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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040662
Receipt No. 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 2020/06/05

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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
Email 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
Email masaki.inaba@astellas.com

Sponsor
Institute Life Intelligence Consortium (LINC)
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 30 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2020 Year 06 Month 05 Day
Last modified on
2020 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046411

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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