UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of luseogliflozin for fattty liver with diabetes mellitus
Acronym	Efficacy of luseogliflozin for fattty liver with diabetes mellitus
Scientific Title	Efficacy of luseogliflozin for fattty liver with diabetes mellitus
Scientific Title:Acronym	Efficacy of luseogliflozin for fattty liver with diabetes mellitus
Region	Japan

Condition
Condition	fatty liver with type 2 diabetes mellitus
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the effect of luseogliflozin for the patients with non-alcoholic fatty liver disease (NAFLD) complicated with type 2 diabetes mellitus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ALT
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral administration of 2.5mg luseogliflozin once a day for 24 weeks
Interventions/Control_2	Dietetic and exercise therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Provide written informed concent 2. Aged >=20, <75 at consent 3. Type 2 diabetes mellitus 4. Diagnosed NAFLD by imaging test 5. AST>=33 or ALT>=30 in males, ALT>=27 in females
Key exclusion criteria	1. Using insulin 2. Has hypersensitivity to luseogliflozin 3. Has history of hepatitis B, hepatitis C and autoimmune hepatitis 4. Excess alcohol consumption: 30g/day for males, 20g/day for females 5. Type 1 diabetes mellitus 6. HbA1c>9% 7. Has severe complication of diabetes 8. BMI<20 9. eGFR<45mL/min/1.73m2 10. Dialysis 11. Severe hepatic dysfunction and cirrhosis 12. Females who have a possibility of pregnancy or is pregnant 13. Has malignant neoplasm 14. After surgery and severe trauma 15. History of myocardinal infarction and angina pectoris 16. Had cerebral stroke, cerebral infanction, urinary infection or genital infection within 12 weeks before giving their consent 17. Using steroid and imunosuppressant 18. Using glimepiride>2mg/day, glibenclamide>1.25mg/day, gliclazide>40mg/day 19. Started other diabetic medicines or changed dose within 8 weeks before giving their consent 20. Using GLP-1 receptor agonist or SGLT2 inhibitors 21. In addition, when principal inverstigator or reseacher deems inappriate as a study subject
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Naoto Middle name Last name Kawabe
Organization	Fujita Health University
Division name	Department of Gastroenterology and Hepatology
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL	0562-93-2324
Email	kawabe@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Naoto Middle name Last name Kawabe
Organization	Fujita Health University
Division name	Department of Gastroenterology and Hepatology
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL	0562-93-2324
Homepage URL
Email	kawabe@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fujita Health University IRB
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
Tel	0562-93-2865
Email	f-irb@fujita-hu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 04 Month 10 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 12 Day
Last modified on	2022 Year 03 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036192