UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058691 |
|---|---|
| Receipt number | R000067093 |
| Scientific Title | Efficacy of imeglimin in stepping down from multiple daily insulin injection with DPP-4 inhibitor |
| Date of disclosure of the study information | 2025/08/30 |
| Last modified on | 2025/08/04 16:25:54 |
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Basic information
Public title
Efficacy of imeglimin in stepping down from multiple daily insulin injection with DPP-4 inhibitor
Acronym
Efficacy of imeglimin in stepping down from multiple daily insulin injection with DPP-4 inhibitor
Scientific Title
Efficacy of imeglimin in stepping down from multiple daily insulin injection with DPP-4 inhibitor
Scientific Title:Acronym
Efficacy of imeglimin in stepping down from multiple daily insulin injection with DPP-4 inhibitor
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the insulin dosage reduction effect of adding imeglimin to patients treated with multiple daily insulin injection and DPP-4 inhibitor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
magnitude of changing insulin dosage from before to 5 days after initiation of imeglimin
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients who were treated adding imeglimin for more than 5 days on combination therapy with multiple daily insulin injection and DPP-4 inhibitors.
Key exclusion criteria
Type 1 diabetes
Patients who couldn't continue to take imeglimin for more than 5 days
Patients who have used drugs other than antidiabetic drugs that may cause fluctuations in blood glucose levels
Patients who had been using antidiabetic drugs other than insulin or DPP-4 inhibitors before or within 5 days after starting Imeglimin.
Patients who have had changes in their condition that may have led to fluctuations in blood glucose levels within 5 days after initiation of imeglimin.
Patients considered ineligible for the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Fukumi |
| Middle name | |
| Last name | Yoshikawa |
Organization
Toho university school of medicine
Division name
Division of Diabetes, Metabolism, and Endocrinology, Department of internal medicine.
Zip code
143-8541
Address
6-11-1Omori-nishi, Ota-ku, Tokyo
TEL
0337624151
fukumi.yoshikawa@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Fukumi |
| Middle name | |
| Last name | Yoshikawa |
Organization
Toho university school of medicine
Division name
Division of Diabetes, Metabolism, and Endocrinology, Department of internal medicine.
Zip code
143-8541
Address
6-11-1Omori-nishi, Ota-ku, Tokyo
TEL
0337624151
Homepage URL
fukumi.yoshikawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Toho university school of medicine
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
Ethics Committee of Toho University Medical Center Omori Hospital
Address
6-11-1 Omorinishi, Ota-ku, Tokyo-to 143-8541 Japan
Tel
03-5763-6534
omori.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 | 08 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study enrolled patients who were admitted to our hospital between September 2021 and January 2025 and who were treated with multiple daily insulin injection and DPP-4 inhibitors and were given 2000 mg of imeglimin for more than five days.
Management information
Registered date
| 2025 | Year | 08 | Month | 04 | Day |
Last modified on
| 2025 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067093
