UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059813 |
|---|---|
| Receipt number | R000068395 |
| Scientific Title | Efficacy and Safety of Escalating Once-weekly Semaglutide from 0.5 mg to 1.0 mg in Type 2 Diabetes:A Retrospective Observational Study |
| Date of disclosure of the study information | 2025/11/18 |
| Last modified on | 2025/11/18 16:37:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy and Safety of Escalating Once-weekly Semaglutide from 0.5 mg to 1.0 mg in Type 2 Diabetes:A Retrospective Observational Study
Acronym
Efficacy and Safety of Escalating Once-weekly Semaglutide from 0.5 mg to 1.0 mg in Type 2 Diabetes:A Retrospective Observational Study
Scientific Title
Efficacy and Safety of Escalating Once-weekly Semaglutide from 0.5 mg to 1.0 mg in Type 2 Diabetes:A Retrospective Observational Study
Scientific Title:Acronym
Efficacy and Safety of Escalating Once-weekly Semaglutide from 0.5 mg to 1.0 mg in Type 2 Diabetes:A Retrospective Observational Study
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate metabolic parameters and the incidence of adverse events before and after dose escalation in patients with diabetes whose dose of once-weekly semaglutide is increased from 0.5 mg to 1.0 mg, and thereby assess the efficacy and safety of this dose escalation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Within-patient change in HbA1c 24 weeks after the initial prescription of 1mg semaglutide.
Key secondary outcomes
Changes in metabolic parameters and the incidence of adverse events.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All adult patients with diabetes who received a prescription for once-weekly injectable semaglutide and whose dose was escalated from 0.5 mg to 1.0 mg during the study interval.
Key exclusion criteria
Exclusion criteria were as follows: diagnosis of type 1 diabetes mellitus, excessive alcohol consumption(defined as a mean daily intake of pure alcohol >60 g for men or >30 g for women), diagnosis of dementia, pregnancy during the data collection period, hospitalization for one week or longer for glycemic management during the data collection period, end-stage renal disease requiring maintenance dialysis at baseline, initiation of once-weekly semaglutide at another institution, insufficient follow-up time to obtain 24-week data (defined as having initiated the 1.0 mg dose less than 18 weeks prior to March 10, 2025), clinically significant non-adherence as judged by the treating physician, and patients deemed unsuitable for participation by the attending physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | GENKI |
| Middle name | |
| Last name | SATO |
Organization
Toho University Omori Medical Center
Division name
Diabetes, Metabolism and Endocrinology Center
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
genki.sato@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Genki |
| Middle name | |
| Last name | Sato |
Organization
Toho University Omori Medical Center
Division name
Diabetes, Metabolism and Endocrinology Center
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
genki.sato@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Omori Medical Center
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
Ethics Committee of Faculty of Medicine, Toho University
Address
6-11-1 Omori-nashi, Ota-Ku, Tokyo
Tel
03-3762-4151
med.rinri@ext.toho-u.ac.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
| 2025 | 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
128
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
| 2025 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection period: from June 29, 2020 to March 10, 2025.
Baseline window: from 12 weeks before initiation of once-weekly semaglutide 1.0 mg through the day of 1.0 mg initiation.
Time points for data collection: baseline, 12 weeks and 24 weeks after initiation of once-weekly semaglutide 1.0 mg.
For baseline data, the value obtained on the date closest to the 1.0 mg index date within the baseline window will be used.
For the 12-week and 24-week post-initiation time points, the value obtained on the date closest to each nominal time point within a +/- 6-week window will be used.
Management information
Registered date
| 2025 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068395
