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

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;
T2DM and treated with Metformin ≥ 1500mg/day or maximum tolerated dose(≥1000mg,<1500mg) constantly for at least 8 consecutive weeks;
7.5% ≤ HbA1c ≤ 10.0% at screening;
18.5 kg/m2 < BMI < 40.0 kg/m2 at screening;

Exclusion Criteria:

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

Sites / Locations

Beijing University People's 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

NCT04504396

First Posted

August 5, 2020

Last Updated

July 27, 2023

Sponsor

PegBio Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04504396

Brief Title

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

Official Title

A Multicenter, Randomized, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of PB-119 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

June 23, 2020 (Actual)

Primary Completion Date

September 15, 2022 (Actual)

Study Completion Date

May 26, 2023 (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

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.

Detailed Description

This is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort study to evaluate the efficacy and safety of PB-119 to patients with T2DM not well-controlled by metformin monotherapy. Patients will be assessed for eligibility over a 2 week screening period prior to a 4-week run-in period,a 24-week double-blind treatment period and a 28-week open-label treatment period. The eligible patients will be randomized to PB-119 or placebo cohort at a 1:1 ratio for the first 24-week. Patients in PB-119 group will subsequently be given active drug and patients in placebo group will take placebo, all patients in two groups will remain metformin background therapy. In the 28-week open-label period, all patients will be administered active drugs. After that, there will be a 4-week follow-up period; All randomized patients will be taken blood samples for the pharmacokinetic (PK) analysis.

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

620 (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; T2DM and treated with Metformin ≥ 1500mg/day or maximum tolerated dose(≥1000mg,<1500mg) constantly for at least 8 consecutive weeks; 7.5% ≤ HbA1c ≤ 10.0% at screening; 18.5 kg/m2 < BMI < 40.0 kg/m2 at screening; Exclusion Criteria: 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

Overall Study Officials: