Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
Trial Parameters
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: * Patient able to provide written informed consent * Adult males \& females between 18 to 65 years * SGLT2i and insulin naïve patients * BMI \>23 Kg/m2 * HbA1C % ≥ 6.5 to 10 * Documented hepatic steatosis or fatty liver disease on Ultrasound * Patient with Type II Diabetes Mellitus Exclusion 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 months * History 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/o