Type 2 diabetes
Conditions
Interventions
Metformin
Imeglimin
Sponsors
Kobe University Graduate School of Medicine
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 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.
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum copper concentration from baseline to the end of the study in the metformin group | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNatsu Otowa-Suematsu
Kobe University Graduate School of Medicine Diabetes and Endocrinology
Outcome results
None listed