NCT00529204 trial results

Inclusion Criteria: * Age \>18 years, \< 70 years, inclusive * Type 2 diabetes on stable doses of sulfonylurea and/or metformin * Body mass index \> 35 kg/m2 * Presumed diagnosis of NAFLD based upon * an ALT \> 1.5 times the upper limit of reference range, * no evidence of other causes of liver disease and * ultrasound findings compatible with fatty liver Exclusion Criteria: * Clinical signs of cirrhosis as evidenced by any of the following * spider angiomata, * splenomegaly, * ascites * jaundice * encephalopathy * INR \> 1.2 * Platelet count \< 100,000/ml * Serum albumin \< 3.0 g/dL * Other liver disease including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis. * Current use of \> 20 g of alcohol per day or unwillingness to avoid alcohol during the course of the study * Treatment with a thiazolidinedione or exenatide within 6 months of enrolling in the study * AST or ALT \> 10 times the upper limit of normal * Treatment with any investigational drug within 4 weeks of enrollment * Pre-menopausal, fertile women unwilling to use contraceptives during the study period. * Pregnancy or lactation * Initiation or change in dose of hypolipidemic drugs (statins, niacin, cholestyramine are allowed) within 6 months of enrollment * Use of anticoagulation, bleeding disorders or other contraindications to liver biopsy