UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040662 |
|---|---|
| Receipt number | R000046411 |
| Scientific Title | Research for finding knowledge of the optimal treatment for patients with type 2 diabetes mellitus using RWD |
| Date of disclosure of the study information | 2020/06/30 |
| Last modified on | 2020/12/17 18:40:10 |
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Basic information
Public title
Identifying the optimal target population for treatment of type 2 diabetes mellitus using receipt data
Acronym
Optimal treatment for patients with type 2 diabetes mellitus
Scientific Title
Research for finding knowledge of the optimal treatment for patients with type 2 diabetes mellitus using RWD
Scientific Title:Acronym
Optimal treatment for patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To search for new knowledge by analyzing the database composed of receipt and DPC data using AI technology that contributes to clarifying the optimal treatment for Japanese patients with type 2 diabetes mellitus according to the patient's background information
Basic objectives2
Others
Basic objectives -Others
To identify the optimal target population for patients with type 2 diabetes mellitus from the viewpoint of safety, efficacy, treatment continuation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
occurrence of efficacy, safety, treatment continuity and adherence events
- HbA1c decreased to less than 7.0
- Changes in HbA1c from baseline
- Severe hypoglycemia expression
- Changes in hepatic and renal parameters from baseline
- Switching hypoglycemic drugs or not and so on
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes mellitus
Key exclusion criteria
Type 1 diabetes mellitus
Target sample size
1400000
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Okuno |
Organization
Graduate School of Medicine and Faculty of Medicine Kyoto University
Division name
Biomedical Data Intelligence, Human Health Sciences
Zip code
606-8507
Address
54 Kawahara-cho, Syogoin, Sakyo-ku, Kyoto
TEL
075-751-4881
okuno.yasushi.4c@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Inaba |
Organization
Astellas Pharma Inc.
Division name
Planning & Administration, Development
Zip code
103-8411
Address
2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo
TEL
03-3244-4589
Homepage URL
masaki.inaba@astellas.com
Sponsor or person
Institute
Life Intelligence Consortium (LINC)
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine and Faculty of Medicine Kyoto University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
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
| 2020 | Year | 06 | Month | 30 | 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
| 2020 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No need for ethics review committee
Management information
Registered date
| 2020 | Year | 06 | Month | 05 | Day |
Last modified on
| 2020 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046411
| Research Plan | |
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| 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 |
