| Trial ID: | L0433 |
| Source ID: | JPRN-jRCTs031190238
|
| Associated Drug: |
Sitagliptin
|
| Title: |
Long-term comparison of luseogliflozin vs sitagliptin for Type 2 diabetes mellitus patients with NASH/NAFLD: a multicenter, open-label, randomized, controlled study
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Type 2 diabetes mellitus with NAFLD/NASH <br>NAFLD,NASH,NAFLD/NASH,Type 2 diabetes mellitus,liver fibrosis,fatty liver
|
| Interventions: |
Group A: Luseogliflozin hydrate tablets 2.5 mg are orally administered once a day before breakfast or after breakfast for 144 weeks. If blood glucose control is insufficient, the dose can be increased to 5 mg once a day.<br>Group B: Sitagliptin Phosphate
|
| Outcome Measures: |
Difference from baseline in MRE value at 72 weeks after administration1) Changes in hepatic steatosis at 24 weeks after administration (assessed by MRI-PDFF)<br>2) Liver disease-related events at 144 weeks after administration: presence of cirrhosis and liver carcinogenesis<br>3) Presence of cardiovascular events and other organ carcinogenesis at 144 weeks after administration<br>4) Changes from baseline in the clinical examination items at 24, 72, and 144 weeks after administration<br>5) Changes from baseline in body weight, BMI and waist circumference at 12, 24, 48, 72, 96, 120, 144 weeks after administration<br><Safety evaluation items><br>Frequency of adverse events and diseases
|
| Sponsor/Collaborators: |
Kobayashi Takashi
|
| Gender: |
All
|
| Age: |
>= 20age old< 80age old
|
| Phases: |
Not applicable
|
| Enrollment: |
210
|
| Study Type: |
Interventional
|
| Study Designs: |
randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
|
| Start Date: |
03/03/2020
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
18 October 2021
|
| Locations: |
Japan
|
| URL: |
https://jrct.niph.go.jp/latest-detail/jRCTs031190238
|
