UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042478 |
|---|---|
| Receipt number | R000047608 |
| Scientific Title | Investigation of beta-cell function by receiving semaglutide among inpatints with type 2 diabetes. |
| Date of disclosure of the study information | 2020/11/18 |
| Last modified on | 2023/03/20 15:09:02 |
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Basic information
Public title
Investigation of beta-cell function by receiving semaglutide among inpatints with type 2 diabetes.
Acronym
Investigation of beta-cell function by receiving semaglutide among inpatints with type 2 diabetes.
Scientific Title
Investigation of beta-cell function by receiving semaglutide among inpatints with type 2 diabetes.
Scientific Title:Acronym
Investigation of beta-cell function by receiving semaglutide among inpatints with type 2 diabetes.
Region
| Japan |
Condition
Condition
type2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of semaglutide on insulin secretory ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference of insulin secretory ability (such as urine CPR, serum C-peptide and CPRindex in fasting, AUC of serum C-peptide during the GST) in three months after discharge between type2 diabetic inpatients who receive semaglutide or not.
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
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Semaglutide group:
In hospitalization, participants inject semaglutide 0.25mg once a week.
After discharge, participants inject semaglutide 0.50mg once a week in 12 weeks.
Interventions/Control_2
Control group:
Paticipants does not inject semaglutide until 12 weeks later discharge.
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) Type2 diabetic inpatients
2) Patinets never receiving GLP-1 receptor agonists
3) Diabetes duration within 10 years
4) Patients with the written informed consent
Key exclusion criteria
1) Patients with severe liver dysfunction
2) Patients with severe renal dysfunction(eGFR<30ml/min/1.73)
3) Patients with fasting serum CPR <0.5 or postprandial serum CPR <1.0
4) Patinet with diabetic ketoacidosis
5) Patient with infection
6) Patients taking steroid
7) Patients with malignant tumor currently undergoing treatment
8) Pregnant or lactating woman
9) Other patients who are judged to be unsuitable as subjects by the judgment of a doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Minami |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
234-0054
Address
3-2-10 Konandai, Konan-ku, Yokohama, Kanagawa, Japan
TEL
045-832-1111
ksqdd034@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Taichi |
| Middle name | |
| Last name | Minami |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
234-0054
Address
3-2-10 Konandai, Konan-ku, Yokohama, Kanagawa, Japan
TEL
045-832-1111
Homepage URL
ksqdd034@yahoo.co.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Yokohamashi Nanbu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Saiseikai Yokohamashi Nanbu Hospital
Address
3-2-10 Konandai, Konan-ku, Yokohama, Kanagawa, Japan
Tel
045-832-1111
soumu01@nanbu.saiseikai.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
| 2020 | Year | 11 | 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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 08 | 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
| 2020 | Year | 11 | Month | 17 | Day |
Last modified on
| 2023 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047608
