UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031549
Receipt number R000035989
Scientific Title Evaluation for effect of SGLT2 inhibitor on postprandial hyperglycemia and cardiac function in diabetic patients with coronary artery disease
Date of disclosure of the study information 2018/03/05
Last modified on 2022/03/05 12:55:01

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Basic information

Public title

Evaluation for effect of SGLT2 inhibitor on postprandial hyperglycemia and cardiac function in diabetic patients with coronary artery disease

Acronym

Evaluation for effect of SGLT2 inhibitor on postprandial hyperglycemia and cardiac function in diabetic patients with coronary artery disease

Scientific Title

Evaluation for effect of SGLT2 inhibitor on postprandial hyperglycemia and cardiac function in diabetic patients with coronary artery disease

Scientific Title:Acronym

Evaluation for effect of SGLT2 inhibitor on postprandial hyperglycemia and cardiac function in diabetic patients with coronary artery disease

Region

Japan


Condition

Condition

Coronary artery disease, Diabetes

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of SGLT2 inhibitor on postprandial hyperglycemia and cardiac function in diabetic patients with coronary artery disease treated with HbA1c < 7.0%

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes of postprandial hyperglycemia after administration SGLT 2 inhibitor for 12 weeks

Key secondary outcomes

Changes of cardiac function and myocardial triglyceride content after administration SGLT 2 inhibitor for 12 weeks


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Tofogliflozin 20mg once daily for 12 weeks in the SGLT2 inhibitor group

Interventions/Control_2

Standard therapy for 12 weeks in the control group

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Patients provided written informed consent
2.Patients with history of coronary intervention.
3.Patients with diabetes treated with HbA1c < 7.0%

Key exclusion criteria

1.Patients who have already taken SGLT2 inhibitor
2.Patients with drug allergy of SGLT2 inhibitor
3.Patients with history of anteroseptal myocardial infarction
4.Patients had received hemodialysis
5.Creatinine Clearance < 30 ml/min
6.Patients with contraindication of MRI
7.Patients who judged as ineligible clinical staffs

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunori Shimada

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

2-1-1 Hongo Bunkyo-ku, Tokyo, Japan

TEL

03-3813-3111

Email

shimakaz@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Hiki

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

2-1-1 Hongo Bunkyo-ku, Tokyo, Japan

TEL

03-3813-3111

Homepage URL


Email

m-hiki@juntendo.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

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 03 Month 05 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

Terminated

Date of protocol fixation

2018 Year 02 Month 23 Day

Date of IRB

2021 Year 03 Month 31 Day

Anticipated trial start date

2018 Year 03 Month 05 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 02 Day

Last modified on

2022 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035989


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name