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

• Status: Recruiting
• Trial end date: 2023-06-13
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 in Drug-naïve T2DM Subjects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PegBio Co., Ltd.

Criteria

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.