UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of metabolic change by SGLT2 inhibitors in type 2 diabetes patients.
Title of the study (Brief title)	Metabolic change by SGLT2 inhibitors.
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 metabolic change by SGLT2 inhibitors in type 2 diabetes patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Body composition Glucose profile Nitrogen balance
Key secondary outcomes	Body weight Glycated hemoglobin Glycated albumin Lipid profile Urinary albumin excretion Urinary protein excretion

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	SGLT2 inhibitors
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. Men and women who were diagnosed with type 2 diabetes in the diagnostic criteria of the Japan Diabetes Society. 2. Patients determined to require hospitalization for education and diabetes management in Kitasato University Hospital of Endocrinology and Metabolism. 3. Patients who are considered treatment with SGLT2 inhibitors is suitable. 4. Patients who obtained informed consent.
Key exclusion criteria	1. severe ketosis, diabetic coma, or before coma 2. before and not long after surgery,or patients with severe trauma 3. alcohol intake's excessive 4. patients who have a fever of 37.0 degrees or more 5. obvious infection 6. severe renal dysfunction or dialysis patients 7. patients with symptoms of urinary retention, difficulty urinating, anuria, or oliguria 8. severe liver dysfunction 9. patients with obvious active malignant tumor 10. women suspected of pregnancy or pregnant 11. patients with a history of use SGLT2 inhibitors
Target sample size	20

Research contact person
Name of lead principal investigator	TAKAHIRO YAMAGISHI
Organization	Kitasato University School of Medicine
Division name	Endocrinology and Metabolism
Address	1-15-1,kitasato,minami-ku,sagamihara-city,kanagawa-ken,JAPAN
TEL	042-778-8111
Email	yamagishi@med.kitasato-u.ac.jp

Public contact
Name of contact person	TAKAHIRO YAMAGISHI
Organization	Kitasato University School of Medicine
Division name	Endocrinology and Metabolism
Address	1-15-1,kitasato,minami-ku,sagamihara-city,kanagawa-ken,JAPAN
TEL	042-778-8111
Homepage URL
Email	yamagishi@med.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine,Endocrinology and Metabolism.
Institute
Department

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	北里大学病院（神奈川県） Kitasato University Hospital

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 16 Day
Anticipated trial start date	2014 Year 08 Month 19 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	2014 Year 09 Month 04 Day
Last modified on	2017 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017514