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
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
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
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
