type 2 diabetes
Conditions
Interventions
PEX168 for patients with ideal drug effect and PEX168 for patients with unsatisfactory drug effect fecal transplant group: fecal transplant
PEX168 for patients with unsatisfactory drug effect fecal transplant group: fecal transplant
PEX168 for patients with ideal drug effect and PEX168 for patients with unsatisfactory drug effect no fecal transplant group:no
PEX168 for patients with unsatisfactory drug effect no fecal transplant group:no
Sponsors
Guo Jianjin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed type 2 diabetes according to the 1999 WHO standard; 2. Men and women are not restricted; 3. Aged 18 to 78 years on the day of signing the informed consent form; 4. Body mass index (BMI): 20-40 Kg/m2; 5. Have received at least 8 weeks of diet control and physical exercise treatment before screening; 6. Did not receive any hypoglycemic drug treatment within 8 weeks before screening; 7. At screening, HbA1c 7.5% to 11.0% (local testing or centralized testing); HbA1c 7.0% to 10.5% (centralized testing) at random enrollment, and fasting blood glucose <13.9 mmol/L (local testing); 8. Able to understand the procedures and methods of this research, willing to strictly abide by the clinical trial protocol to complete the trial, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The researcher suspects that the subject may be allergic to the study drug; 2. Any of the following drugs or treatments were used before screening: 1) Have received GLP-1 receptor agonist, GLP-1 analogue, DPP-4 inhibitor or any other incretin analogue treatment; 2) Growth hormone therapy has been performed within 6 months before screening; 3) A history of drug abuse (defined as the use of banned drugs) or alcohol abuse (defined as the daily regular consumption of alcohol does not exceed the following standard amounts: 570ml of beer, 750ml of light beer, 200ml of red wine or 60ml of white wine) within 6 months before screening , Each containing about 20g of alcohol); 4) Participated in any drug or medical device clinical trial within 3 months before screening; 5) Long-term (more than 7 consecutive days) intravenous, oral, and intra-articular administration of corticosteroids received within 2 months before screening; 3. Have any medical history or evidence of any of the following diseases before screening: 1) Type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury or secondary diabetes, such as diabetes caused by Cushing syndrome or acromegaly; 2) Have a history of hypertension, and apply a stable dose (at least 4 weeks) of antihypertensive drugs after treatment with systolic blood pressure (SBP)> 160 mmHg and/or diastolic blood pressure (DBP)>100 mmHg; 3) A history of acute and chronic pancreatitis, a history of symptomatic gallbladder disease, a history of pancreatic injury and other high-risk factors that may cause pancreatitis; 4) History of medullary C-cell carcinoma, MEN (multiple endocrine tumor) 2A or 2B syndrome, or related family history; 5) There are clinically significant abnormal gastric emptying (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as active ulcers within 6 months), long-term use of drugs that have a direct impact on gastrointestinal motility, or acceptance Have undergone gastrointestinal surgery; 6) A history of severe hypoglycemia (such as hypoglycemia causing drowsiness, disturbance of consciousness, nonsense, or even coma), or a history of severe unconscious hypoglycemia; 7) There are obvious blood system diseases (such as aplastic anemia, myelodysplastic syndrome) or any disease that causes hemolysis or red blood cell instability (such as malaria); 8) There are serious complications of diabetes (such as complications of large and small blood vessels), and the investigator believes that it is not suitable to participate in this trial; 9) Any organ system tumor that has been treated or not treated within 5 years before screening, regardless of whether there is evidence of local recurrence or metastasis, except for local skin basal cell carcinoma; 10) Have received coronary angioplasty, coronary stent implantation, coronary artery bypass surgery within 6 months before screening, and decompensated heart failure (New York Heart Association NYHA classification III and IV), stroke or Transient ischemic attack, unstable angina, myocardial infarction, persistent and clinically significant arrhythmia; 11) Acute metabolic complications (such as ketoacidosis, lactic acidosis, or hyperosmolar coma) occurred within 6 months before screening; 12) Patients with abnormal thyroid function (such as thiourea, thyroid hormone drugs) whose therapeutic dose is not stable within 6 months before screening; 13) Patients with dyslipidemia (such as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal Microbial Genomic DNA; | — |
Countries
China
Contacts
Public ContactGuo Jianjin
The Second Hospital of Shanxi Medical University
Outcome results
None listed