| Trial ID: | L5076 |
| Source ID: | NCT02875821
|
| Associated Drug: |
Ipragliflozin
|
| Title: |
Effects of Ipragliflozin on Excessive Fat in Type 2 Diabetes Patients With Non-alcoholic Fatty Liver Disease Treated With Metformin and Pioglitazone
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes With Non-alcoholic Fatty Liver (NAFLD)
|
| Interventions: |
DRUG: Ipragliflozin|DRUG: metformin with pioglitazone
|
| Outcome Measures: |
Primary: changes in visceral fat area, The visceral fat area is measured by dual-energy x-ray absorptiometry (DEXA) at baseline and after 6 months treatment, 6 months | Secondary: Changes in subcutaneous fat area, The subcutaneous fat area is measured by dual-energy x-ray absorptiometry (DEXA) and fat computed tomography (CT) at baseline and after 6 months treatment., 6 months after treatment|Changes in liver fat, Changes in the degree of fatty liver is measured by fibroscan using controlled attenuation parameter (CAP) score., 6 months after treatment
|
| Sponsor/Collaborators: |
Sponsor: Yonsei University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-04-26
|
| Completion Date: |
2017-06-07
|
| Results First Posted: |
|
| Last Update Posted: |
2017-06-23
|
| Locations: |
Yonsei University College of Medicine, Department of internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center, Seoul, 03722, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT02875821
|
