UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055507 |
|---|---|
| Receipt number | R000063429 |
| Scientific Title | Glycaemic control efficacy of switching from semaglutide to tirzepatide in subjects with type 2 diabetes |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/03/17 19:10:48 |
* 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
Glycaemic control efficacy of switching from semaglutide to tirzepatide in subjects with type 2 diabetes
Acronym
Glycaemic control efficacy of switching from semaglutide to tirzepatide in subjects with type 2 diabetes
Scientific Title
Glycaemic control efficacy of switching from semaglutide to tirzepatide in subjects with type 2 diabetes
Scientific Title:Acronym
Glycaemic control efficacy of switching from semaglutide to tirzepatide in subjects with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tirzepatide is a dual glucose-depenndennt insulinotoropic polypeptide and glucagon-like peptide-1(GLP-1)receptor agonist that is under development for the treatment of type 2 diabetes. The efficacy and safety of tirzepatide as compared with semaglutide, a selective GLP-1 receptor agonist, are unkown.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary end point was the change in the glycated hemoglobin level from beseline to week 52.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Tirzepatide is initiated at a dose of 2.5 mg once weekly, and the doses is increased by 2.5 mg every 4 weeks until the assigned dose.
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
Key inclusion criteria for the trial were an age of 20 years or older and type 2 diabetes that was inadeguately contorolled with semaglutide 1.0 mg.Eligible patients had a glycated hemoglobin level of 6.5 to 10.5%
Key exclusion criteria
Key exclusion criteria were type 1 diabetes;and a histoly of any of the following:nonproliferatine diabtetic retinopathy that warranted urgent treatment,proliferative diabetic reitopathy, or diabetic maculopathy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Shimada |
Organization
Saitama Medical University Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
350-0495
Address
38 MOROHONGO,MOROYAMA-MACHI,IRUMA-GUN,SAITAMA
TEL
049-276-1204
asmd@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Kurihara |
Organization
Saitama Medical University Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
350-0495
Address
38 MOROHONGO,MOROYAMA-MACHI,IRUMA-GUN,SAITAMA
TEL
049-276-1204
Homepage URL
sk3512@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Hospital
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
Saitama Medical University Hospital
Address
38 MOROHONGO,MOROYAMA-MACHI,IRUMA-GUN,SAITAMA
Tel
419101
saitama-med@esct.bvist.com
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 | 10 | 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
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
| 2024 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 15 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063429
