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

ClinConnect Summary

This clinical trial is studying a medication called Ertugliflozin to see how it affects liver fat, liver damage, and blood sugar control in people with Type 2 Diabetes who also have a condition called Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH). The researchers want to find out if this medication can help improve these health issues. The trial is currently recruiting participants aged 18 to 65 who are new to diabetes treatments and have a body mass index (BMI) over 23. To join, participants need to have certain blood sugar levels and documented liver fat issues from an ultrasound.

If you decide to participate, you will receive Ertugliflozin and will be monitored for changes in liver fat, liver fibrosis (a measure of liver health), and blood sugar levels over time. This trial is important because it may help find better treatments for people with diabetes and liver issues. It's also essential to know that individuals with a history of certain liver diseases, substance abuse, or who are pregnant or nursing cannot participate.

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