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Safety Study of Pioglitazone Compared To Glyburide on Liver Function

NCT00494312 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2120

Last updated 2012-02-28

No results posted yet for this study

Summary

The purpose of this study is to determine the liver safety of pioglitazone, once daily (QD), versus glyburide taken with metformin and insulin.

Conditions

Interventions

DRUG

Pioglitazone

Pioglitazone 15 mg or 30 mg titrated to 45 mg, tablets, orally, once daily and glyburide placebo-matching capsules, orally, once daily for up to 156 weeks.

DRUG

Glyburide

Pioglitazone placebo-matching tablets, orally, once daily and glyburide 5 mg or 10 mg titrated to 15 mg, capsules, orally, once daily for up to 156 weeks.

Sponsors & Collaborators

Principal Investigators

  • VP Clinical Science Strategy · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-10-31
Primary Completion
2005-06-30
Completion
2005-06-30

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Entities

Diseases
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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 NCT00494312 on ClinicalTrials.gov