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

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

— PB119  

Official title:

A Phase III, Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504370
• Other study ID #: PB119301
• Status: Completed
• Phase: Phase 3
• Start date: April 27, 2020
• Est. completion date: November 28, 2022

Study information

• Verified date: July 2023
• Source: PegBio Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: November 28, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Intervention

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

Locations

Country	Name	City	State
China	Central South University The Second Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
PegBio Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change in HbA1c from baseline(week 1) to week 25	week 1, week 25
Secondary	HbA1c Below 7.0%	Percentage of participants with HbA1c below 7.0% was evaluated at week 25.	week 1, week 25
Secondary	Change in Body Weight (kg)	Change from baseline (week 1) in body weight was evaluated at week 25	week 1, week 25
Secondary	Change in Fasting Plasma Glucose (FPG)	Change from baseline (week 1) in FPG was evaluated at week 25	week 1, week 25
Secondary	Change in Body Mass Index	Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25.	week 1, week 25