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 byWHO1999；
• 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 orbefore randomization；
• Treatment with any dipeptidylpeptidase 4 (DPP-4) inhibitor or glucose-dependentinsulin-stimulating peptide (GIP) or/and glucagon-like peptide-1 (GLP-1) receptoragonist prior to screening or randomized prior treatment；
• Screening for any of the following heart diseases within the first 6 months or beforerandomization；
• Patients whose hypertension was not effectively controlled during screening or beforerandomization (after resting ≥5 minutes, systolic blood pressure ≥160mmHg and/ordiastolic blood pressure ≥100mmHg)；
• Serum amylase or lipase >3×ULN or those with previous diagnosis of acute/chronicpancreatitis were screened or randomly screened；
• Screening for severe trauma or infection that may affect glycemic control within thefirst month or before randomization；
• A history or family history of medullary thyroid carcinoma (MTC) or multiple endocrineadenomatosis type 2 (MEN2)；
• Known to be allergic or intolerant to the study drug or metformin；
• Female subjects during pregnancy or lactation.