UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051278 |
|---|---|
| Receipt number | R000058486 |
| Scientific Title | Glucagon-like peptide-1 receptor agonists decrease cancer incidences in type 2 diabetes: A cohort study using the database of Health Insurance Claims and Specific Health Checkups of Gifu and Mie Prefecture in Japan |
| Date of disclosure of the study information | 2023/06/07 |
| Last modified on | 2023/06/07 13:30:47 |
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Basic information
Public title
Glucagon-like peptide-1 receptor agonists decrease cancer incidences in type 2 diabetes: A cohort study using the database of Health Insurance Claims and Specific Health Checkups of Gifu and Mie Prefecture in Japan
Acronym
Glucagon-like peptide-1 receptor agonists decrease cancer incidences in type 2 diabetes: A cohort study using the database of Health Insurance Claims and Specific Health Checkups of Gifu and Mie Prefecture in Japan
Scientific Title
Glucagon-like peptide-1 receptor agonists decrease cancer incidences in type 2 diabetes: A cohort study using the database of Health Insurance Claims and Specific Health Checkups of Gifu and Mie Prefecture in Japan
Scientific Title:Acronym
Glucagon-like peptide-1 receptor agonists decrease cancer incidences in type 2 diabetes: A cohort study using the database of Health Insurance Claims and Specific Health Checkups of Gifu and Mie Prefecture in Japan
Region
| Japan |
Condition
Condition
Type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In Japanese patients with diabetes mellitus (DM), the risk in total cancer incidence had been increased up to 20%, and nowadays, the leading cause of death in Japanese patients with DM is cancer, that amounted to 38% and had been in increased trend with aging. The real-world evidence of cancer incidences in users of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) is limited for Asian. The aim of this study is to clarify the cancer incidences in GLP-1 RA users compared to non-users (controls) using the Japanese data from the database of Health Insurance Claims and Specific Health Checkups of Gifu Prefecture and Mie Prefecture.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All cancer incidences during observation period
Key secondary outcomes
All cardiovascular events during observation period
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type2 Diabetes
Key exclusion criteria
the patients under 20 years old, treated without anti-diabetic drugs, not treated new drugs during observation period, with cancer, or undergoing dialysis treatment.
Target sample size
50000
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
Medicine, division of Diabetes, Endocrinology and Metabolism
Zip code
2920822
Address
1010 Sakurai, Kisarazu, Chiba
TEL
0438361071
ishibashi-cib@umin.net
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
Medicine, division of Diabetes, Endocrinology and Metabolism
Zip code
2920822
Address
1010 Sakurai, Kisarazu, Chiba
TEL
0438361071
Homepage URL
ishibashi-cib@umin.net
Sponsor or person
Institute
Kimitsu Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kimitsu Chuo Hospital
Address
1010 Sakurai, Kisarazu, Chiba
Tel
0438361071
soumu@kc-hosp.or.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 | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
356266
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
| 2019 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Currently analyzing
Management information
Registered date
| 2023 | Year | 06 | Month | 07 | Day |
Last modified on
| 2023 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058486
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
