UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects for glucose metabolism, body composition, and circulatory dynamics of SGLT2 inhibitor
Title of the study (Brief title)	Pleiotropic effects of SGLT2 inhibitor
Region	Japan

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

Objectives
Narrative objectives1	Solve the pleiotropic effects of SGLT2 inhibitor
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes of glucose metabolism, incretin secretion, gut peptides secretion, body weight, body composition, and basal metabolic rate.
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	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	SGLT2 inhibitor
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients with type 2 diabetes. HbA1c: 6.5%~9.0%
Key exclusion criteria	1. The patients with severe macroangiopathy 2. The patients with severe renal and/or liver dysfunction. 3. Women who were pregnant, lactating, or capable of pregnancy
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroaki Ueno
Organization	Faculty of Medicine, University of Miyazaki
Division name	Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Address	5200, Kihara, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-2965
Email	intron@med.miyazaki-u.ac.jp

Public contact
Name of contact person	Hiroaki Ueno
Organization	Faculty of Medicine, University of Miyazaki
Division name	Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Address	5200, Kihara, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-2965
Homepage URL
Email	intron@med.miyazaki-u.ac.jp

Sponsor
Institute	Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Institute
Department

Funding Source
Organization	Faculty of Medicine, University of Miyazaki
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	2015 Year 04 Month 22 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 09 Day
Anticipated trial start date	2015 Year 04 Month 22 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 04 Month 20 Day
Last modified on	2018 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019950