Type 2 Diabetes MellitusPhase 2NCT01658501
Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the PD Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM
A Phase 2 study testing 50 mg PB1023, 70 mg PB1023 and 100 mg PB1023 in people with Type 2 Diabetes Mellitus, run by PhaseBio Pharmaceuticals Inc. at 93 sites in United States.
Trial summary
Primary objective: The primary objective of this study is to define the dose response of Glymera as measured as the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- 50 mg PB1023, 70 mg PB1023 and 100 mg PB1023
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 593 participants
- Where
- 93 sitesUnited States
- Study dates
- Jul 2012to Jul 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects 18 to 75 years of age, inclusive;
- Body mass index ≤45 kg/m2;
- Diagnosed with T2DM with HbA1c of ≥7.0% and ≤11.0% and treated with diet and exercise alone, or with stable doses of metformin alone, sulfonylurea alone or metformin and sulfonylurea.
Who cannot join
- Currently taking or have taken within the last 6 months non-oral antihyperglycemic agents (eg, insulin, Byetta®, Bydureon®, or Victoza). Short-term use of insulin within this period will not be cause for exclusion if insulin was used during the treatment of an acute intercurrent illness;
- Known allergy to or serious adverse effect caused by an approved or investigational glucagon-like peptide-1 (GLP-1) receptor analog/agonist;
- Unstable cardiovascular disease;
- History of weight loss surgery or other gastrointestinal surgical procedures that could possibly interfere with the mechanism of action of GLP-1 receptor agonists;
- Based on contraindications/warnings identified with other GLP-1 receptor agonists, subjects will be excluded if they have: History, symptoms, or signs of pancreatitis or severe gastrointestinal disease (ie, gastroparesis) or Personal or family history of medullary thyroid tumors or history of Multiple Endocrine Neoplasia Syndrome Type 2;
- Clinically significant renal and/or hepatic dysfunction;
- Pregnant or lactating female subjects.
Trial locations and contacts
93 sites in 1 country.
93 sites in 1 country
United States93 sites
Study site
Anniston, Alabama
Study site
Arlington Heights, Illinois
Study site
Augusta, Kansas
Study site
Austin, Texas
Study site
Berlin, New Jersey
Study site
Birmingham, Alabama
Study site
Boise, Idaho
Study site
Brandenton, Florida
Study site
Brooksville, Florida
Study site
Burke, Virginia
Study site
Chandler, Arizona
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Chula Vista, California
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Colorado Springs, Colorado
Study site
Concord, California
Study site
Corpus Christi, Texas
Study site
Council Bluffs, Iowa
Study site
Dallas, Texas
Study site
Decatur, Georgia
Study site
Delaware, Ohio
Study site
Denver, Colorado
Study site
Durham, North Carolina
Study site
Escondido, California
Study site
Eugene, Oregon
Study site
Evansville, Indiana
Study site
Fort Lauderdale, Florida
Study site
Fremont, Nebraska
Study site
Glendale, Arizona
Study site
Goodyear, Arizona
Study site
Greer, South Carolina
Study site
Gulf Shores, Alabama
Study site
Harrisburg, Arkansas
Study site
Hawaiian Gardens, California
Study site
Hialeah, Florida
Study site
Hickory, North Carolina
Study site
Houston, Texas
Study site
Huntsville, Alabama
Study site
Hurst, Texas
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Katy, Texas
Study site
Kenosha, Wisconsin
Study site
Kettering, Ohio
Study site
La Mesa, California
Study site
Las Vegas, Nevada
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Lyndhurst, Ohio
Study site
Magna, Utah
Study site
Marietta, Georgia
Study site
Miami, Florida
Study site
Mobile, Alabama
Study site
Morehead City, North Carolina
Study site
Muscle Shoals, Alabama
Study site
New Orleans, Louisiana
Study site
New Port Richey, Florida
Study site
New Windsor, New York
Study site
Newton, Kansas
Study site
Oceanside, California
Study site
Oklahoma City, Oklahoma
Study site
Omaha, Nebraska
Study site
Overland Park, Kansas
Study site
Oviedo, Florida
Study site
Oxon Hill, Maryland
Study site
Raleigh, North Carolina
Study site
Renton, Washington
Study site
Richmond, Virginia
Study site
Rochester, New York
Study site
Roswell, Georgia
Study site
Saint Paul, Minnesota
Study site
San Jose, California
Study site
Santa Rosa, California
Study site
Savannah, Georgia
Study site
Searcy, Arkansas
Study site
Spartanburg, South Carolina
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Stamford, Connecticut
Study site
Tampa, Florida
Study site
Tucson, Arizona
Study site
Tulsa, Oklahoma
Study site
Virginia Beach, Virginia
Study site
Wadsworth, Ohio
Study site
Walnut Creek, California
Study site
West Jordan, Utah
Study site
Wichita, Kansas
Study site
Willoughby Hills, Ohio
Study site
Wilmington, North Carolina
Study site
Winston-Salem, North Carolina
Study site
Ypsilanti, Michigan
About this study
Official title: Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the Pharmacodynamic Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Once-Weekly Subcutaneous Dosing in Adult Subjects With Inadequately Treated Type 2 Diabetes Mellitus
Primary objective:
The primary objective of this study is to define the dose response of Glymera as measured as the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing.
