UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Dapagliflozin, a SGLT2 inhibitor, on Body Composition in Japanese Type 2 Diabetes Patients without severe Obesity
Title of the study (Brief title)	Effects of Dapagliflozin 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 examine effects of Dapagliflozin, a SGLT2 inhibitor, on Body Composition including Fat, muscle, and water, in Japanese Type 2 DM
Basic objectives2	Others
Basic objectives -Others	To examine effects of Dapagliflozin, a SGLT2 inhibitor, on Endothelial Function in Japanese Type 2 DM
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in Skeletal Muscle Mass
Key secondary outcomes	Changes in Fat mass, water volume, endothelial function, liver fat content, and kidney function

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dapagliflozin; 5mg/day
Interventions/Control_2	non-SGLT2 inhibitor treatment for DM
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	Type 2 DM HbA1c>7.0% no history of SGLT2 inhibitor-treatment patients with on-going diet and exercise therapies
Key exclusion criteria	severe obesity (BMI>35) Type 1 DM ketoacidosis unstable clinical conditions active infection, liver disease, cancer eGFR<45
Target sample size	60

Research contact person
Name of lead principal investigator	Seigo Sugiyama
Organization	Jinnouchi Hospital
Division name	Diabetes Care Center
Address	6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL	096-363-0011
Email	seigosugiyama@jinnouchi.or.jp

Public contact
Name of contact person	Seigo Sugiyama
Organization	Jinnouchi Hospital
Division name	Diabetes Care Center
Address	6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL	096-363-0011
Homepage URL
Email	seigosugiyama@jinnouchi.or.jp

Sponsor
Institute	Jinnouchi Hispital
Institute
Department

Funding Source
Organization	Jinnouchi Hospital
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	陣内病院　（熊本県）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 12 Day
Anticipated trial start date	2014 Year 05 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 09 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/jat/25/6/25_40873/_article
Results
Other related information

Management information
Registered date	2017 Year 09 Month 20 Day
Last modified on	2018 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033385