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

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.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

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.

Sponsors & Collaborators

• PegBio Co., Ltd.

  lead OTHER

Principal Investigators

• Zhiguang Zhou, MD,PhD · Central South University The Second Xiangya Hospital

• WeiHong Song, MD,PhD · First People's Hospital of Chenzhou

• Jing Yang, MD,PhD · The First Affiliated Hospital of Shanxi Medical University

• Bin Gao, MD,PhD · Tang-Du Hospital

• Lin Liao, MD,PhD · Qianfoshan Hospital

• YanJun Wang, MD,PhD · Second Hospital of Jilin University

• Minxiu Yao, MD,PhD · Qingdao Central Hospital

• Huige Shao, MD,PhD · Changsha Central Hospital

• Jingna Lin, MD,PhD · Tianjin People's Hospital

• Jiarui Li, MD,PhD · Cangzhou Central Hospital

• Xiaohong Lin, MD,PhD · ZhuZhou Central Hospital

• Guixia Wang, MD,PhD · The First Hospital of Jilin University

• Jianhua Ma, MD,PhD · The First Affiliated Hospital with Nanjing Medical University

• Zhinong Zhang, MD,PhD · Qiqihar First Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-27

Primary Completion

2022-03-30

Completion

2022-11-28

Countries

• China

Study Locations