UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055791 |
|---|---|
| Receipt number | R000063759 |
| Scientific Title | A Multicenter Crossover Comparative Study of Appropriate Dosing Dates for Tilzepatide |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2024/10/09 10:08:33 |
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Basic information
Public title
A Multicenter Crossover Comparative Study of Appropriate Dosing Dates for Tilzepatide
Acronym
A Multicenter Crossover Comparative Study of Appropriate Dosing Dates for Tilzepatide
Scientific Title
A Multicenter Crossover Comparative Study of Appropriate Dosing Dates for Tilzepatide
Scientific Title:Acronym
A Multicenter Crossover Comparative Study of Appropriate Dosing Dates for Tilzepatide
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to elucidate the appropriate day of the week for administering tilzepatide, a drug used to treat diabetes mellitus. The day of the week with the highest calorie intake will be estimated based on the weekly dietary records of the subject patients, and two dosing days will be set up: Dosing Day A, which is the day after that day, and Dosing Day B, which is the day before that day, and each parameter will be compared after crossing over.
Translated with DeepL.com (free version)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference between the dietary record charts (average of calorie, carbohydrate, fat, protein, and fiber intake for each day of the week) for Treatment Day A and Treatment Day B groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The day of the week with the highest average caloric intake on each day of the week is used as the reference day, with the next day set as Dose Day A and the day before as Dose Day B. On Dose Day A, tilzepatide 2.5 mg is administered for 4 weeks, on Dose Day B, tilzepatide 5 mg for 4 weeks, and on Dose Day A, tilzepatide 5 mg for 4 weeks.
Interventions/Control_2
The day of the week with the highest average caloric intake on each day of the week is used as the reference day, with the next day set as Dose Day A and the day before as Dose Day B. On Dose Day B, tilzepatide 2.5 mg is administered for 4 weeks, on Dose Day A, tilzepatide 5 mg for 4 weeks, and on Dose Day B, tilzepatide 5 mg for 4 weeks.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients with type 2 diabetes aged 20-75 years at the time of consent
(2) Patients with a body mass index (BMI) of 22 kg/m2 or higher at the time of consent
(3) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding.
Key exclusion criteria
(1) Patients who have difficulty in recording their diet
(2) Other subjects deemed inappropriate as research subjects by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
Faculty of Internal Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine
Zip code
889-1692
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
TEL
0985859121
intron@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Uchida |
Organization
Faculty of Internal Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine
Zip code
8891692
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
TEL
0985859121
Homepage URL
taisuke_uchida@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
Tel
0985859403
rinken@med.miyazaki-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
| 2026 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 01 | 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 | 10 | Month | 09 | Day |
Last modified on
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063759
