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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031549
Receipt No. 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 2018/03/02

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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
Institute Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine
Institute
Department

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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 05 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 03 Month 02 Day
Last modified on
2018 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.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


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