UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047221 |
|---|---|
| Receipt number | R000053857 |
| Scientific Title | Effectiveness of once-weekly Semaglutide in patients with type 2 diabetes undergoing hemodialysis. |
| Date of disclosure of the study information | 2022/03/20 |
| Last modified on | 2023/09/18 14:37:28 |
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Basic information
Public title
Effectiveness and safety of once-weekly Semaglutide in patients with type 2 diabetes undergoing hemodialysis.
Acronym
Effectiveness of once-weekly Semaglutide in patients with type 2 diabetes undergoing hemodialysis.
Scientific Title
Effectiveness of once-weekly Semaglutide in patients with type 2 diabetes undergoing hemodialysis.
Scientific Title:Acronym
Effectiveness of once-weekly Semaglutide in patients with type 2 diabetes undergoing hemodialysis.
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes undergoing hemodialysis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We elucidate the effectiveness and safety of once-weekly semaglutide in patients with type 2 diabetes on hemodialysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in glucose profiles before and after semaglutide administration
Key secondary outcomes
HbA1c, Glycated albumin, Interdialysis weight, Side effect
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
Patients with type 2 diabetes undergoing hemodialysis in Sohbudai Nieren Clinic from September 2020 to March 2022.
Key exclusion criteria
Patients who refused to participate in this research.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara
TEL
0427788706
ahayashi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara
TEL
0427788706
Homepage URL
ahayashi@kitasato-u.ac.jp
Sponsor or person
Institute
Sohbudai Nieren Clinic
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
Ethics Committees of Sohbudai Nieren Clinic
Address
1-35-10, Sohbudai, Zama, Kanagawa
Tel
0462982552
n-kobi@ka2.so-net.ne.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 | 03 | Month | 20 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000047221
Publication of results
Partially published
Result
URL related to results and publications
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=202302235899434051
Number of participants that the trial has enrolled
8
Results
weekly semaglutide is a safe and effective option for glycemic control and weight management in obese people with T2D on HD.
Results date posted
| 2023 | Year | 09 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eight obese participants with type 2 diabetes undegoing hemodialysis (men 4 and women 4, HbA1c 7.9[0.9]%, glycated albumin 24.6[4.2]%)
Participant flow
No particular problem
Adverse events
No serious adverse events were reported
Outcome measures
HbA1c, glycated albumin, glucose profiles using continuous glucose monitoring
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We enrolled 9 patients in January 2022.
Management information
Registered date
| 2022 | Year | 03 | Month | 18 | Day |
Last modified on
| 2023 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053857
