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

NCT ID: NCT04504370

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 273 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-27
• Study Completion Date: 2022-11-28

Brief 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.

Detailed Description

The study included a maximum 2-week screening period, a 4-week single-blind introduction period, a 24-week double-blind treatment period, a 28-week open extension treatment period, and a 4-week safety follow-up period.

At the end of the single-blind entry period, eligible subjects were randomly assigned to two different administration groups in a 1:1 ratio and received a 24-week double-blind treatment.

All subjects who completed the double-blind treatment entered the open extension treatment phase.Open extension treatment with subcutaneous injection of 150μg PB-119 once a week for 28 weeks.

Safety follow-up was conducted 4 weeks after the end of treatment/completion of early exit visit in the open extension period.

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;
• Confirmed T2DM patients meet the diagnostic criteria for type 2 diabetes published by WHO1999；
• 18.5 kg/m2 < BMI < 40.0 kg/m2 at screening;
• 7.5% ≤ HbA1c ≤ 11.0% at screening;
• 7.0% ≤ HbA1c ≤ 10.5% when the random;
• 18.5 kg/m2 < BMI < 40.0 kg/m2 during screening and before randomization

Exclusion Criteria

• T1DM;
• Continuous use of insulin for more than 14 days within 1 year before screening or before randomization；
• Treatment with any dipeptidylpeptidase 4 (DPP-4) inhibitor or glucose-dependent insulin-stimulating peptide (GIP) or/and glucagon-like peptide-1 (GLP-1) receptor agonist prior to screening or randomized prior treatment；
• Screening for any of the following heart diseases within the first 6 months or before randomization；
• Patients whose hypertension was not effectively controlled during screening or before randomization (after resting ≥5 minutes, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)；
• Serum amylase or lipase >3×ULN or those with previous diagnosis of acute/chronic pancreatitis were screened or randomly screened；
• Screening for severe trauma or infection that may affect glycemic control within the first month or before randomization；
• A history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2)；
• Known to be allergic or intolerant to the study drug or metformin；
• Female subjects during pregnancy or lactation.

• 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

Zhiguang Zhou, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Central South University The Second Xiangya Hospital

WeiHong Song, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Chenzhou

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

Lin Liao, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Qianfoshan Hospital

YanJun Wang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Second Hospital of Jilin University

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

Jiarui Li, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Cangzhou Central Hospital

Xiaohong Lin, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

ZhuZhou Central Hospital

Guixia Wang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Jianhua Ma, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Zhinong Zhang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Qiqihar First Hospital

Locations

Central South University The Second Xiangya Hospital

Changsha, Hunan, China

Countries

China

References

Yan X, Ma J, Liu Y, Wang X, Li S, Yan S, Mo Z, Zhu Y, Lin J, Liu J, Jia Y, Liu L, Ding K, Xu M, Zhou Z. Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial. Lancet Reg Health West Pac. 2024 Jun 7;47:101101. doi: 10.1016/j.lanwpc.2024.101101. eCollection 2024 Jun.

Reference Type: DERIVED

PMID: 38948164 (View on PubMed)

Other Identifiers

PB119301

Identifier Type: -

Identifier Source: org_study_id