NCT04504370

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

A Phase III, Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: PegBio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study included a maximum 2-week screening period, a 4-week single-blind introduction period, a 24-week double-blind treatment period, a 28-week open extension treatment period, and a 4-week safety follow-up period. At the end of the single-blind entry period, eligible subjects were randomly assigned to two different administration groups in a 1:1 ratio and received a 24-week double-blind treatment. All subjects who completed the double-blind treatment entered the open extension treatment phase.Open extension treatment with subcutaneous injection of 150μg PB-119 once a week for 28 weeks. Safety follow-up was conducted 4 weeks after the end of treatment/completion of early exit visit in the open extension period.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	GLP-1 receptor agonist	PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28).
DRUG	Placebo	PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.

Timeline

• Start date: 2020-04-27
• Primary completion: 2022-03-30
• Completion: 2022-11-28
• First posted: 2020-08-07
• Last updated: 2023-07-28

Locations

1 site across 1 country: China