UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057021 |
|---|---|
| Receipt number | R000065174 |
| Scientific Title | Effects of oral or injectable semaglutide on Diabetes Therapy-Related Quality of Life scores in obese patients with type 2 diabetes: A single-center observational study. |
| Date of disclosure of the study information | 2025/02/18 |
| Last modified on | 2026/02/15 21:01:15 |
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Basic information
Public title
Effects of oral or injectable semaglutide on Diabetes Therapy-Related Quality of Life scores in obese patients with type 2 diabetes: A single-center observational study.
Acronym
An observational study of the effects of oral or injectable semaglutide on DTR-QOL scores.
Scientific Title
Effects of oral or injectable semaglutide on Diabetes Therapy-Related Quality of Life scores in obese patients with type 2 diabetes: A single-center observational study.
Scientific Title:Acronym
An observational study of the effects of oral or injectable semaglutide on DTR-QOL scores.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of oral and injectable semaglutide on Diabetes Therapy-Related Quality of Life scores in obese patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in total score of the Diabetes Therapy-Related QOL questionnaire from baseline to week 12
Key secondary outcomes
1)The percentage change in total score of the Diabetes Therapy-Related QOL questionnaire from baseline to week 12
2)The change or percentage change in clinical variables from baseline to week 12
3)The relationship between the change in total score of the DTR-QOL questionnaire and clinical variables/characteristics of participants
4)The relationship between the change in each domain score of the DTR-QOL questionnaire and clinical variables/characteristics of participants
5)Nutrient and energy intake evaluated by the Brief-type self-administered Diet History Questionnaire (BDHQ)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Obese patients with type 2 diabetes aged 20 years or older who are planned to be treated with oral or injectable semaglutide
2)Patients who showed written consent form
Key exclusion criteria
1)Patients who have contraindications for semaglutide
2)Patients who have previously received semaglutide treatment
3)Patients with a history of hypersensitivity to the components of semaglutide
4)Patients with type 1 diabetes or diabetes due to other causes
5)Pregnant women, breastfeeding women, and patients planning to become pregnant
6)Patients who require treatment due to serious complications such as diabetic ketoacidosis, diabetic coma or precoma, and severe infections and who are deemed inappropriate for participation in this study by a doctor
7)Patients with poorly controlled type 2 diabetes with HbA1c of 10.0% or higher
8)Patients undergoing treatment for malignant tumors
9)Patients with obvious dementia
10)Patients who are deemed inappropriate for participation in this study by the principal investigator or co-investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Kumashiro |
Organization
Kanazawa Medical University
Division name
Department of Diabetology & Endocrinology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Ishikawa, Japan
TEL
076-286-2211
naokik@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Takeda |
Organization
Kanazawa Medical University
Division name
Department of Diabetology & Endocrinology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Ishikawa, Japan
TEL
076-286-2211
Homepage URL
yktake5@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
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
Kanazawa Medical University Research Ethics Committee
Address
1-1 Daigaku, Uchinada, Ishikawa, Japan
Tel
076-218-8347
crtc@kanazawa-med.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
| 2025 | Year | 02 | Month | 18 | 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
36
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Study design] Single-center prospective observational study.
[Subjects] Obese patients with type 2 diabetes aged 20 years or older who are attending the Department of Diabetes and Endocrinology at Kanazawa Medical University Hospital and who are planned to be treated with semaglutide.
[Methods] Pharmacotherapy with oral or injectable semaglutide will be started according to the patient's preference. Patients who give consent to participate in this study will be enrolled. Pharmacotherapy with semaglutide will be carried out according to the dosage and administration instructions in the package insert for each agent. Answers to DTR-QOL questionnaire will be obtained before and 12 weeks after the initiation of treatment, and clinical variables will be evaluated during routine medical care.
Management information
Registered date
| 2025 | Year | 02 | Month | 13 | Day |
Last modified on
| 2026 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065174
