UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of ipragliflozin on body composition and beta-cell function in Japanese patients with type 2 diabetes
Title of the study (Brief title)	Effects of ipragliflozin on body composition and beta-cell function
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the effect of an SGLT2 inhibitor (ipraglifrozin) on body composition and beta-cell function.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	%Change of visceral fat volume assessed by CT and %change of intrahepatic lipid content assessed by 1H-MRS at 0-, 12- and 24-week of ipraglifrozin treatment
Key secondary outcomes	beta-cell stress assessed by the change of plasma intact proinsulin / C-peptide (PI/CPR) ratio at 0-, 12- and 24-week of ipraglifrozin treatment

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	ipraglifrozin 50mg/day for 24 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Outpatients HbA1c >= 6.5% 20 <= BMI <= 40
Key exclusion criteria	The exclusion criteria were pregnancy, severe illness, CKD (eGFR < 60 ml/min/1.73m2), and malignancy.
Target sample size	20

Research contact person
Name of lead principal investigator	Yasushi Tanaka
Organization	St. Marianna University School of Medicine
Division name	Division of Metabolism and Endocrinology, Department of Internal Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL	044-977-8111
Email	smu.tainai@gmail.com

Public contact
Name of contact person	Yoshio Nagai
Organization	St. Marianna University School of Medicine
Division name	Division of Metabolism and Endocrinology, Department of Internal Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL	044-977-8111
Homepage URL
Email	ynagai@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 24 Day
Anticipated trial start date	2014 Year 07 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 26 Day
Last modified on	2016 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024937