Type 2 Diabetes Mellitus (T2DM)Phase 2NCT03604419

Dose-finding of PB-119 Administered Subcutaneously Once Weekly Versus Placebo in Subjects With Type 2 Diabetes

A Phase 2 study testing PB-119 100 μg+ Glucophage®, PB-119 150 μg+ Glucophage® and PB-119 200 μg+ Glucophage® in people with Type 2 Diabetes Mellitus (T2DM), run by PegBio Co., Ltd. at 1 site in United States.

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

A phase 2, multicenter study to evaluate the efficacy and safety of twelve once weekly subcutaneous doses of PB-119 to patients with type 2 diabetes mellitus (T2DM) not well-controlled by metformin mono therapy. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus (T2DM)
What is being tested?: PB-119 100 μg+ Glucophage®, PB-119 150 μg+ Glucophage® and PB-119 200 μg+ Glucophage®
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 214 participants
Where: 1 siteUnited States
Study dates: 13 Jun 2018to 23 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

Patients in whom T2DM has been diagnosed according to 2018 American Diabetes Association T2DM diagnostic criteria, have made lifestyle modifications (ie, diet and exercise) for at least 3 months prior to Screening, and have been taking metformin for at least 3 months before Screening with a stable dosage for at least 8 weeks (stable dosage is defined as metformin dosage ≥1500 mg/day or maximum tolerated dose).
Males and/or females between the ages of ≥18 and ≤70 years at Screening
HbA1c ≥7.5% and ≤11% at Screening and at Week -1, Visit 3.1;
FPG ≥126 and ≤240 mg/dL (≥7.0 and ≤13.3 mmol/L) at Screening and at Week -1, Visit 3.1;
Body mass index (BMI) ≥18.5 and ≤40.0 kg/m2 at Screening, with inclusion of patients with BMIs at the lower end of the range enrolled into the study to enable comparisons across BMI range;

Who cannot join

Medical history or current diagnosis of:
Type 1 diabetes mellitus, diabetes caused by pancreas injury or by other diseases (like acromegaly or Cushing syndrome);
Diabetes acute complication, like ketoacidosis or hyperosmolar coma;
Diagnosed proliferative retinopathy;
3 instances of severe hypoglycemia (events during which the patient required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions; episodes may be associated with sufficient neuroglycopenia to have induced seizure or coma) in the 6 months prior to Screening;
Significant vascular disease;
Current/ongoing diagnosis of any type of malignant tumor or evidence of recurrence in the 6 months prior to Screening (patients who have been stable for ≥6 months or those who have had basal or squamous cell skin cancers removed and have no evidence of recurrence will not be excluded). Patients with a medical history of any other type of cancer in the last 5 years prior to Screening will be excluded;
Severe cardiovascular diseases occurring within 6 months prior to Screening (eg, congestive heart disease, myocardial infarction, acute coronary syndrome, apoplexy, transient ischemic attack);

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Pharmacology of Miami
Miami, Florida, 33014

Other trials in United States

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 to Patients With Type 2 Diabetes Mellitus (T2DM) Not Well-controlled by Metformin Monotherapy

Read the detailed description

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 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 and a 12-week double-blind treatment period.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 to patients with type 2 diabetes mellitus (T2DM) not well-controlled by metformin monotherapy 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 1) active drug or placebo at a 3:1 active drug:placebo ratio and 2) exclusion from or inclusion in the pharmacokinetic (PK) blood sample collection subgroup at a 3:1 excluded:included ratio

Conditions: Type 2 Diabetes Mellitus (T2DM)
Being tested: PB-119 100 μg+ Glucophage®, PB-119 150 μg+ Glucophage®, PB-119 200 μg+ Glucophage®, PB-119 placebo + Glucophage®
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-119 100 μg+ Glucophage®Drug
Each patient will subsequently be randomized within the designated cohort to active drug or placebo
PB-119 150 μg+ Glucophage®Drug
Each patient will subsequently be randomized within the designated cohort to active drug or placebo
PB-119 200 μg+ Glucophage®Drug
Each patient will subsequently be randomized within the designated cohort to active drug or placebo
PB-119 placebo + Glucophage®Drug
Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Study groups in NCT03604419
Study group	Role	What they receive
PB-119 100 μg	Experimental	PB-119 100 μg subcutaneous (SC) once weekly (QW) + Metformin oral (p.o.) Glucophage® (stable dosage) Receives: Drug: PB-119 150 μg+ Glucophage®; Drug: PB-119 200 μg+ Glucophage®; Drug: PB-119 placebo + Glucophage®
PB-119 150 μg	Experimental	PB-119 150 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage) Receives: Drug: PB-119 100 μg+ Glucophage®; Drug: PB-119 200 μg+ Glucophage®; Drug: PB-119 placebo + Glucophage®
PB-119 200 μg	Experimental	PB-119 200 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage) Receives: Drug: PB-119 100 μg+ Glucophage®; Drug: PB-119 150 μg+ Glucophage®; Drug: PB-119 placebo + Glucophage®
PB-119 Placebo	Placebo comparator	PB-119 Placebo SC QW + Metformin oral (p.o.) Glucophage® (stable dosage) Receives: Drug: PB-119 100 μg+ Glucophage®; Drug: PB-119 150 μg+ Glucophage®; Drug: PB-119 200 μg+ Glucophage®

