Improving fatty liver by SGLT-2 inhibitor

JRCT ID: jRCTs031200093

Registered date:24/08/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus with hepatic steatosis
• Date of first enrollment: 27/08/2021
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Switching from DPP4 inhibitor/other drug to or adding Luseogliflozin versus switching from other drugs to DPP4 inhibitor or continuing of DPP4 inhibitor
Arm 1: SGLT2 inhibitor (Luseogliflozin)
Arm 2: DPP4 inhibitor

Outcome(s)

Primary Outcome

Change in proton density fat fraction (PDFF) as measured by MRI from baseline* to 24 weeks after the intervention
Comparison of Arm 1 and Arm 2
*before the intervention

Secondary Outcome

1) Change in liver stiffness as measured by MRI from baseline to 24 weeks after the intervention
Comparison of Arm 1 and Arm 2 using t-test
2) Change in liver stiffness as measured by Fibroscan and CAP from baseline to 12 and 24 weeks after the intervention
Comparison of Arm 1 and Arm 2 using t-test
3) Change in the following serum markers from baseline to 4, 12 and 24 weeks after the intervention;
gamma-GTP, AST, ALT, TG, LDL-Chol, HDL- Chol, HbA1c, M2BPGI, Type 4 collagen7S, HMGB1
Comparison of Arm 1 and Arm 2 using t-test
4) Change in body weight and body fat percentage from baseline to 24 weeks after the intervention
Comparison of Arm 1 and Arm 2 using t-test

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Type 2 diabetes mellitus
2) Hepatic steatosis
3) Outpatients or inpatients
4) Meeting the following criteria with the tests results <=14 days before enrollment
(1) HbA1c >=6.5% and <=10%
(2) CAP >=250db/m
5) Aged >=20 years, =<75 years at consent
6) Written informed consent

Exclude criteria

1) SGLT2 inhibitor taken within 1 year before consent
2) Pioglitazone taken within 1 year before consent
3) Viral hepatitis
4) Severe ketosis, diabetic coma or precoma
5) Severe infection, pre and post surgery, and severe injury
6) History of hypersensitivity to any of the ingredients of the study drug
7) Servere hepatic dysfunction
8) Severe renal dysfunction or patients requiring dialysis (including peritoneal dialysis)
9) Dehydration or pre-clinical dehydration
10) malnutrition, famine, debilitation, pituitary (gland) malfunction or adrenal gland dysfunction
11) Severe impairment of cardiovascular or lung function (such as shock, heart failure, cardiac infarct, pulmonary embolism) or patient tend to be hypoxia
12) Excessive alcohol intake
13) Diabetic ketoacidosis
14) History of lactic acidosis
15) Pregnant
16) Nursing
17) Female patient who is unable to take abstinence or effective contraceptive methods during this study
18) Contraindication to MRI
19) Judged ineligible by doctor in charge for other reasons

Related Information

• Primary Sponsor: Tsuchiya Kyoichiro
• Source(s) of Monetary Support: Taisho Pharmaceutical Co., Ltd.