UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018344 |
|---|---|
| Receipt number | R000020956 |
| Scientific Title | Evaluation of Preventive Effect of tofogliflozin on cardiovascular function in type 2 diabetes with cardiovascular diseases |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2019/03/11 20:44:20 |
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Basic information
Public title
Evaluation of Preventive Effect of tofogliflozin on cardiovascular function in type 2 diabetes with cardiovascular diseases
Acronym
tofogliflozin study
Scientific Title
Evaluation of Preventive Effect of tofogliflozin on cardiovascular function in type 2 diabetes with cardiovascular diseases
Scientific Title:Acronym
tofogliflozin study
Region
| Japan |
Condition
Condition
type 2 diabetes with cardiovascular disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to clarify the effect of tofogliflozin on cardiac function in type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BNP, marker of cardiac echography after 6 months
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
tofogliflozin 20 mg / day
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) HbA1c level is higher than 7.0%
2) Patients with ischemic heart disease, valbular disease, cardiacmyopathy, or hypertensive heart disease
Key exclusion criteria
1) BMI < 18.0
2) history of cerebral infarction
3) patients whose dose of diuretics are changed within 3 months
4) estimated GFR < 45 ml/min
5) patients inplanted pacemaker
6) patients with pregnancy and lactation
7) patiets enrolled other clinical trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Makino |
Organization
National Cerbral and Cardiovascular Center
Division name
Atherosclerosis and Diabetes
Zip code
5658565
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
makinoh@hsp.ncvc.go.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Makino |
Organization
National Cerbral and Cardiovascular Center
Division name
Atherosclerosis and Diabetes
Zip code
5658565
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
Homepage URL
makinoh@hsp.ncvc.go.jp
Sponsor or person
Institute
tofogliflozin study group
Institute
Department
Personal name
Funding Source
Organization
Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cerebral and cardiovascular center ethical committee
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
Tel
06-6833-5012
rec-office-ac@ncvc.go.jp
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
国立循環器病研究センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | 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
30
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
| 2015 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020956
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/03/11 | makinoDR_臨床試験実施計画書_トホグリフロジン ver4 20170529.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/03/11 | とほ.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/03/11 | トホ研究.xlsb |
