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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031394
Receipt No. R000035825
Scientific Title early response to Combination Action oN Active Reaction to Incetin agent and SGLT2i
Date of disclosure of the study information 2018/02/20
Last modified on 2018/02/20

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Basic information
Public title early response to Combination Action oN Active Reaction to Incetin agent and SGLT2i
Acronym CANARIS
Scientific Title early response to Combination Action oN Active Reaction to Incetin agent and SGLT2i
Scientific Title:Acronym 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
1st name
Middle name
Last name OKAHATA SUMIE
Organization Toho University Ohashi Medical Center
Division name Division of Diabetes and Metabolism
Zip code
Address 2-17-6, Ohashi Meguro-ku, Tokyo
TEL 03-3468-1251
Email sokahata-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name OKAHATA SUMIE
Organization Toho University Ohashi Medical Center
Division name Division of Diabetes and Metabolism
Zip code
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)

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 02 Month 20 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 Enrolling by invitation
Date of protocol fixation
2015 Year 02 Month 20 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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