UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050556 |
|---|---|
| Receipt number | R000057579 |
| Scientific Title | The Efficacy and Safety of Imeglimine in Elderly People with Type 2 Diabetes Mellitus |
| Date of disclosure of the study information | 2023/03/11 |
| Last modified on | 2023/03/10 12:32:11 |
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Basic information
Public title
The Efficacy and Safety of Imeglimine in Elderly People with Type 2 Diabetes Mellitus
Acronym
Imeglimin in Elderly Diabetes
Scientific Title
The Efficacy and Safety of Imeglimine in Elderly People with Type 2 Diabetes Mellitus
Scientific Title:Acronym
Imeglimin in Elderly Diabetes
Region
| Japan |
Condition
Condition
Elderly people with type 2 diabetes (65 years and older)
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the safety and efficacy of Imeglimine in people with type 2 diabetes aged 65 years and older.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic profilse after treatment with Imeglimin
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
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Imeglimin 2000 mg a day
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) People with type 2 diabetes over 65 years old
2) HbA1c of 6.5% to 10.0% before intervention (4 to 8 weeks ago)
3) People scheduled to receive Imeglimine who have an indication to use Imeglimine
Key exclusion criteria
1) Patients on multiple insulin injection therapy (basal and bolus insulin therapy)
2) Patients with renal dysfunction (glomerular filtration rate (eGFR) <45 mL/min/1.73 m2)
3) Patients with severe anemia (Hb < 10g/dL)
4) Patients who are using an implantable medical device (e.g. pacemaker)
5) Patients with severe cognitive impairment
6) Patients with active malignant tumors
7) Patients who are judged by the principal investigator or subinvestigator to be inappropriate to participate in this clinical research
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
2520374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
ahayashi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | |
| Last name | Fujishima |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
2520374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
Homepage URL
ahayashi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Akinori Hayashi
Funding Source
Organization
JSPS KAKEN
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Grants for young researchers from Japan Association for Diabetes Education and Care
IRB Contact (For public release)
Organization
Kitasato University Medical School Ethics Committee
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
rinrib@med.kitasato-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
| 2023 | Year | 03 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | 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 | 03 | Month | 10 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057579
