UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of canagliflozin on the hepatic steatosis, adipose tissue and skeletal muscle in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease / non-alcoholic steatohepatitis
Title of the study (Brief title)	Effects of canagliflozin on hepatic steatosis, adipose tissue and skeletal muscle in patients with Type 2 diabetes mellitus with NAFLD/NASH
Region	Japan

Condition
Condition	Type 2 diabetes mellitus with NAFLD/NASH
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the ameliorating effect of a canagliflozin on hepatic steatosis and examination of changes in the areas of visceral/subcutaneous fat and skeletal muscle.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	A change in liver fat fraction after administrating a canagliflozin using MRI
Key secondary outcomes	-A change in hepatic CT HU using CT -A change in visceral and subcutaneous fat cross sectional area using CT. -A change in cross sectional area, CT HU and ratio of fat infiltration of skeletal muscles using CT. -A change in CAP and liver stiffness measurements by FibroScan. -Evaluation of the degree of FDG accumulation of liver, brain, skeletal muscles using FDGPETCT. -Changes of blood pressure, body weight, blood glucose(HbA1c,fasting plasma glucose),GA,HOMAbeta,CPRindex,insulin resistance(HOMAIR), NAFIC score, FIB4 index.

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	Prevention
Type of intervention	Other
Interventions/Control_1	Implementation of FDG-PET/CT. Plain CT, plain MRI,FDG-PET/CT and Fibroscan are performed twice for six 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with type 2 diabetes who fulfilled the following criteria. 1) Patients with HbA1c equal to or greater than 6.0% and lesser than 9.0%. 2) Patients treated with diet, exercise or antidiabetic medications except SGLT2 inhibitor. 3) Patients with a BMI more than 20. 4) Patients with fatty liver diagnosed by abdominal US, and who have a diagnosis of NAFLD or NASH based on the definition of the medical treatment guide of NASH, NAFLD of the Japan society of hepatology. 5) Patients that blood pressure and lipids are well controlled. 6)Having provided voluntary written consent for participation in this study.
Key exclusion criteria	-Patients corresponding to any of the following are inapplicable -Patients with a history of allergy to any component of the study medications -Patients with severe ketosis or diabetic coma. -Patients with severe infections, perioperative status, or severe trauma -Patients with severe complications( liver disease, renal disease, mental disorder, cancer) -Patients that we may be running out of plasticity of enforcement for image or analysis of the examination, for example, remarkable spinal column scoliosis -Patients who has difficulty in MRI study implementation including having a Implantable cardioverter-defibrillator and internal metal et al -Pregnancy or lactation in women -Inadequacy of usingig this therapy
Target sample size	20

Research contact person
Name of lead principal investigator	Yasuo Terauchi
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2639
Email	terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person	Kazuki Tajima
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2639
Homepage URL
Email	kztajima@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	横浜市立大学附属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 15 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2017 Year 06 Month 30 Day
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 08 Month 26 Day
Last modified on	2017 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021434