Diabetes Mellitus, Type 2Phase 1/2NCT01236404
Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, Study to Assess Safety, Tolerability, PK and PD Response of PB1023 Injection Following Single and Multiple SQ Doses in Adults With Type 2 Diabetes Mellitus
A Phase 1/2 study of Diabetes Mellitus, Type 2, run by PhaseBio Pharmaceuticals Inc. at 3 sites in United States.
Trial summary
Primary objective: To evaluate the safety and tolerability of single and multiple ascending doses of PB1023 administered as a subcutaneous (SC) injection in adult subjects with T2DM. Secondary objectives: 1. To characterize the pharmacokinetic profile of PB1023 after single and multiple ascending doses of PB1023. 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to Nov 2011
- Phase
- Phase 1/2
- 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
- Males or post menopausal or surgically sterile females age 18-75 years of age inclusive.
- Diagnosed with T2DM for > or = 6 months with HbA1c > or = 6.0% but < or = 9.0% while taking stable doses of one oral antihyperglycemic agent but < or = 8.5% when taking two oral antihyperglycemic agents for up to a maximum of 3 months prior to screening.
- Fasting Plasma glucose between 115 mg/dL and 269 mg/dL.
- Fasting C-peptide of > or = 0.8 ng/mL.
- BMI < or = 40 kg/m2.
- Otherwise stable health except for T2DM.
Who cannot join
- Currently taking a non-oral antihyperglycemic agent.
- Have taken a PPARg agonist within 90 days of screening.
- Known allergy to an approved or investigational GLP-1 receptor analog/agonist.
- Unstable cardiovascular disease as defined in clinical protocol.
- History, symptoms or signs of pancreatitis or severe gastrointestinal disease.
- Personal or family history of medullary thyroid tumors history of Multiple Endocrine Neoplasia Syndrome Type 2.
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- Poor glucose control as defined in clinical protocol.
- Clinically significant renal and/or hepatic dysfunction as defined in clinical protocol.
- Absolute requirement for corticosteroids or received systemic steroids within 90 days prior to PB1023 administration.
- Pregnant or lactating females.
- Known history or active alcohol or drug abuse within 12 months prior to screening.
- Positive for HIV, Hepatitis B surface antigen or Hepatitis C antibodies.
- Participating in any other study within 30 days prior to screening.
- Other medical or psychiatric condition which in the opinion of the investigator would place the subject at increased risk.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
Prism Research
Saint Paul, Minnesota, 55114
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: Phase 1/2a, Randomized, Double-Blind Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Response of PB1023 Injection Following Single and Multiple Ascending Subcutaneous Doses in Adult Subjects With Type 2 Diabetes Mellitus (T2DM)
Primary objective:
To evaluate the safety and tolerability of single and multiple ascending doses of PB1023 administered as a subcutaneous (SC) injection in adult subjects with T2DM.
Secondary objectives:
- To characterize the pharmacokinetic profile of PB1023 after single and multiple ascending doses of PB1023.
- To assess the pharmacodynamic response of various single and multiple doses of PB1023 (daily fasting plasma glucose, and serial glucose, c-peptide and insulin levels in response to a liquid Mixed Meal Tolerance Test (MMTT).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl), Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)
- 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.
Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl)Drug
Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)Drug
Once weekly injections for up to four weeks
| Study group | Role | What they receive |
|---|---|---|
| PB1023 Injection | Experimental | Subcutaneous injection PB1023 Receives: Drug: Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl); Drug: Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl) |
| Placebo (0.9% Sodium Chloride Injection) | Placebo comparator | Subcutaneous Injection Placebo Receives: Drug: Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl); Drug: Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Tolerability
Safety will be evaluated by analyses of incidence of adverse events of interest (possibly related to the class of drug) and other adverse events. Vital signs, ECGs and safety laboratory parameters will also be presented.
Measured: Screening to Final Visit (up to approximately 10 weeks for SAD and 14 weeks for MAD)
Secondary outcomes (2)
Pharmacokinetic Profile
To characterize the PK profile of PB1023 after single and multiple ascending doses of PB1023. The following parameters will be evaluated: t1/2, AUC(inf), AUC(0-t), Tmax, Cmax, Elimination Rate Constant, Clearance and Distribution.
Measured: SAD: Pre-dose, 1, 4, 8, and 12 hours post-dose and Day 1, 2, 3, 5, 7, 10, 14, 21 and 28. MAD: Pre-dose, 1, 4, 8, and 12 hours post-dose and Day 1, 2, 3, 5, pre-dose Days 7, 14 and 21 and at 1, 4, 8, and 12 hours post-dose and Day 22, 23, 26, 28, 35, 42,
Pharmacodynamic Response
To assess the pharmacodynamic response of various single and multiple doses of PB1023 (daily fasting plasma glucose and serial glucose (and continuous monitoring as defined in time frame), c-peptide and insulin levels in response to a liquid mixed meal tolerance test (MMTT) pre and post dose) on subjects washed off their baseline oral antihyperglycemic agents.
