| Trial ID: | L0472 |
| Source ID: | JPRN-jRCTs071180069
|
| Associated Drug: |
Ipragliflozin
|
| Title: |
Study of ipragliflozin effect on type 2 diabetes with nonalcoholic fatty liver disease - Study of ipragliflozin effect on type 2 diabetes with nonalcoholic fatty liver disease
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
Has Results
|
| Results: |
--
|
| Conditions: |
Type 2 diabetes with nonalcoholic fatty liver disease
|
| Interventions: |
Oral administration of ipragliflozin (50mg tablet) once a day after meal
|
| Outcome Measures: |
Decrease in HbA1c after interventions for 72 weeks1. Changes in HbA1c after 12 week, 24 week and 48 week of intervention.<br>2. Changes in bodyweight after 24 week and 72 week of intervention.<br>3. Changes in the parameters described below after 12 week, 24 week, 48 week and 72 week of intervention.<br>Serum liver function test, imaging analysis, serum inflammatory marker, liver histology, serum biochemistry exams, blood counts and adverse events.
|
| Sponsor/Collaborators: |
Anzai Keizo
|
| Gender: |
All
|
| Age: |
>= 20age old<= 80age old
|
| Phases: |
Phase 3
|
| Enrollment: |
54
|
| Study Type: |
Interventional
|
| Study Designs: |
randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
|
| Start Date: |
20/03/2019
|
| Completion Date: |
01/03/2019
|
| Results First Posted: |
31/03/2020
|
| Last Update Posted: |
20 April 2020
|
| Locations: |
Japan
|
| URL: |
https://jrct.niph.go.jp/latest-detail/jRCTs071180069
|
