Efficacy and Safety of Dapagliflozin for reduction of steatohepatitis in patients of Type 2 diabetes with Nonalcoholic Steatohepatitis: A prospective, randomized, double-blinded, placebo-controlled study.

Dr Shashi Panicker0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Subjects who are willing and given their informed consent prior to any study-specific prodedures.
•2.Female or male aged 30 years or more
•3. Recently diagnosed or known cases of type 2 diabetes
•4.HbA1c above 7%
•5.Presence of NASH
•6.Fulfilment of criteria for non-alcoholic fatty liver disease
•7.eGFR >45/ml/1.73m squared

•1.Diagnosis of Type 1 Diabetes
•2.History of Bladder cancer
•3.History of radiation therapy to the lower abdomen or pelvis at any time
•4.Chronic cystitis and/ or recurrent urinary tract infections
•5.Pregnant or breastfeeding women
•6.Subjects with cirrhosis of the liver or obstructive biliary disease will be excluded.
•7.Chronic Hepatitis B and hepatitis C
•8.Subjects with alpha-1 antitrypsin deficiency and Wilsonâ??s disease will be excluded.
•9.Patients on Tamoxifen, methotrexate, amiodarone, thiazolidinediones, incretin mimetics like liraglutide and DPP4 inhibitors, or SGLT2 inhibitors like dapagliflozin, canagliflozin, or empagliflozin, will be excluded from the study.

发起方

Dr Shashi Panicker