Type 2 Diabetes
Conditions
Interventions
Met+HQT:Metformin Hydrochloride Tablets (approved and marketed by the state), 0.5 g each time, 3 times a day, for 4 weeks
Huangqin Decoction, 100 mL/time, 2 times/day, for 4 weeks
Metformin effective patients:N/A
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Volunteer to participate in and sign the informed consent form, be able to understand and willing to comply with the requirements of the research protocol to complete the study; 2) Men and women aged = 18 and = 75; 3) According to the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999, patients with type 2 diabetes were diagnosed; 4) At least 8 weeks after treatment with a single dose of stabilizer of metformin and the dose of metformin = 1500mg/day or the maximum tolerated dose (<1500mg/day but = 1000mg/day); 5) At screening, the HbA1c value met: HbA1c < 7.0% (patients with metformin effective) or 7.0% = HbA1c = 9.0% (patients with metformin ineffective); 6) Body mass index BMI = 18.5kg/m2 and = 35kg/m2; 7) No probiotics or antibiotics were used within 4 weeks before enrollment; 8) Women with fertility (WOCBP) subjects should take reliable contraceptive measures at least 1 month before screening, during the whole test process and within 3 months after completing the test; Male subjects should take reliable contraceptive measures to avoid pregnancy of their sexual partners during the whole test and within 3 months after the test.
Exclusion criteria
Exclusion criteria: 1) Non type 2 diabetes: type 1 diabetes, pregnancy diabetes or other special types of diabetes; 2) Patients with severe complications of diabetes; 3) Those who have used drugs other than metformin that may affect blood glucose metabolism within 8 weeks before screening, such as other types of hypoglycemic drugs, systemic glucocorticoids (except for inhalation or local external use), growth hormone, etc; 4) Continuous use of insulin for more than 14 days within 1 year before screening (the time of receiving insulin treatment for gestational diabetes is not within the limit); 5) Those who have used any dipeptidyl peptidase 4 (DPP-4) inhibitor or glucose-dependent insulin-promoting polypeptide (GIP) or/or glucagon-like peptide-1 (GLP-1) receptor agonist before screening; 6) Pregnancy or lactation; 7) The New York Heart Association (NYHA) defines congestive heart failure as Grade III or IV; 8) Those who have a significant history of cardio-cerebrovascular disease within 6 months before screening are defined as myocardial infarction, coronary artery bypass grafting or angioplasty, cardiac valve disease or repair, unstable angina pectoris, transient ischemic attack or cerebrovascular accident; 9) Malignant tumor (excluding the cured basal cell carcinoma) within 5 years before screening; 10) Lower limb edema or systemic edema; 11) Moderate and severe renal insufficiency (eGFR300 mg/g; 13) Triglyceride value exceeds 5.6 mmol/L; 14) Active liver disease and/or obvious liver function abnormality, which is defined as alanine aminotransferase (ALT)>2.5 times the upper limit of normal value and/or aspartate aminotransferase (AST)>2.5 times the upper limit of normal value and/or total bilirubin>1.5 times the upper limit of normal value; 15) ECG examination has clinically significant arrhythmia and requires treatment or intervention. Some researchers have judged that it is not suitable to participate in this clinical trial; 16) Human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive; Hepatitis B surface antigen is positive and the quantitative detection value of HBV DNA is higher than the upper limit; Those with positive hepatitis C antibody and HCV RNA quantitative detection value higher than the upper limit; 17) Have a history of illicit drug abuse within 12 months before screening; 18) Participated in other clinical trials within 90 days before screening; 19) Those who have donated whole blood, plasma or platelets within 3 months before screening; 20) Those who are allergic or contraindicated to the drugs or related excipients involved in this study; 21) The researcher judged that the subject followed the study protocol or had poor compliance with drug treatment, which was defined as the subject taking less than 80% or more than 120% of the prescribed dose of baicalin decoction or metformin tablets; 22) The researcher believes that it is not suitable to participate in this clinical trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Efficiency;Gastrointestinal adverse reactions;routine blood test;urinalysis;Liver and kidney function;Intestinal bacteria;Key protease;Metabolites (such as imidazolpropionic acid); | — |
Primary
| Measure | Time frame |
|---|---|
| HbA1c;FPG; | — |
Countries
China
Contacts
Public ContactWang Aiting
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed