UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	early response to Combination Action oN Active Reaction to Incetin agent and SGLT2i
Title of the study (Brief title)	CANARIS
Region	Japan

Condition
Condition	type 2 daibetes mellitus
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy including hormone and metabolic system using dietary load test
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose level, insulin level, glucagon level, FFA
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	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Before administration of SGLT2 inhibitor, after administration
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	In hospitalized type 2 diabetic patients who are not receiving SGLT-2 inhibitor and incretin agonist (DPP 4 inhibitor, GLP-1 inhibitor)
Key exclusion criteria	Patients with a history of hypersensitivity to the study drug Patients with severe ketosis, diabetic coma or precoma, type 1 diabetes Patients with severe infections, before and after surgery, serious trauma Pregnant or lactating women and pregnant women Patients who the doctor judged unsuitable for research participation Explain participation of this research, patients who can not obtain consent
Target sample size	30

Research contact person
Name of lead principal investigator	OKAHATA SUMIE
Organization	Toho University Ohashi Medical Center
Division name	Division of Diabetes and Metabolism
Address	2-17-6, Ohashi Meguro-ku, Tokyo
TEL	03-3468-1251
Email	sokahata-tky@umin.ac.jp

Public contact
Name of contact person	OKAHATA SUMIE
Organization	Toho University Ohashi Medical Center
Division name	Division of Diabetes and Metabolism
Address	2-17-6, Ohashi Meguro-ku, Tokyo
TEL	03-3468-1251
Homepage URL
Email	sokahata-tky@umin.ac.jp

Sponsor
Institute	Toho University Ohashi Medical Center
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Other
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	2018 Year 02 Month 20 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 02 Month 20 Day
Anticipated trial start date	2015 Year 03 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 02 Month 20 Day
Last modified on	2018 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035825