UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of ipragliflozin on ectopic fat accumulation in non-obese type 2 diabetic patients with increased visceral fat
Title of the study (Brief title)	SGLT2 inhibitor and ectopic fat accumulation in diabetes
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 whether ipragliflozin could reduce ectopic fat accumulation in non-obese type 2 diabetic patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of epicaridial fat volume from baseline at 12 weeks
Key secondary outcomes

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	Ipragliflozin 50 mg for 12 weeks
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	Type 2 diabetes with BMI < 25.0 kg/m2 and HbA1c 6.5-9.0% and visceral fat area equal to or greater than 100 cm2
Key exclusion criteria	Patients who are taking SGLT2 inhibitors Patients with insulin treatment Patients with severe diabetic retinopathy Patients who are hypersensitive to SGLT2 inhibitors Patients with cogestive heart failure (NYHA classification class III or IV) Patients with active infection, malignancy, severe liver or renal diseases Patients who had recently received operation or had severe trauma Patients who had experienced atherothrombotic events including myocardila infarction and/or stroke Patients with severe ketosis or diabetic coma/pre-coma Patients who are unable to figure out the consent due to dementia or impairment of consciousness Pregnant women, lactating woman, women who are planning to get pregnant Patients who were judged inadequate to enroll in the study by medical doctors
Target sample size	20

Research contact person
Name of lead principal investigator	Ryotaro Bouchi
Organization	Tokyo Medical and Dental University
Division name	Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
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	Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
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

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
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 10 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 25 Day
Anticipated trial start date	2015 Year 10 Month 15 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 09 Month 19 Day
Last modified on	2017 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022051