| Eligibility |
Inclusion Criteria:
1. Voluntarily participate in this study, be able to communicate well with the
investigator, understand and voluntarily complete the research process in accordance
with this protocol, and sign the Informed Consent Form (ICF).
2. Male or female, aged =18 and =75 years old at the time of signing the ICF.
3. Diagnosis of type 2 diabetes for at least 6 months (WHO, 1999) at screening.
4. Use a stable dose of metformin for at least 60 days before screening (stable dose of
metformin: =1500 mg/day or maximum tolerated dose =1000 mg/day).
5. Glycosylated Hemoglobin(HbA1c) >7.0% and <11.0% at screening (local lab).
6. BMI =18.5 and =35 kg/m2 at screening.
Exclusion Criteria:
1. Laboratory tests meeting any of the following criteria at screening:
1. Calcitonin =50ng/L (pg/mL);
2. Blood amylase =3×ULN (upper limit of normal value);
3. Blood lipase =3×ULN;
4. Triglycerides =5.7mmol/L (500mg/dL);
5. Alanine aminotransferase =3×ULN;
6. Aspartate aminotransferase =3×ULN;
7. Total bilirubin =2×ULN;
8. Estimated glomerular filtration rate (eGFR) <60ml/min/1.73m2 (eGFR=175×Scr-1.234
(mg/dl)×age-0.179 (female×0.79), Scr unit conversion: 1mg/dl = 88.4µmol/L).
2. Positive HIV antibodies at screening.
3. Patients who have received other anti-diabetic drugs other than metformin within 60
days before screening. Such drugs include, but are not limited to, alpha-glycosidase
inhibitors (such as acarbose), thiazolidinediones, glucagon-like peptide-1(GLP-1)
analogs, dipeptidyl peptidase 4 (DPP-4) inhibitors, except short-term treatment with
insulin (cumulative insulin treatment is allowed for =7 days within 60 days before
screening).
4. Patients who have used GLP-1 receptor agonists within 3 months before screening, or
have stopped using GLP-1 receptor agonists due to poor safety or efficacy.
5. Patients who have used weight loss drugs or have a weight change of more than 5%
within 3 months before screening.
6. Continuous or cumulative use of systemic glucocorticoids for more than 7 days within 3
months before screening (systemic glucocorticoids: intravenous, oral or
intra-articular glucocorticoid treatment).
7. Plan to receive glucocorticoids, immunosuppressants, or other drugs (except topical
medications and inhaled preparations) that are assessed as unsuitable during the trial
by the investigator.
8. Those who have participated in other clinical trials and received experimental drugs
or placebo intervention within 3 months before screening (except those who only signed
the ICF and did not receive any drug or placebo).
9. Those who are known to be allergic to the investigational drug or its excipients, or
have a history of allergy to GLP-1 drugs, or are in an allergic state at the time of
screening, or are unfit for the study due to allergy risks, per investigator's
judgment.
10. Diagnosis of type 1 diabetes, diabetes caused by pancreatogenic injury or other
special types of diabetes.
11. Have a history of acute diabetic complications (diabetic ketoacidosis, lactic acidosis
or hyperosmolar hyperglycemic state) within 6 months before screening.
12. Recurrent (=3 times) severe hypoglycemia or asymptomatic hypoglycemia events within 6
months before screening.
13. Patients who have hemoglobinopathies or hemolytic anemia, have received blood or
plasma products within 3 months before screening, or have donated blood or lost more
than 400 mL of blood within 3 months before screening.
14. History of congestive heart failure: New York Heart Association (NYHA) Class IV.
15. Patients who have acute coronary syndrome or cerebrovascular event (except old lacunar
infarction) within 3 months before screening, including but not limited to acute
myocardial infarction, unstable angina, stroke/transient cerebral ischemia attack, or
have undergone heart-related surgery (including coronary artery bypass grafting,
percutaneous coronary intervention) within 3 months before screening, or have poor
blood pressure control at the time of screening (defined as systolic blood pressure
=160 millimeter of mercury(mmHg) and /or diastolic blood pressure =100 mmHg with
antihypertensive drugs) or any other cardiovascular/cerebrovascular diseases that are
not suitable for participating in this trial.
16. History of proliferative retinopathy or diabetic macular edema, or any other unstable
retinopathy (rapidly progressive) recorded in medical history and may require
treatment during the study.
17. Patients with a history of acute/chronic pancreatitis, symptomatic gallbladder (such
as multiple gallbladder stones, excluding cholecystectomy), pancreatic injury, or
other conditions that may lead to high risk for pancreatitis.
18. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
neoplasia syndrome type 2 (MEN2).
19. Diagnosis of malignant tumors within 5 years before screening (except for adequately
treated cervical carcinoma in situ, basal cell or squamous cell skin cancer).
20. Patients who have clinically significant gastric emptying abnormalities (such as
severe diabetic gastroparesis, gastric outlet obstruction, etc.), have undergone or
plan to undergo surgery that affects gastric emptying during the study period, or have
long-term use of drugs that affect gastrointestinal motility.
21. Patients with history of alcohol abuse or drug addiction within 6 months before
screening; or who have a mental illness (such as depression, etc.) that the may affect
participation in the study, in the judgment of the Investigator.
22. Uncured active or recurrent bacterial, fungal or viral infection before randomization.
23. Females who are pregnant or lactating, or have a positive pregnancy test (woman of
childbearing potential).
24. During the trial, men and women who have plans to have children or are of childbearing
potential but not willing to use effective contraceptive methods.
25. In the judgment of the investigator, the patient suffers from diseases that may
endanger his or her safety or compliance with the protocol, or other conditions that
are not suitable for participation in this study.
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