UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of canagliflozin on body fat volume
Title of the study (Brief title)	Canagliflozin for body fat
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effects of canagliflozin on body fat volume including visceral, subcutaneous, and epicardial fat
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Epicardial Adipose Tissue Thickness,HbA1c6 month after the treatment
Key secondary outcomes	body weight, voluem of visceral fat, subcutaneous fat, skeletal muscle

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	Administration of 100 mg of canagliflozin for 6 month
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	Type 2 diabetes
Key exclusion criteria	Hypersensitivity to canagliflozin, Complicated with sever ketoacidosis, diabetic coma, Type 1 diabetes Complicated with severe infection, sever trauma
Target sample size	15

Research contact person
Name of lead principal investigator	Shusuke Yagi
Organization	Institute of Biomedical Sciences, Tokushima University Graduate School
Division name	Department of Cardiovascular Medicine
Address	Tokushima University Graduate School, 3-18-15, Kuramoto, Tokushima
TEL	088-633-7851
Email	syagi@tokushima-u.ac.jp

Public contact
Name of contact person	Shusuke Yagi
Organization	Institute of Biomedical Sciences, Tokushima University Graduate School
Division name	Department of Cardiovascular Medicine
Address	3-18-15, Kuramoto, Tokushima
TEL	088-633-7851
Homepage URL
Email	syagi@tokushima-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Other
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	2016 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 31 Day
Anticipated trial start date	2016 Year 05 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	2016 Year 03 Month 03 Day
Last modified on	2017 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024178