Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects

Inclusion Criteria: * Male or female, aged 18\~75 years old; * Confirmed T2DM patients meet the diagnostic criteria for type 2 diabetes published by WHO1999； * 18.5 kg/m2 \< BMI \< 40.0 kg/m2 at screening; * 7.5% ≤ HbA1c ≤ 11.0% at screening; * 7.0% ≤ HbA1c ≤ 10.5% when the random; * 18.5 kg/m2 \< BMI \< 40.0 kg/m2 during screening and before randomization Exclusion Criteria: * T1DM; * Continuous use of insulin for more than 14 days within 1 year before screening or before randomization； * Treatment with any dipeptidylpeptidase 4 (DPP-4) inhibitor or glucose-dependent insulin-stimulating peptide (GIP) or/and glucagon-like peptide-1 (GLP-1) receptor agonist prior to screening or randomized prior treatment； * Screening for any of the following heart diseases within the first 6 months or before randomization； * Patients whose hypertension was not effectively controlled during screening or before randomization (after resting ≥5 minutes, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)； * Serum amylase or lipase \>3×ULN or those with previous diagnosis of acute/chronic pancreatitis were screened or randomly screened； * Screening for severe trauma or infection that may affect glycemic control within the first month or before randomization； * A history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2)； * Known to be allergic or intolerant to the study drug or metformin； * Female subjects during pregnancy or lactation.