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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027362
Receipt No. R000031027
Scientific Title Examination of the liver fibrosis improvement effect with the SGLT2 inhibitor for diabetes complicated by non-alcoholic steatohepatitis.
Date of disclosure of the study information 2017/05/16
Last modified on 2017/05/26

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Basic information
Public title Examination of the liver fibrosis improvement effect with the SGLT2 inhibitor for diabetes complicated by non-alcoholic steatohepatitis.
Acronym SGLT2 inhibitor for diabetes complicated by NASH.
Scientific Title Examination of the liver fibrosis improvement effect with the SGLT2 inhibitor for diabetes complicated by non-alcoholic steatohepatitis.
Scientific Title:Acronym SGLT2 inhibitor for diabetes complicated by NASH.
Region
Japan

Condition
Condition Type 2 diabetes complicated by non-alcoholic fatty liver disease
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Study of the liver fibrosis improvement effect with the SGLT2 inhibitor for diabetes complicated by NASH
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Histologial changes of liver biopsy of treament are evaluated at two points of the baseline and 1 year after the start of treatment.

Key secondary outcomes Fasting plasma glucose, hemoglobin A1c, aspartate aminotransferase, alanine aminotransferase, and liver fibrosis are evaluated at two points of the baseline and 1 year 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 1 year 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
80 years-old >=
Gender Male and Female
Key inclusion criteria Type 2 diabetes with liver dysfunction, and NASH diagnosed by liver biopsy.
Key exclusion criteria Contraindication for SGLT2 inhibitor.
Ineligible patients by judgement of family doctor.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Irie
Organization Fukuoka University Hospital
Division name Hepatology
Zip code
Address 7-45-1 Nanakuma, Johnan-ku, Fukuoka-shi814-0180, Japan
TEL 092-801-1011
Email mirie@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Irie
Organization Fukuoka University Hospital
Division name Hepatology
Zip code
Address 7-45-1 Nanakuma, Johnan-ku, Fukuoka-shi814-0180, Japan
TEL 092-801-1011
Homepage URL
Email mirie@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Hospital
Institute
Department

Funding Source
Organization Fukuoka 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
Address
Tel
Email

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
2017 Year 05 Month 16 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 Preinitiation
Date of protocol fixation
2017 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 16 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 16 Day
Last modified on
2017 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031027

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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