UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045687 |
|---|---|
| Receipt number | R000051781 |
| Scientific Title | DatabasE Study For patIeNts trEated with GLP-1RA in Japan |
| Date of disclosure of the study information | 2021/10/06 |
| Last modified on | 2022/01/13 14:50:57 |
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Basic information
Public title
DatabasE Study For patIeNts trEated with GLP-1RA in Japan
Acronym
DEFINE-G
Scientific Title
DatabasE Study For patIeNts trEated with GLP-1RA in Japan
Scientific Title:Acronym
DEFINE-G
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
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
jdreams-info@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
| 2022 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051781
