Code
55116
Country
Germany

12. IPD Sharing Statement

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

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