UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031987 |
|---|---|
| Receipt number | R000033431 |
| Scientific Title | An observational study on adult type 2 diabetic patients to demonstrate the utility of "Conversion of clinical information standardized in SS-MIX format to CDISC standard (ODM, CDASH, SDTM)" |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/04/15 12:30:25 |
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Basic information
Public title
An observational study on adult type 2 diabetic patients to demonstrate the utility of "Conversion of clinical information standardized in SS-MIX format to CDISC standard (ODM, CDASH, SDTM)"
Acronym
Observational study on adult type 2 diabetic patients
Scientific Title
An observational study on adult type 2 diabetic patients to demonstrate the utility of "Conversion of clinical information standardized in SS-MIX format to CDISC standard (ODM, CDASH, SDTM)"
Scientific Title:Acronym
Observational study on adult type 2 diabetic patients
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observational study for adult patients with type 2 diabetes mellitus to
compare prescription patterns and changes in HbA1c value (NGSP value).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in HbA1c value (NGSP value)
Key secondary outcomes
Transition of eGFR value, side effects of diabetes remedy drugs and major cardiovascular events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who are diagnosed with type 2 diabetes.
2) Patients who aged 20 years or older at the time of acquiring consent
3) Patients who are expected to survive for more than 1 year from the date of registration.
4) Surgery is not received within 6 months before the registration date, or registration
Patients who are not planning to undergo surgery within the next 6 months.
5) Patient with written informed consent.
Key exclusion criteria
1) Patients who participated in other trials within one year before consent acquisition
2) Others, patients who are judged not eligible for this research by responsible investigator
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Watanabe |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu
TEL
+81-53-435-2385
hwat@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Tatsuguchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu
TEL
+81-53-435-2385
Homepage URL
hakamata@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Translational Research Informatics Center,Foundation for Biomedical Research and Innovation
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, HIgashi-ku, Hamamatsu
Tel
053-435-2385
hwat@hama-med.ac.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | 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
| 2017 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Utilizing the actual medical information, the "CDISC (Clinical Data Interchange Standards Consortium) standard (Clinical Data Interchange Standards Consortium) standard (ODM: Operational Data Model]", which is standardized in the SS - MIX format in real world compliant with CDISC TAS, Conversion to clinical data acquisition standard harmonization [CDASH: Clinical Data Acquisition Standards Harmonization], test data table format model [SDTM: Study Data Tabulation Model]) "through prospective observational research.
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2021 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033431
| 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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| Registered date | File name |
