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Clinical Trial Details

Trial ID: L3717
Source ID: NCT01658501
Associated Drug: 50 Mg Pb1023
Title: 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
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: 50 mg PB1023|DRUG: 70 mg PB1023|DRUG: 100 mg PB1023|DRUG: Placebo (0.9% Sodium Chloride)|DRUG: Victoza®|OTHER: Diet and Exercise|DRUG: Metformin|DRUG: Sulfonylurea|DRUG: Metformin and Sulfonylurea
Outcome Measures: Primary: Evaluation of dose response of Glymera as measured as the change from baseline in HbA1c after 20 weeks of dosing with Glymera compared to placebo and active comparator, Baseline and 20 weeks | Secondary: Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator, Up to 23 weeks|Compare change from baseline in weekly fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator, Baseline and 20 weeks|Describe the frequencies of adverse events in the treatment groups, Up to 23 weeks|Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing, Baseline and 20 weeks
Sponsor/Collaborators: Sponsor: PhaseBio Pharmaceuticals Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 593
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-07
Completion Date: 2013-07
Results First Posted:
Last Update Posted: 2015-12-07
Locations: 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|Ft. 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
URL: https://clinicaltrials.gov/show/NCT01658501

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details