UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048407 |
|---|---|
| Receipt number | R000054991 |
| Scientific Title | A prospective observational study assessing patient preference for oral vs. injectable semaglutide in Japanese patients with type 2 diabetes using insulin and GLP-1 receptor agonists |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2023/07/21 13:09:47 |
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Basic information
Public title
A prospective observational study assessing patient preference for oral vs. injectable semaglutide in Japanese patients with type 2 diabetes using insulin and GLP-1 receptor agonists
Acronym
Patient preference for oral vs. injectable semaglutide
Scientific Title
A prospective observational study assessing patient preference for oral vs. injectable semaglutide in Japanese patients with type 2 diabetes using insulin and GLP-1 receptor agonists
Scientific Title:Acronym
Patient preference for oral vs. injectable semaglutide
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess patient preference for oral vs. injectable semaglutide in Japanese patients with type 2 diabetes using insulin and GLP-1 receptor agonists
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the proportion of patients who selected oral or injectable semaglutide
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients treated with insulin and GLP-1RA at least for 3 months
2) HbA1c>or=7% or BMI>or=25.0
3) written informed consent
Key exclusion criteria
1) a history of hospitalization to improve glycemic control within the past 3 months
2) considered to be ineligible for other reasons at the discretion of the attending physician.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Nagai |
Organization
Kanto Rosai Hospital
Division name
Diabetes and Endocrinology
Zip code
211-8510
Address
1-1, Kizukisumiyoshicho, Nakahara-ku, Kawasaki, Kanagawa
TEL
044-411-3131
yoshio-nagai@kantoh.johas.go.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Nagai |
Organization
Kanto Rosai Hospital
Division name
Diabetes and Endocrinology
Zip code
211-8510
Address
1-1, Kizukisumiyoshicho, Nakahara-ku, Kawasaki, Kanagawa
TEL
044-411-3131
Homepage URL
yoshio-nagai@kantoh.johas.go.jp
Sponsor or person
Institute
Kanto Rosai Hospital
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
Kanto Rosai Hospital
Address
1-1, Kizukisumiyoshicho, Nakahara-ku, Kawasaki, Kanagawa
Tel
044-411-3131
kikakuka@kantoh.johas.go.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
| 2022 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
65
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 05 | Month | 12 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 12 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
From the pretreatment GLP-1 receptor agonist, injectable semaglutide or oral semaglutide, or current treatment continuation is selected at the patients' preference.
Management information
Registered date
| 2022 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054991
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
