type 2 diabetes diabetes
Conditions
Interventions
Sponsors
Sakaguchi Kazuhiko
Eligibility
Sex/Gender
All
Inclusion criteria
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 at the time of providing informed consent. (3) Patients who have not received treatment with either metformin or imeglimin for at least 12 weeks prior to providing informed consent. (4) Patients for whom initiation of metformin or imeglimin is clinically indicated. (5) Patients whose HbA1c level is between 6.0 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.
Exclusion criteria
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 who have used any of the following medications or dietary supplements within the past 6 months: oral or intravenous iron preparations; oral zinc preparations; multimineral supplements containing copper; vitamin B12 preparations (including combination products containing vitamin B12); folic acid preparations; corticosteroids; or immunosuppressive agents (e.g., tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, methotrexate, or biologic agents). (13) Patients with low hemoglobin levels (14) Patients with rheumatoid arthritis or collagen diseases. (15) Patients deemed inappropriate for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in serum copper levels at 52 weeks after initiation of study drug administration in the metformin group and the imeglimin group, along with the corresponding 95% confidence intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline at 26 and 52 weeks after initiation of study drug administration in metal dynamics (serum ceruloplasmin concentration, serum iron concentration, serum ferritin concentration, transferrin concentration, UIBC, TSAT, and serum zinc concentration), serum vitamin B12 concentration, and serum homocysteine concentration 2. Change from baseline at 26 and 52 weeks after initiation of study drug administration in inflammatory markers (high-sensitivity CRP, TNF-alpha, and IL-6 levels) 3. Change from baseline at 26 and 52 weeks after initiation of study drug administration in HbA1c 4. Change from baseline at 26 and 52 weeks after initiation of study drug administration in glucose metabolism indices (HOMA-IR and HOMA-beta) 5. Change from baseline at 26 and 52 weeks after initiation of study drug administration in urinary albumin concentration and eGFR 6. Change from baseline at 26 and 52 weeks after initiation of study drug administration in handgrip strength | — |
Contacts
Public ContactNatsu Otowa-Suematsu
Kobe University Hospital
Outcome results
None listed