UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054704 |
|---|---|
| Receipt number | R000062513 |
| Scientific Title | Clinical Factors Associated with Decrease in Body weight Induced by treatment with Weekly Semaglutide 1.0mg in Patient with Type 2 Diabetes Mellitus |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2024/06/19 09:20:02 |
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Basic information
Public title
Clinical Factors Associated with Decrease in Body weight Induced by treatment with Weekly Semaglutide 1.0mg in Patient with Type 2 Diabetes Mellitus
Acronym
Clinical Factors Associated with Decrease in Body weight Induced by treatment with Weekly Semaglutide 1.0mg
Scientific Title
Clinical Factors Associated with Decrease in Body weight Induced by treatment with Weekly Semaglutide 1.0mg in Patient with Type 2 Diabetes Mellitus
Scientific Title:Acronym
Clinical Factors Associated with Decrease in Body weight Induced by treatment with Weekly Semaglutide 1.0mg
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of factors influencing weight loss induced by weekly semaglutide 1.0mg administration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of weight loss of 7% or more 180 days after starting weekly Semaglutide 1.0mg administration.
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes mellitus
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Kurinami |
Organization
Jinnouchi Hospital
Division name
Internal Medicine
Zip code
862-0976
Address
6-2-3 Kuhonji, Chuo-ku, Kumamoto City, Kumamoto
TEL
0963630011
kurinami@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | NOBORU |
| Middle name | |
| Last name | KURINAMI |
Organization
Jinnouchi Hospital
Division name
Internal Medicine
Zip code
862-0976
Address
6-2-3 Kuhonji, Chuo-ku, Kumamoto City, Kumamoto
TEL
0963630011
Homepage URL
kurinami@jinnouchi.or.jp
Sponsor or person
Institute
Jinnouchi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jinnouchi
Address
6-2-3 Kuhonji, Chuo-ku, Kumamoto City, Kumamoto
Tel
0963630011
kurinami@jinnouchi.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
| 2024 | Year | 12 | Month | 31 | 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
97
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with T2DM who visited the Diabetes Care Center of Jinnouchi Hospital and were treated with Weekly Semaglutide 1.0mg in addition to their ongoing medications were retrospectively registered. We measured body weight both before administration of Weekly Semaglutide 1.0mg and 180 days after treatment and calculated the change in weight.
Management information
Registered date
| 2024 | Year | 06 | Month | 19 | Day |
Last modified on
| 2024 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062513
