UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042482 |
|---|---|
| Receipt number | R000047304 |
| Scientific Title | Effect of Semaglutide 0.25mg on glycemic controls in type2 diabetes patients compared with dulaglutide 0.75mg. |
| Date of disclosure of the study information | 2020/11/18 |
| Last modified on | 2023/03/20 15:07:00 |
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Basic information
Public title
Effect of Semaglutide 0.25mg on glycemic controls in type2 diabetes patients compared with dulaglutide 0.75mg.
Acronym
Effect of Semaglutide 0.25mg on glycemic controls in type2 diabetes patients compared with dulaglutide 0.75mg.
Scientific Title
Effect of Semaglutide 0.25mg on glycemic controls in type2 diabetes patients compared with dulaglutide 0.75mg.
Scientific Title:Acronym
Effect of Semaglutide 0.25mg on glycemic controls in type2 diabetes patients compared with dulaglutide 0.75mg.
Region
| Japan |
Condition
Condition
type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the change of HbA1c levels when patients who have recieved dulaglutide stop it and start semaglutide 0.25mg.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients are goint to stop receiving dulaglutide 0.75mg and start receiving semaglutide 0.25mg. We compare HbA1c levels before receiving semaglutide 0.25mg with those after receiving semaglutide 0.25mg in 12 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients who have received dulaglutide 0.75mg stop it and start receiving semaglutide 0.25mg. Patinets continue to receive it for 12 weeks.
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
1) type2 diabetes
2) Patints who have received duraglutide 0.75mg
3) HbA1c fluctuation within 0.4% in the last year
4) Patints with the written informed consent
Key exclusion criteria
1) Pationts received insulin
2) Patients with severe liver dysfunction
3) Patients with severe renal dysfunction(eGFR<30ml/min/1.73)
4) Patients with fasting serum CPR <0.5 or postprandial serum CPR <1.0
5) Patients taking steroid
6) Patients with malignant tumor currently undergoing treatment
7) Pregnant or lactating woman
8) Other patients who are judged to be unsuitable as subjects by the judgment of a doctor
Target sample size
20
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
Other
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 | 06 | 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=R000047304
| Research Plan | |
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| Registered date | File name |
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