Effect of tofogliflozin and pioglitazone on hepatic steatosis in NAFLD patients with type 2 diabetes

Abstract

Authors » [No authors listed]

Category » Primary study

Registry of Trials»Japan Primary Registry Network

Year » 2019

Links » jRCT, ICTRP

INTERVENTION: Arm A:Tofogliflozin 20mg , Tofogliflozin 20mg + Pioglitazone 15‐30mg Arm B: Pioglitazone 15‐30mg , Tofoglifozin 20mg + Pioglitazone 15‐30mg CONDITION: Type 2 Diabetes, NAFLD ; Diabetes, NAFLD PRIMARY OUTCOME: Change in liver fat content as measured by MRI‐based proton density fat fraction (PDFF). SECONDARY OUTCOME: 1)Important secondary outcome; Change in serum ALT level. ; ; 2)other secondary outcomes ; <1> ; Secondary outcomes during randomization phase (mono‐therapy), ; ; % change in liver fat by MRI‐PDFF., >=10%, >=20% and >=30% reduction of MRI‐PDFF., change in liver stiffness by MR elastography., >=5%, >=10% and >=15% reduction of liver stiffness., change in HbA1c, glucose, insulin, and HOMA‐R., change in body weight and BMI., change in ALT, AST, gamma‐GTP, ALP, total bilirubin and ALT/AST ratio., the proportion of normalization of ALT and AST level., platelet count, total protein albumin and choline esterase and ferritin., type IV collagen 7S, hsCRP, cytokeratin 18 fragment, adiponectin, ketone body fraction, M2BPG1, and urinary 8‐OHdG., number(%) of adverse event. ; <2> ; Secondary outcomes during combination therapy phase ; liver fat content, liver stiffness, HbA1c, glucose, insulin, HOMA‐R., body weight, BMI, ALT, AST, gamma‐GTP, ALP, total bilirubin, ALT/AST ratio., the proportion of normalization of ALT and AST level, platelet count, total protein albumin and choline esterase, ferritin, type IV collagen 7S, hsCRP, cytokeratin 18 fragment, adiponectin, ketone body fraction, M2BPG1, urinary 8‐OHdG., number(%) of adverse event. INCLUSION CRITERIA: <1>Inclusion criteria for study entry; 1. men and women, aged 20‐74 years. 2. Type 2 diabetic patients who have been treated with diet/exercise therapy. 3. HbA1c higher than 6.5% (measured within 90 days before study registration). 4. Clinically diagnosed NAFLD 5. ALT higher than the upper limited normal (measured within 90 days before study registration). 6. Patients who provide written consent to participate in the trial of their own free will. <2>Inclusion criteria for randomization; Patients with screening MRI‐PDFF >= 10% steatosis.

Epistemonikos ID: 82d6ba64ab231826172277bf0dc106da3c4dd79c
First added on: Aug 24, 2024