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

NCT ID: NCT04504396

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-23
• Study Completion Date: 2023-05-26

Brief 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.

Detailed 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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PB-119 once-weekly-subcutaneous injection

PB119 (polyethylene glycol exenatide) is a long-acting GLP-1RA for injection, which will be administered 150μg once-weekly subcutaneously to patients in active drug group for 24 weeks.

Group Type: EXPERIMENTAL

GLP-1 receptor agonist

Intervention Type: DRUG

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).

Placebo once-weekly-subcutaneous injection

PB-119 150μg matched placebo which will be used in placebo group for 24 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.

Interventions

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).

Intervention Type: DRUG

Placebo

PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.

Intervention Type: DRUG

Other Intervention Names

PB-119 Placebo

Eligibility Criteria

Inclusion Criteria

• Male or female, aged 18~75 years old;
• T2DM and treated with Metformin ≥ 1500mg/day or maximum tolerated dose(≥1000mg,<1500mg) constantly for at least 8 consecutive weeks;
• 7.5% ≤ HbA1c ≤ 10.0% at screening;
• 18.5 kg/m2 < BMI < 40.0 kg/m2 at screening;

Exclusion Criteria

• Any anti-diabetic therapy other than Metformin within 8 weeks before screening；
• T1DM;
• Received insulin therapy more than 14 days within 1 year before screening;
• Female who is pregnant, breast-feeding;
• Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol;
• History of acute diabetic complications, such as diabetic ketoacidosis or hyperglycemic hyperosmolar status within 6 months before screening；
• History or presence of pancreatitis (acute or chronic);
• Presence or history of malignant neoplasms within the past 5 years prior to the day of screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PegBio Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HuiMin Zhou, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

First Hospital of Hebei Medical University

WeiHong Song, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Chenzhou

YanJun Wang, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Second Hospital of Jilin University

Jing Yang, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Shanxi Medical University

Bin Gao, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Tang-Du Hospital

XinLing Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Xinjiang Uygur Autonomous Region

MingHui Hou, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Hebei University

Lin Liao, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Qianfoshan Hospital

Linong Ji, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing University People's Hospital

Minxiu Yao, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Qingdao Central Hospital

Huige Shao, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Changsha Central Hospital

Jingna Lin, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Tianjin People's Hospital

Xiaohong Lin, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

ZhuZhou Central Hospital

Jianhua Ma, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Wei Zhang, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Qiqihar First Hospital

Hui Liu, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Luoyang Central Hospital

Tao Ning, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Baotou Central Hospital

Xiaohong Wu, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Province People's Hospital

Xueying Wang, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Jingzhou Central Hospital

Lan Xu, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

WuXi Central Hospital

Locations

Beijing University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PB119302

Identifier Type: -

Identifier Source: org_study_id