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Clinical Trial Details

Trial ID: L2296
Source ID: NCT02649465
Associated Drug: Tofogliflozin
Title: SGLT2 Inhibitor Versus Sulfonylurea on Type 2 Diabetes With NAFLD
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Non-alcoholic Fatty Liver Disease
Interventions: DRUG: Tofogliflozin|DRUG: Glimepiride
Outcome Measures: Primary: The improvement in histologic features of NAFLD, 48 weeks | Secondary: Change from baseline in liver enzymes, 48 weeks|Change from baseline in body composition, 48 weeks|Change from baseline in fasting plasma glucose level and glucose metabolism assessed with arginine tolerance test, 48 weeks|Changes from baseline in organ-specific insulin sensitivity and glucagon response during a euglycemic hyperinsulinemic clamp study, 48 weeks|Change from baseline in lipid profile, 48 weeks|Change from baseline in renal function and electrolyte balances, 48 weeks|Change from baseline in oxidative stress, 48 weeks|Change from baseline in cytokine (TNF-alpha, leptin, adiponectin) levels, 48 weeks|Change from baseline in hepatokine (Selenoprotein P, LECT2) levels, 48 weeks|Change from baseline in organ-specific fat accumulation, 48 weeks|Change from baseline in oxidative and non-oxidative glucose disposal, 48 weeks|Change from baseline in respiratory quotients, 48 weeks|Change from baseline in energy expenditure, 48 weeks|Change from baseline in autonomic nerve function., 48 weeks|Changes from baseline in minerals and bone metabolism, 48 weeks|Changes from baseline in endothelial functions, 48 weeks|Changes from baseline in fatty acids profiles, 48 weeks|Factors associated with the changes in autonomic nerve function, organ-specific fat accumulation, and glucagon response., 48 weeks|Changes from baseline in gene expression profiles in the liver and blood cells, 48 weeks|Changes from baseline in microRNAs and exosome contents, 48 weeks|Epigenomic changes from baseline in genes of the liver and blood cells, 48 weeks
Sponsor/Collaborators: Sponsor: Kanazawa University | Collaborators: Kowa Company, Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-11-11
Completion Date: 2021-06-30
Results First Posted:
Last Update Posted: 2021-07-02
Locations: Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, 920-8640, Japan
URL: https://clinicaltrials.gov/show/NCT02649465