UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047011 |
|---|---|
| Receipt number | R000050623 |
| Scientific Title | Real-World Clinical Effects of Semaglutide Injection in Outpatients with Type 2 Diabetes |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/11/17 12:10:19 |
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Basic information
Public title
Investigation of Clinical Effects of Semaglutide Injection in Outpatients with Type 2 Diabetes
Acronym
Investigation of Clinical Effects of Semaglutide Injection
Scientific Title
Real-World Clinical Effects of Semaglutide Injection in Outpatients with Type 2 Diabetes
Scientific Title:Acronym
Clinical Effects of Semaglutide Injection
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 real-world clinical effects of semaglutide injection in outpatients with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of HbA1c at baseline and one, three and six months after semaglutide injection.
Key secondary outcomes
Body weight, Bioelectrical impedance analysis (BIA), Questionnaire of gastrointestinal symptoms, Diabetes treatment satisfaction questionnaire(DTSQ) at baseline and one, three and six months after semaglutide injection.
Index of glycemic variability from professional CGM at baseline and six months
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The study term is six months.
Participants are outpatients with type 2 diabetes in our hospital. They are categorized as cases of adding semaglutide injection to GLP-1RA-naive or switching from liraglutide and duraglutide use cases to semaglutide injection.
Start dose of Semaglutide injection is 0.25mg once a week for the first 4 weeks. After 4 weeks, increase the dose to 0.5mg once a week at week 5. If, after at least 4 weeks on the 0.5 mg dose, additional clinical control is still needed, increase the dose to 1.0 mg once a week.
DPP4 inhibitor therapies are discontinued.
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
| 19 | years-old | <= |
Age-upper limit
| 91 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type2 diabetes
Key exclusion criteria
1.Patients with pregnancy
2.Patients with allergy
3.Patients who hospitalize over one week
4.Patients with serious gastrointestinal illness
5.Patients with cancer
6.Patients with a history of diabetic ketoacidosis and hyperglycemic crises
7.Patients with severe infection
8.Patients with high dose corticosteroid
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Nobutoshi |
| Middle name | |
| Last name | Fushimi |
Organization
Ichinomiyanishi Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
494000
Address
1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL
0586480077
nobutoshi243@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Matsubara |
Organization
Ichinomiyanishi Hospital
Division name
Research Planning Division
Zip code
494000
Address
1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL
0586480077
Homepage URL
matsubara@anzu.or.jp
Sponsor or person
Institute
Ichinomiynishi Hospital
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
Ichinomiya Nishi Hospital
Address
1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
Tel
0586480077
nobutoshi243@yahoo.co.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 | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 21 | 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 | 26 | Day |
Last modified on
| 2022 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050623
