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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031987
Receipt No. 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 2018/03/29

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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
Middle name
Last name HIroshi Watanabe
Organization Hamamatsu University School of Medicine
Division name Department of Clinical Pharmacology and Therapeutics
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu
TEL +81-53-435-2385
Email hwat@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akio Hakamata
Organization Hamamatsu University School of Medicine
Division name Department of Clinical Pharmacology and Therapeutics
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu
TEL +81-53-435-2385
Homepage URL
Email hakamata@hama-med.ac.jp

Sponsor
Institute Translational Research Informatics Center,Foundation for Biomedical Research and Innovation
Institute
Department

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
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 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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 04 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 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
2018 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033431

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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