UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031694 |
|---|---|
| Receipt number | R000036192 |
| Scientific Title | Efficacy of luseogliflozin for fattty liver with diabetes mellitus |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2022/03/16 21:04:08 |
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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
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
kawabe@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036192
