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

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.

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

• HuiMin Zhou, MD，PhD · First Hospital of Hebei Medical University

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

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

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

• Bin Gao, MD，PhD · Tang-Du Hospital

• XinLing Wang, Doctor · People's Hospital of Xinjiang Uygur Autonomous Region

• MingHui Hou, MD，PhD · Affiliated Hospital of Hebei University

• Lin Liao, MD，PhD · Qianfoshan Hospital

• Linong Ji, MD，PhD · Beijing University People's Hospital

• Minxiu Yao, MD，PhD · Qingdao Central Hospital

• Huige Shao, MD，PhD · Changsha Central Hospital

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

• Xiaohong Lin, MD，PhD · ZhuZhou Central Hospital

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

• Wei Zhang, MD，PhD · Qiqihar First Hospital

• Hui Liu, MD，PhD · Luoyang Central Hospital

• Tao Ning, MD，PhD · Baotou Central Hospital

• Xiaohong Wu, MD，PhD · Zhejiang Province People's Hospital

• Xueying Wang, MD，PhD · Jingzhou Central Hospital

• Lan Xu, MD，PhD · WuXi Central 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

2020-06-23

Primary Completion

2022-09-15

Completion

2023-05-26

Countries

• China

Study Locations