UMIN-CTR Clinical Trial

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
Email	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
Email	hakamata@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
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	Hamamatsu University School of Medicine
Address	1-20-1 Handayama, HIgashi-ku, Hamamatsu
Tel	053-435-2385
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033431