UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048621 |
|---|---|
| Receipt number | R000055401 |
| Scientific Title | Add-on imeglimin versus metformin dose escalation regarding blood glucose fluctuation in patients with type 2 diabetes treated with low-dose metformin |
| Date of disclosure of the study information | 2022/08/08 |
| Last modified on | 2024/09/30 10:02:02 |
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Basic information
Public title
Add-on imeglimin versus metformin dose escalation regarding blood glucose fluctuation in patients with type 2 diabetes treated with low-dose metformin
Acronym
Imeglimin CGM study
Scientific Title
Add-on imeglimin versus metformin dose escalation regarding blood glucose fluctuation in patients with type 2 diabetes treated with low-dose metformin
Scientific Title:Acronym
Add-on imeglimin versus metformin dose escalation regarding blood glucose fluctuation in patients with type 2 diabetes treated with low-dose metformin
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 assess the effects of add-on imeglimin or metformin dose escalation on glucose fluctuation in patients with type 2 diabetes treated with metformin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of indices for glycemic variability before and after changing the treatment
Key secondary outcomes
Influencing factors on changes of CGM parameters
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with type 2 diabetes who were hospitalized in Hokkaido University Hospital from August 2020 to December 2020.
2) 20-90 years old
3) Patients who have been treated with metformin 500-1,000 mg/day with appropriate dietary therapy
4) Treatment with imeglimin or metformin dose escalation will be appropriate to achieve preferable glycemic control
5) Patients who will receive CGM assessment
6) Agreement to participate to this study
Key exclusion criteria
1) History of anaphylaxis of imeglimin or metformin
2) Unstable diabetic retinopathy
3) Severe hepatic dysfunction, renal dysfunction(eGFR<45 mL/min/1.73m2)
4) Pregnancy
5) Diabetic ketosis, coma and precoma
6) Serious infection, pre-or post-surgery
7) Poor adherence to dietary therapy
8) Poor insulin secretion
9) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Hokkaido University Hospital
Division name
Department of diabetology and endocrinology
Zip code
060-0811
Address
North 15 West 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
hnomoto@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Hokkaido University Hospital
Division name
Department of diabetology and endocrinology
Zip code
060-0811
Address
North 15 West 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
hnomoto@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
North 14 West 5, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.15639
Number of participants that the trial has enrolled
16
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 | 07 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 08 | 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
After obtaining written informed consent from the participants, a CGM device will be attached, in accordance with the manufacturer's instructions. Then, the participants will be monitored for at least 2 days while on their original metformin therapy, after which imeglimin or metformin will be added. After a 24-hour transition period, the participants will be monitored again for at least 48 hours. If patients will be appropriate to be switched to other treatment arm, additional 48 hours of CGM assessment will be performed.
Management information
Registered date
| 2022 | Year | 08 | Month | 08 | Day |
Last modified on
| 2024 | 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=R000055401
