NCT00479986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
Last Updated

April 1, 2015

Status Verified

May 1, 2007

First QC Date

May 29, 2007

Last Update Submit

March 31, 2015

Conditions

Type 2 Diabetes MellitusCardiovascular Disease

Keywords

diabetes mellitusmonocyte activationcardiovascular risk

Outcome Measures

Primary Outcomes (1)

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

    4 weeks

Secondary Outcomes (2)

  • Safety

    4 weeks

  • Metabolic control (HbA1c, Glucose)

    4 weeks

Study Arms (2)

Pioglitazone

EXPERIMENTAL
Drug: pioglitazone

placebo

ACTIVE COMPARATOR
Drug: placebo

Interventions

pioglitazoneDRUG
Pioglitazone
placeboDRUG
placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes mellitus
  • stable oral treatment with metfromin and/or sulfonylurea
  • age 20 - 80 years
  • angiographically confirmed atherosclerosis or hsCRP \> 1 mg/l

You may not qualify if:

  • type 1 diabetes
  • HbA1c \> 8.5 %
  • severe disease
  • acute coronary syndrome
  • contraindications to pioglitazone (heart failure etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr. Michael Morcos

Heidelberg, Germany

Location

IKFE

Mainz, 55116, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular DiseasesDiabetes Mellitus

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Thomas Forst, MD

    IKFE - Institute for Clinical Research and Development, Mainz

    PRINCIPAL INVESTIGATOR

  • Andreas Pfützner, MD, PhD

    IKFE - Institute for Clinical Research and Development, Mainz

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 29, 2007

First Posted

May 30, 2007

Study Start

June 1, 2005

Study Completion

November 1, 2006

Last Updated

April 1, 2015

Record last verified: 2007-05

Locations

DE(2)