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

NCT04504370 | Completed Phase 3

• 1 other identifier: PB119301
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in HbA1c from baseline(week 1) to week 25

  week 1, week 25

Secondary Outcomes (4)

• HbA1c Below 7.0%

  week 1, week 25

• Change in Body Weight (kg)

  week 1, week 25

• Change in Fasting Plasma Glucose (FPG)

  week 1, week 25

• Change in Body Mass Index

  week 1, week 25

Study Arms (2)

PB-119 once-weekly-subcutaneous injection

EXPERIMENTAL

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.

Drug: GLP-1 receptor agonist

Placebo once-weekly-subcutaneous injection

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

GLP-1 receptor agonist 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).

PB-119 once-weekly-subcutaneous injection

Placebo DRUG

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

Also known as: PB-119 Placebo

Placebo once-weekly-subcutaneous injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18\~75 years old;
• Confirmed T2DM patients meet the diagnostic criteria for type 2 diabetes published by WHO1999；
• kg/m2 \< BMI \< 40.0 kg/m2 at screening;
• % ≤ HbA1c ≤ 11.0% at screening;
• % ≤ HbA1c ≤ 10.5% when the random;
• kg/m2 \< BMI \< 40.0 kg/m2 during screening and before randomization

You may not qualify if:

• 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.

Sponsors & Collaborators

• PegBio Co., Ltd.: lead

Study Sites (1)

Central South University The Second Xiangya Hospital

Changsha, Hunan, China

Location

Related Publications (1)

• 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.

  PMID: 38948164 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Zhiguang Zhou, MD,PhD

  Central South University The Second Xiangya Hospital

  PRINCIPAL INVESTIGATOR

• WeiHong Song, MD,PhD

  First People's Hospital of Chenzhou

  PRINCIPAL INVESTIGATOR

• Jing Yang, MD,PhD

  The First Affiliated Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

• Bin Gao, MD,PhD

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

• Lin Liao, MD,PhD

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

• YanJun Wang, MD,PhD

  Second Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• Minxiu Yao, MD,PhD

  Qingdao Central Hospital

  PRINCIPAL INVESTIGATOR

• Huige Shao, MD,PhD

  Changsha Central Hospital

  PRINCIPAL INVESTIGATOR

• Jingna Lin, MD,PhD

  Tianjin People's Hospital

  PRINCIPAL INVESTIGATOR

• Jiarui Li, MD,PhD

  Cangzhou Central Hospital

  PRINCIPAL INVESTIGATOR

• Xiaohong Lin, MD,PhD

  ZhuZhou Central Hospital

  PRINCIPAL INVESTIGATOR

• Guixia Wang, MD,PhD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• Jianhua Ma, MD,PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Zhinong Zhang, MD,PhD

  Qiqihar First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: April 27, 2020
• Primary Completion: March 30, 2022
• Study Completion: November 28, 2022
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)