Type 2 diabetes
Conditions
Interventions
treatment group:IBOB001
control group:placebo
Sponsors
Anhui Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-75 years old; (2) Glycosylated hemoglobin levels ranged from 7.0% to 9.0% (inclusive); a. Blood glucose level measurement: fasting blood glucose (FPG): >= 7.0 mmol/l. random blood glucose or OGTT (oral glucose tolerance test) 2-hour blood glucose: >= 11.1 mmol/L. b. Glycosylated hemoglobin (HbA1c) level: HbA1c is one of the diagnostic criteria for diabetes, and HbA1c >= 6.5% is taken as the cut-off point to assist in the diagnosis of diabetes. (3) At least 8 weeks before screening, on the basis of regular diet control and exercise, patients were treated with a stable dose of metformin, and the dose of metformin was >= 1500mg/d; (4) Voluntary participation in this clinical trial
Exclusion criteria
Exclusion criteria: (1) Antibiotics were taken orally within one month; (2) Taking fermented products such as yogurt, pickles and pickles or allergic to intervention preparations in the past two weeks; (3) Type 1 diabetes, special types of diabetes (such as diabetes caused by pancreatic injury, Cushing syndrome or diabetes caused by acromegaly, etc.) (4) Any of the following drugs or treatments were used before screening: 1) Any drug other than metformin that may affect blood glucose metabolism, such as other hypoglycemic drugs, systemic glucocorticoids (except for inhalation or local external use), growth hormone, etc., has been used within 8 weeks before screening; 2) The cumulative use of insulin in the first year before screening was more than 14 days. 3) Have used any dipeptidyl peptidase 4 (DPP-4) inhibitor or Glucose dependent insulinotropic peptide (GIP) or/and glucagon like peptide-1 (GLP-1) receptor agonist for treatment; (5) The self-reported weight change was more than 5 kg within 90 days before screening; (6) Diseases or living habits that may affect weight regulation, such as thyroid disease, eating disorders, etc; (7) Have digestive tract diseases (such as chronic diarrhea or severe constipation), or have a history of intestinal resection or other digestive tract operations (such as cholecystectomy) in the past 1 year Or history of other non gastrointestinal operations in the past 6 months; (8) Severe liver dysfunction was defined as serum alanine aminotransferase concentration exceeding 2.5 times the upper limit of the normal range. Or renal function impairment (defined as serum creatinine>132 umol/L or estimated glomerular filtration rate (EGFR)= grade III; (10) The history of malignant tumors (except local skin basal cell carcinoma) in the past 5 years, whether there is evidence of recurrence or metastasis; (11) Pregnant or lactating women, or planned pregnancy in the next 6 months; (12) A person who has a history of abusing alcohol, drugs or other substances that can easily lead to dependence and is unable to abstain from alcohol during the trial; (13) Participate in other clinical trials in the past 6 months; (14) Any condition that the investigator believes may interfere with the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;2h postprandial blood glucose; | — |
Countries
China
Contacts
Public ContactXueying Zheng
Subordinate to Anhui Provincial Hospital
Outcome results
None listed