UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051451 |
|---|---|
| Receipt number | R000058676 |
| Scientific Title | Effect on blood glucose fluctuation after addition of imeglimin in patients with type 2 diabetes mellitus under pre-administration of metformin |
| Date of disclosure of the study information | 2023/06/26 |
| Last modified on | 2023/06/27 09:18:54 |
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Basic information
Public title
Effect on blood glucose fluctuation after addition of imeglimin in patients with type 2 diabetes mellitus under pre-administration of metformin
Acronym
Effect on blood glucose fluctuation after addition of imeglimin in patients with type 2 diabetes mellitus under pre-administration of metformin
Scientific Title
Effect on blood glucose fluctuation after addition of imeglimin in patients with type 2 diabetes mellitus under pre-administration of metformin
Scientific Title:Acronym
Effect on blood glucose fluctuation after addition of imeglimin in patients with type 2 diabetes mellitus under pre-administration of metformin
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Additional administration of 2000 mg of imeglimin to type 2 diabetes patients receiving metformin, and verification of the efficacy of imeglimin using blood glucose fluctuation parameters
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose fluctuation by CGM (Continuous Glucose Monitoring System)
TIR(Time in range)
TAR(Time above range)
TBR(Time below range)
Key secondary outcomes
Blood glucose fluctuation(Blood glucose,GMI,SD,CV,MAGE,CONGA2,MODD,Mvalue)
HbA1c,Body weight
BMI,Fasting blood glucose
Fasting CPR
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Imeglimin group
Interventions/Control_2
within the group
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 7.0 and 12.4 %) under medical treatment by dieting and exercise cure and/or drug treatment.
2)Over 20 years old and less than 80 years old
3)Sex unquestioned
4)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization.
5)The patient who gives a written informed
Key exclusion criteria
1)Type 1 diabetes
2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges)
3)A pregnant woman and/or a woman under breast-feeding
4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)
5)Diabetic proliferative retinopathy
6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug
7)Patient with intolerance of medical reasons by doctor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | teruo |
| Middle name | |
| Last name | jojima |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL
0282872150
joima@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Teruo |
| Middle name | |
| Last name | Jojima |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL
0282872150
Homepage URL
jojima@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nasu red cross hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nasu red cross hospital
Address
1081-4 nakatahara, ootawara city, tochgi
Tel
0287-23-1122
nrchp@nasu.jrc.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 | 06 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2025 | 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 | 06 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058676
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| Registered date | File name |
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