UMIN-CTR Clinical Trial

Basic information
Public title	Effects of SGLT2 inhibitor on insulin resistance possbly through the amelioration of glucose toxicity
Acronym	SGLT2 inhibitor and insulin resistance
Scientific Title	Effects of SGLT2 inhibitor on insulin resistance possbly through the amelioration of glucose toxicity
Scientific Title:Acronym	SGLT2 inhibitor and insulin resistance
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the change of insulin sensitivity by the administration of SGLT2 inhibitor using glucose clamp method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of glucose infusion rate as an marker of insulin sensitivity by the administration of SGLT2 inhibitor for one week
Key secondary outcomes	The change of insulin secretion, daily profile of blood glucose level, body composition, liver function, lipid profile, uric acid, urine volume and urine sugar by the administration of SGLT2 inhibitor for one week

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	SGLT2 inhibitor, Empagliflrozin 10mg/day, is administered for one week.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with type 2 diabetes from whom informed consent have been obtained and whose HbA1c level are 8% or over.
Key exclusion criteria	Patients who are treated by insulin, and who have severe acute metabolic disorder.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Tajiri
Organization	Faculty of Internal Medicine, Kurume University Shcool of Medicine
Division name	Division of Endocrinology and Metabolism
Zip code	830-0011
Address	Asahi-machi 67, Kurume 830-0011, Japan
TEL	0942-31-7563
Email	tajiriy@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Tajiri
Organization	Faculty of Internal Medicine, Kurume University Shcool of Medicine
Division name	Division of Endocrinology and Metabolism
Zip code	830-0011
Address	Asahi-machi 67, Kurume 830-0011, Japan
TEL	0942-31-7563
Homepage URL
Email	tajiriy@med.kurume-u.ac.jp

Sponsor
Institute	Division of Endocrinology and Metabolism, Faculty of Internal Medicine, Kurume University Shcool of Medicine
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical Committee, Kurume University
Address	Asahi-machi 67, Kurume 830-0011, Japan
Tel	0942-35-3311
Email	tajiriy@med.kurume-u.ac.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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 12 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 09 Month 19 Day
Date of IRB	2017 Year 09 Month 19 Day
Anticipated trial start date	2017 Year 09 Month 20 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 08 Day
Last modified on	2022 Year 09 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033241