| Trial ID: | L0066 |
| Source ID: | NCT02649465
|
| Associated Drug: |
Tofogliflozin
|
| Title: |
SGLT2 Inhibitor Versus Sulfonylurea on Type 2 Diabetes With NAFLD
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Tofogliflozin|Drug: Glimepiride
|
| Outcome Measures: |
The improvement in histologic features of NAFLD|Change from baseline in liver enzymes|Change from baseline in body composition|Change from baseline in fasting plasma glucose level and glucose metabolism assessed with arginine tolerance test|Changes from baseline in organ-specific insulin sensitivity and glucagon response during a euglycemic hyperinsulinemic clamp study|Change from baseline in lipid profile|Change from baseline in renal function and electrolyte balances|Change from baseline in oxidative stress|Change from baseline in cytokine (TNF-alpha, leptin, adiponectin) levels|Change from baseline in hepatokine (Selenoprotein P, LECT2) levels|Change from baseline in organ-specific fat accumulation|Change from baseline in oxidative and non-oxidative glucose disposal|Change from baseline in respiratory quotients|Change from baseline in energy expenditure|Change from baseline in autonomic nerve function.|Changes from baseline in minerals and bone metabolism|Changes from baseline in endothelial functions|Changes from baseline in fatty acids profiles|Factors associated with the changes in autonomic nerve function, organ-specific fat accumulation, and glucagon response.|Changes from baseline in gene expression profiles in the liver and blood cells|Changes from baseline in microRNAs and exosome contents|Epigenomic changes from baseline in genes of the liver and blood cells
|
| Sponsor/Collaborators: |
Kanazawa University|Kowa Company, Ltd.
|
| Gender: |
All
|
| Age: |
20 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 4
|
| Enrollment: |
40
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
November 11, 2015
|
| Completion Date: |
June 30, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
July 2, 2021
|
| Locations: |
Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan
|
| URL: |
https://ClinicalTrials.gov/show/NCT02649465
|
