UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024667
Receipt number 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 15:11:58

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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 or person

Institute

Medical Center for Translational and Clinical Research, Hiroshima University Hospital

Institute

Department

Personal name



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

Value
https://center6.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