UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients with chronic liver disease
Acronym	Efficacy of sodium-glucose co-transporter (SGLT2) inhibitor in chronic liver disease
Scientific Title	Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients with chronic liver disease
Scientific Title:Acronym	Efficacy of sodium-glucose co-transporter (SGLT2) inhibitor in chronic liver disease
Region	Japan

Condition
Condition	Diabetic patients with chronic liver disease
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate safety and efficacy of SGLT2 inhibitor for diabetic patients with liver cirrhosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	change in HbA1c after 24 weeks of treatment
Key secondary outcomes	1 Change in body weight after 24 weeks of treatment 2 Change in T-cho, LDL, HDL, TG after 24 weeks of treatment. 3 Change in liver enzyme after 24 weeks of treatment. 4 Change in skeletal muscle mass after 24 weeks of treatment. 5 Safety.

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 once a day for 6 months.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients diagnosed with diabetes 2. Patients diagnosed with liver cirrhosis 3. Patients judged to have indications to use SGLT 2 inhibitors under normal medical treatment 4. Patients with HbA1c (NGSP) of 6.5% or more and 10% or less 5. Male and female aged 20 years or over at the time of agreement acquisition
Key exclusion criteria	1. Type 1 diabetes 2. Patients with severe ketosis or diabetic coma 3. Patients with diabetes insidious 4 Patients with Estimated Glomerular Filtration Rate (eGFR) of 45 mL / min / 1.73 m ^ 2 or less 5. Patients with malignancy 6. Patients with end-stage liver failure who have hepatic ascites, child-Pugh class BC and hepatic encephalopathy 7. Pregnant women or patients with potential pregnancy 8. Patients who research managers judged inappropriate as subjects
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Haruki Middle name Last name Uojima
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology, Internal Medicine
Zip code	252-0373
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL	+81-42-778-8111
Email	kiruha@kitasato-u.ac.jp

Public contact
1st name of contact person	1st name Uojima Middle name Last name Haruki
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology, Internal Medicine
Zip code	252-0373
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL	+81-42-778-8111
Homepage URL
Email	kiruha@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Kitasato University School of Medicine
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	Research Ethics Committee
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
Tel	+81-42-778-8111
Email	rinrib@med.kitasato-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

Other administrative information
Date of disclosure of the study information	2018 Year 11 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	Open public recruiting
Date of protocol fixation	2018 Year 10 Month 24 Day
Date of IRB	2018 Year 12 Month 10 Day
Anticipated trial start date	2018 Year 12 Month 10 Day
Last follow-up date	2022 Year 04 Month 02 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 11 Month 27 Day
Last modified on	2019 Year 05 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039924