Type 2 Diabetes mellitus
Conditions
Interventions
Experimental group:Polyethylene glycol loxenatide
Control group:Metformin
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent; 2. Aged 18-65 years; 3. Patients with type 2 diabetes, 7.0%=25kg/m^2; 6. Agree to use contraception during the intervention.
Exclusion criteria
Exclusion criteria: 1. A clinically relevant history of gastrointestinal disorders associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and uncontrolled gastroesophageal reflux disease in the 6 months prior to screening; 2. History of acute and chronic pancreatitis; 3. Personal or family history of medullary thyroid carcinoma (MTC) or genetic predisposition to MTC (e.g., multiple endocrine tumor syndrome); 4. Allergy to any of the therapeutic drugs in this study; 5. History of drug or alcohol abuse in the 6 months prior to screening; 6. Treatment with GLP-1RA and DPP4 inhibitors within 3 months prior to screening; 7. Body weight change >5% in the first 3 months; 8. Subjects who have participated in any clinical trials of rosenatide within the 3 months prior to screening; 9. Currently participating in clinical trials of other investigational drugs; 10. Laboratory test for specific abnormalities: eGFR 3x ULN; Total bilirubin > 1.5 ULN (no history of Gilbert syndrome); Amylase or lipase > 3 ULN; 11. Subjects with severe anemia, congestive heart failure (New York Heart Association [NYHA] III/IV), respiratory, liver, nervous system, psychosis, active malignancy, or other major systemic diseases were identified by the investigator as having a high risk of death or difficulty in implementing the protocol or interpreting the findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in body weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| visceral fat area;glycated haemoglobin A1c (HbA1c);fasting plasma glucose (FPG);blood lipid;alanine aminotransferase (ALT);aspartate aminotransferase (AST);body mass index (BMI); | — |
Countries
China
Contacts
Public ContactZhang Xiujuan
Outcome results
None listed