UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect on Insulin Resistance in Tofogliflozin-treated Japanese Type 2 diabetic patients
Title of the study (Brief title)	Tofogliflozin and insulin sensitivity
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 effect of SGLT2 inhibitor(Tofogliflozin) on insulin sennsitivity in patients with type 2 diabetes treated with DPP4 inhibitor. Insulin resistance is measured by glucose clamp method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mean change from baseline in GIR using glucose clamp technique.
Key secondary outcomes

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	Tofogliflozin
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	(1)Diagnosed as Type 2 diabetes (2)7=<HbA1c<10% (3)18.5=<BMI<45 (4)20=<informed conscent age<75 (5)Registration inspection before 8 weeks or more, patients are administered without prescription change in the approved dosage regimen of diet and exercise therapy and DPP-4 inhibitors (6)Subjects who give consent document about participation in the clinical study
Key exclusion criteria	1) Has hypersensitivity to tofogliflozin or any other excipient of tofogliflozin 2) With severe ketosis, diabetic coma, or precoma within 6 months 3) With severe infection, pre or post surgery, and serious trauma 4) With severe renal dysfunction 5) With severe liver dysfunction 6) Entered already with another clinical trials (7) Considered as inadequate by the investigator
Target sample size	15

Research contact person
Name of lead principal investigator	Ikuro Matsuba
Organization	Matsuba Medical Clinic
Division name	Department of Diabetes & Endocrinology
Address	2-159 Tsukagoshi, Saiwai Ward, Kawasaki City, Kanagawa, Japan
TEL	+810445221678
Email	ikuro@matsuba-web.com

Public contact
Name of contact person	Ikuro Matsuba
Organization	Matsuba Medical Clinic
Division name	Department of Diabetes and Endocrinology
Address	2-159 Tsukagoshi, Saiwai Ward, Kawasaki City, Kanagawa, Japan
TEL	+810445221678
Homepage URL
Email	ikuro@matsuba-web.com

Sponsor
Institute	Matsuba Medical Clinic
Institute
Department

Funding Source
Organization	KOWA COMPANY,LTD
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 17 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 11 Month 18 Day
Date trial data considered complete	2016 Year 11 Month 30 Day
Date analysis concluded	2017 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 01 Day
Last modified on	2018 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019710