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

Effects of Pioglitazone in Patients With Type 2 Diabetes Mellitus and Coronary Heart Disease at High Risk for Vascular Complications : A Placebo-Controlled Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00479986

Acronym

PIOcard

Enrollment

Registered

2007-05-30

Start date

2005-06-30

Completion date

2006-11-30

Last updated

2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Type 2 Diabetes Mellitus

Keywords

diabetes mellitus, monocyte activation, cardiovascular risk

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.

Interventions

DRUGpioglitazone

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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.)

Design outcomes

Primary

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

Secondary

Measure	Time frame
Safety	4 weeks
Metabolic control (HbA1c, Glucose)	4 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026