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A study of additional effect of SGLT-2 inhibitor in the improvement of fat accumulation in the liver (SESIFAL)

Improving fatty liver by SGLT-2 inhibitor (SESIFAL)

1

55-year-old female (HbA1c 8.0% at entry), DPP4 group

There were no patients available for inclusion and the pace of enrollment did not go as planned. Only one case was able to obtain consent.

No adverse events were observed.

Primary endpoint: Change in liver fat percentage 20.8 -> 2.2 Secondary endpoint: Change in liver hardness (MR elastography) 2.3 -> 2.2 Change in liver function test values gamma-GTP 28 -> 11IU/L, AST 20 -> 11IU/L, ALT 32 -> 8IU/L Change in weight 61.7 -> 53.7kg Change in body fat percentage 35.3 -> 23.7% Safety: No adverse events

Liver fat was decreased without any adverse events.

May. 31, 2023

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs031200093

Tsuchiya Kyoichiro

University of Yamanashi Hospital

1110, Shimokato, Chuo-shi, Yamanashi

tsuchiyak@yamanashi.ac.jp

Tsuchiya Kyoichiro

University of Yamanashi Hospital

1110, Shimokato, Chuo-shi, Yamanashi

+81-55-273-9602

tsuchiyak@yamanashi.ac.jp

Complete

Aug. 24, 2020

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

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

Both

Type 2 diabetes mellitus with hepatic steatosis

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

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

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

+81-55-273-9065

July. 09, 2020

none