UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049203 |
|---|---|
| Receipt number | R000055825 |
| Scientific Title | Evaluation of effect on the postprandial glucose elevation and glycemic variability of Imeglimin |
| Date of disclosure of the study information | 2022/10/13 |
| Last modified on | 2024/01/25 14:52:39 |
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Basic information
Public title
Investigation of the efficacy of Imeglimin on glycemic control and the underlying mechanisms
Acronym
IMAGINE
IMeglimin Amplifies Glucose-stimulated INsulin secretion and modifies glycemic Elevation in type 2 diabetes
Scientific Title
Evaluation of effect on the postprandial glucose elevation and glycemic variability of Imeglimin
Scientific Title:Acronym
IMAGINE
IMeglimin Amplifies Glucose-stimulated INsulin secretion and modifies glycemic Elevation in type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine of the effect on the postprandial glucose elevation and the glycemic variability of Imeglimin as add-on therapy in patients with type 2 diabetes inadequately controled with DPP-4 inhibitor monotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of the AUC insulin/AUC glucose between pre and post intervention
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
Imeglimin 2000mg/day for 12 weeks
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patients with type 2 diabetes
(2)Patients with an eGFR of 45mL/min/1.73m2 or more
(3)Patients aged 20 to 80
(4)Patients who have the avility to consent to participation in this study and who can understand the consent form and other explanatory documents
(5) Patients who have been treated with monotherapy of DPP-4 inhibitors in the past 3months
Key exclusion criteria
(1)Type 1 diabetes mellitus patients
(2)Patients with severe liver disease or AST (GOT) or ALT (GPT) >100 IU/L
(3)Patients with serious renal disease and patients with a serum creatinine level of 2.0 mg/dL or higher before the start of the study
(4)Patients with overt heart failure and those who had myocardial infarction within 3 months before the start of the study
(5)Patients with severe pancreatic disease
(6)Patients with acute stage/serious condition that may cause change in condition due to blood sugar fluctuation or addition of drugs
(7)Patients with serious infections or serious trauma. Patients before and after surgery
(8)Patients with severe chronic bowel disease accompanied by inflammatory bowel disease, colonic ulcer, focal bowel obstruction, bowel obstruction predisposition, or digestive/absorptive disorders
(9) Excessive habitual drinkers
(10) Pregnant women, women who may be pregnant, women who wish to become pregnant, and women who are breastfeeding
(11) Patients who are judged to be inappropriate by the investigator
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Hirose |
Organization
Toho University School of Medicine
Division name
Divsion of diabetes, metabolism and endocrinology
Zip code
143-8541
Address
6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
TEL
03-3762-4151
takahisa.hirose@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Itsukaichi |
Organization
Toho University School of Medicine
Division name
Divsion of diabetes, metabolism and endocrinology
Zip code
143-8541
Address
6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
TEL
03-3762-4151
Homepage URL
atsushi.itsukaichi@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university
Institute
Department
Personal name
Funding Source
Organization
Toho 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
Toho University Medical Center Omori Hospital Ethics Committee Secretariat
Address
6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
Tel
03-5763-6534
omori.rinri@ext.toho-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
| 2022 | Year | 10 | Month | 13 | 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
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055825
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