Read more
Secondary objectives:
The secondary objectives are to:
- Describe incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator;
- Compare change from baseline in HbA1c following 20 weeks of dosing compared to placebo and active comparator;
- Compare change from baseline in fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator;
- Describe the frequencies of adverse events in the treatment groups; and
- Describe the above endpoints for the following subgroups of subjects according to baseline type 2 diabetes mellitus (T2DM) therapy: diet and exercise only, metformin only, sulfonylurea only, or metformin and sulfonylurea combination therapy.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- 50 mg PB1023, 70 mg PB1023, 100 mg PB1023, Placebo (0.9% Sodium Chloride), Victoza®
- 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.
50 mg PB1023Drug
70 mg PB1023Drug
100 mg PB1023Drug
Placebo (0.9% Sodium Chloride)Drug
Also called SC Weekly Injection
Victoza®Drug
Also called daily SC injection
Diet and ExerciseOther
MetforminDrug
SulfonylureaDrug
Metformin and SulfonylureaDrug
| Study group | Role | What they receive |
|---|---|---|
| Diet and Exercise | Experimental | Diet and exercise only. Receives: Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Drug: Victoza® |
| Metformin | Experimental | Metformin only Receives: Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Drug: Victoza® |
| Sulfonylurea | Experimental | Sulfonylurea only Receives: Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Drug: Victoza® |
| Metformin and Sulfonylurea | Experimental | Metformin and Sulfonylurea combination therapy Receives: Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Drug: Victoza® |
| PB1023 | Experimental | PB1023 weekly SC injection Receives: Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Other: Diet and Exercise; Drug: Metformin; Drug: Sulfonylurea; Drug: Metformin and Sulfonylurea |
| Placebo Comparator | Placebo comparator | Placebo (0.9% Sodium Chloride) weekly SC injection Receives: Drug: Placebo (0.9% Sodium Chloride); Other: Diet and Exercise; Drug: Metformin; Drug: Sulfonylurea; Drug: Metformin and Sulfonylurea |
| Active Comparator | Active comparator | Active Comparator (Victoza) daily SC injection Receives: Drug: Victoza®; Other: Diet and Exercise; Drug: Metformin; Drug: Sulfonylurea; Drug: Metformin and Sulfonylurea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of dose response of Glymera as measured as the change from baseline in HbA1c after 20 weeks of dosing with Glymera compared to placebo and active comparator
Measured: Baseline and 20 weeks
Secondary outcomes (4)
Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator
Measured: Up to 23 weeks
Compare change from baseline in weekly fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator
Measured: Baseline and 20 weeks
Describe the frequencies of adverse events in the treatment groups
Measured: Up to 23 weeks
Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing
Measured: Baseline and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 593 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658501
- Sponsor's protocol ID
- PB1023-PT-CL-0004
- Status last verified
- Nov 2015
- First submitted
- 24 Jul 2012
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the Pharmacodynamic Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Once-Weekly Subcutaneous Dosing in Adult Subjects With Inadequately Treated Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01658501
- Acronym / sponsor ID
- PB1023-PT-CL-0004
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 Aug 2012 (estimated)
- 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.
Primary objective:
The primary objective of this study is to define the dose response of Glymera as measured as the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing.
