UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058554 |
|---|---|
| Receipt number | R000066729 |
| Scientific Title | A Prospective, Randomized, Open-Label, Parallel-Group Study of the Effects of Metformin on Metal Dynamics in Patients With Type 2 Diabetes: Comparison With Imeglimin |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/07/22 22:17:31 |
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Basic information
Public title
A study investigating the effects of metformin on metal balance in patients with type 2 diabetes
Acronym
Metformin Metal Balance Study
Scientific Title
A Prospective, Randomized, Open-Label, Parallel-Group Study of the Effects of Metformin on Metal Dynamics in Patients With Type 2 Diabetes: Comparison With Imeglimin
Scientific Title:Acronym
MIMET Study (Metformin vs Imeglimin on Metal dynamics Trial)
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of metformin on serum metal homeostasis and glycemic control in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in serum copper concentration from baseline to the end of the study in the metformin group
Key secondary outcomes
1) Changes in metal dynamics and related biomarkers from baseline to 52 weeks after initiation of the study drug in both the metformin and imeglimin groups, including:
serum copper concentration (imeglimin group),ceruloplasmin concentration, serum iron concentration, ferritin concentration, transferrin concentration, unsaturated iron-binding capacity (UIBC),transferrin saturation (TSAT),serum zinc concentration, serum vitamin B12 concentration, serum homocysteine concentration
2) Changes in inflammatory markers (high-sensitivity C-reactive protein [hsCRP], tumor necrosis factor-alpha [TNF-alpha], and interleukin-6 [IL-6]) from baseline to 52 weeks after initiation of the study drug
3) Change in HbA1c from baseline to 52 weeks after initiation of the study drug
4) Changes in glycemic parameters (HOMA-IR and HOMA-beta) from baseline to 52 weeks after initiation of the study drug
5) Changes in urinary albumin concentration and estimated glomerular filtration rate (eGFR) from baseline to 52 weeks after initiation of the study drug
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Metformin
Interventions/Control_2
Imeglimin
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients who have been diagnosed with type 2 diabetes at the time of providing informed consent.
(2) Patients who are 20 years of age or older and younger than 75 years at the time of providing informed consent.
(3) Patients whose body mass index (BMI) is 18.5 kilograms per square meter or higher at the time of eligibility screening.
(4) Patients who have not received treatment with either metformin or imeglimin for at least 12 weeks prior to providing informed consent.
(5) Patients whose HbA1c level is between 5.9 percent (inclusive) and 9.5 percent (exclusive) at the time of eligibility screening.
(6) Patients who have voluntarily provided written informed consent to participate in this study.
Key exclusion criteria
(1) Patients with a history of surgical resection of the stomach, duodenum, or small intestine (excluding EMR/ESD).
(2) Patients with malabsorption disorders (e.g., chronic pancreatitis, IBD, malabsorption syndrome).
(3) Patients with eGFR below 45 mL/min/1.73 m2.
(4) Patients with severe liver dysfunction or cirrhosis.
(5) Patients under active treatment for malignancy.
(6) Patients with a history of lactic acidosis.
(7) Patients with excessive alcohol intake.
(8) Patients classified as NYHA class III or IV within the past year.
(9) Patients with a history of severe ketosis, diabetic coma, or precoma.
(10) Patients with severe infection or major trauma.
(11) Pregnant, possibly pregnant, or breastfeeding women.
(12) Patients using iron supplements.
(13) Patients using zinc supplements.
(14) Patients taking supplements containing copper.
(15) Patients using vitamin B12 preparations (including combination tablets).
(16) Patients using folic acid preparations.
(17) Patients with low hemoglobin levels:
(18) Patients on oral or intravenous corticosteroids.
(19) Patients with rheumatoid arthritis or collagen diseases.
(20) Patients deemed inappropriate for participation by the investigator.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kobe University Graduate School of Medicine
Division name
Diabetes and Endocrinology, General Internal Medicine
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Natsu |
| Middle name | |
| Last name | Otowa-Suematsu |
Organization
Kobe University Graduate School of Medicine
Division name
Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city
TEL
078-382-5861
Homepage URL
suematsu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kobe University Hospital
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city
Tel
078-382-6669
ctrcpj-kenkyukanrijimu@med.kobe-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
| 2025 | Year | 11 | 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
| 2025 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 07 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066729
