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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Cardiovascular Disease
• Interventions: Drug: placebo; Drug: pioglitazone

• Registration Number: NCT00479986
• Lead Sponsor: IKFE Institute for Clinical Research and Development

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.

Study Timeline

• Study Start: 2005-06
• Study Completion: 2006-11
• Status Verified: 2007-05
• Study First Submitted: 2007-05-29
• Study First Submitted QC: 2007-05-29
• Study First Posted: 2007-05-30
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
Pioglitazone	pioglitazone	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Metabolic control (HbA1c, Glucose)	4 weeks
Safety	4 weeks

Trial Locations

Locations (2)

Dr. Michael Morcos; 🇩🇪 Heidelberg, Germany

IKFE; 🇩🇪 Mainz, Germany