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

NCT00699036 | Unknown Phase 2 DMC

• 1 other identifier: C.2007.066
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease

Keywords

nonalcoholic steatohepatitis (NASH); fatty liver; insulin resistance

Outcome Measures

Primary Outcomes (1)

• liver biopsy histologic improvement

  end of study

Secondary Outcomes (1)

• serum transaminases

  throughout study (ongoing)

Study Arms (3)

1

EXPERIMENTAL

avandia

Drug: avandia

2

EXPERIMENTAL

avandia plus metformin

Drug: avandia; Drug: metformin

3

EXPERIMENTAL

avandia plus losartan

Drug: avandia; Drug: losartan

Interventions

avandia DRUG

4 mg twice daily

1; 2; 3

metformin DRUG

500 mg twice daily for 48 weeks

2

losartan DRUG

losartan 50 mg once daily

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Insulin Resistance

Interventions

Rosiglitazone; Metformin; Losartan

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Tetrazoles

Study Officials

• Dawn M Torres, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: June 17, 2008
• Study Start: April 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 19, 2009

Record last verified: 2009-06

Locations

US (1)