UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy and safety of SGLT2 inhibitor for non alcholic fatty liver disease in Japanese patients with type 2 diabetes
Title of the study (Brief title)	SGLT2 inhibitor and NAFLD
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of SGLT2 inhibitor, dapagliflozin, for NAFLD in patients with type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Liver attenuation index
Key secondary outcomes	Visceral fat area

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit
Blinding	Open -but assessor(s) 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	Dapagliflozin 5 mg/day
Interventions/Control_2	Glimepiride 0.5 mg/day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Type 2 diabetic patients with BMI >_ 25 kg/m2 alchol consumption less than 30 g/day in men and less than 20 g/day in women diagnosed as fatty liver disease by abdominal imaging test
Key exclusion criteria	Patients treated with Sulphonyl urea, SGLT2 inhibitor, or insulin Patients with active infection, malignant disease, severe liver or renal dysfunction Pregnant women Patients with dementia or disturbance in consciousness
Target sample size	50

Research contact person
Name of lead principal investigator	Ryotaro Bouchi
Organization	Tokyo Medical and Dental University
Division name	Departmet of Molecular Endocrinology and Metabolism
Address	1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL	03-3813-6111
Email	bouchi.mem@tmd.ac.jp

Public contact
Name of contact person	Ryotaro Bouchi
Organization	Tokyo Medical and Dental University
Division name	Departmet of Molecular Endocrinology and Metabolism
Address	1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL	03-3813-6111
Homepage URL
Email	bouchi.mem@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 01 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 15 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 22 Day
Last modified on	2016 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018927