Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients

Prior treatment

• History of acute complications of diabetes within 6 months before screening (diabetic ketoacidosis, diabetic hyperglycemic hyperosmolar syndrome or lactic acidosis, etc.);
• 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.);
• Experienced more than 3 episodes of grade 3 hypoglycemia within 6 months before screening;
• Have used systemic (intravenous, oral or intra-articular) glucocorticoids continuously or cumulatively for ≥ 7 days within 3 months before screening;
• Severe infection within 3 months before screening;
• 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.;
• Accompanied by thyroid dysfunction that cannot be controlled with stable drug dosage during screening;
• 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;
• 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;
• Blood donation or massive blood loss (\>400 mL) within 3 months before screening;
• Participated in any interventional drug clinical research within 3 months before screening;

Other illness

• Non-type 2 diabetes: type 1 diabetes, gestational diabetes, special types of diabetes;
• 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);
• 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;
• History of organ transplantation or severe autoimmune diseases in the past or present;
• History of clinically significant drug allergy or atopic allergic disease (asthma, urticaria, eczematous dermatitis);
• History of alcohol, tobacco addiction or drug abuse is known or suspected at the time of screening;
• Allergic to study drugs and their ingredients;

Lab values

• 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;
• 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)

Other

• 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;
• Participants who the researcher believes have any other factors that are inappropriate for participating in this study.

• Age 18-75 years (inclusive), male or female;
• Patients diagnosed with T2DM ≥ 8 weeks according to the 2020 WHO diagnostic criteria and classification;
• 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;
• Body mass index (BMI) ≥ 19 kg/m2;
• Glycated hemoglobin (HbA1c) ≥ 7.0% and \< 10.5% at screening;
• Fasting plasma glucose (FPG) \< 13.9 mmol/L at screening;
• 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