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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035015
Receipt No. R000039924
Scientific Title Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients with chronic liver disease
Date of disclosure of the study information 2018/11/27
Last modified on 2019/05/05

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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
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
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

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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