UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063493 |
|---|---|
| Receipt number | R000071787 |
| Scientific Title | A prospective observational study to investigate the effects of imeglimin treatment on glucose metabolism and body composition in middle-aged and older patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2026/11/02 |
| Last modified on | 2026/11/02 17:19:07 |
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Basic information
Public title
A prospective observational study to evaluate the effects of imeglimin treatment on glycemic control and body composition in middle-aged and older patients with type 2 diabetes
Acronym
The study to evaluate the effects of imeglimin on glycemic control and body composition in middle-aged and older patients with type 2 diabetes
Scientific Title
A prospective observational study to investigate the effects of imeglimin treatment on glucose metabolism and body composition in middle-aged and older patients with type 2 diabetes mellitus
Scientific Title:Acronym
The study to evaluate the effects of imeglimin on glucose metabolism and body composition in middle-aged and older patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of newly initiated oral imeglimin treatment on body composition and glucose metabolism in middle-aged and older patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the skeletal muscle index by the bioelectrical impedance analysis
Key secondary outcomes
Changes in the following parameters between the initiation of imeglimin treatment and 12 weeks after treatment initiation:
Anthropometric and body composition measurements(height, body weight, body composition assessed by bioelectrical impedance analysis (BIA), waist circumference, calf circumference, and grip strength)
Laboratory tests(hematological and blood biochemical tests
White blood cell differential: monocyte count, neutrophil count, eosinophil count, and basophil count),NAD+ levels in peripheral blood mononuclear cells (PBMCs),Mitochondrial content in peripheral blood mononuclear cells (PBMCs),Serum eNAMPT
Physical function tests: grip strength, 30-second chair stand test, and walking speed,Skin examination,Questionnaires,Cognitive function assessment
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals who have received a sufficient explanation of the study, fully understood the study procedures, and provided written informed consent to participate voluntarily.
2. Individuals aged 45 years or older who have been diagnosed with type 2 diabetes mellitus.
3. Individuals who have no prior history of treatment with imeglimin.
4. Individuals who are considered eligible for participation based on the overall judgment of the principal investigator or sub-investigator.
Key exclusion criteria
Individuals with type 1 diabetes mellitus, serious complications, or habitual excessive alcohol consumption.
Individuals who are considered inappropriate for participation in the study by the principal investigator or sub-investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Igarashi |
Organization
The University of Tokyo Hospital
Division name
Department of Diabetes and Metabolic Diseases
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-ku
TEL
03-3815-5411
igarashi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Igarashi |
Organization
The University of Tokyo Hospital
Division name
Department of Diabetes and Metabolism Diseases
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-ku
TEL
03-3815-5411
Homepage URL
igarashi-tky@umin.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
The University of Tokyo, Clinical Research Review Board
Address
7-3-1 Hongo Bunkyo-ku
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2026 | Year | 11 | Month | 02 | 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
40
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
| 2024 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study after initiation of imeglimin treatment
Management information
Registered date
| 2026 | Year | 11 | Month | 02 | Day |
Last modified on
| 2026 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071787
