UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046411