Type 2 Diabetes mellitus
Conditions
Interventions
Experimental group:Polyethylene glycol loxenatide 0.2 mg
Placebo group:Placebo
Sponsors
Tianjin Medical University Chu Hsien-I Memorial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent; 2. T2DM with 7.0% = 7.0 mmol/L; 3. Participants who met at least one of the cardiovascular disease criteria or one cardiovascular risk factor; 4. BMI >= 25kg/m2; 5. Female participants agreed to follow contraceptive guidance during/up to 5 weeks after the intervention.
Exclusion criteria
Exclusion criteria: 1. T1DM; 2. Clinically relevant history of GI disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and uncontrolled gastroesophageal reflux disease within 6 months prior to screening; 3. History of chronic pancreatitis or acute idiopathic pancreatitis; 4. Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (eg, multiple endocrine neoplasia syndromes); 5. Systolic BP > 180 mmHg and/or DBP > 100 mmHg at screening; 6. Hospitalization for hypertensive emergency within 3 months prior to randomization; 7. Planning coronary, carotid, or peripheral arterial revascularization, electrophysiological device implantation, or cardiac surgery; 8. A prior solid organ transplant or awaiting solid organ transplant; 9. Known or suspected hypersensitivity to trial products or related products; 10. Patients with severe non-proliferative diabetic retinopathy /proliferative diabetic retinopathy /Diabetic Macular Edema, or planned intravitreal injections or laser or vitrectomy surgery within 3 months prior to randomization and during the study; 11. Patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult in the opinion of the investigator including severe anemia, congestive heart failure (New York Heart Association [NYHA] III/IV), respiratory, hepatic, neurological, psychiatric, active malignant tumor or other major systemic disease; 12. History of drug or alcohol abuse within 6 months prior to the time of screening; 13. Treated with any GLP-1 RA product or DPP4 inhibitor within 3 months prior to screening.; 14. Use in past 3 months of medications known to induce significant weight loss (e.g., prescription weight loss medications); 15. Participation in any previous loxenatide clinical trial within 3 months prior to screening; 16. Current enrollment in any other clinical study involving an investigational study treatment; 17. Laboratory findings at the Screening Visit: (1) eGFR 3 times the ULN; (3) Total bilirubin > 1.5 times the ULN (except in case of documented Gilberts syndrome); (4) Amylase and/or lipase >3 times the ULN laboratory range. 18. Cardiovascular events occurred within 3 months prior to randomisation: cerebrovascular disease (cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, transient ischemic attack); new or recurrent non-fatal coronary Arterial disease (myocardial infarction, unstable angina); arteriosclerotic disease requiring hospitalization (aneurysm, arterial dissection, arteriosclerotic occlusion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke [ Time Frame: Time from randomisation up to end of follow-up (scheduled at week 96) ]; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time From Randomisation to First Occurrence of an Expanded MACE. Defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke,coronary revascularization or hospitalization for unstable angina [ Time Frame: Time from randomisation up to end of follow-up (scheduled at week 96) ];Time From Randomisation to First Occurrence of Composite Renal Endpoint [ Time Frame: Time from randomisation up to end of follow-up (scheduled at week 96) ]; | — |
Countries
China
Contacts
Public ContactChen Liming
Tianjin Medical University Chu Hsien-I Memorial Hospital
Outcome results
None listed