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

Condition(s) targeted: Type 2 Diabetes Mellitus; Cardiovascular Disease

Intervention: pioglitazone (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: IKFE Institute for Clinical Research and Development

Official(s) and/or principal investigator(s):
Thomas Forst, MD, Principal Investigator, Affiliation: IKFE - Institute for Clinical Research and Development, Mainz
Andreas Pfützner, MD, PhD, Study Director, Affiliation: IKFE - Institute for Clinical Research and Development, Mainz

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

Safety

Metabolic control (HbA1c, Glucose)

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.

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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.)

Dr. Michael Morcos, Heidelberg, Germany

IKFE, Mainz 55116, Germany

Starting date: June 2005
Ending date: November 2006
Last updated: May 29, 2007