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
NCT ID: NCT01658501
Last Updated: 2015-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
593 participants
INTERVENTIONAL
2012-07-31
2013-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Diet and Exercise
Diet and exercise only.
50 mg PB1023
70 mg PB1023
100 mg PB1023
Placebo (0.9% Sodium Chloride)
Victoza®
Metformin
Metformin only
50 mg PB1023
70 mg PB1023
100 mg PB1023
Placebo (0.9% Sodium Chloride)
Victoza®
Sulfonylurea
Sulfonylurea only
50 mg PB1023
70 mg PB1023
100 mg PB1023
Placebo (0.9% Sodium Chloride)
Victoza®
Metformin and Sulfonylurea
Metformin and Sulfonylurea combination therapy
50 mg PB1023
70 mg PB1023
100 mg PB1023
Placebo (0.9% Sodium Chloride)
Victoza®
PB1023
PB1023 weekly SC injection
50 mg PB1023
70 mg PB1023
100 mg PB1023
Diet and Exercise
Metformin
Sulfonylurea
Metformin and Sulfonylurea
Placebo Comparator
Placebo (0.9% Sodium Chloride) weekly SC injection
Placebo (0.9% Sodium Chloride)
Diet and Exercise
Metformin
Sulfonylurea
Metformin and Sulfonylurea
Active Comparator
Active Comparator (Victoza) daily SC injection
Victoza®
Diet and Exercise
Metformin
Sulfonylurea
Metformin and Sulfonylurea
Interventions
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50 mg PB1023
70 mg PB1023
100 mg PB1023
Placebo (0.9% Sodium Chloride)
Victoza®
Diet and Exercise
Metformin
Sulfonylurea
Metformin and Sulfonylurea
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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PhaseBio Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Anniston, Alabama, United States
Birmingham, Alabama, United States
Gulf Shores, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Muscle Shoals, Alabama, United States
Chandler, Arizona, United States
Glendale, Arizona, United States
Goodyear, Arizona, United States
Tucson, Arizona, United States
Harrisburg, Arkansas, United States
Little Rock, Arkansas, United States
Searcy, Arkansas, United States
Chula Vista, California, United States
Concord, California, United States
Escondido, California, United States
Hawaiian Gardens, California, United States
La Mesa, California, United States
Los Angeles, California, United States
Oceanside, California, United States
San Jose, California, United States
Santa Rosa, California, United States
Walnut Creek, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Stamford, Connecticut, United States
Brandenton, Florida, United States
Brooksville, Florida, United States
Fort Lauderdale, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Oviedo, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
Roswell, Georgia, United States
Savannah, Georgia, United States
Boise, Idaho, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Council Bluffs, Iowa, United States
Augusta, Kansas, United States
Newton, Kansas, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
New Orleans, Louisiana, United States
Oxon Hill, Maryland, United States
Ypsilanti, Michigan, United States
Saint Paul, Minnesota, United States
St Louis, Missouri, United States
Fremont, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
New Windsor, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Hickory, North Carolina, United States
Morehead City, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Delaware, Ohio, United States
Kettering, Ohio, United States
Lyndhurst, Ohio, United States
Wadsworth, Ohio, United States
Willoughby Hills, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Greer, South Carolina, United States
Spartanburg, South Carolina, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Hurst, Texas, United States
Katy, Texas, United States
Magna, Utah, United States
West Jordan, Utah, United States
Burke, Virginia, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Renton, Washington, United States
Kenosha, Wisconsin, United States
Countries
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Other Identifiers
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PB1023-PT-CL-0004
Identifier Type: -
Identifier Source: org_study_id