UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046316 |
|---|---|
| Receipt number | R000052856 |
| Scientific Title | A Prospective Observational Study of clinical use of Imeglimin for type 2 diabetes mellitus |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2023/06/10 19:09:08 |
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Basic information
Public title
A Prospective Observational Study of clinical use of Imeglimin for type 2 diabetes mellitus
Acronym
A Prospective Observational Study of clinical use of Imeglimin for type 2 diabetes mellitus
Scientific Title
A Prospective Observational Study of clinical use of Imeglimin for type 2 diabetes mellitus
Scientific Title:Acronym
A Prospective Observational Study of clinical use of Imeglimin for type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical safety and efficacy of imeglimin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c in 3 months after imeglimin initiation
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who is clinically planned to start imeglimin treatment.
1) Clinically diagnosed type 2 diabetes mellitus
2) Age >= 20 years old
3) Written informed consent
4) HbA1c < 10.5%, eGFR >=45 mL/min/1.73m2
Key exclusion criteria
1) Allergy against imeglimin
2) Severe ketosis, coma, type 1 diabetes
3) Severe infection, surgery, injury
4) eGFR < 45 mL/min/1.73m2
5) Severe liver dysfunction (Child-Pugh C)
6) Subjects with pregnancy or lactation
7) Use of Insulin
8) Others who medical doctors judge as inappropriate subjects for imeglimin use.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nobuya |
| Middle name | |
| Last name | Inagaki |
Organization
Kyoto University Hospital
Division name
Department of Diabetes, Endocrinology, and Nutrition
Zip code
606-8507
Address
54 Kawahara-cho SHogoin SAkyo-ku, Kyoto City
TEL
075-751-3560
inagaki@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Murakami |
Organization
Kyoto University Hospital
Division name
Department of Diabetes, Endocrinology, and Nutrition
Zip code
606-8507
Address
54 Kawahara-cho SHogoin SAkyo-ku, Kyoto City
TEL
075-751-3560
Homepage URL
tmurakam@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Department of Diabetes, Endocrinology, and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2021 | Year | 12 | Month | 10 | 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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study. In daily clinical setting, The subjects with type 2 diabetes who is planned to start imeglimin treatment are enrolled and their datas on electronic health record are used for the analysis.
Management information
Registered date
| 2021 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052856
