- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01236404
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
May 13, 2013 updated by: PhaseBio Pharmaceuticals Inc.
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).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Walnut Creek, California, United States, 94598
- Diablo Clinical Research
-
-
Minnesota
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Saint Paul, Minnesota, United States, 55114
- Prism Research
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Washington
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Renton, Washington, United States, 98057
- Rainier Clinical Research Center, Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PB1023 Injection
Subcutaneous injection PB1023
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Once weekly injections for up to four weeks
|
Placebo Comparator: Placebo (0.9% Sodium Chloride Injection)
Subcutaneous Injection Placebo
|
Once weekly injections for up to four weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Screening to Final Visit (up to approximately 10 weeks for SAD and 14 weeks for MAD)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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,
|
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.
|
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.
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
November 5, 2010
First Submitted That Met QC Criteria
November 5, 2010
First Posted (Estimate)
November 8, 2010
Study Record Updates
Last Update Posted (Estimate)
May 21, 2013
Last Update Submitted That Met QC Criteria
May 13, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PB1023-PT-CL-0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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