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

IKFE Institute for Clinical Research and Development

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus; Cardiovascular Disease

Treatments: Drug: placebo; Drug: pioglitazone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00479986

ATS-K-016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

92 participants in 2 patient groups

Pioglitazone

Experimental group

Treatment:

Drug: pioglitazone

placebo

Active Comparator group

Treatment:

Drug: placebo