Overview

The goal of this investigator-initiated clinical trial is to investigate the efficacy and safety of sequential therapy of Fuling Yunhua Granules (prescription A) and Dihuang Baoyuan Granule (prescription B) in the treatment of type 2 diabetes patients with poor glycemic control after diet and exercise intervention.

Eligibility

Inclusion Criteria:

1. Age 18-75 years (inclusive), male or female;
2. Patients diagnosed with T2DM ≥ 8 weeks according to the 2020 WHO diagnostic criteria and classification;
3. Have controlled blood sugar through diet and exercise for 3 months before screening and did not receive any hypoglycemic drugs, or used hypoglycemic drugs for no more than 2 weeks within 3 months before screening and did not use hypoglycemic drugs within 1 month before screening;
4. Body mass index (BMI) ≥ 19 kg/m2;
5. Glycated hemoglobin (HbA1c) ≥ 7.0% and < 10.5% at screening;
6. Fasting plasma glucose (FPG) < 13.9 mmol/L at screening;
7. Able to understand the procedures and methods of this study, willing to strictly abide by the clinical research protocol to complete this study, and voluntarily sign the ICF

Exclusion Criteria:

1. Non-type 2 diabetes: type 1 diabetes, gestational diabetes, special types of diabetes;
2. History of acute complications of diabetes within 6 months before screening (diabetic ketoacidosis, diabetic hyperglycemic hyperosmolar syndrome or lactic acidosis, etc.);
3. History of chronic complications of diabetes with unstable condition or requiring treatment within 6 months before screening (proliferative retinal disease, severe diabetic neuropathy or intermittent claudication, etc.);
4. Experienced more than 3 episodes of grade 3 hypoglycemia within 6 months before screening;
5. Have used systemic (intravenous, oral or intra-articular) glucocorticoids continuously or cumulatively for ≥ 7 days within 3 months before screening;
6. Severe infection within 3 months before screening;
7. Diagnosed with malignant tumors within 5 years before screening (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
8. Severe cardiovascular disease, such as heart failure (New York Heart Association [NYHA] grade III-IV), myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention, occurred within 6 months before screening, Sustained and clinically significant arrhythmia (such as second- or third-degree atrioventricular block or QTc interval prolongation ≥470 ms in men and ≥480 ms in women), acute coronary syndrome or transient ischemic attack or stroke wait;
9. Suffering from diseases that may significantly affect drug absorption, distribution, metabolism and excretion within 6 months before screening: inflammatory bowel disease, peptic ulcer, history of gastrointestinal or rectal bleeding, history of important gastrointestinal surgery (such as : Gastrectomy, gastrointestinal anastomosis, or intestinal resection), etc.;
10. Accompanied by thyroid dysfunction that cannot be controlled with stable drug dosage during screening;
11. History of hypertension and take antihypertensive treatment regularly for more than 4 weeks but still have poor blood pressure control, with systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg;
12. History of organ transplantation or severe autoimmune diseases in the past or present;
13. History of clinically significant drug allergy or atopic allergic disease (asthma, urticaria, eczematous dermatitis);
14. History of major surgery (intrathoracic, intracranial, abdominal, etc.) within 6 months before screening, or those who plan to undergo surgery during the study that may affect study completion or compliance;
15. Any laboratory test meets any of the following criteria during screening:

    Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN) × 2.5 times Glomerular filtration rate (eGFR) calculated using the CKD-EPI formula < 60 mL/min /1.73m2 Total bilirubin (TBIL)>ULN×1.5 times Fasting triglyceride (TG)>5.7 mmol/L Fasting C-peptide <0.8 ng/ml (or 0.26 nmol/L)

16. Those who are positive for hepatitis B surface antigen during screening (except those whose quantitative test results of hepatitis B virus deoxyribonucleic acid [HBV-DNA] are lower than the lower limit of the detection reference range and who are not using anti-hepatitis B virus drugs during screening), or who are receiving anti-hepatitis B virus drug treatment , or those who are hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody positive, or Treponema pallidum antibody positive;
17. Blood donation or massive blood loss (>400 mL) within 3 months before screening;
18. Pregnant or lactating women, or men or women of childbearing potential who plan to become pregnant during the study or are unwilling to take medically recognized contraceptive measures;
19. History of alcohol, tobacco addiction or drug abuse is known or suspected at the time of screening;
20. Participated in any interventional drug clinical research within 3 months before screening;
21. Allergic to study drugs and their ingredients;
22. Participants who the researcher believes have any other factors that are inappropriate for participating in this study.