Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD

Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis & glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH)

Inclusion Criteria:Patient able to provide written informed consentAdult males & females between 18 to 65 yearsSGLT2i and insulin naïve patientsBMI >23 Kg/m2HbA1C % ≥ 6.5 to 10Documented hepatic steatosis or fatty liver disease on UltrasoundPatient with Type II Diabetes MellitusExclusion Criteria:History of use of SGLT 2 inhibitors or Glucagon-like peptide (GLP) 1 agonist or insulin; 3 months prior to enrollment in the study.Pioglitazone use in the past 6 monthsHistory of vitamin E use (400mg twice daily) 3 months prior to enrollment in the study.History of anti-obesity medication or weight loss procedure (bariatric surgery) use within 3 months prior to enrollment in the study.History of uncontrolled Endocrine disorder (for example uncontrolled hypothyroidism, or that requires frequent dose adjustment, or Cushing's syndrome)History of liver disease including viral hepatitis, auto-immune hepatitis, liver cirrhosis, hepatocellular carcinoma and/or HIVHistory of recurrent UTIs and mycotic infection.Severely ill patients (who have high grade fever, sepsis or acute infection)Pregnant woman, lactating woman or planning pregnancy during study durationHistory of Drug-induced liver disease (e.g. amiodarone, valproate, tamoxifen, methotrexate, steroids (including homeopathic medicines).History of active substance abuse (cannabinoid-derived substances like heroin, cocaine, amphetamines) based on history and/or laboratory testsAlcohol intake 10 - 30 g/day (three drinks per day) within the previous yearActive substance abuse such as acetaminophen over-use, hashish, tobacco products, heroin, cocaine or amphetamines.Severe hepatic impairment ( AST & ALT levels > 3 times upper limit normal