UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Ipragliflozin, a new oral hypoglycemic agent, on body composition in patients with diabetes
Title of the study (Brief title)	Effect of Ipragliflozin on body composition
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of Ipragliflozin, a new oral hypoglycemic agent, on body composition
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Lean body mass
Key secondary outcomes	body weight fasting plasma glucose HbA1c free fatty acid (24 fraction)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ipragliflozin
Interventions/Control_2	Metformin
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	patients without severe complications patients who can do diet and exercise therapy
Key exclusion criteria	Contraindication for Ipragliflozin Patients who had been treated with metformin or GLP-1 analogues Pregnant woman
Target sample size	30

Research contact person
Name of lead principal investigator	Toshihide Kawai
Organization	Keio University School of Medicine
Division name	Internal Medicine & Institute for Integrated Sports Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	tkawai@keio.jp

Public contact
Name of contact person	Toshihide Kawai
Organization	Keio University School of Medicine
Division name	Internal Medicine & Institute for Integrated Sports Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	tkawai@keio.jp

Sponsor
Institute	Keio University School of Medicine, Internal Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine, Internal Medicine
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	2014 Year 08 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 08 Month 15 Day
Anticipated trial start date	2014 Year 08 Month 15 Day
Last follow-up date	2017 Year 03 Month 27 Day
Date of closure to data entry	2017 Year 03 Month 27 Day
Date trial data considered complete	2017 Year 03 Month 27 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 06 Day
Last modified on	2017 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=R000017180