UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035015
Receipt number 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 18:05:50

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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 or person

Institute

Kitasato University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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