UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053067 |
|---|---|
| Receipt number | R000059869 |
| Scientific Title | Assessing patient satisfaction following treatment with Semaglutide injection for type 2 diabetes mellitus |
| Date of disclosure of the study information | 2023/12/12 |
| Last modified on | 2023/12/12 09:47:40 |
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Basic information
Public title
Assessing patient satisfaction following treatment with Semaglutide injection for type 2 diabetes mellitus
Acronym
Assessing patient satisfaction following treatment with Semaglutide injection for type 2 diabetes mellitus
Scientific Title
Assessing patient satisfaction following treatment with Semaglutide injection for type 2 diabetes mellitus
Scientific Title:Acronym
Assessing patient satisfaction following treatment with Semaglutide injection for type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify patient satisfaction in using Semaglutide injection in patients with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of Satisfaction score measured in the DTSQ by seven possible responses (varying from 0; very dissatisfied, to 6; very satisfied, varying by integers), both previous and six months subsequent to Semaglutide injection.
Key secondary outcomes
Changes in eating behavior measured by the eating behavior questionnaire and the assessment of the efficacy of the drug before and after six months of semaglutide injection.
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 |
Interventions/Control_1
Semaglutide injection
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes mellitus obtained consent to participate in research
Key exclusion criteria
Patients who do not agree to participate in the study
Patients judged by the attending physician that there is no indication for Semaglutide injection
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-8535
Address
1010 Sakurai, Kisarazu-city, Chiba
TEL
+81-438-36-1071
ishibashi-cib@umin.net
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-8535
Address
1010 Sakurai, Kisarazu-city, Chiba
TEL
+81-438-36-1071
Homepage URL
ishibashi-cib@umin.net
Sponsor or person
Institute
Kimitsu Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kimitsu Chuo Hospital
Address
1010 Sakurai, Kisarazu-city, Chiba
Tel
+81-438-36-1071
soumu@kc-hosp.or.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 | 12 | Month | 12 | 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
103
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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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 | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059869
