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Efficacy Study of Pioglitazone Compared to Glimepiride on Coronary Atherosclerotic Disease Progression in Subjects With Type 2 Diabetes Mellitus

NCT00225277 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 547

Last updated 2012-02-28

Study results available
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Summary

The purpose of this study was to determine the efficacy of pioglitazone, once daily (QD), compared to glimepiride on atherosclerotic disease measured by intravascular ultrasound.

Conditions

Interventions

DRUG

Pioglitazone

Up to 45 mg pioglitazone (optimized for glucose control), tablets, orally, once daily for up to 72 weeks.

DRUG

Glimepiride

Up to 4 mg of glimepiride (optimized for glucose control), tablets, orally, once daily for up to 72 weeks.

Sponsors & Collaborators

Principal Investigators

  • VP Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States
  • Argentina
  • Canada
  • Chile

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00225277 on ClinicalTrials.gov