UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053289 |
|---|---|
| Receipt number | R000052979 |
| Scientific Title | Investigation of the effects of imeglimin administration on the metabolism of mitochondrial diabetes mellitus |
| Date of disclosure of the study information | 2024/01/08 |
| Last modified on | 2024/05/10 19:17:50 |
* 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
Investigation of the effects of imeglimin administration on the metabolism of mitochondrial diabetes mellitus
Acronym
Investigation of the effects of imeglimin administration on the metabolism of mitochondrial diabetes mellitus
Scientific Title
Investigation of the effects of imeglimin administration on the metabolism of mitochondrial diabetes mellitus
Scientific Title:Acronym
Investigation of the effects of imeglimin administration on the metabolism of mitochondrial diabetes mellitus
Region
| Japan |
Condition
Condition
mitochondrial diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the efficacy of imeglimin for mitochondrial diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of HbA1c 12 weeks after the start of administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The dosage was gradually increased from 500 mg of imeglimine to a maximum dosage of 2000 mg in 8 weeks. To confirm the efficacy of the combination, 1 mg of glimepiride, 5 mg of linagliptin, and 10 mg of empagliflozin were then administered for 2 weeks each.
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
| 47 | years-old | <= |
Age-upper limit
| 47 | years-old | >= |
Gender
Female
Key inclusion criteria
Mitochondrial diabetic patients who consented to participate in the study
Key exclusion criteria
nothing
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | HIRAYAMA |
| Middle name | |
| Last name | KIICHI |
Organization
Kimitsu Chuo Hospital
Division name
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-8535
Address
1010 Sakurai, Kisarazu-city, Chiba
TEL
+81-438-36-1071
m14097kh@jichi.ac.jp
Public contact
Name of contact person
| 1st name | HIRAYAMA |
| Middle name | |
| Last name | KIICHI |
Organization
Kimitsu Chuo Hospital
Division name
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-8535
Address
1010 Sakurai, Kisarazu-city, Chiba
TEL
+81-438-36-1071
Homepage URL
m14097kh@jichi.ac.jp
Sponsor or person
Institute
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism, Kimitsu Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Kimitsu Chuo Hospital
Address
Kimitsu Chuo Hospital
Tel
+81-438-36-1071
soumu@kc-hosp.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 | 01 | Month | 08 | Day |
Related information
URL releasing protocol
https://onlinelibrary-wiley-com.jmul.idm.oclc.org/doi/10.1111/jdi.14085
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary-wiley-com.jmul.idm.oclc.org/doi/10.1111/jdi.14085
Number of participants that the trial has enrolled
1
Results
The HbA1c level had been maintained at approximately 8.0%. After imeglimin administration, the HbA1c level decreased from 7.7% to 6.9%, and the total insulin dose was reduced from 38 to 29 units over 3 months.
Results date posted
| 2024 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patient is a 47-year-old woman with a height of 155.3 cm and a weight of 54.0 kg (BMI 22.4 kg/m2). She began experiencing sensorineural hearing loss at age 32 and developed insulin-insulin-deficiency diabetes mellitus with myogenic muscle weakness at age 37. Her mother, aunt, and two cousins had MIDD with the A3243G mutation. Her mother died at age 62 years from heart failure, and her cousins, details of whom are unknown, have already died. Her aunt is still alive but is being treated for complications of heart failure. After blood and urine sample collection at our hospital, genetic analysis was performed at Chiba Children's Hospital, which revealed the A3243G mutation in 17.92% of the blood and 62.72% of the urine samples.
Participant flow
Considering the lack of previous studies of imeglimin in MIDD and the need to pay attention to side effects, the dosage was carefully increased from 500 mg to the maximum dosage of 2000 mg in 8 weeks. To confirm the onset of effect, administration was continued for 3 months.
Adverse events
nothing
Outcome measures
This is the change in HbA1c after 16 weeks of imeglimin treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 08 | Day |
Last modified on
| 2024 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052979