Measured: Fasting plasma glucose collected the day before dosing and with PK samples, excluding day of dosing. SAD MMTT to occur on day 0 and 2, MAD MMTT to occur on Day 0 and 22 with continuous glucose monitoring on Day -8/-7 to Day 0 and on Day 21 to Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Matson, M.D., Principal investigator, Prism Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236404
- Sponsor's protocol ID
- PB1023-PT-CL-0001
- Status last verified
- May 2013
- First submitted
- 5 Nov 2010
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a, Randomized, Double-Blind Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Response of PB1023 Injection Following Single and Multiple Ascending Subcutaneous Doses in Adult Subjects With Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT01236404
- Acronym / sponsor ID
- PB1023-PT-CL-0001
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 Nov 2010 (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:
To evaluate the safety and tolerability of single and multiple ascending doses of PB1023 administered as a subcutaneous (SC) injection in adult subjects with T2DM.
Secondary objectives:
- To characterize the pharmacokinetic profile of PB1023 after single and multiple ascending doses of PB1023.
- To assess the pharmacodynamic response of various single and multiple doses of PB1023 (daily fasting plasma glucose, and serial glucose, c-peptide and insulin levels in response to a liquid Mixed Meal Tolerance Test (MMTT).
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 |
|---|---|---|
| PB1023 Injection | Experimental | Drug: Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl), Drug: Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)Subcutaneous injection PB1023 |
| Placebo (0.9% Sodium Chloride Injection) | Placebo comparator | Drug: Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl), Drug: Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)Subcutaneous Injection Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or post menopausal or surgically sterile females age 18-75 years of age inclusive.
- Diagnosed with T2DM for > or = 6 months with HbA1c > or = 6.0% but < or = 9.0% while taking stable doses of one oral antihyperglycemic agent but < or = 8.5% when taking two oral antihyperglycemic agents for up to a maximum of 3 months prior to screening.
- Fasting Plasma glucose between 115 mg/dL and 269 mg/dL.
- Fasting C-peptide of > or = 0.8 ng/mL.
- BMI < or = 40 kg/m2.
Key exclusion criteria (14 listed)
- Currently taking a non-oral antihyperglycemic agent.
- Have taken a PPARg agonist within 90 days of screening.
- Known allergy to an approved or investigational GLP-1 receptor analog/agonist.
- Unstable cardiovascular disease as defined in clinical protocol.
- History, symptoms or signs of pancreatitis or severe gastrointestinal disease.
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 |
|---|---|---|
| Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl) | Drug | PB1023 Injection, Placebo (0.9% Sodium Chloride Injection) |
| Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)Once weekly injections for up to four weeks | Drug | PB1023 Injection, Placebo (0.9% Sodium Chloride Injection) |
Primary outcome
Safety/Tolerability
Time frame: Screening to Final Visit (up to approximately 10 weeks for SAD and 14 weeks for MAD)
Safety will be evaluated by analyses of incidence of adverse events of interest (possibly related to the class of drug) and other adverse events. Vital signs, ECGs and safety laboratory parameters will also be presented.
2 secondary outcomes
Pharmacokinetic Profile
Time frame: SAD: Pre-dose, 1, 4, 8, and 12 hours post-dose and Day 1, 2, 3, 5, 7, 10, 14, 21 and 28. MAD: Pre-dose, 1, 4, 8, and 12 hours post-dose and Day 1, 2, 3, 5, pre-dose Days 7, 14 and 21 and at 1, 4, 8, and 12 hours post-dose and Day 22, 23, 26, 28, 35, 42,
Pharmacodynamic Response
Time frame: Fasting plasma glucose collected the day before dosing and with PK samples, excluding day of dosing. SAD MMTT to occur on day 0 and 2, MAD MMTT to occur on Day 0 and 22 with continuous glucose monitoring on Day -8/-7 to Day 0 and on Day 21 to Day 28.
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 21 May 2013.
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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.
Mark Matson, M.D. principal investigator
Prism Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Diabetes Mellitus, Type 2, run by PhaseBio Pharmaceuticals Inc. at 3 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 6 inclusion and 14 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 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety/Tolerability (time frame: Screening to Final Visit (up to approximately 10 weeks for SAD and 14 weeks for MAD)). 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 21 May 2013.