UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017974 |
|---|---|
| Receipt number | R000020821 |
| Scientific Title | The open-label study of the impact of dapagliflozin to the visceral fat for diabetes patients |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2017/02/17 13:07:25 |
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Basic information
Public title
The open-label study of the impact of dapagliflozin to the visceral fat for diabetes patients
Acronym
The open-label study of the impact of dapagliflozin to the visceral fat for diabetes patients
Scientific Title
The open-label study of the impact of dapagliflozin to the visceral fat for diabetes patients
Scientific Title:Acronym
The open-label study of the impact of dapagliflozin to the visceral fat for diabetes patients
Region
| Japan |
Condition
Condition
Type 2 diabetes patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the clinical indicators, the abdominal circumference and the visceral fat
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visceral fat
Key secondary outcomes
clinical indicators
abdominal circumference
Hypoglycemia
Body weight
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Dapagliflozin 5mg
Interventions/Control_2
current treatment
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HbA1c(NGSP value) >=7.0%
metabolic syndrome
Key exclusion criteria
Dapagliflozin in use
History of hypersensitivity to dapagliflozin containing components
Severe ketosis
diabetic coma or precoma
Severe infection
before and after surgery
severe trauma
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Yamashina |
Organization
Tokyo Medical University
Division name
Cardiovascular medicine
Zip code
Address
6-1-1, Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3351-6141
akyam@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaharu Hirano |
Organization
Tokyo Medical University
Division name
Cardiovascular medicine
Zip code
Address
6-1-1, Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3351-6141
Homepage URL
m-hirano@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2015 | Year | 07 | 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
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
| 2014 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | 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
| 2015 | Year | 06 | Month | 19 | Day |
Last modified on
| 2017 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020821
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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