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

RecruitingPhase 4Ages 18 Years - 65 YearsAllGetz Pharma
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patient able to provide written informed consent * Adult males \& females between 18 to 65 years * SGLT2i and insulin naรฏve patients * BMI \>23 Kg/m2 * HbA1C % โ‰ฅ 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
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What it tests

  • Ertugliflozin 5 mg, 15mg
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Where

1 site
North west general hospital
Peshawar, Pakistan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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