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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000045687
Receipt No. R000051781
Scientific Title Retrospective Analysis of Diabetes Patients treated with GLP-1 Receptor agonists utilizing a database J-DREAMS
Date of disclosure of the study information 2021/10/06
Last modified on 2021/10/06

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Basic information
Public title Retrospective Analysis of Diabetes Patients treated with GLP-1 Receptor agonists utilizing J-DREAMS
Acronym (Tentative) DEEP-DREAM
Scientific Title Retrospective Analysis of Diabetes Patients treated with GLP-1 Receptor agonists utilizing a database J-DREAMS
Scientific Title:Acronym (Tentative) DEEP-DREAM
Region
Japan

Condition
Condition Type 2 Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To describe clinical characteristics of patients with type 2 diabetes treated with GLP-1 receptor agonists between 2015-2021 utilizing a dibetes registry J-DREAMS
Basic objectives2 Others
Basic objectives -Others To describe clinical characteristics of patients with type 2 diabetes treated with GLP-1 receptor agonists.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Annual descriptions of numbers and clinical characteristics of patients with type 2 diabetes treated with GLP-1 receptor agonists between 2015 -2021.
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 Primary Outcome
1. Age: 18 y.o. or older
2. Those with type 2 diabetes mellitus.
3. Those with prescription of GLP-1 Receptor Agonists between December 1, 2015 to March 31, 2021
Key exclusion criteria Primary Outcome
1. Those with type 1 diabetes mellitus.
2. Those with history of gestational diabetes between 360 days before the index date and 360 days after the index date
Target sample size 3800

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name
Last name Ohsugi
Organization National Center for Global Health and Medicine
Division name Diabetes and Metabolism Information Center
Zip code 162-8655
Address 1-21-1 Toyama, Shinjiku-ku, Tokyo, Japan
TEL 03-3202-7181
Email jdreams-info@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Ohsugi
Organization National Center for Global Health and Medicine
Division name Diabetes and Metabolism Information Center
Zip code 162-8655
Address 1-21-1 Toyama, Shinjiku-ku, Tokyo, Japan
TEL 03-3202-7181
Homepage URL
Email jdreams-info@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization Novo Nordisk Pharma Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center for Global Health and Medicine
Address 1-21-1 Toyama, Shinjiku-ku, Tokyo, Japan
Tel 03-3202-7181
Email rinrijm"AT"hosp.ncgm.go.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
2021 Year 10 Month 06 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 3800
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 No longer recruiting
Date of protocol fixation
2021 Year 05 Month 16 Day
Date of IRB
2021 Year 07 Month 09 Day
Anticipated trial start date
2021 Year 07 Month 10 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is an observational study regarding GLP-1 receptor agonists in Japan utilizing a diabetes registry J-DREAMS

Management information
Registered date
2021 Year 10 Month 06 Day
Last modified on
2021 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051781

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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