Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?

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Detailed Description

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Conditions

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Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

avandia

Group Type EXPERIMENTAL

avandia

Intervention Type DRUG

4 mg twice daily

2

avandia plus metformin

Group Type EXPERIMENTAL

avandia

Intervention Type DRUG

4 mg twice daily

metformin

Intervention Type DRUG

500 mg twice daily for 48 weeks

3

avandia plus losartan

Group Type EXPERIMENTAL

avandia

Intervention Type DRUG

4 mg twice daily

losartan

Intervention Type DRUG

losartan 50 mg once daily

Interventions

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avandia

4 mg twice daily

Intervention Type DRUG

metformin

500 mg twice daily for 48 weeks

Intervention Type DRUG

losartan

losartan 50 mg once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients between 18-70 years old
2. Negative urine pregnancy test in females
3. History of elevated liver associated enzymes (ALT \> 40)
4. Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH

Exclusion Criteria

1. ALT greater than three times normal
2. NYHA class 3 or 4 heart failure
3. Any congestive heart failure patient on insulin
4. Patients on one of the 3 study drugs within the past 3 months prior to enrollment
5. Alcohol consumption \>20 gm/day in a female and \> 30 gm/day in a male
6. Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis
7. Serum creatinine on initial screening of greater than 1.4
8. Known hypersensitivity to rosiglitazone, metformin, or losartan
9. Known history of diabetic ketoacidosis
10. Female that is breastfeeding
11. Insulin dependent diabetic

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No