Comparison of The Effects of Thiazolidinediones(TZD), Sodium- Glucose Cotransporter 2 Inhibitors(SGLT2i) Alone and TZD / SGLT2i Combination Therapy on Non-alcoholic Fatty Liver Disease in Type 2 Diabetic Patients With Fatty Liver

• Status: Recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the synergic therapeutic effect of thiazolidinediones and SGLT2 inhibitor on nonalcoholic fatty liver disease, the effect of empagliflozin 10mg, pioglitazone 15mg monotherapy and combination therapy n patients with type 2 diabetes and fatty liver will be compared and analyzed.

This study included a total of 60 patients (20 per subgroup) for randomized controlled trials with prospective, open label, randomized, single-institution clinical trials.

The drug will be maintained for a total of six months. The primary endpoint is the difference of liver fat change measured by MRI-PDFF in co-localized regions of interest within nine liver segments between three groups.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: 2,4-thiazolidinedione; Empagliflozin; Pioglitazone

Criteria

Inclusion Criteria:

• Men or women aged 19 years or over, under 75 years

• A person diagnosed with nonalcoholic fatty liver in abdominal ultrasound (abdominal ultrasound can be substituted if there is a diagnosis of fatty liver through ultrasound within 1 year), or a person diagnosed with fatty liver in abdominal ultrasonography through screening because of clinical suspicion of fatty liver

• Patients who are diagnosed with type 2 diabetes and who are treated with oral medication, excluding TZD or SGLT2i drug users within the last 12 weeks

• Those who have voluntarily agreed in written form to participate in the clinical trial after hearing the explanation of this clinical trial

• Those who understand the content of the clinical trial and are able to participate in the trial until the end of the clinical trial

Exclusion Criteria:

• Diabetic patients other than type 2 diabetes, including type 1 diabetes and gestational diabetes

• Type 2 diabetic patients undergoing insulin therapy

• Patients who have taken TZD or SGLT2i drugs within the last 12 weeks or have had a history of severe side effects after taking the above drugs

• Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, and those with a history of ketone phosphatemia (within 6 months)

• Patients who meet the criteria for alcoholic liver disease (210 g / week for men in the last two years, 140 g / week for women)

• People who take drugs that can cause fatty liver (amiodarone, methotrexate, tamoxifen, valproate, etc.)

• Allergic or hypersensitive to the drug or its constituents

• Patients receiving oral or parenteral corticosteroid therapy chronic (within consecutive 14 days) within 8 weeks prior to screening require continual changes in corticosteroid dosage for therapeutic purposes

• Patients with genetic problems such as galactosemia, Lapp lactase deficiency or glucose-galactose uptake

• Malignant tumors that are currently undergoing treatment or progressive

• Patients with a history of substance abuse or alcohol intoxication within 12 weeks

• Human immunodeficiency virus (HIV)

• Patients with severe infection, pre- and post-operative, and severe trauma

• Patients with cardiac failure within 6 months (class III to IV in the NYHA classification)

• Patients with acute cardiovascular disease within 12 weeks (patients with unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass grafting, or coronary intervention)

• People with renal failure, chronic renal disease (estimated glomerular filtration rate <45 mL / min / 1.73 m2) or those who are difficult to use the medication due to dialysis

• Pregnant or lactating women

• A person who the examiner considers not eligible for clinical trials