Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects

NCT03520972 | Completed Phase 2

• 1 other identifier: PB119201
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of PB-119 in drug-naïve subjects with T2DM.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change of glycosylated hemoglobin(HbA1c)

  Change of HbA1c from baseline value to end of treatment

  12 weeks

Secondary Outcomes (8)

• Percentage of patients achieving HbA1c <7%

  12 weeks

• Percentage of patients achieving HbA1c ≤6.5%

  12 weeks

• HbA1c

  2, 4, and 8 weeks

• Fasting plasma glucose(FPG)

  2, 4, 8, and 12 weeks

• 2-hour postprandial glucose(2-h PPG)

  4, 8, and 12 weeks

Other Outcomes (4)

• Body mass index(BMI)

  2, 4, 8, and 12 weeks

• Waist and hip circumferences and waist-to-hip ratio

  12 weeks

• Blood pressure(both systolic and diastolic)

  2, 4, 8, and 12 weeks

Study Arms (4)

PB-119 75ug

EXPERIMENTAL

PB-119 injection 75ug subcutaneously injected once-weekly for 12 weeks

Drug: PB-119 75ug

PB-119 150ug

EXPERIMENTAL

PB-119 injection 150ug subcutaneously injected once-weekly for 12 weeks

Drug: PB-119 150ug

PB-119 200ug

EXPERIMENTAL

PB-119 injection 200ug subcutaneously injected once-weekly for 12 weeks

Drug: PB-119 200ug

placebo

PLACEBO COMPARATOR

placebo injection subcutaneously injected once-weekly for 12 weeks

Drug: placebo

Interventions

PB-119 75ug DRUG

60 eligible patients will be included in this group

PB-119 75ug

PB-119 150ug DRUG

60 eligible patients will be included in this group

PB-119 150ug

PB-119 200ug DRUG

60 eligible patients will be included in this group

PB-119 200ug

placebo DRUG

60 eligible patients will be included in this group

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and/or females between the ages of ≥18 and ≤70 years at Screening
• Patients in whom T2DM has been diagnosed according to 1999 WHOT2DM diagnostic criteria
• HbA1c ≥7.5% and ≤11% at Screening and at Week -1
• Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at Screening

You may not qualify if:

• Female who is pregnant, intends to become pregnant or breast-feeding or is of child-bearing potential and not using adequate contraception methods throughout the trial
• Treatment with any glucose lowing agent(s) within 3 months prior to screening.An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness
• Calcitonin ≥50 ng/L at screening
• Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2
• Fasting triglyceride ≥500 mg/dL at Screening, or patients with a history of lipid disorders taking unstable treatment dosage (eg, statins) within 3 months prior to screening
• Any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this trial
• Blood amylase or lipase \>3x ULN, history of acute or chronic pancreatitis, or history of symptomatic gallbladder disease at Screening
• Serum creatinine ≥1.5 mg/dL (male patients) or ≥1.4 mg/dL (female patients), or estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m2 at Screening
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2x upper limit of normal (ULN) at Screening and pre-randomization
• Severe cardiovascular diseases occurring within 6 months prior to screening

Sponsors & Collaborators

• PegBio Co., Ltd.: lead
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, 100000, China

Location

Related Publications (2)

• Ji L, Du Y, Xu M, Zhou X, Mo Z, Ma J, Li J, Li Y, Lin J, Wang Y, Yang J, Song W, Jin H, Pang S, Liu H, Li P, Liu J, Yao M, Li W, Jiang X, Shen F, Geng H, Zhou H, Ran J, Lei M, Du Y, Ye S, Guan Q, Lv W, Tan H, Chen T, Yang J, Qin G, Li S, Chen L. Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study. Diabetologia. 2021 May;64(5):1066-1078. doi: 10.1007/s00125-021-05392-9. Epub 2021 Mar 9.

  PMID: 33687487 DERIVED

• Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

  PMID: 30957581 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

• Linong Ji, MD,PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 11, 2018
• Study Start: June 5, 2018
• Primary Completion: July 29, 2019
• Study Completion: July 29, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

CN (1)