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

NCT04504396 | Completed Phase 3

• 1 other identifier: PB119302
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

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.

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;
• T2DM and treated with Metformin ≥ 1500mg/day or maximum tolerated dose(≥1000mg,\<1500mg) constantly for at least 8 consecutive weeks;
• % ≤ HbA1c ≤ 10.0% at screening;
• kg/m2 \< BMI \< 40.0 kg/m2 at screening;

You may not qualify if:

• 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

Sponsors & Collaborators

• PegBio Co., Ltd.: lead

Study Sites (1)

Beijing University People's Hospital

Beijing, Beijing Municipality, China

Location

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

• HuiMin Zhou, MD，PhD

  First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• WeiHong Song, MD，PhD

  First People's Hospital of Chenzhou

  PRINCIPAL INVESTIGATOR

• YanJun Wang, MD，PhD

  Second Hospital of Jilin University

  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

• XinLing Wang, Doctor

  People's Hospital of Xinjiang Uygur Autonomous Region

  PRINCIPAL INVESTIGATOR

• MingHui Hou, MD，PhD

  Affiliated Hospital of Hebei University

  PRINCIPAL INVESTIGATOR

• Lin Liao, MD，PhD

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

• Linong Ji, MD，PhD

  Beijing University People's Hospital

  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

• Xiaohong Lin, MD，PhD

  ZhuZhou Central Hospital

  PRINCIPAL INVESTIGATOR

• Jianhua Ma, MD，PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Wei Zhang, MD，PhD

  Qiqihar First Hospital

  PRINCIPAL INVESTIGATOR

• Hui Liu, MD，PhD

  Luoyang Central Hospital

  PRINCIPAL INVESTIGATOR

• Tao Ning, MD，PhD

  Baotou Central Hospital

  PRINCIPAL INVESTIGATOR

• Xiaohong Wu, MD，PhD

  Zhejiang Province People's Hospital

  PRINCIPAL INVESTIGATOR

• Xueying Wang, MD，PhD

  Jingzhou Central Hospital

  PRINCIPAL INVESTIGATOR

• Lan Xu, MD，PhD

  WuXi Central 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: June 23, 2020
• Primary Completion: September 15, 2022
• Study Completion: May 26, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)