Overview
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
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/or HIV
- History 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 duration
- History 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 tests
- Alcohol intake 10 - 30 g/day (three drinks per day) within the previous year
- Active 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