UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027304 |
|---|---|
| Receipt number | R000031263 |
| Scientific Title | A study on the effect of diabetes drugs (SGLT2 inhibitor and DPP4 inhibitor) for nonalcoholic fatty liver disease |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2020/11/13 18:11:20 |
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Basic information
Public title
A study on the effect of diabetes drugs (SGLT2 inhibitor and DPP4 inhibitor) for nonalcoholic fatty liver disease
Acronym
A study on the effect of diabetes drugs (SGLT2 inhibitor and DPP4 inhibitor) for nonalcoholic fatty liver disease
Scientific Title
A study on the effect of diabetes drugs (SGLT2 inhibitor and DPP4 inhibitor) for nonalcoholic fatty liver disease
Scientific Title:Acronym
A study on the effect of diabetes drugs (SGLT2 inhibitor and DPP4 inhibitor) for nonalcoholic fatty liver disease
Region
| Japan |
Condition
Condition
nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of diabetes treatment drugs on nonalcoholic fatty liver disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of change of ALT value after 12 weeks from the start of administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved 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
For 12 weeks, dapagliflozin 5 mg is administered daily.
Interventions/Control_2
For 12 weeks, tengliptin 5 mg is administered daily.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Nonalcoholic fatty liver disease case without diabetes mellitus
Key exclusion criteria
Cases with severe heart, liver and kidney disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tobita |
| Middle name | |
| Last name | Hiroshi |
Organization
Shimane University Hospital
Division name
Department of Hepatology
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853202190
ht1020@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Tobita |
| Middle name | |
| Last name | Hiroshi |
Organization
Shimane University Hospital
Division name
Department of Hepatology
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2190
Homepage URL
ht1020@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Hepatology, Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Hepatology, Shimane University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University School of Medicine Medical Ethics Committee
Address
89-1 Enyacho, Izumo City, Shimane Prefecture
Tel
0853-20-2515
kenkyu@med.shimane-u.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
島根大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
private
Publication of results
Unpublished
Result
URL related to results and publications
in press
Number of participants that the trial has enrolled
26
Results
Administration of SGLT2 inhibitors or DPP4 inhibitors significantly reduced ALT levels.
Results date posted
| 2020 | Year | 11 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Nonalcoholic fatty liver disease (NAFLD) patients without type 2 diabetes mellitus (T2DM)
Participant flow
NAFLD patients without T2DM were enrolled in this single center double-blind randomized prospective study, and allocated to receive either SGLT2 inhibitor or DPP4 inhibitor for 12 weeks.
Adverse events
no special instruction
Outcome measures
HbA1c, ALT, body composition, etc.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 11 | Day |
Last modified on
| 2020 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031263
| Research Plan | |
|---|---|
| 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 |
