Type 2 diabetes mellitus
Conditions
Interventions
Case series:Polyethylene Glycol Loxenatide Injection 0.2mg qw s.c.
Sponsors
Shantou Longhu People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 25-70 years old; 2. Newly diagnosed T2DM patients without oral hypoglycemic drugs or insulin treatment; T2DM patients are treated with a single drug (metformin) and have poor blood sugar control; 3. HbA1c 6.3 to 10.5%; 4. Fasting c-peptide>1nmol/L; 5. Voluntary participation in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes or secondary diabetes; 2. Complicated with severe diabetic complications such as diabetic ketoacidosis, hyperosmolar hyperglycemia syndrome, lactic acidosis; 3. Patients with clinically significant hepatobiliary disease, including but not limited to, chronic active hepatitis and(or) severe hepatic insufficiency, cirrhosis. ALT or AST >3 ULN (150U/L) or TB >34.2 umol/L (>2mg/dL); 4. Patients with the following history or characteristics of nephropathy: (1) Unstable or rapidly progressive nephropathy; (2) Moderate/severe renal injury or end-stage renal disease: eGFR=133 umol/L (>=1.50mg/dL) in male; Cr >=124 umol/L(>1.40mg/dL) in female; 5. Any of the following cardiovascular diseases occurred within 12 weeks: (1) Miocardial infarction; (2) Cerebral infarction; (3) Heart surgery or revascularization(CABG/PCI); (4) Unstable angina; (5) Congestive heart failure (NYHA III-IV); (6) Transient ischemic attack or significant cerebrovascular disease; 6. Gastrointestinal disease or surgical history, including intestinal obstruction, intestinal ulcer, weight reduction or banding surgery, gastroenterostomy, or enterectomy; 7. Pregnant or breast-feeding; 8. Urinary tract infection within 2 weeks; 9. At the investigator's discretion, subjects who are not likely to follow the protocol, and patients with severe physical or psychological conditions that may affect effectiveness or safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose control;Insulin resistance;intestinal microbiota sequencing;Immunological indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| endothelial microparticles,EMPs;Endothelial cell function;biochemical criterion;inflammatory factor; | — |
Countries
China
Contacts
Public ContactHou Kaijian
Shantou Longhu People's Hospital
Outcome results
None listed