UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052214 |
|---|---|
| Receipt number | R000059593 |
| Scientific Title | A Study on the Safety and Efficacy of Tirzepatide in People with Type 2 Diabetes |
| Date of disclosure of the study information | 2023/09/14 |
| Last modified on | 2023/09/14 19:35:38 |
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Basic information
Public title
A Study on the Safety and Efficacy of Tirzepatide in People with Type 2 Diabetes
Acronym
A Study on the Safety and Efficacy of Tirzepatide in People with Type 2 Diabetes
Scientific Title
A Study on the Safety and Efficacy of Tirzepatide in People with Type 2 Diabetes
Scientific Title:Acronym
A Study on the Safety and Efficacy of Tirzepatide in People with Type 2 Diabetes
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 Safety and Efficacy of Tirzepatide Self-Administered Treatment in People with Type 2 Diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Percentage of Time within Target Glucose Range by Continuous Glucose Monitoring.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tirzepatide
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
1. People with Type 2 Diabetes
2. HbA1c levels between 6.5% and 10.0% in the last 4 to 8 weeks
3. People eligible for Tirzepatide use and scheduled for Tirzepatide administration.
Key exclusion criteria
1. Individuals with severe anemia (Hb < 10g/dL)
2. Patinets with implanted medical devices (such as pacemakers)
3. Patients with active malignant tumors
4. Participants for whom the Principal Investigator or Sub-Investigator has determined are not suitable for participation in this clinical study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Department of Endocrinology, Diabetes and Metabolisim
Zip code
2520374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
ahayashi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
2520374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
Homepage URL
ahayashi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Self
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
Kitasato University Medical School Ethics Committee
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
rinrib@med.kitasato-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
| 2023 | Year | 09 | Month | 14 | 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
| 2023 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 09 | Month | 14 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059593