Secondary objectives:
The secondary objectives are to:
- Describe incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator;
- Compare change from baseline in HbA1c following 20 weeks of dosing compared to placebo and active comparator;
- Compare change from baseline in fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator;
- Describe the frequencies of adverse events in the treatment groups; and
- Describe the above endpoints for the following subgroups of subjects according to baseline type 2 diabetes mellitus (T2DM) therapy: diet and exercise only, metformin only, sulfonylurea only, or metformin and sulfonylurea combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Diet and Exercise | Experimental | Drug: 50 mg PB1023, Drug: 70 mg PB1023, Drug: 100 mg PB1023, Drug: Placebo (0.9% Sodium Chloride), Drug: Victoza®Diet and exercise only. |
| Metformin | Experimental | Drug: 50 mg PB1023, Drug: 70 mg PB1023, Drug: 100 mg PB1023, Drug: Placebo (0.9% Sodium Chloride), Drug: Victoza®Metformin only |
| Sulfonylurea | Experimental | Drug: 50 mg PB1023, Drug: 70 mg PB1023, Drug: 100 mg PB1023, Drug: Placebo (0.9% Sodium Chloride), Drug: Victoza®Sulfonylurea only |
| Metformin and Sulfonylurea | Experimental | Drug: 50 mg PB1023, Drug: 70 mg PB1023, Drug: 100 mg PB1023, Drug: Placebo (0.9% Sodium Chloride), Drug: Victoza®Metformin and Sulfonylurea combination therapy |
| PB1023 | Experimental | Drug: 50 mg PB1023, Drug: 70 mg PB1023, Drug: 100 mg PB1023, Other: Diet and Exercise, Drug: Metformin, Drug: Sulfonylurea, Drug: Metformin and SulfonylureaPB1023 weekly SC injection |
| Placebo Comparator | Placebo comparator | Drug: Placebo (0.9% Sodium Chloride), Other: Diet and Exercise, Drug: Metformin, Drug: Sulfonylurea, Drug: Metformin and SulfonylureaPlacebo (0.9% Sodium Chloride) weekly SC injection |
| Active Comparator | Active comparator | Drug: Victoza®, Other: Diet and Exercise, Drug: Metformin, Drug: Sulfonylurea, Drug: Metformin and SulfonylureaActive Comparator (Victoza) daily SC injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects 18 to 75 years of age, inclusive;
- Body mass index ≤45 kg/m2;
- Diagnosed with T2DM with HbA1c of ≥7.0% and ≤11.0% and treated with diet and exercise alone, or with stable doses of metformin alone, sulfonylurea alone or metformin and sulfonylurea.
Key exclusion criteria (7 listed)
- Currently taking or have taken within the last 6 months non-oral antihyperglycemic agents (eg, insulin, Byetta®, Bydureon®, or Victoza). Short-term use of insulin within this period will not be cause for exclusion if insulin was used during the treatment of an acute intercurrent illness;
- Known allergy to or serious adverse effect caused by an approved or investigational glucagon-like peptide-1 (GLP-1) receptor analog/agonist;
- Unstable cardiovascular disease;
- History of weight loss surgery or other gastrointestinal surgical procedures that could possibly interfere with the mechanism of action of GLP-1 receptor agonists;
- Based on contraindications/warnings identified with other GLP-1 receptor agonists, subjects will be excluded if they have: History, symptoms, or signs of pancreatitis or severe gastrointestinal disease (ie, gastroparesis) or Personal or family history of medullary thyroid tumors or history of Multiple Endocrine Neoplasia Syndrome Type 2;
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 |
|---|---|---|
| 50 mg PB1023 | Drug | Diet and Exercise, Metformin, Metformin and Sulfonylurea, PB1023, Sulfonylurea |
| 70 mg PB1023 | Drug | Diet and Exercise, Metformin, Metformin and Sulfonylurea, PB1023, Sulfonylurea |
| 100 mg PB1023 | Drug | Diet and Exercise, Metformin, Metformin and Sulfonylurea, PB1023, Sulfonylurea |
| Placebo (0.9% Sodium Chloride)Also: SC Weekly Injection | Drug | Diet and Exercise, Metformin, Metformin and Sulfonylurea, Placebo Comparator, Sulfonylurea |
| Victoza®Also: daily SC injection | Drug | Active Comparator, Diet and Exercise, Metformin, Metformin and Sulfonylurea, Sulfonylurea |
| Diet and Exercise | Other | Active Comparator, PB1023, Placebo Comparator |
| Metformin | Drug | Active Comparator, PB1023, Placebo Comparator |
| Sulfonylurea | Drug | Active Comparator, PB1023, Placebo Comparator |
| Metformin and Sulfonylurea | Drug | Active Comparator, PB1023, Placebo Comparator |
Primary outcome
Evaluation of dose response of Glymera as measured as the change from baseline in HbA1c after 20 weeks of dosing with Glymera compared to placebo and active comparator
Time frame: Baseline and 20 weeks
4 secondary outcomes
Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator
Time frame: Up to 23 weeks
Compare change from baseline in weekly fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator
Time frame: Baseline and 20 weeks
Describe the frequencies of adverse events in the treatment groups
Time frame: Up to 23 weeks
Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing
Time frame: Baseline and 20 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 7 Dec 2015.
Related trials for Type 2 Diabetes Mellitus
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
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.
93 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 50 mg PB1023, 70 mg PB1023 and 100 mg PB1023 in people with Type 2 Diabetes Mellitus, run by PhaseBio Pharmaceuticals Inc. at 93 sites in United States.
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 3 inclusion and 7 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 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites 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?
Evaluation of dose response of Glymera as measured as the change from baseline in HbA1c after 20 weeks of dosing with Glymera compared to placebo and active comparator (time frame: Baseline and 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2015.