UMIN-CTR Clinical Trial

Basic information
Public title	Study on glycemic control, weight, body fat and insulin resistance in SGLT2 inhibitor-treated Japanese patients
Acronym	SGLT2 Study
Scientific Title	Study on glycemic control, weight, body fat and insulin resistance in SGLT2 inhibitor-treated Japanese patients
Scientific Title:Acronym	SGLT2 Study
Region	Japan

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

Objectives
Narrative objectives1	To confirm and describe the main factors of weight loss even in Japanese is the reduction of body fat To weigh and describe the correlations between each items such as body weight, abdominal circumference, body fat, HbA1c, visceral fat, blood pressure, adiponectin, and insulin resistance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	HbA1c ,FPG ,Body weight ,Body mass index ,Body fat
Key secondary outcomes	Visceral fat area ,Waist circumference ,Amount of body fat distribution ,Lean body weight ,HOMA-IR ,HOMA-b ,iHOMA2 ,Blood pressure ,Lipid ,Uric acid ,eGFR ,GIR ,Liver function ,Renal function ,Adiponectin ,TNFa ,IL-6 ,NTpro-BNP

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	Take CANAGLU Tablets 100mg at the oral. 1tablet/day Period of 24 weeks Conducted blood sampling and body fat,abdominalCT ,etc. before and after intervention.
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	Not applicable
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Informed consent obtained in writing before any trial-related activities. Type 2 Diabetes Age <= 70 years old HbA1c between 7.0% and 10.0% BMI >= 23 kg/m2 Creatinine < 1.0mg/dL for male < 0.8mg/dL for female
Key exclusion criteria	Extreme low carbohydrate therapy practitioner. Considered as inappropriate by the attending physician. A person who falls under contraindication in the medical package insert.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shin-ichiro Middle name Last name Shirabe
Organization	Medical Corporation H.E.C Science Clinic
Division name	Diabetes medicine
Zip code	235-0045
Address	4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan
TEL	045-831-0031
Email	hec-soum@asahi-net.email.ne.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Makuuchi
Organization	Medical Corporation H.E.C Science Clinic
Division name	Clinical Trial Secretariat
Zip code	235-0045
Address	4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan
TEL	045-831-0031
Homepage URL
Email	hec-soum@asahi-net.email.ne.jp

Sponsor
Institute	Medical Corporation H.E.C Science Clinic
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics review committee of Medical Corporation H.E.C Science Clinic
Address	4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan
Tel	045-831-0031
Email	hec-soum@asahi-net.email.ne.jp

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	医療法人社団一洋会　H.E.Cサイエンスクリニック（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 06 Day
Date of IRB	2014 Year 08 Month 06 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2015 Year 10 Month 31 Day
Date of closure to data entry	2015 Year 11 Month 30 Day
Date trial data considered complete	2015 Year 11 Month 30 Day
Date analysis concluded	2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 02 Month 25 Day
Last modified on	2020 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019290