UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046938 |
|---|---|
| Receipt number | R000053555 |
| Scientific Title | Effect of oral semaglutide on glucose variability and oxidative stress in type 2 diabetes patients |
| Date of disclosure of the study information | 2022/02/17 |
| Last modified on | 2023/06/11 22:17:06 |
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Basic information
Public title
Effect of oral semaglutide on glucose variability and oxidative stress in type 2 diabetes patients
Acronym
Effect of oral semaglutide on glucose variability and oxidative stress in type 2 diabetes patients
Scientific Title
Effect of oral semaglutide on glucose variability and oxidative stress in type 2 diabetes patients
Scientific Title:Acronym
Effect of oral semaglutide on glucose variability and oxidative stress in type 2 diabetes patients
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to investigate the effects of DPP-4 inhibitors and oral semaglutide on oxidative stress and glucose variability before and 24 weeks after the start of the study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary end point was d-ROMs change from baseline after completing 24 weeks of treatment intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
| Medicine |
Interventions/Control_1
semaglutide 7mg (maintenance dose reached after 4 weeks of 3 mg semaglutide once daily).
Interventions/Control_2
Continue DPP-4 inhibitors (regular dose)
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
a diagnosis of type 2 diabetes mellitus
1) HbA1c 7.0% or more
2) treatment with DPP-4 inhibitors for 12weeks or longer
3) written informed consent
4) 20 years and over
Key exclusion criteria
1)the use of steroids or anti-inflammatory drugs,
2)diabetic ketosis and coma within 3 months before the study,
3)severe infection, severe trauma, pre-and post-operation,
4)an estimated glomerular filtration rate are within 30mL/min/1.73m2,
5)malignancy,
6)pregnancy
7)Patients who are judged as inappropriate for inclusion by phsicians
8)Patients using implantable medical devices such as cardiac pacemakers
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ohara |
Organization
Showa University School of Medicine
Division name
Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
0337848000
s6018@nms.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ohara |
Organization
Showa University School of Medicine
Division name
Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
0337848000
Homepage URL
s6018@nms.ac.jp
Sponsor or person
Institute
Showa University School of Medicine, Division of Diabetes and Endocrinology, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine, Division of Diabetes and Endocrinology, Department of Internal Medicine
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
Ethics committee specializing in human subjects reserch at the Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
0337848129
ura-ec@ofc.showa-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
| 2022 | Year | 02 | Month | 17 | 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
60
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
| 2021 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 05 | 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
| 2022 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053555
