UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055241 |
|---|---|
| Receipt number | R000063122 |
| Scientific Title | Benefits and disadvantages of combining imeglimin with other antidiabetic agents in patients with type 2 diabetes |
| Date of disclosure of the study information | 2024/08/14 |
| Last modified on | 2025/02/13 16:26:01 |
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Basic information
Public title
Benefits and disadvantages of combining imeglimin with other antidiabetic agents in patients with type 2 diabetes
Acronym
Benefits and disadvantages of combining imeglimin with other antidiabetic agents in patients with type 2 diabetes
Scientific Title
Benefits and disadvantages of combining imeglimin with other antidiabetic agents in patients with type 2 diabetes
Scientific Title:Acronym
Benefits and disadvantages of combining imeglimin with other antidiabetic agents in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine benefits and disadvantages of combining imeglimin with other antidiabetic agents in patients with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Adverse events, body weight, FIB-4
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who were administered imeglimin 1,000 mg twice daily between November 2022 and January 2024
Key exclusion criteria
Patients who had already been administered imeglimin at the initial consultation
Patients discontinued treatment or were transferred to other medical institutions during the observation period
Patients with eGFR of <45 mL/min/1.73 m2 at the initiation of imeglimin
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL
03-3673-1221
ito@edogawa.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL
03-3673-1221
Homepage URL
ito@edogawa.or.jp
Sponsor or person
Institute
Edogawa Hospital
Institute
Department
Personal name
Hiroyuki Ito
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Ethics Committee of Edogawa Hospital
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
Tel
03-3673-1221
ito@edogawa.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
江戸川病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 14 | 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
94
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
| 2023 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
under analyses
Management information
Registered date
| 2024 | Year | 08 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063122
