Clinical Trial Details
| Trial ID: | L0547 |
| Source ID: | JPRN-UMIN000027337 |
| Associated Drug: | SGLT2 inhibitor |
| Title: | |
| Acronym: | -- |
| Status: | Recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Type 2 diabetes with nonalcoholic fatty liver disease |
| Interventions: | SGLT2 inhibitor for 60 weeks<br>Bezafibrate 200~400mg for 60 weeks<br>SGLT2 inhibitor/Bezafibrate 200-400mg combined group for 60 weeks<br>Conventional treatment group for 60 weeks |
| Outcome Measures: | Change from baseline in liver-to-spleen attenuation ratio (L/S ratio) by CT at week 60Changes from baseline in AST, ALT, HbA1c, fasting plasma glucose, bodyweight, abdominal visceral adipose tissue, and subcutaneous adipose tissue, Hypoglycemia by using CGM, electrocardiogram change by using Holter electrocardiogram |
| Sponsor/Collaborators: | Saitama Medical University Hospital |
| Gender: | All |
| Age: | 20years-old75years-old |
| Phases: | Not selected |
| Enrollment: | 80 |
| Study Type: | Interventional |
| Study Designs: | Parallel Randomized |
| Start Date: | 14/05/2017 |
| Completion Date: | -- |
| Results First Posted: | -- |
| Last Update Posted: | 2 April 2019 |
| Locations: | Japan |
| URL: | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031322 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D549 | SGLT2 inhibitor | Chemical drug | -- | SGLT2 inhibitor | -- | Under clinical trials | Details |
| D033 | Bezafibrate | Chemical drug | DB01393 | PPARA agonist; PPARD agonist; PPARG agonist; NR1I2 partial agonist | Improve insulin resistance; Anti-inflammatory | Under clinical trials | Details |
| D248 | Obeticholic Acid | Chemical drug | DB05990 | NR1H4 activator; NR1H4 agonist; FXR agonist | Enhance lipid metabolism | Approval rejected | Details |