- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01835730
Phase 1 Multicenter, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus
October 13, 2014 updated by: PhaseBio Pharmaceuticals Inc.
Phase 1 Multicenter, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus
This study is a first-in-human randomized, double-blind (Investigator and subject), placebo controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
Phase
- 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
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Alabama
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Anniston, Alabama, United States, 36207
- Pinnacle Research Group, LLC
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-
Florida
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Hialeah, Florida, United States, 33012
- Palm Springs Research Institute
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Washington
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Renton, Washington, United States, 98057
- Rainier Clinical Research
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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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Willing and able to sign a written informed consent and follow all study-related procedures;
- Male and female subjects at least 18 years of age;
- Male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their dose of study drug;
- Body mass index ≤45 kg/m2;
- Diagnosed with T2DM and who is currently taking a stable daily dose of a basal insulin (Lantus) plus at least one oral antihyperglycemic agent at a stable dose for 3 months prior to screening.
Exclusion Criteria:
- Currently taking or have taken within 3 months prior to screening an approved or investigational GLP-1 analogue/agonist (e.g., Victoza®) or pramlintide;
- Currently taking or have routinely taken, within 3 months prior to screening , a short-acting insulin;
- Currently taking or have taken, within 3 months prior to screening, a long acting insulin other than Lantus®;
- Known allergy to, or serious adverse effect caused by an approved, or investigational insulin product or any of its components;
- Currently taking any of the following medications: thiazide or furosemide diuretics, beta-blockers, estrogens or other hormonal replacement therapy, or other chronic medications with known adverse effects on glucose tolerance levels unless the subject has been on stable doses of such agents for at least 2 months prior to screening and have no planned changes during the study period;
- History of recurrent severe hypoglycemia (more than 2 episodes within the last 6 months prior to randomization or hypoglycemic unawareness;
- Malignant disease defined as 1) any history of malignant melanoma or breast cancer and/or 2) history of other types of cancer within the last 5 years prior to screening;
- Unstable cardiovascular disease defined as one or more of the following: History of stroke, transient ischemic attack, or myocardial infarction within 6 months prior to screening; History of or currently have New York Heart Association Class III-IV heart failure prior to screening; Uncontrolled/sustained hypertension; History or evidence of long QT syndrome or mean triplicate 12-lead electrocardiogram demonstrating QT interval;
- Clinically significant renal and/or hepatic dysfunction;
- Absolute requirement for corticosteroids or have received systemic steroids within 3 months prior to Randomization (V5, Day -1). Note: Use of inhaled or topical corticosteroids will be permitted;
- Pregnant or lactating female subjects;
- Known history of or active alcohol abuse or use of illicit drugs within 1 year prior to screening;
- Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at V1;
- Participating in any other study and have received any other investigational medication or device within 30 days prior to Visit 1.
- 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: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PE0139 Injection
Single subcutaneous injection of PE0139, 40 mg/mL
|
|
Placebo Comparator: Placebo
Single subcutaneous injection of 0.9% Sodium Chloride (NaCl) (Placebo)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Vital Signs from baseline (Day 0 Pre-dose)
Time Frame: Vital signs Day 0, 1, 2, 3, 4, 5, 6, 7, 14 and 28
|
Safety will be evaluated by analyses of the change from baseline in vital signs.
|
Vital signs Day 0, 1, 2, 3, 4, 5, 6, 7, 14 and 28
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Change in ECGs from baseline (Day -1)
Time Frame: ECG Days 2 and 28
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Safety will be evaluated by analyses of the change from baseline in 12-lead ECG.
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ECG Days 2 and 28
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Change in Safety Labs from baseline (Pre-dose)
Time Frame: Safety Labs Days 0, 7 and 28
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Safety will be evaluated by analyses of the safety laboratory parameters.
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Safety Labs Days 0, 7 and 28
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Incidence and severity of immunogenicity
Time Frame: Immunogenicity Days 0, 7, 14 and 28
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Safety will be evaluated by the incidence and severity of immunogenicity.
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Immunogenicity Days 0, 7, 14 and 28
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Incidence and severity of adverse events including hypoglycemia
Time Frame: As reported between Days -10 to 28
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Safety will be evaluated by the incidence and severity of adverse events including hypoglycemia.
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As reported between Days -10 to 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic Profile
Time Frame: Day 0, 1, 2, 3, 4, 5, 6, and 7
|
Pharmacokinetic parameters include: Area under the concentration curve from time 0 to infinity (AUC(0-inf)), Area under the concentration curve to the final sample with a concentration greater than or equal to Limit of Quantitation (LOQ) (AUC(0-t)), Time to maximum concentration (Tmax), Maximum serum concentration (Cmax), Elimination rate constant (Lambda-z), Elimination half-life (t1/2), Clearance uncorrected for bioavailability (CL/F), Distribution uncorrected for bioavailability (Vz/F)
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Day 0, 1, 2, 3, 4, 5, 6, and 7
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Pharmacodynamic Response
Time Frame: FPG Day -10, -4, 0, 1, 2, 3, 4, 5, 6, 7, and 28; 4-pt Glucose and CGM - Day -10 to -7, -6, -5, and -4 to 7
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To assess the pharmacodynamic response (time action profile) of various single doses of PE0139.
Assessments include Fasting plasma glucose (FPG), 4-point serial glucose monitoring and glucose assessed by continuous glucose monitoring (CGM).
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FPG Day -10, -4, 0, 1, 2, 3, 4, 5, 6, 7, and 28; 4-pt Glucose and CGM - Day -10 to -7, -6, -5, and -4 to 7
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ronald Brazg, MD, Rainier Clinical Research
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
April 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
March 28, 2013
First Submitted That Met QC Criteria
April 16, 2013
First Posted (Estimate)
April 19, 2013
Study Record Updates
Last Update Posted (Estimate)
October 15, 2014
Last Update Submitted That Met QC Criteria
October 13, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PE0139-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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