UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061320 |
|---|---|
| Receipt number | R000070158 |
| Scientific Title | A Retrospective Comparative Cohort Study of Tirzepatide and Semaglutide in Real-World Clinical Practice in Patients with Type 2 Diabetes |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/20 13:10:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Real-World Comparison of Tirzepatide and Semaglutide in Patients with Type 2 Diabetes
Acronym
TIRASEMA study
Scientific Title
A Retrospective Comparative Cohort Study of Tirzepatide and Semaglutide in Real-World Clinical Practice in Patients with Type 2 Diabetes
Scientific Title:Acronym
TIRASEMA 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
The aim of this study is to compare the effects of semaglutide and tirzepatide on eating behavior and treatment satisfaction among patients with type 2 diabetes in real-world clinical practice in Japan using existing treatment cohorts.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes are the changes from baseline to 6 months after treatment initiation in the Eating Behavior Questionnaire (EBQ) score and the Diabetes Treatment Satisfaction Questionnaire (DTSQ) score.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who were receiving treatment during the study period, were considered by the treating physician to be appropriate candidates for treatment with semaglutide or tirzepatide, and provided written informed consent for study participation.
Key exclusion criteria
Patients from whom written informed consent for study participation could not be obtained
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-8535
Address
1010 Sakurai, Kisarazu, Chiba, Japan
TEL
0438-36-1071
ishibashi-cib@umin.net
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Suzuki |
Organization
Kimitsu Chuo Hospital
Division name
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-8535
Address
1010 Sakurai, Kisarazu, Chiba, Japan
TEL
0438-36-1071
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 Ethics Committee
Address
1010 Sakurai, Kisarazu, Chiba, Japan
Tel
0438-36-1071
ishibashi-cib@umin.net
Secondary IDs
Secondary IDs
YES
Study ID_1
885
Org. issuing International ID_1
Kimitsu Chuo Hospital Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 01 | 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
215
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
| 2026 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective comparative cohort study using existing treatment cohorts. The study includes patients with type 2 diabetes who initiated semaglutide or tirzepatide treatment in routine clinical practice at each participating site during the study period, met the eligibility criteria, and provided written informed consent. The primary outcomes are the changes in EBQ and DTSQ scores from baseline to 6 months after treatment initiation.
Management information
Registered date
| 2026 | Year | 04 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070158
