UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050499 |
|---|---|
| Receipt number | R000057521 |
| Scientific Title | Ozempic Retrospective study, Investigation from real-world data of GLP-1 receptor Agonist, semaglutide, Multicenter trial In Japan |
| Date of disclosure of the study information | 2023/03/06 |
| Last modified on | 2024/07/03 08:51:01 |
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Basic information
Public title
Ozempic Retrospective study, Investigation from real-world data of GLP-1 receptor Agonist, semaglutide, Multicenter trial In Japan
Acronym
Ozempic Retrospective study, Investigation from real-world data of GLP-1 receptor Agonist, semaglutide, Multicenter trial In Japan
Scientific Title
Ozempic Retrospective study, Investigation from real-world data of GLP-1 receptor Agonist, semaglutide, Multicenter trial In Japan
Scientific Title:Acronym
ORIGAMI study
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 investigate safety and efficacy of Ozempic, a long-acting GLP-1 receptor agonist, using real world data
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c
Key secondary outcomes
Change or percent change in the following items;
- Major blood tests
- Other general blood tests
- vital signs
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
Patients who meet all of the following criteria are included in this study;
1. Patients with type 2 diabetes mellitus
2. Patients who used Ozempic at least once till 2022/6/30
3. Patients aged 18 years or older at the initiation of this study (at approval by institutional review board)
Key exclusion criteria
Patients who fall into any of the following criteria are excluded from participating in the study;
1. Patients with type 1 diabetes mellitus
2. Patients with excessive drinking of alcohol (net alcohol intake is more than 60g/day for male or 30g/day for female)
3. Patients with dementia
4. Patients who were pregnant during data collection period
5. Patients who were hospitalized for a week or longer within 52 weeks after the initial date
6. Patients with poor medication adherence (judged by attending physician)
7. Patients with other conditions that the attending physician think inappropriate to participate in the study
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Hirose |
Organization
Toho University Omori Medical Center
Division name
Diabetes, Metabolism and Endocrinology Center
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
takahisa.hirose@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Arata |
| Middle name | |
| Last name | Yoneda |
Organization
EviPRO Co., Ltd.
Division name
EviPRO Co., Ltd.
Zip code
101-0063
Address
Tensho Office Ochanomizu 206, Kanda-Awajicho 1-9-5, Chiyoda, Tokyo
TEL
03-3255-8286
Homepage URL
yoneda_arata@evipro.co.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Omori Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Toho University School of Medicine
Address
6-11-1 Omori-nashi, Ota-Ku, Tokyo
Tel
03-3762-4151
med.rinri@ext.toho-u.ac.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
| 2023 | Year | 03 | 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
504
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
| 2022 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study retrospectively collects the medical record within 52 weeks before and after the initial date, which is the date to initiate the administration of Ozempic, in patients who used Ozempic at least once till 2022/6/30.
Management information
Registered date
| 2023 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057521
