Trials / Completed
CompletedNCT03646292
Antidiabetic Drugs for Steatotic Liver Disease
Comparison of The Effects of Thiazolidinediones(TZD), Sodium- Glucose Cotransporter 2 Inhibitors(SGLT2i) Alone and TZD / SGLT2i Combination Therapy on Metabolic Dysfunction-Associated Steatotic Liver Disease in Patients With Type 2 Diabetes
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Yonsei University · Academic / Other
- Sex
- All
- Age
- 19 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To investigate the synergic therapeutic effect of thiazolidinediones and SGLT2 inhibitor on metabolic dysfunction-associated steatotic liver disease, the effect of empagliflozin 10mg, pioglitazone 15mg monotherapy and combination therapy in patients with type 2 diabetes and steatotic liver disease will be compared and analyzed. 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.
Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- Type 2 Diabetes
- Digestive System Disease
- Liver Diseases
- Fatty Liver
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- Non-Alcoholic Fatty Liver Disease
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Sodium-Glucose Cotransporter 2 Inhibitors
- Pioglitazone
- Molecular Mechanisms of Pharmacological Action
- Empagliflozin
- Thiazolidinediones
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pioglitazone | The investigators will compare the degree of liver fat before and after pioglitazone monotherapy. |
| DRUG | Empagliflozin | The investigators will compare the degree of liver fat before and after empagliflozin monotherapy. |
| DRUG | Combination of pioglitazone and empagliflozin | The investigators will compare the degree of liver fat before and after pioglitazone and empagliflozin combination therapy. |
Timeline
- Start date
- 2018-12-06
- Primary completion
- 2022-06-16
- Completion
- 2022-06-16
- First posted
- 2018-08-24
- Last updated
- 2025-03-05
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03646292. Inclusion in this directory is not an endorsement.