UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057510 |
|---|---|
| Receipt number | R000065711 |
| Scientific Title | Effects of Switching from Semaglutide 1.0 mg to Tirzepatide on Body Weight and HbA1c: A Retrospective Observational Study |
| Date of disclosure of the study information | 2025/04/04 |
| Last modified on | 2025/04/04 06:24:52 |
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Basic information
Public title
Effects of Switching from Semaglutide 1.0 mg to Tirzepatide on Body Weight and HbA1c: A Retrospective Observational Study
Acronym
Effects of Switching from Semaglutide 1.0 mg to Tirzepatide on Body Weight and HbA1c
Scientific Title
Effects of Switching from Semaglutide 1.0 mg to Tirzepatide on Body Weight and HbA1c: A Retrospective Observational Study
Scientific Title:Acronym
Effects of Switching from Semaglutide 1.0 mg to Tirzepatide on Body Weight and HbA1c
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 evaluate the efficacy and safety of a treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in body weight (after 3 months), Change in HbA1c (after 3 months)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed with type 2 diabetes mellitus
Switched from semaglutide 1.0 mg to tirzepatide (7.5 mg or 10 mg)
Body weight and HbA1c data available before and after tirzepatide initiation
Received tirzepatide treatment for at least 3 months
Key exclusion criteria
Patients who were treated with other GLP-1 receptor agonists concurrently
Patients who discontinued tirzepatide within 3 months
Patients with missing data on key endpoints (body weight or HbA1c)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Kurinami |
Organization
Jinnouchi Hospital
Division name
Internal Medicine
Zip code
862-0976
Address
6-2-3 Kuhonji, Chuo-ku, Kumamoto City, Kumamoto
TEL
0963630011
kurinami@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | NOBORU |
| Middle name | |
| Last name | KURINAMI |
Organization
Jinnouchi Hospital
Division name
Internal Medicine
Zip code
862-0976
Address
6-2-3 Kuhonji, Chuo-ku, Kumamoto City, Kumamoto
TEL
0963630011
Homepage URL
kurinami@jinnouchi.or.jp
Sponsor or person
Institute
Jinnouchi 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
Jinnouchi
Address
6-2-3 Kuhonji, Chuo-ku, Kumamoto City, Kumamoto
Tel
0963630011
kurinami@jinnouchi.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
| 2025 | Year | 04 | Month | 04 | 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
15
Results
Switching from semaglutide 1.0 mg to tirzepatide resulted in dose-dependent reductions in HbA1c and body weight. Significant reductions were observed in the 10 mg group, while no significant changes were found in the 7.5 mg group.
Results date posted
| 2025 | Year | 04 | Month | 04 | Day |
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
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study evaluating changes in body weight and HbA1c after switching from semaglutide 1.0 mg to tirzepatide (7.5 mg or 10 mg) in patients with type 2 diabetes mellitus. Data were collected from electronic medical records without any intervention.
Management information
Registered date
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065711
