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)"

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000031987

Enrollment

500

Registered

2018-04-01

Start date

2018-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Changes in HbA1c value (NGSP value)	—

Secondary

Measure	Time frame
Transition of eGFR value, side effects of diabetes remedy drugs and major cardiovascular events	—

Countries

Japan

Contacts

Public ContactMariko Tatsuguchi

Hamamatsu University School of Medicine Department of Clinical Pharmacology and Therapeutics

hakamata@hama-med.ac.jp+81-53-435-2385

Outcome results