T2DM
Conditions
Interventions
Treatment group:Daidzein 50 mg orally three times daily (total 150 mg/day) plus metformin 1.5g orally three times daily (total 1.5 mg/day)for 12 weeks.
Control group:Matched placebo orally three times daily plus metformin 1.5g orally three times daily (total 1.5 mg/day)for 12 weeks.
Sponsors
Jiangsu Province Hospital on Integration of Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years; 2. Physician-diagnosed type 2 diabetes; 3. Uninterrupted metformin at a stable total dose of >=1,500 mg/day for at least 12 weeks before screening, with willingness to maintain the dose during the 12-week intervention; 4. Metformin-low responder (MLR) status, defined as week-12 HbA1c remaining >6.5% and absolute HbA1c reduction <=1.0% from the pre-metformin baseline; 5. Screening HbA1c 6.5%-11.0%; 6. BMI 23.5-35.0 kg/m²; 7. Willing and able to comply with standardized lifestyle counselling and study procedures; 8. Able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Use of any glucose-lowering medication other than metformin within 12 weeks before screening; 2. Insulin use for >30 days within the previous 12 months; 3. Type 1 diabetes, secondary diabetes, prior diabetic ketoacidosis, lactic acidosis, or hyperosmolar coma; 4. Unexplained severe hypoglycaemia within 3 months before screening or recurrent hypoglycaemia (>3 episodes in the month before screening); 5. Fasting C-peptide 2.5 x ULN, total bilirubin >1.5 x ULN, or known active viral hepatitis); 8. Clinically significant renal impairment (e.g., eGFR <60 mL/min/1.73 m²); 9. Clinically significant psychiatric illness, haemoglobinopathy, immunodeficiency, active malignancy, or other major endocrine/immune disorder requiring systemic treatment; 10. Systemic corticosteroid exposure within 12 months before screening; 11. Excessive alcohol intake, substance misuse, or any condition judged likely to compromise safety, adherence, or data integrity; 12. Other clinically significant screening abnormalities that could interfere with participation or interpretation of outcomes.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose ;Change in 2-hour postprandial glucose (2h-PPG);Change in plasma metformin concentration;Change in fecal metformin concentration;Change in fecal microbiome;AST;ALT;Urea nitrogen;Serum uric acid;Total bilirubin;Creatinine;Microbial enzyme; | — |
Primary
| Measure | Time frame |
|---|---|
| HbA1c ; | — |
Countries
China
Contacts
Public ContactJuan Xu
Jiangsu Province Hospital on Integration of Chinese and Western Medicine
Outcome results
None listed