UMIN-CTR Clinical Trial

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