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Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects (PB119)

Primary Purpose

Type 2 Diabetes Mellitus (T2DM)

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

GLP-1 receptor agonist

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Central South University The Second Xiangya Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PB-119 once-weekly-subcutaneous injection

Placebo once-weekly-subcutaneous injection

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in HbA1c

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

Secondary Outcome Measures

HbA1c Below 7.0%

Percentage of participants with HbA1c below 7.0% was evaluated at week 25.

Change in Body Weight (kg)

Change from baseline (week 1) in body weight was evaluated at week 25

Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 1) in FPG was evaluated at week 25

Change in Body Mass Index

Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25.

Full Information

NCT ID

NCT04504370

First Posted

August 5, 2020

Last Updated

July 27, 2023

Sponsor

PegBio Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04504370

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

April 27, 2020 (Actual)

Primary Completion Date

March 30, 2022 (Actual)

Study Completion Date

November 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PegBio Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus (T2DM)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

273 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PB-119 once-weekly-subcutaneous injection

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo once-weekly-subcutaneous injection

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GLP-1 receptor agonist

Intervention Description

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

Intervention Name(s)

Placebo

Other Intervention Name(s)

PB-119 Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in HbA1c

Description

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

Time Frame

week 1, week 25

Secondary Outcome Measure Information:

Title

HbA1c Below 7.0%

Description

Percentage of participants with HbA1c below 7.0% was evaluated at week 25.

Time Frame

week 1, week 25

Title

Change in Body Weight (kg)

Description

Change from baseline (week 1) in body weight was evaluated at week 25

Time Frame

week 1, week 25

Title

Change in Fasting Plasma Glucose (FPG)

Description

Change from baseline (week 1) in FPG was evaluated at week 25

Time Frame

week 1, week 25

Title

Change in Body Mass Index

Description

Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25.

Time Frame

week 1, week 25

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: