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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042478
Receipt No. 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 2020/11/17

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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 Taku
Middle name
Last name Yamada
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
Email hyyoh16y@yahoo.co.jp

Public contact
Name of contact person
1st name Taku
Middle name
Last name Yamada
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
Email hyyoh16y@yahoo.co.jp

Sponsor
Institute Saiseikai Yokohamashi Nanbu Hospital
Institute
Department

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
Email 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
2020 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047608

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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