UMIN-CTR Clinical Trial

Basic information
Public title	Effects of an Inhibitor of Sodium-glucose Cotransporter 2 for Type 2 Diabetes Mellitus with Nonalcoholic Fatty Liver Disease (NAFLD).
Acronym	SGLT2 Inhibitor for T2DM with NAFLD.
Scientific Title	Effects of an Inhibitor of Sodium-glucose Cotransporter 2 for Type 2 Diabetes Mellitus with Nonalcoholic Fatty Liver Disease (NAFLD).
Scientific Title:Acronym	SGLT2 Inhibitor for T2DM with NAFLD.
Region	Japan

Condition
Condition	Patients of type 2 diabetes mellitus with nonalcoholic fatty liver disease (NAFLD).
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of adding canagliflozin, an inhibitor of sodium-glucose cotransporter 2,in patients with type 2 diabetes mellitus and nonalcoholic fatty liver disease(NAFLD).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hepatic fat fraction (HFF) by hepatic magnetic resonance imaging (MRI) after 6 or 12 months.
Key secondary outcomes	body weight, HbA1c, glucagon, type IV collagen, hyaluronic acid and NAFLD fibrosis score.

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	canagliflozin100mg/day
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1: Type 2 diabetes 2: Patients with NAFLD diagnosed by clinical data 3: Patients provided with informed consent
Key exclusion criteria	1: Diabetic ketoacidosis and hyperosmolar hyperglycemic state 2: Insulin dependent diabetes 3: Before and after surgery and severe trauma 4: Taking excessive alcohol 5: Severe renal failure or undergoing hemodialysis 6: Proliferative diabetic retinopathy 7: Obvious orthostatic hypotension 8: Patient who cannot be ruled out other liver disease including viral hepatitis, autoimmune hepatitis, a drug-induced hepatitis. 9: Severe hepatic dysfunction 10: Malignant neoplasm 11: Women who have a possibility of pregnancy or is pregnant 12: Allergy to SGLT2 inhibitors, having a recent history of taking SGLT2 inhibitors 13: Patient who is suspected type 1 diabetes and other diabetes
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mitsuko Inoue
Organization	Kitasato University School of Medicine.
Division name	Department of Endocrinology, Diabetes and Metabolism
Zip code
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan
TEL	042-778-8111
Email	mitsuko_oku325@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Mitsuko Inoue
Organization	Kitasato University School of Medicine.
Division name	Department of Endocrinology, Diabetes and Metabolism.
Zip code
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan.
TEL	042-778-8111
Homepage URL
Email	mitsuko_oku325@yahoo.co.jp

Sponsor
Institute	Department of Endocrinology, Diabetes and Metabolism, Kitasato University School of Medicine.
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	北里大学病院

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 01 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	Enrolling by invitation
Date of protocol fixation	2015 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 01 Month 18 Day
Last modified on	2017 Year 07 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023342

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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