Clinical Trial Details

Trial ID: L0740
Source ID: JPRN-jRCTs031190040
Associated Drug: Tofogliflozin
Title: Effect of tofogliflozin on liver fat content compared to metformin in type 2 diabetes patients with nonalcoholic fatty liver disease
Acronym: --
Status: Not Recruiting
Study Results: Has Results
Results: --
Conditions: Type 2 diabetes mellitus <br>Type 2 diabetes mellitus
Interventions: Arm A<br><Time Frame 0 to 24 weeks><br>Tofogliflozin 20mg/day<br><Time Frame 24 to 48 weeks><br>Tofogliflozin 20mg/day + Metformin 1500mg/day<br><br>Arm B<br><Time Frame 0 to 4-8 weeks><br>Metformin 500mg/day<br><Time Frame 4-8 to 24 weeks><br>Metformin 1
Outcome Measures: Change in liver fat content as measured by MRI-PDFF( proton density fat fraction). <Time frame: 24 weeks, comparison of arm A and B>Important secondary endpoint<br>Change in liver stiffness as measured by MR elastography. <Time frame: 24 weeks, comparison of arm A and B><br><br>Secondary endpoint<br>1.% change of liver fat content as measured by MRI-PDFF. <Time frame: 24 weeks, comparison of arm A and B><br>2.Change in, and % change of liver fat content as measured by MRI-PDFF. <Time frame: 24 weeks, comparison of before and after ><br>3.Change in, and % change of liver fat content as measured by MRI-PDFF. <Time frame: 48 weeks, comparison of arm A and B, and before and after ><br>4.% Change of liver stiffness as measured by MR elastography. <Time frame: 24 weeks, comparison of arm A and B><br>5.Change in, and % Change of liver stiffness as measured by MR elastography. <Time frame: 24 weeks, comparison of before and after ><br>6.Change in, and % change of liver stiffness as measured by MR elastography. <Time frame: 48 weeks, comparison of arm A and B, and before and after ><br>7.Change in, and % change of following parameters. <Time frame: 24, and 48 weeks, comparison of arm A and B, and before and after ><br>8.Change in, and % change of following parameters from 24 to 48 weeks. <Comparison of week 24 and 48, and arm A and B ><br>9.Incidence of adverse events<br><br><Parameters><br>ALT, AST, gamma-GTP, PT, TP, Alb, ChE, type IV collagen 7S, P-III-P, hyaluronic acid<br>Body weight, body mass index, west circumference, blood pressure<br>HbA1c, fasting blood glucose, glycoalbumin, insulin, HOMA-R, CPI<br>TC, HDL-C, LDL-C, TG, RLP-C<br>Serum creatinine, eGFR<br>White blood cell, red blood cell, hemoglobin, hematocrit, platelet<br>Total ketone, beta-hydroxybutyric acid, acetoacetic acid<br>Uric acid<br>BUN, Na, K, P, Ca, Mg, Fe, ferritin, bilirubin fraction<br>Urine sugar, urinary ketone body, urinary albumin<br>Visceral fat area<br>Fat accumulation content of intrahepatic<br>Body fat mass, fat-free mass, muscle mass <Arbitrary parameters>
Sponsor/Collaborators: Yumi Takiyama
Gender: All
Age: >= 20age oldNot applicable
Phases: Not applicable
Enrollment: 40
Study Type: Interventional
Study Designs: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
Start Date: 17/06/2019
Completion Date: 04/02/2021
Results First Posted: 24/08/2021
Last Update Posted: 10 January 2022
Locations: Japan
URL: https://jrct.niph.go.jp/latest-detail/jRCTs031190040