What is being measured

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

The change from baseline value of HbA1c will be compared between treatments
Measured: From Baseline to end of treatment (up to Week 12)

Secondary outcomes (1)

The change from baseline value of Fasting Plasma Glucose at Weeks 2, 4, 8, and 12
Measured: From Baseline to end of treatment (up to Week 12)

Timeline

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

13 Jun 201823 Jul 2019

First posted27 Jul 2018
Study start13 Jun 2018
Primary completion23 Jul 2019
Study completion23 Jul 2019

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 214 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03604419
Sponsor's protocol ID: PB119202
Status last verified: Jan 2020
First submitted: 25 May 2018
Last updated: 22 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Park 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

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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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 to Patients With Type 2 Diabetes Mellitus (T2DM) Not Well-controlled by Metformin Monotherapy
ClinicalTrials.gov ID: NCT03604419
Acronym / sponsor ID: PB119202
Conditions: Type 2 Diabetes Mellitus (T2DM)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 214 participants (actual)
Lead sponsor: PegBio Co., Ltd.University, hospital or other
Collaborators: Covance
Study start: 13 Jun 2018 (actual)
Primary completion: 23 Jul 2019 (actual)
Study completion: 23 Jul 2019 (actual)
First posted: 27 Jul 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.

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: 4

Arm	Type	Receives
PB-119 100 μg	Experimental	Drug: PB-119 150 μg+ Glucophage®, Drug: PB-119 200 μg+ Glucophage®, Drug: PB-119 placebo + Glucophage®PB-119 100 μg subcutaneous (SC) once weekly (QW) + Metformin oral (p.o.) Glucophage® (stable dosage)
PB-119 150 μg	Experimental	Drug: PB-119 100 μg+ Glucophage®, Drug: PB-119 200 μg+ Glucophage®, Drug: PB-119 placebo + Glucophage®PB-119 150 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
PB-119 200 μg	Experimental	Drug: PB-119 100 μg+ Glucophage®, Drug: PB-119 150 μg+ Glucophage®, Drug: PB-119 placebo + Glucophage®PB-119 200 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
PB-119 Placebo	Placebo comparator	Drug: PB-119 100 μg+ Glucophage®, Drug: PB-119 150 μg+ Glucophage®, Drug: PB-119 200 μg+ Glucophage®PB-119 Placebo SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients in whom T2DM has been diagnosed according to 2018 American Diabetes Association T2DM diagnostic criteria, have made lifestyle modifications (ie, diet and exercise) for at least 3 months prior to Screening, and have been taking metformin for at least 3 months before Screening with a stable dosage for at least 8 weeks (stable dosage is defined as metformin dosage ≥1500 mg/day or maximum tolerated dose).
Males and/or females between the ages of ≥18 and ≤70 years at Screening
HbA1c ≥7.5% and ≤11% at Screening and at Week -1, Visit 3.1;
FPG ≥126 and ≤240 mg/dL (≥7.0 and ≤13.3 mmol/L) at Screening and at Week -1, Visit 3.1;
Body mass index (BMI) ≥18.5 and ≤40.0 kg/m2 at Screening, with inclusion of patients with BMIs at the lower end of the range enrolled into the study to enable comparisons across BMI range;

Key exclusion criteria (8 listed)

Medical history or current diagnosis of:
Current/ongoing diagnosis of any type of malignant tumor or evidence of recurrence in the 6 months prior to Screening (patients who have been stable for ≥6 months or those who have had basal or squamous cell skin cancers removed and have no evidence of recurrence will not be excluded). Patients with a medical history of any other type of cancer in the last 5 years prior to Screening will be excluded;
Severe cardiovascular diseases occurring within 6 months prior to Screening (eg, congestive heart disease, myocardial infarction, acute coronary syndrome, apoplexy, transient ischemic attack);

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-119 100 μg+ Glucophage®Each patient will subsequently be randomized within the designated cohort to active drug or placebo	Drug	PB-119 150 μg, PB-119 200 μg, PB-119 Placebo
PB-119 150 μg+ Glucophage®Each patient will subsequently be randomized within the designated cohort to active drug or placebo	Drug	PB-119 100 μg, PB-119 200 μg, PB-119 Placebo
PB-119 200 μg+ Glucophage®Each patient will subsequently be randomized within the designated cohort to active drug or placebo	Drug	PB-119 100 μg, PB-119 150 μg, PB-119 Placebo
PB-119 placebo + Glucophage®Each patient will subsequently be randomized within the designated cohort to active drug or placebo	Drug	PB-119 100 μg, PB-119 150 μg, PB-119 200 μg

Primary outcome

The change from baseline value of HbA1c will be compared between treatments
Time frame: From Baseline to end of treatment (up to Week 12)

1 secondary outcome

The change from baseline value of Fasting Plasma Glucose at Weeks 2, 4, 8, and 12
Time frame: From Baseline to end of treatment (up to Week 12)

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 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.
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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 5 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 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 United States. 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?

The change from baseline value of HbA1c will be compared between treatments (time frame: From Baseline to end of treatment (up to Week 12)). 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 NCT03604419, 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 22 Jan 2020; AzTrials last refreshed its copy on 3 Nov 2026.