UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for the effect of visceral fat reduction by SGLT2 inhibitor Ipragliglozinin patients with type 2 diabetes
Title of the study (Brief title)	Visceral fat reduction by SGLT2 inhibitor Ipragliflozin
Region	Japan

Condition
Condition	type 2 diabetes mellitus
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the change in fat and lean volume by treating with SGLT2 inhibitor Ipragliflozin in patients with type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Change in visceral fat volume
Key secondary outcomes	1) glucose and lipid metabolism, 2) Abdominal circumference, 3) Weight, 4) Insulin secretion and insulin resistance, 5) microalbuminuria, 6) blood test(complete blood count, electrolytes, kidney and liver function test), 7) several biomarkers (adipokines, oxidative stress, etc)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1) outpatients with type 2 diabetes who will start taking Ipragliflozin, 2) well-controlled in terms of blood pressure and lipids, 3) made a written informed consent
Key exclusion criteria	1) hypersensitivity to Ipragliflozin, 2) unstable diabetic retinopathy, 3) severe hepatic, renal, or heart dysfunction, 4) pregnancy, 5) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size	26

Research contact person
Name of lead principal investigator	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Email	hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Homepage URL
Email	hmiyoshi@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 26 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 05 Month 23 Day
Anticipated trial start date	2014 Year 05 Month 27 Day
Last follow-up date	2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	To examine the change in fat and lean volume by treating with SGLT2 inhibitor Ipragliflozin in patients with type 2 diabetes

Management information
Registered date	2014 Year 05 Month 24 Day
Last modified on	2018 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016369