UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053150 |
|---|---|
| Receipt number | R000060541 |
| Scientific Title | Evaluation of the efficiency and safety of imeglimin on insulin secretion ability and insulin sensitivity in the treatment of type 2 diabetes mellitus |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2024/12/19 09:11:51 |
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Basic information
Public title
Evaluation of the efficiency and safety of imeglimin on insulin secretion ability and insulin sensitivity in the treatment of type 2 diabetes mellitus
Acronym
Evaluation of the efficacy and safety of imeglimin on insulin secretion ability and insulin sensitivity
Scientific Title
Evaluation of the efficiency and safety of imeglimin on insulin secretion ability and insulin sensitivity in the treatment of type 2 diabetes mellitus
Scientific Title:Acronym
Evaluation of the efficacy and safety of imeglimin on insulin secretion ability and insulin sensitivity
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of imeglimin on insulin secretion ability and insulin sensitivity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fasting blood glucose and IRI are set to be measured at baseline,3,6,9,12 months
Key secondary outcomes
Body mass index (BMI),blood pressure,albumin creatinine ratio (ACR),lipid and liver function are set to be measured at baseline,3,6,9,12 months
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Active treatment of imeglimin 2000mg a day
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
type 2 diabetes patients
Key exclusion criteria
1) eGFR<30
2) Pregnancy or breastfeeding
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Hattori |
Organization
Foundation Health Medicine Association Tohto Clinic
Division name
Department of Diabetes and Metabolism
Zip code
102-0094
Address
4-1Kioi-Cho,Chiyoda-Ku,Tokyo,Japan
TEL
03-3239-0301
s-hattori@kenkoigaku.or.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Hattori |
Organization
Foundation Health Medicine Association Tohto Clinic
Division name
Department of Diabetes and Metabolism
Zip code
102-0094
Address
4-1Kioi-Cho,Chiyoda-Ku,Tokyo,Japan
TEL
03-3239-0301
Homepage URL
s-hattori@kenkoigaku.or.jp
Sponsor or person
Institute
Department of Diabetes and Metabolism,Tohto Clinic
Institute
Department
Personal name
Funding Source
Organization
None
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
REC,Tohto Clinic
Address
4-1Kioi-Cho,Chiyoda-Ku,Tokyo,Japan
Tel
03-3239-0301
rinri-tohto@kenkoigaku.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
| 2023 | Year | 12 | Month | 25 | 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
| 2023 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060541
