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

Type 2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479986
• Other study ID #: ATS-K-016
• Status: Completed
• Phase: Phase 4
• First received: May 29, 2007
• Last updated: March 31, 2015
• Start date: June 2005
• Est. completion date: November 2006

Study information

• Verified date: May 2007
• Source: IKFE Institute for Clinical Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Diseases
• Myocardial Ischemia
• Type 2 Diabetes Mellitus

Intervention

Drug:
• pioglitazone

• placebo

Locations

Country	Name	City	State
Germany	Dr. Michael Morcos	Heidelberg
Germany	IKFE	Mainz

Sponsors (4)

Lead Sponsor	Collaborator
IKFE Institute for Clinical Research and Development	Heidelberg University, Johannes Gutenberg University Mainz, Takeda

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term effect of Pioglitazone on Markers of vascular risk (MMP-9, hsCRP, monocyte activation)		4 weeks
Secondary	Safety		4 weeks
Secondary	Metabolic control (HbA1c, Glucose)		4 weeks