Type 2 Diabetes
Conditions
Interventions
Metformin group:Metformin hydrochloride tablets (approved by the state to be on the market), oral, dosage in accordance with the doctor's advice (to maintain the stable tolerance dose before enrollmen
Baicalin combined with metformin group:Metformin hydrochloride tablet, oral, dosage in accordance with the doctor's advice (maintain stable tolerance dose before enrollment), continuous 12 weeks
Baicalin capsule (approved to be on the market) was taken orally, 0.5 g/ time, three times a day, for 12 weeks
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Voluntarily participate in and sign informed consent, understand and be willing to comply with the requirements of the research protocol to complete the study; 2) Men and women aged =18 years and =75 years; 3) Diagnosed as type 2 diabetes according to the diabetes diagnostic criteria issued by the World Health Organization (WHO) in 1999; 4) At least 8 weeks of metformin monotherapy at a steady dose =1500mg/ day or maximum tolerated dose (< 1500mg/ day but =1000mg/ day); 5) HbA1c values during screening and before randomization were 7.5%=HbA1c=9.0%; 6) body mass index (BMI) =18.5kg/m2 =35kg/m2; 7) No probiotics or antibiotics were used within 4 weeks before enrollment; 8) Fertile women (WOCBP) subjects should use reliable contraceptive methods at least 1 month before screening, throughout the trial, and for 3 months after completion of the trial; Male subjects should use reliable contraception to avoid impregnating their sexual partners throughout the trial and within 3 months after the trial.
Exclusion criteria
Exclusion criteria: 1) Non-type 2 diabetes: type 1 diabetes, gestational diabetes, or other special types of diabetes; 2) Patients with severe diabetes complications; 3) Those who used drugs other than metformin that may affect blood glucose metabolism within 8 weeks before screening or before randomization, such as other types of hypoglycemic drugs, systemic glucocorticoids (except inhalation or topical application), growth hormone, etc.; 4) Continuous use of insulin for more than 14 days within 1 year before screening or prior to randomization (the duration of receiving insulin therapy for gestational diabetes mellitus is not within this limitation range); 5) Prior to screening or randomized treatment with any dipeptidyl peptidase 4 (DPP-4) inhibitor or glucose-dependent insulin stimulating polypeptide (GIP) or/and glucagon-like peptide-1 (GLP-1) receptor agonist; 6) Pregnancy or lactation; 7) Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA); 8) Patients with significant history of cardiovascular and cerebrovascular diseases within 6 months prior to screening were defined as myocardial infarction, coronary artery bypass grafting or angioplasty, valvular heart disease or repair, unstable angina, transient ischemic attack or cerebrovascular accident; 9) Malignant tumor (except cured basal cell carcinoma) within 5 years prior to screening; 10) Lower limb edema or systemic edema; 11) Moderate to severe renal insufficiency (eGFR 300 mg/g; 13) Triglyceride value over 5.6 mmol/L; 14) Active liver disease and/or significant liver dysfunction, with significant liver dysfunction defined as alanine aminotransferase (ALT) > 2.5 times the upper limit of normal and/or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal and/or total bilirubin > 1.5 times the upper limit of normal; 15) Ecg examination showed clinically significant arrhythmias that required treatment or intervention, and some researchers judged that they were not suitable to participate in the clinical trial; 16) Positive antibodies to human immunodeficiency virus (HIV); Treponema pallidum antibody positive; Hepatitis B surface antigen positive and HBV DNA quantitative detection value is higher than the upper limit; Hepatitis C antibody positive and HCV RNA quantitative detection value higher than the upper limit; 17) History of illicit drug abuse in the 12 months prior to screening; 18) Participated in other clinical trials within 90 days prior to screening; 19) Those who have donated whole blood, plasma or platelets within 3 months prior to screening; 20) Allergy or contraindication of drugs or related excipients involved in this study; 21) Before randomization, the researchers judged that the subjects had poor adherence to study protocol or drug therapy, and poor adherence was defined as taking less than 80% or more than 120% of the prescribed dose of baicalin capsule or metformin tablet; 22) The investigator considered it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| FPG;2h PG;ALT;AST; | — |
Countries
China
Contacts
Public ContactWang Aiting
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed