Type 2 Diabetes Mellitus (T2DM)Phase 3NCT04504396

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

A Phase 3 study testing GLP-1 receptor agonist in people with Type 2 Diabetes Mellitus (T2DM), run by PegBio Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus (T2DM)
What is being tested?: GLP-1 receptor agonist
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 620 participants
Where: 1 siteChina
Study dates: 23 Jun 2020to 26 May 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing University People's Hospital
Beijing, Beijing Municipality

Other trials in China

About this study

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

Read the 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.

Conditions: Type 2 Diabetes Mellitus (T2DM)
Being tested: GLP-1 receptor agonist, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GLP-1 receptor agonistDrug
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).
PlaceboDrug
Also called PB-119 Placebo
PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.

Study groups in NCT04504396
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c
Change in HbA1c from baseline(week 1) to week 25
Measured: week 1, week 25

Secondary outcomes (4)

HbA1c Below 7.0%
Percentage of participants with HbA1c below 7.0% was evaluated at week 25.
Measured: week 1, week 25
Change in Body Weight (kg)
Change from baseline (week 1) in body weight was evaluated at week 25
Measured: week 1, week 25
Change in Fasting Plasma Glucose (FPG)
Change from baseline (week 1) in FPG was evaluated at week 25
Measured: week 1, week 25
Change in Body Mass Index
Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25.
Measured: week 1, week 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jun 202026 May 2023

First posted7 Aug 2020
Study start23 Jun 2020
Primary completion15 Sep 2022
Study completion26 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 620 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04504396
Sponsor's protocol ID: PB119302
Status last verified: Jul 2023
First submitted: 5 Aug 2020
Last updated: 28 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus (T2DM) trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04504396
Acronym / sponsor ID: PB119302
Conditions: Type 2 Diabetes Mellitus (T2DM)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 620 participants (actual)
Lead sponsor: PegBio Co., Ltd.University, hospital or other
Study start: 23 Jun 2020 (actual)
Primary completion: 15 Sep 2022 (actual)
Study completion: 26 May 2023 (actual)
First posted: 7 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PB-119 once-weekly-subcutaneous injection	Experimental	Drug: GLP-1 receptor agonistPB119 (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.
Placebo once-weekly-subcutaneous injection	Placebo comparator	Drug: PlaceboPB-119 150μg matched placebo which will be used in placebo group for 24 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GLP-1 receptor agonistPB-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).	Drug	PB-119 once-weekly-subcutaneous injection
PlaceboAlso: PB-119 PlaceboPB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.	Drug	Placebo once-weekly-subcutaneous injection

Primary outcome

Change in HbA1c
Time frame: week 1, week 25
Change in HbA1c from baseline(week 1) to week 25

4 secondary outcomes

HbA1c Below 7.0%
Time frame: week 1, week 25
Change in Body Weight (kg)
Time frame: week 1, week 25
Change in Fasting Plasma Glucose (FPG)
Time frame: week 1, week 25
Change in Body Mass Index
Time frame: week 1, week 25

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes Mellitus (T2DM)

Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

HuiMin Zhou, MD，PhD principal investigator

First Hospital of Hebei Medical University

WeiHong Song, MD，PhD principal investigator

First People's Hospital of Chenzhou

YanJun Wang, MD，PhD principal investigator

Second Hospital of Jilin University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GLP-1 receptor agonist in people with Type 2 Diabetes Mellitus (T2DM), run by PegBio Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: week 1, week 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04504396.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.