UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018166 |
|---|---|
| Receipt number | R000021037 |
| Scientific Title | Efficacy and safety in SGLT2 inhibitor for diabetes complicated by non-alcoholic fatty liver disease. |
| Date of disclosure of the study information | 2015/07/02 |
| Last modified on | 2022/08/25 16:24:24 |
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Basic information
Public title
Efficacy and safety in SGLT2 inhibitor for diabetes complicated by non-alcoholic fatty liver disease.
Acronym
SGLT2 inhibitor for diabetes complicated by NAFLD.
Scientific Title
Efficacy and safety in SGLT2 inhibitor for diabetes complicated by non-alcoholic fatty liver disease.
Scientific Title:Acronym
SGLT2 inhibitor for diabetes complicated by NAFLD.
Region
| Japan |
Condition
Condition
Type 2 diabetes complicated by non-alcoholic fatty liver disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and safety in SGLT2 inhibitor for diabetes complicated by NAFLD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Histologial changes of liver and safety of treament are evaluated at two points of the baseline and 24 weeks after the start of treatment.
Key secondary outcomes
Fasting plasma glucose, hemoglobin A1c, aspartate aminotransferase, alanine aminotransferase, and body composition are evaluated at two points of the baseline and 24 weeks after the start of treatment.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SGLT2 inhibitor is administered orally for 24 weeks or more.
Interventions/Control_2
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes with liver dysfunction, and/or fatty liver diagnosed by abdominal ultrasonography.
Key exclusion criteria
Contraindication for SGLT2 inhibitor.
Ineligible patients by judgement of family doctor.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Akuta |
Organization
Toranomon Hospital
Division name
Hepatology
Zip code
213-0015
Address
1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-0015, Japan
TEL
044-877-5111
norioakuta@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Akuta |
Organization
Toranomon Hospital
Division name
Hepatology
Zip code
213-0015
Address
1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-0015, Japan
TEL
044-877-5111
Homepage URL
norioakuta@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital, Department of Hepatology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital institutional review board
Address
2-2-2 Toranomon, Minato-ku, Tokyo, Japan
Tel
03-3588-1111
chiken-jim@toranomon.gr.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
| 2015 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2015 | Year | 07 | Month | 02 | Day |
Last modified on
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021037
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
