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 |
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)"
Observational study on adult type 2 diabetic patients
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)"
Observational study on adult type 2 diabetic patients
Japan |
Diabetes
Endocrinology and Metabolism |
Others
NO
Observational study for adult patients with type 2 diabetes mellitus to
compare prescription patterns and changes in HbA1c value (NGSP value).
Safety,Efficacy
Changes in HbA1c value (NGSP value)
Transition of eGFR value, side effects of diabetes remedy drugs and major cardiovascular events
Observational
20 | years-old | <= |
90 | years-old | >= |
Male and Female
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.
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
500
1st name | Hiroshi |
Middle name | |
Last name | Watanabe |
Hamamatsu University School of Medicine
Department of Clinical Pharmacology and Therapeutics
431-3192
1-20-1 Handayama, Higashi-ku, Hamamatsu
+81-53-435-2385
hwat@hama-med.ac.jp
1st name | Mariko |
Middle name | |
Last name | Tatsuguchi |
Hamamatsu University School of Medicine
Department of Clinical Pharmacology and Therapeutics
431-3192
1-20-1 Handayama, Higashi-ku, Hamamatsu
+81-53-435-2385
hakamata@hama-med.ac.jp
Hamamatsu University School of Medicine
Translational Research Informatics Center,Foundation for Biomedical Research and Innovation
Non profit foundation
Hamamatsu University School of Medicine
1-20-1 Handayama, HIgashi-ku, Hamamatsu
053-435-2385
hwat@hama-med.ac.jp
NO
2018 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2017 | Year | 07 | Month | 25 | Day |
2017 | Year | 08 | Month | 01 | Day |
2018 | Year | 04 | Month | 01 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
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.
2018 | Year | 03 | Month | 29 | Day |
2021 | Year | 04 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033431