UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056556 |
|---|---|
| Receipt number | R000064629 |
| Scientific Title | Efficacy and safety of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists in patients with diabetes ~ Multicenter retrospective cohort study |
| Date of disclosure of the study information | 2024/12/24 |
| Last modified on | 2025/12/25 17:46:41 |
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Basic information
Public title
Efficacy and safety of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists in patients with diabetes ~ Multicenter retrospective cohort study
Acronym
Study on the efficacy and safety of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists in patients with diabetes
Scientific Title
Efficacy and safety of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists in patients with diabetes ~ Multicenter retrospective cohort study
Scientific Title:Acronym
Study on the efficacy and safety of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists in patients with diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
GLP-1 receptor agonists or GIP/GLP-1 receptor agonists are daily or weekly subcutaneous or oral formulations used in the treatment of type 2 diabetes mellitus. They are reported to have potent hypoglycemic and weight-reducing effects, and evidence of renal and cardioprotective effects has been reported for some drugs. On the other hand, gastrointestinal side effects are relatively common in cases using these drugs, and in some cases, there is little hypoglycemia or weight loss. However, it is not clear at this point what kind of cases the drug is effective in and whether side effects are likely to occur. Therefore, the present study was designed to clarify the efficacy and safety of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists in patients with diabetes mellitus in the real-world setting, as well as the background factors affecting the efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in HbA1c and body weight before and after initiation of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists
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
Patients aged 18 years or older who received a new GLP-1 receptor agonist (Liraglutide, exenatide, lixisenatide, dulaglutide, semaglutide) or GIP/GLP-1 receptor agonist (tilzepatide) during the observation period. Gender includes both men and women.
Key exclusion criteria
1. Patients with advanced-stage malignancies at the time of introduction of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists.
2. Patients with active infection at the time of introduction of GLP-1 or GIP/GLP-1 receptor agonists.
3. Patients with reduced ADL at the time of introduction of GLP-1 or GIP/GLP-1 receptor agonists.
4. Patients with inadequate data from 4 weeks before initiation of GLP-1 receptor agonists or GIP/GLP-1 receptor agonists to 24 weeks after initiation.
5. Patients in whom another antidiabetic drug was added within 3 months prior to the observation period.
6. Other subjects judged by the research director to be inappropriate as research subjects.
7. Those who have expressed their intention to refuse participation by opting out.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
Faculty of Internal Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology,Department of Internal Medicine
Zip code
889-1692
Address
5200 Kihara Kiyotake, Miyazaki
TEL
+81-985-85-9121
intron@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
Faculty of Internal Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology,Department of Internal Medicine
Zip code
889-1692
Address
5200 Kihara Kiyotake, Miyazaki
TEL
+81-985-85-9121
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
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
Faculty of Internal Medicine, University of Miyazaki
Address
5200 Kihara Kiyotake, Miyazaki
Tel
+81-985-85-9121
intron@med.miyazaki-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
| 2024 | Year | 12 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It will also collect data from Chiyoda Hospital, Koga General Hospital, Miyanaga Hospital and Miyazaki Prefectural Nichinan Hospital.
Management information
Registered date
| 2024 | Year | 12 | Month | 24 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064629
