UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056962 |
|---|---|
| Receipt number | R000065098 |
| Scientific Title | Study for the efficacy and safety of tirzepatide in subjects with type 2 diabetes -retrospective observation trial- |
| Date of disclosure of the study information | 2025/02/07 |
| Last modified on | 2025/02/07 09:23:26 |
* 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
Study for the efficacy and safety of tirzepatide in subjects with type 2 diabetes
Acronym
Study for the usefulness and safety of tirzepatide
Scientific Title
Study for the efficacy and safety of tirzepatide in subjects with type 2 diabetes -retrospective observation trial-
Scientific Title:Acronym
Study for the usefulness and safety of tirzepatide
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes in glycemic control before and after tirzepatide treatment in addition to safety analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
1) The change in HbA1c before and after tirzepatide treatment
2) The safety of tirzepatide
Key secondary outcomes
1) The change in body weight
2) The changes in plasma glucose, systolic/diastolic blood pressure, lipid metabolism, liver function, kidney function, microalbuminuria and/or proteinuria after 6 months tirzepatide treatment
3) The changes in treatment for diabetes, dyslipidemia, and hypertension for 6 months tirzepatide treatment
4) Adverse events
5) Patient background
6) The factors associated with improvement of metabolic index
7) Effects of continuation or discontinuation of antihyperglycemic agents other than tirzepatide
8) Effects on metabolic parameters by patient background status, including by facility and with/without nutritional guidance
9) Effects of medications for the comorbidities on HbA1c and body weight after tirzepatide treatment
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
Subjects with type 2 diabetes who were newly treated with tirzepatide between 4/18/2023 to 12/31/2024
Key exclusion criteria
1) Subjects for whom administration of tirzepatide is contraindicated in the package insert (a history of hypersensitivity to the components of this drug, diabetic ketoacidosis,
diabetic coma, severe infections)
2) Subjects who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Asahikawa Medical University Hospital
Division name
Department of diabetology and endocrinology
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL
0166-65-2111
hnomoto@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Asahikawa Medical University Hospital
Division name
Department of diabetology and endocrinology
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL
0166-65-2111
Homepage URL
hnomoto@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
Tel
0166-68-2297
rs-kp.g@asahikawa-med.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
旭川医科大学病院（北海道）、旭川厚生病院（北海道）、市立旭川病院（北海道）、旭川赤十字病院（北海道）、北海道大学病院（北海道）、あさひまちクリニック（北海道）、さっぽろ糖尿病・甲状腺クリニック（北海道）、栗原内科（北海道）、青木内科クリニック（北海道）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Laboratory and physical examinations will be compared between week 0 and each examination time point (-6 months, -3 months, -1 month, 3 months, and 6 months after tirzepatide administration). Regarding safety, all subjects who started tirzepatide will be included. Analysis of other tests will be performed on a Per Protocol Set basis.
Management information
Registered date
| 2025 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065098
