type 2 diabetes
Conditions
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years (including the cut-off value), regardless of gender; 2. Type 2 diabetes according to the 1999 WHO diagnostic criteria, and 7.0% =24kg/m^2; 5. Patients gave informed consent before the trial and voluntarily signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. The patient has a history of allergy to the test drug or its preparations and excipients or other related drugs, or has present allergic diseases, or has a high sensitivity constitution; 2. Liver and renal function damage. According to the reference value index of each hospital laboratory, serum ALT and AST exceeded the upper limit of the reference value range by 2 times; The estimated glomerular filtration rate (eGFR) was =50pg/mL (ng/L) at the time of screening; 4. Clinically significant and active cardiovascular disease (within the past 12 months) was defined as: (1) Myocardial infarction (MI); (2) Severe arrhythmia or grade ? type ? or ? block on ECG; (3) Unstable angina pectoris; (4) Congestive heart failure (NYHA class II or above); 5. Poor blood pressure control: blood pressure >=160/110mmHg (including treatment with antihypertensive drugs); 6. Patients with a history of pancreatitis, acute or chronic cholecystitis or gallstones; 7. Patients with previous or family history of medullary thyroid cancer (MTC) and patients with multiple endocrine tumor syndrome type 2 (MEN2); 8. Diagnose gastrointestinal motility disorders or obstructive diseases, such as gastroparesis and gastroesophageal reflux disease; 9. Use drugs that may cause significant weight gain within 3 months before screening: including systemic glucocorticoid therapy lasting more than 1 week (excluding topical and inhaled agents); Tricyclic antidepressants; Antipsychotic or antidepressant drugs (mipramine, amitriptyline, mirtazapine, paroxetine, phenylhydrazine, chlorpromazine hydrochloride, clozapine, olanzapine, valerate and its derivatives, lithium preparations, methionidazine, etc.); 10. Patients with history of bariatric surgery; 11. Obesity caused by other endocrine diseases, such as Cushing's syndrome, hypothyroidism, polycystic ovary disease or other genetic endocrine diseases; 12. Have a clear history of mental illness, such as depression, schizophrenia, bipolar disorder; 13. Have a definite history of tumor; 14. Amylase or lipase >=3 x ULN during screening; 15. Severe lipid metabolism disorders: TG >=500 mg/dL (5.7 mmol/L) at screening; 16. Patients with inflammatory bowel disease and other diseases affecting intestinal flora; 17. Patients who received antibiotics for more than 7 days in the first three months of the trial and medications affecting gut microbiota such as dietary supplements, fiber supplements, antibiotics, bile acid chelators, proton pump inhibitors, H2 receptor antagonists, probiotics, herbs, and nutrients during treatment; 18. Active proliferative diabetic retinopathy confirmed by local or panretinal photocoagulation or vitrectomy within 6 months before the first visit, or other unstable (rapidly progressing) retinopathy during the study that may require surgical treatment (including laser coagulation); 19. Recurrent hypoglycemic events as judged by the investigator; 20. The patients were unable to comply with the treatment protocol and diabetic diet formulated by the researcher, and were unwilling or unable to perform self-monitoring of blood glucose; 21. Pregnant or lactating patients or patients intending to become pregnant (including their spouse's pregnancy), and patients of childbearing age who do not use effective contraceptive measures (referring
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal gut microbiota abundance;HbA1c; | — |
Countries
China
Contacts
Public ContactZhang Li'na
Beijing Hospital
Outcome results
None listed