Type 2 Diabetes MellitusPhase 2NCT03520972
Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects
A Phase 2 study testing PB-119 75ug, PB-119 150ug and PB-119 200ug in people with Type 2 Diabetes Mellitus, run by PegBio Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of PB-119 in drug-naïve subjects with T2DM. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- PB-119 75ug, PB-119 150ug and PB-119 200ug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2018to 29 Jul 2019
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and/or females between the ages of ≥18 and ≤70 years at Screening
- Patients in whom T2DM has been diagnosed according to 1999 WHOT2DM diagnostic criteria
- HbA1c ≥7.5% and ≤11% at Screening and at Week -1
- Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at Screening
Who cannot join
- Female who is pregnant, intends to become pregnant or breast-feeding or is of child-bearing potential and not using adequate contraception methods throughout the trial
- Treatment with any glucose lowing agent(s) within 3 months prior to screening.An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness
- Calcitonin ≥50 ng/L at screening
- Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2
- Fasting triglyceride ≥500 mg/dL at Screening, or patients with a history of lipid disorders taking unstable treatment dosage (eg, statins) within 3 months prior to screening
- Any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this trial
Show all 10Show fewer
- Blood amylase or lipase >3x ULN, history of acute or chronic pancreatitis, or history of symptomatic gallbladder disease at Screening
- Serum creatinine ≥1.5 mg/dL (male patients) or ≥1.4 mg/dL (female patients), or estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 at Screening
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) at Screening and pre-randomization
- Severe cardiovascular diseases occurring within 6 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Dose Cohort Study to Evaluate the Efficacy and Safety of Twelve Once-weekly Subcutaneous Doses of PB-119 in Drug-naïve Subjects With Type 2 Diabetes Mellitus
This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of PB-119 in drug-naïve subjects with T2DM.
Read the detailed description
Subjects will be assessed for eligibility over a 2-week screening period prior to a 2-week run-in period and a 12-week double-blind treatment period,4-week follow up period. The eligible patients will be randomized to 1 of 3 dose cohorts (A, B, or C). Each patient will subsequently be randomized within the designated cohort to active drug or placebo at a 3:1 active drug:placebo ratio.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- PB-119 75ug, PB-119 150ug, PB-119 200ug, 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.
PB-119 75ugDrug
60 eligible patients will be included in this group
PB-119 150ugDrug
60 eligible patients will be included in this group
PB-119 200ugDrug
60 eligible patients will be included in this group
placeboDrug
60 eligible patients will be included in this group
| Study group | Role | What they receive |
|---|---|---|
| PB-119 75ug | Experimental | PB-119 injection 75ug subcutaneously injected once-weekly for 12 weeks Receives: Drug: PB-119 75ug |
| PB-119 150ug | Experimental | PB-119 injection 150ug subcutaneously injected once-weekly for 12 weeks Receives: Drug: PB-119 150ug |
| PB-119 200ug | Experimental | PB-119 injection 200ug subcutaneously injected once-weekly for 12 weeks Receives: Drug: PB-119 200ug |
| placebo | Placebo comparator | placebo injection subcutaneously injected once-weekly for 12 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of glycosylated hemoglobin(HbA1c)
Change of HbA1c from baseline value to end of treatment
Measured: 12 weeks
Secondary outcomes (8)
Percentage of patients achieving HbA1c <7%
Percentage of patients achieving HbA1c <7% at Week 12
Measured: 12 weeks
Percentage of patients achieving HbA1c ≤6.5%
Percentage of patients achieving HbA1c ≤6.5% at Week 12
Measured: 12 weeks
HbA1c
Changes of HbA1c from baseline value at Weeks 2, 4, and 8
Measured: 2, 4, and 8 weeks
Fasting plasma glucose(FPG)
Changes of fasting plasma glucose(FPG) from baseline value at Weeks 2, 4, 8, and 12.
Measured: 2, 4, 8, and 12 weeks
2-hour postprandial glucose(2-h PPG)
Changes of 2-hour postprandial glucose(2-h PPG) from baseline value at Weeks 4, 8, and 12.
Measured: 4, 8, and 12 weeks
Insulin
Changes of insulin from baseline value at Weeks 4, 8, and 12
Measured: 4, 8, and 12 weeks
C-peptide
Changes of C-peptide from baseline value at Weeks 4, 8, and 12
Measured: 4, 8, and 12 weeks
Self-monitoring of blood glucose (SMBG)
Changes of mean profile and mean increments from baseline value of the 7-point SMBG
Measured: 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start5 Jun 2018
- Primary completion29 Jul 2019
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- PegBio Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Linong Ji, MD,PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520972
- Sponsor's protocol ID
- PB119201
- Status last verified
- Jan 2020
- First submitted
- 18 Apr 2018
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ji L, Du Y, Xu M, Zhou X, Mo Z, Ma J, Li J, Li Y, Lin J, Wang Y, Yang J, Song W, Jin H, Pang S, Liu H, Li P, Liu J, Yao M, Li W, Jiang X, Shen F, Geng H, Zhou H, Ran J, Lei M, Du Y, Ye S, Guan Q, Lv W, Tan H, Chen T, Yang J, Qin G, Li S, Chen L. Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study. Diabetologia. 2021 May;64(5):1066-1078. doi: 10.1007/s00125-021-05392-9. Epub 2021 Mar 9.
