Status:
COMPLETED
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
Lead Sponsor:
PhaseBio Pharmaceuticals Inc.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 objec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01236404
Start Date
November 1 2010
End Date
November 1 2011
Last Update
May 21 2013
Active Locations (3)
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1
Diablo Clinical Research
Walnut Creek, California, United States, 94598
2
Prism Research
Saint Paul, Minnesota, United States, 55114
3
Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057