Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
51 participants
INTERVENTIONAL
2018-12-06
2022-06-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study was designed to include 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 24 weeks. The primary endpoint is the difference of liver fat change measured by MRI-PDFF in the largest possible polygonal region of interest encompassing both lobes of the liver between three groups.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes
NCT06989723
Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver
NCT04976283
Effects of Ipragliflozin on Excessive Fat in Type 2 Diabetes Patients With Non-alcoholic Fatty Liver Disease Treated With Metformin and Pioglitazone
NCT02875821
Association of SGLT2 Inhibitors Therapy With Elastographic and Molecular Markers of Liver Injury in Type 2 Diabetes
NCT07269197
A Study to Identify the Risk of Non-alcoholic Fatty Liver Disease (NAFLD) in Patients With Type 2 Diabetes in Clinical Practice and to Evaluate the Clinical Usefulness of Dapagliflozin/Pioglitazone Combination Therapy
NCT06649162
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pioglitazone monotherapy
Pioglitazone 15mg 1T daily for 24 weeks
Pioglitazone
The investigators will compare the degree of liver fat before and after pioglitazone monotherapy.
Empagliflozin monotherapy
Empagliflozin 10mg 1T daily for 24 weeks
Empagliflozin
The investigators will compare the degree of liver fat before and after empagliflozin monotherapy.
Pioglitazone + Empagliflozin combination therapy
Pioglitazone 15mg 1T + Empagliflozin 10mg 1T combination daily for 24 weeks
Combination of pioglitazone and empagliflozin
The investigators will compare the degree of liver fat before and after pioglitazone and empagliflozin combination therapy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pioglitazone
The investigators will compare the degree of liver fat before and after pioglitazone monotherapy.
Empagliflozin
The investigators will compare the degree of liver fat before and after empagliflozin monotherapy.
Combination of pioglitazone and empagliflozin
The investigators will compare the degree of liver fat before and after pioglitazone and empagliflozin combination therapy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Individuals who are diagnosed with type 2 diabetes (HbA1c ≥ 7.5% and \< 11.0%) and treated with antidiabetic drugs excluding TZD and SGLT2i over the previous 12 weeks
3. Individuals diagnosed with steatotic liver disease as documented by abdominal ultrasonography within the previous year
4. Individuals who have voluntarily agreed in written form to participate in the clinical trial after hearing the explanation of this clinical trial
5. Individuals 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
2. Highly uncontrolled diabetes (HbA1c ≥ 11.0%)
3. Excessive alcohol intake (210 g and 140 g/week for men and women, respectively) within the previous 2 years
4. A history of taking thiazolidinedione or sodium-glucose cotransporter 2 inhibitor class medications within the last 12 weeks, or a history of discontinuing these medications due to severe side effects
5. Treatment with four or more classes of antidiabetic medications
6. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma, within 24 weeks
7. Intake of drugs that can cause steatotic liver disease (amiodarone, methotrexate, tamoxifen, valproate, etc.)
8. Allergy or hypersensitivity to the study drugs or their constituents
9. Oral or parenteral chronic corticosteroid therapy (more than 14 consecutive days) that requires continual adjustments in corticosteroid dose for therapeutic purposes within 8 weeks
10. Galactosemia
11. Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
12. Malignant tumors currently undergoing treatment or progression
13. A history of substance abuse or alcohol intoxication within 12 weeks
14. Infection of human immunodeficiency virus
15. Severe infection
16. Pre- and post-operative status, or severe trauma
17. Cardiac failure within 24 weeks (class III to IV in the NYHA classification)
18. Acute cardiovascular event within 12 weeks (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass grafting, or coronary intervention)
19. AAcute and chronic renal disease (estimated glomerular filtration rate \< 45 mL/min/1.73 m²) or dialysis
20. Pregnant or lactating women
21. Individuals whom the investigator determines to be unsuitable for participation in the clinical trial
19 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yonsei University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lee M, Hong S, Cho Y, Rhee H, Yu MH, Bae J, Lee YH, Lee BW, Kang ES, Cha BS. Synergistic benefit of thiazolidinedione and sodium-glucose cotransporter 2 inhibitor for metabolic dysfunction-associated steatotic liver disease in type 2 diabetes: a 24-week, open-label, randomized controlled trial. BMC Med. 2025 May 7;23(1):266. doi: 10.1186/s12916-025-04017-x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4-2018-0655
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.