PubMed 33687487Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
PubMed 30957581
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Dose Cohort Study to Evaluate the Efficacy and Safety of Twelve Once-weekly Subcutaneous Doses of PB-119 in Drug-naïve Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03520972
- Acronym / sponsor ID
- PB119201
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- PegBio Co., Ltd.University, hospital or other
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 11 May 2018 (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.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of PB-119 in drug-naïve subjects with T2DM.
Detailed description
Subjects will be assessed for eligibility over a 2-week screening period prior to a 2-week run-in period and a 12-week double-blind treatment period,4-week follow up period. The eligible patients will be randomized to 1 of 3 dose cohorts (A, B, or C). Each patient will subsequently be randomized within the designated cohort to active drug or placebo at a 3:1 active drug:placebo ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PB-119 75ug | Experimental | Drug: PB-119 75ugPB-119 injection 75ug subcutaneously injected once-weekly for 12 weeks |
| PB-119 150ug | Experimental | Drug: PB-119 150ugPB-119 injection 150ug subcutaneously injected once-weekly for 12 weeks |
| PB-119 200ug | Experimental | Drug: PB-119 200ugPB-119 injection 200ug subcutaneously injected once-weekly for 12 weeks |
| placebo | Placebo comparator | Drug: placeboplacebo injection subcutaneously injected once-weekly for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and/or females between the ages of ≥18 and ≤70 years at Screening
- Patients in whom T2DM has been diagnosed according to 1999 WHOT2DM diagnostic criteria
- HbA1c ≥7.5% and ≤11% at Screening and at Week -1
- Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at Screening
Key exclusion criteria (10 listed)
- Female who is pregnant, intends to become pregnant or breast-feeding or is of child-bearing potential and not using adequate contraception methods throughout the trial
- Treatment with any glucose lowing agent(s) within 3 months prior to screening.An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness
- Calcitonin ≥50 ng/L at screening
- Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2
- Fasting triglyceride ≥500 mg/dL at Screening, or patients with a history of lipid disorders taking unstable treatment dosage (eg, statins) within 3 months prior to screening
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 |
|---|---|---|
| PB-119 75ug60 eligible patients will be included in this group | Drug | PB-119 75ug |
| PB-119 150ug60 eligible patients will be included in this group | Drug | PB-119 150ug |
| PB-119 200ug60 eligible patients will be included in this group | Drug | PB-119 200ug |
| placebo60 eligible patients will be included in this group | Drug | placebo |
Primary outcome
Change of glycosylated hemoglobin(HbA1c)
Time frame: 12 weeks
Change of HbA1c from baseline value to end of treatment
8 secondary outcomes
Percentage of patients achieving HbA1c <7%
Time frame: 12 weeks
Percentage of patients achieving HbA1c ≤6.5%
Time frame: 12 weeks
HbA1c
Time frame: 2, 4, and 8 weeks
Fasting plasma glucose(FPG)
Time frame: 2, 4, 8, and 12 weeks
2-hour postprandial glucose(2-h PPG)
Time frame: 4, 8, and 12 weeks
Insulin
Time frame: 4, 8, and 12 weeks
C-peptide
Time frame: 4, 8, and 12 weeks
Self-monitoring of blood glucose (SMBG)
Time frame: 4, 8, and 12 weeks
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 22 Jan 2020.
- Derived from this study: PubMed 33687487Ji L, Du Y, Xu M, Zhou X, Mo Z, Ma J, Li J, Li Y, Lin J, Wang Y, Yang J, Song W, Jin H, Pang S, Liu H, Li P, Liu J, Yao M, Li W, Jiang X, Shen F, Geng H, Zhou H, Ran J, Lei M, Du Y, Ye S, Guan Q, Lv W, Tan H, Chen T, Yang J, Qin G, Li S, Chen L. Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study. Diabetologia. 2021 May;64(5):1066-1078. doi: 10.1007/s00125-021-05392-9. Epub 2021 Mar 9.
- Derived from this study: PubMed 30957581Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Linong Ji, MD,PhD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PB-119 75ug, PB-119 150ug and PB-119 200ug in people with Type 2 Diabetes Mellitus, 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 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 22 Jan 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 of glycosylated hemoglobin(HbA1c) (time frame: 12 weeks). 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 NCT03520972, which also lists 2 linked publications.
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 22 Jan 2020.