UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049071 |
|---|---|
| Receipt number | R000055907 |
| Scientific Title | Effects of imeglimin in patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2022/09/30 11:31:11 |
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Basic information
Public title
Effects of imeglimin in patients with type 2 diabetes mellitus
Acronym
Effects of imeglimin in patients with type 2 diabetes mellitus
Scientific Title
Effects of imeglimin in patients with type 2 diabetes mellitus
Scientific Title:Acronym
Effects of imeglimin in patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of imeglimin on various parameters in patients with type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose and skeletal muscle related parameters
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes attending the Department of Diabetes and Metabolism
HbA1c between 7.0% and 10%.
Patients with written consent
Key exclusion criteria
Patients with a history of severe ketoacidosis, diabetic coma, or pre-coma
Patients with malignant tumors and other serious diseases with poor prognosis
Impaired renal function: eGFR <45 mL/min/1.73 m2
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | satoshi |
| Middle name | |
| Last name | ida |
Organization
Ise Red Cross Hospital
Division name
Department of diabetes and metabolism
Zip code
516-8512
Address
1-471-2, Funae, 1-chome
TEL
0596282171
bboy98762006@yahoo.co.jp
Public contact
Name of contact person
| 1st name | satoshi |
| Middle name | |
| Last name | ida |
Organization
Ise Red Cross Hospital
Division name
Department of diabetes and metabolism
Zip code
516-8512
Address
1-471-2, Funae, 1-chome
TEL
0596282171
Homepage URL
bboy98762006@yahoo.co.jp
Sponsor or person
Institute
Ise Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Ise Red Cross Hospital
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
Ethics committee of Ise Red Cross Hospital
Address
1-471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
Tel
0596282171
bboy98762006@yahoo.co.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 | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 09 | Month | 30 | Day |
Last modified on
| 2022 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055907
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
