UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048782 |
|---|---|
| Receipt number | R000055578 |
| Scientific Title | The therapeutic effect of Oral Semaglutide in older patients with type 2 diabetes mellitus; retrospective study. |
| Date of disclosure of the study information | 2022/08/29 |
| Last modified on | 2023/08/30 13:35:40 |
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Basic information
Public title
The therapeutic effect of oral Semaglutide in older patients with type 2 diabetes mellitus
Acronym
Effect of oral Semaglutide in older patients
Scientific Title
The therapeutic effect of Oral Semaglutide in older patients with type 2 diabetes mellitus; retrospective study.
Scientific Title:Acronym
Effect of oral Semaglutide in older patients
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate therapeutic effects of oral semaglutide on glycemic control in older patients with type 2 diabetes mellitus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change from baseline in HbA1c after 6 months of treatment
Key secondary outcomes
1) The change of various parameters in blood and urine tests (liver, kidney, lipid, etc.)
2) The changes of weight, abdominal circumference, blood pressure, and pulse rate.
3) Adverse events during observation period
4) Factors contributed to changes in HbA1c and secondary endpoints
5) The change of each factor when the degree of dementia is stratified by the simple cognitive function tests
6) Association between scores of simple cognitive function tests and the change of HbA1c
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are 65-year-old or older
2) Patients with HbA1c of 7.0% or higher
3) Patients who do not refuse to participate in this study
Key exclusion criteria
1) Patients with a history of hypersensitivity to the components of semaglutide
2) Patients with severe ketosis, diabetic coma or pre-coma
3) Other patients deemed to be unsuitable by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Oe |
Organization
Hokkaido University Graduate School
Division name
Department of Rheumatology, Endocrinology and Nephrology
Zip code
060-8638
Address
N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
o-e.yuki@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Oe |
Organization
Hokkaido University Graduate School
Division name
Department of Rheumatology, Endocrinology and Nephrology
Zip code
060-8638
Address
N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
o-e.yuki@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Otaru general hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Otaru general hospital
Address
1-1-1, Wakamatsu, Otaru, Hokkaido, Japan
Tel
0134-25-1211
tarubyo-jimu@city.otaru.lg.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
04-001
Org. issuing International ID_1
Otaru general hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
小樽市立病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 29 | 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
30
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
| 2022 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate therapeutic effects of oral semaglutide in older patients with type 2 diabetes.
Management information
Registered date
| 2022 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055578
