Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of PB-119 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone

Status Completed

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 to subjects with type 2 diabetes mellitus (T2DM) not well-controlled by metformin monotherapy.

Clinical Trial Description

This is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort study to evaluate the efficacy and safety of PB-119 to patients with T2DM not well-controlled by metformin monotherapy. Patients will be assessed for eligibility over a 2 week screening period prior to a 4-week run-in period,a 24-week double-blind treatment period and a 28-week open-label treatment period. The eligible patients will be randomized to PB-119 or placebo cohort at a 1:1 ratio for the first 24-week. Patients in PB-119 group will subsequently be given active drug and patients in placebo group will take placebo, all patients in two groups will remain metformin background therapy. In the 28-week open-label period, all patients will be administered active drugs. After that, there will be a 4-week follow-up period; All randomized patients will be taken blood samples for the pharmacokinetic (PK) analysis. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

• NCT number: NCT04504396
• Study type: Interventional
• Source: PegBio Co., Ltd.
• Status: Completed
• Phase: Phase 3
• Start date: June 23, 2020
• Completion date: May 26, 2023