UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024667
Receipt No. R000028375
Scientific Title Effect of canagliflozin on endothelial function in patients with type 2 diabetes
Date of disclosure of the study information 2016/12/01
Last modified on 2019/08/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of canagliflozin on endothelial function in patients with type 2 diabetes
Acronym Effect of canagliflozin on endothelial function in patients with type 2 diabetes
Scientific Title Effect of canagliflozin on endothelial function in patients with type 2 diabetes
Scientific Title:Acronym Effect of canagliflozin on endothelial function in patients with type 2 diabetes
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the effects of canagliflozin on endothelial function in patients with type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in FMD from baseline to 2 hours and 12 weeks
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 Administration of Canagliflozin 100 mg once a day post breakfast.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Type 2 diabetes
2. >=20 of age at the time of informed consent acquisition
3. Type 2 diabetes with HbA1c (NGSP) >=6.0% and <10.0%
4.The patient provided written informed consent to participate in the study
Key exclusion criteria 1. Has history of hypersensitivity to Canagliflozin
2. Has history of administration of SGLT2 inhibitor within 4 weeks before initiation of the study
3.patient with insulin dependent diabetes mellitus
4. Has history of myocardial infarction, angina, cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attacks within 3 months before initiation of the study
5. patient with ASO
6. With severe renal dysfunction (eGRF <45 mL/min or patient undergoing artificial dialysis)
7. Has history of severe ketosis, diabetic coma, or precoma within 6 months
8. Has history of cancer, severe infection
9. Pregnant, possibly pregnant, planned to become pregnant or nursing women
10. Are considered not eligible for the study by the attending doctor due to other reasons
Target sample size 23

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihito Higashi
Organization Hiroshima University Hospital
Division name Medical Center for Translational and Clinical Research
Zip code
Address 1-2-3 Kasumi, Minamiku, Hiroshima
TEL 082-257-5831
Email yhigashi@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihito Higashi
Organization Hiroshima University Hospital
Division name Medical Center for Translational and Clinical Research
Zip code
Address 1-2-3 Kasumi, Minamiku, Hiroshima
TEL 082-257-5831
Homepage URL
Email yhigashi@hiroshima-u.ac.jp

Sponsor
Institute Medical Center for Translational and Clinical Research, Hiroshima University Hospital
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2016 Year 12 Month 01 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 6
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
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 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
2016 Year 11 Month 01 Day
Last modified on
2019 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028375

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.