Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058554) titled 'A study investigating the effects of metformin on metal balance in patients with type 2 diabetes' on Nov. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Kobe University Graduate School of Medicine

Condition: Condition - Type 2 diabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the impact of metformin on serum metal homeostasis and glycemic control in patients with type 2 diabetes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Metformin Interventions/Control_2 - Imeglimin

Eligibility: Age-lower limit - 20 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 Size - 64

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 19 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066729

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