UMIN-CTR Clinical Trial

Basic information
Public title	The effects of peroral administration of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance, single effet and chronic effect.
Acronym	The effect of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance
Scientific Title	The effects of peroral administration of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance, single effet and chronic effect.
Scientific Title:Acronym	The effect of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance
Region	Japan

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

Objectives
Narrative objectives1	To examine the effects of peroral administration of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance, a single effect and chronic effect.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To examine the effects of peroral administration of Tofogliflozin(SGLT2 inhibitor) on endogenous glucose production and insulin clearance, a single effect and chronic effect.
Key secondary outcomes	After administration of Tofogliflozin -Intrahepatic lipid -Intramyocellular lipid -Visceral fat area -Subcutaneous fat area -Body weight, Body composition -Endogenous glucose production -Insulin sensitivity -Metabolic flexibility -Metabolome analysis

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	take Tofogliflozin orally One day and 8 weeks
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	40 years-old <=
Age-upper limit	65 years-old >=
Gender	Male
Key inclusion criteria	-type 2 diabetes mellitus men -BMI range: 18.5-30 kg/m2 -HbA1c range:7.5-10.0% -The patient who did not being changed the way to take diabetes medicines(additional dosage, discontinulation of administration or changing dosage) within 12 weeks before agreement acquisition -Persons who gained document consent by the patient's free intention after having sufficient explanation for participation in this study and having sufficient understanding
Key exclusion criteria	-type 1 diabetes mellitus -past history of taking Tofogliflozin -BMI range:>30 or <18.5 kg/m2 -liver dysfunction(AST,ALT => 51U/L,gamma-GTP over 101U/L) -renal dysfunction or eGFR level =< 60mL/min/1.73m2 -Patient with severe heart diseases (for example, heart failure and unstable angina) or the patient who occured myocardial infarction and anginal attack after 24 weeks ago from observation period -patient who had an apoplexy spasm (cerebral infarction and cerebral hemorrhage) within 24 weeks until agreement acquisition -patient with malignant tumor -patient with advanced diabetes complications (neuropathy , retinopathy and nephropathy) -patient of serious illness ketotic, a diabetic coma or the previous coma -Patient with the endocrine diseases for which treatment is insufficient for hormone replenishment method of treatment (for example,pituitary disease, thyroid disease and adrenal disease) -anemia beyond the degree of middle class (hemoglobin < 9.5g/dL) -drunkard(for example 1 daily mean sake, by 3 gou and beer, more than 3 flagons) -subjects judged unsuitable to the study from staff
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshifumi Tamura
Organization	University of Juntendo
Division name	Department of Endocrinology & Metabolism,Sportology center, Faculty of International Liberal Arts. Area of Global Health service
Zip code
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421 JAPAN
TEL	03-3837-0618
Email	hkaga@juntendo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hideyoshi Kaga
Organization	University of Juntendo
Division name	Department of Endocrinology and Metabolism, Sportology Center
Zip code
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421 JAPAN
TEL	03-3887-0618
Homepage URL
Email	hkaga@juntendo.ac.jp

Sponsor
Institute	University of Juntendo
Institute
Department

Funding Source
Organization	University of Juntendo
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 03 Month 16 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	2017 Year 11 Month 15 Day
Date of IRB	2017 Year 11 Month 15 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2019 Year 02 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 12 Day
Last modified on	2019 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036188