Type 2 Diabetes Mellitus (T2DM)Phase 3PB119NCT04504370
Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects
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.
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. 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
- 273 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2020to 28 Nov 2022
- 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;
- 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
Who cannot join
- 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；
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Central South University The Second Xiangya Hospital
Changsha, Hunan
About this study
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
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.
Read the 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.
- 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 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.
- First posted7 Aug 2020
- Study start27 Apr 2020
- Primary completion30 Mar 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- PegBio Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhiguang Zhou, MD,PhD, Principal investigator, Central South University The Second Xiangya HospitalWeiHong Song, MD,PhD, Principal investigator, First People's Hospital of ChenzhouJing Yang, MD,PhD, Principal investigator, The First Affiliated Hospital of Shanxi Medical UniversityBin Gao, MD,PhD, Principal investigator, Tang-Du HospitalLin Liao, MD,PhD, Principal investigator, Qianfoshan HospitalYanJun Wang, MD,PhD, Principal investigator, Second Hospital of Jilin UniversityMinxiu Yao, MD,PhD, Principal investigator, Qingdao Central HospitalHuige Shao, MD,PhD, Principal investigator, Changsha Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504370
- Sponsor's protocol ID
- PB119301
- Acronym
- PB119
- 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
Publications
Yan X, Ma J, Liu Y, Wang X, Li S, Yan S, Mo Z, Zhu Y, Lin J, Liu J, Jia Y, Liu L, Ding K, Xu M, Zhou Z. Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial. Lancet Reg Health West Pac. 2024 Jun 7;47:101101. doi: 10.1016/j.lanwpc.2024.101101. eCollection 2024 Jun.
PubMed 38948164
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 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
- ClinicalTrials.gov ID
- NCT04504370
- Acronym / sponsor ID
- PB119 / PB119301
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- PegBio Co., Ltd.University, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 28 Nov 2022 (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.
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.
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 (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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)；
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.
- Derived from this study: PubMed 38948164Yan X, Ma J, Liu Y, Wang X, Li S, Yan S, Mo Z, Zhu Y, Lin J, Liu J, Jia Y, Liu L, Ding K, Xu M, Zhou Z. Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial. Lancet Reg Health West Pac. 2024 Jun 7;47:101101. doi: 10.1016/j.lanwpc.2024.101101. eCollection 2024 Jun.
- Individual participant dataSharing planned: No
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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.
Zhiguang Zhou, MD,PhD principal investigator
Central South University The Second Xiangya Hospital
WeiHong Song, MD,PhD principal investigator
First People's Hospital of Chenzhou
Jing Yang, MD,PhD principal investigator
The First Affiliated Hospital of Shanxi Medical 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 6 inclusion and 10 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 NCT04504370, which also lists 1 linked publication.
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.