The Study of Henagliflozin in Relieving Progression of Type 2 Diabetes With Non-alcoholic Fatty Liver Disease

2023412

This study is a randomized, non-blinded clinical trial specifically designed to assess the initial feasibility and efficacy of SGLT2 inhibitors in treating NAFLD among adults diagnosed with type 2 diabetes.

2024-02-15

2025-12-31

2025-12-31

Not yet recruiting

Early phase I

156

Inclusion Criteria: * Age between 20 and 70 years old. * Diagnosed with type 2 diabetes according to World Health Organization (WHO) diagnostic criteria, with evidence of fatty liver on ultrasound, and FIB-4 index \>1.3. * Willing to participate in this study and sign an informed consent form. In case the subject lacks the ability to read the informed consent form (e.g., illiterate subjects), the informed process must be witnessed by a designated person who will sign the informed consent form. * Have not used oral antidiabetic medications or have used one to three oral antidiabetic medications (limited to metformin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, alpha-glucosidase inhibitors, or sulfonylureas) with an HbA1c between 7% and 10%, and fasting venous blood glucose ≤13.3 mmol/L. * Have not used thiazolidinediones (TZDs), sodium-glucose co-transporter-2 inhibitors (SGLT-2i), glucagon-like peptide-1 receptor agonists (GLP-1RA), or other antidiabetic drugs that may affect liver fat content in the last 90 days. * Weight change of less than 5% in the last 3 months. * If of childbearing age, must use reliable contraceptive measures. Exclusion Criteria: * Daily alcohol intake of \>30 g in the past 10 years or daily alcohol intake of \>10 g in the last year. * History of liver diseases such as hepatitis B, chronic hepatitis C, primary biliary cholangitis (PBC), biliary obstruction disorders, drug-induced liver damage, hemochromatosis, liver cirrhosis, autoimmune hepatitis. * Patients with decompensated liver cirrhosis, concurrent liver cancer, HIV-positive status, or substance abuse. * Type 1 diabetes. * Participation in other clinical trials of diabetes treatment drugs in the 3 months prior to the start of this study. * Occurrence of diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma in the past 6 months. * Occurrence of unexplained severe hypoglycemic events in the past 6 months (requiring assistance for recovery) or recurrent hypoglycemia: such as experiencing two or more low blood sugar events (blood glucose ≤3.9 mmol/L) in the month before screening. * Severe heart disease patients, such as New York Heart Association (NYHA) class IV, unstable angina, or history of myocardial infarction. * Abnormal liver function, with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 3 times the upper normal limit, or total bilirubin (TBIL) greater than 2 times the upper normal limit. * Chronic kidney damage, with a creatinine level (Cr) \>200 µmol/L or an estimated glomerular filtration rate (eGFR) \<30 mL·min-1. * Use of corticosteroid medications (excluding short-term topical or inhaled use). * Patients with malignant tumors, active tuberculosis, or acute/chronic infections. * Vulnerable populations, including pregnant women, individuals with mental illness, critically ill patients, individuals with cognitive impairments, etc. * History of recurrent urinary tract infections or genital infections, or allergies to the investigational drug or its components. * Patients assessed by the clinical doctor as having low blood volume. * Patients deemed unsuitable for participation in this clinical study by the investigator, for reasons not covered above.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 156, 'type': 'ESTIMATED'}}

2024-01-23