NCT03520972

Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Dose Cohort Study to Evaluate the Efficacy and Safety of Twelve Once-weekly Subcutaneous Doses of PB-119 in Drug-naïve Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: PegBio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of PB-119 in drug-naïve subjects with T2DM.

Detailed description

Subjects will be assessed for eligibility over a 2-week screening period prior to a 2-week run-in period and a 12-week double-blind treatment period,4-week follow up period. The eligible patients will be randomized to 1 of 3 dose cohorts (A, B, or C). Each patient will subsequently be randomized within the designated cohort to active drug or placebo at a 3:1 active drug:placebo ratio.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	PB-119 75ug	60 eligible patients will be included in this group
DRUG	PB-119 150ug	60 eligible patients will be included in this group
DRUG	PB-119 200ug	60 eligible patients will be included in this group
DRUG	placebo	60 eligible patients will be included in this group

Timeline

• Start date: 2018-06-05
• Primary completion: 2019-07-29
• Completion: 2019-07-29
• First posted: 2018-05-11
• Last updated: 2020-01-22

Locations

1 site across 1 country: China