UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016306 |
|---|---|
| Receipt number | R000018927 |
| Scientific Title | The efficacy and safety of SGLT2 inhibitor for non alcholic fatty liver disease in Japanese patients with type 2 diabetes |
| Date of disclosure of the study information | 2015/01/27 |
| Last modified on | 2016/07/21 10:58:39 |
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Basic information
Public title
The efficacy and safety of SGLT2 inhibitor for non alcholic fatty liver disease in Japanese patients with type 2 diabetes
Acronym
SGLT2 inhibitor and NAFLD
Scientific Title
The efficacy and safety of SGLT2 inhibitor for non alcholic fatty liver disease in Japanese patients with type 2 diabetes
Scientific Title:Acronym
SGLT2 inhibitor and NAFLD
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of SGLT2 inhibitor, dapagliflozin, for NAFLD in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver attenuation index
Key secondary outcomes
Visceral fat area
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
Dapagliflozin 5 mg/day
Interventions/Control_2
Glimepiride 0.5 mg/day
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients with
BMI >_ 25 kg/m2
alchol consumption less than 30 g/day in men and less than 20 g/day in women
diagnosed as fatty liver disease by abdominal imaging test
Key exclusion criteria
Patients treated with Sulphonyl urea, SGLT2 inhibitor, or insulin
Patients with active infection, malignant disease, severe liver or renal dysfunction
Pregnant women
Patients with dementia or disturbance in consciousness
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryotaro Bouchi |
Organization
Tokyo Medical and Dental University
Division name
Departmet of Molecular Endocrinology and Metabolism
Zip code
Address
1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL
03-3813-6111
bouchi.mem@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryotaro Bouchi |
Organization
Tokyo Medical and Dental University
Division name
Departmet of Molecular Endocrinology and Metabolism
Zip code
Address
1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
bouchi.mem@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Address
Tel
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 | 01 | Month | 27 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 22 | Day |
Last modified on
| 2016 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018927
