UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054715 |
|---|---|
| Receipt number | R000062519 |
| Scientific Title | Effects of Imeglimin on Muscle Strength and Mass in Diabetic Patients |
| Date of disclosure of the study information | 2024/06/20 |
| Last modified on | 2024/06/19 21:08:12 |
* 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
Effects of Imeglimin on Muscle Strength and Mass in Diabetic Patients
Acronym
Effects of Imeglimin on Muscle Strength and Mass in Diabetic Patients
Scientific Title
Effects of Imeglimin on Muscle Strength and Mass in Diabetic Patients
Scientific Title:Acronym
Effects of Imeglimin on Muscle Strength and Mass in Diabetic Patients
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A bidirectional relationship has been observed between type 2 diabetes mellitus and sarcopenia, especially among older adults. Imeglimin improves mitochondrial function; however, previous studies of imeglimin have not assessed muscle strength in patients with type 2 diabetes. The aim of this study is to investigate the effects of imeglimin on muscle strength in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the percent change in quadriceps strength and grip strength from baseline (week 0) to week 24 in the imeglimine and control groups.
Key secondary outcomes
Secondary endpoints were changes in total body muscle mass and total body fat mass from week 0 to week 24 in the imeglimine and control groups.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes mellitus who are outpatients, aged 20 to 75 years, and who have given full explanation of their participation in this study, and who have given written consent of their own free will based on their full understanding of the study.
Key exclusion criteria
Patients with type 1 diabetes, patients requiring emergency response or drug adjustment (such as those with extremely poor diabetes control, repeated severe hypoglycemia, patients before and after surgery, acute infection, diabetic gangrene, and severe trauma), and patients with expected edema (including those with severe heart failure and renal failure)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Kawanabe |
Organization
St. Marianna University School of Medicine
Division name
Department of Internal Medicine, Division of Metabolism and Endocrinology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
s2kawanabe@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Oyanagi |
Organization
St. Marianna University School of Medicine
Division name
Department of Internal Medicine, Division of Metabolism and Endocrinology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
takeshi.oyanagi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna 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
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa,Japan
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2024 | Year | 06 | Month | 20 | 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
56
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
| 2022 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Changes in total body muscle mass, fat mass, quadriceps muscle strength, and grip strength from baseline (week 0) to week 24 were evaluated patients treated with imeglimin therapy
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=R000062519
