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

Launched by GETZ PHARMA · Nov 30, 2022

Keywords

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Gender

ALL

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/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

Trial Officials