Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety
NCT ID: NCT00359801
Last Updated: 2010-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1976 participants
INTERVENTIONAL
2006-07-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exubera
Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for Exubera to guide prescribing and treatment decisions.
Usual Diabetes Care
Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Subjects are randomized to use usual diabetes care. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).
Interventions
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Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for Exubera to guide prescribing and treatment decisions.
Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Subjects are randomized to use usual diabetes care. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Have a progressive fatal disease or a life expectancy that prohibits them from participating in a five-year research study
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Bay Minette, Alabama, United States
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Fairhope, Alabama, United States
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Graysville, Alabama, United States
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Pell City, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Forrest City, Arkansas, United States
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Searcy, Arkansas, United States
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Cudahy, California, United States
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El Cajon, California, United States
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Huntington Beach, California, United States
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Rolling Hills Estates, California, United States
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San Jose, California, United States
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Santa Ana, California, United States
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Westminster, California, United States
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Denver, Colorado, United States
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Milford, Connecticut, United States
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Wilmington, Delaware, United States
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Boca Raton, Florida, United States
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Clearwater, Florida, United States
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DeBary, Florida, United States
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Gainesville, Florida, United States
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Green Cove Springs, Florida, United States
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Hollywood, Florida, United States
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Kissimmee, Florida, United States
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Kissimmee, Florida, United States
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Marianna, Florida, United States
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Merritt Island, Florida, United States
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Miami, Florida, United States
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Niceville, Florida, United States
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Opa-locka, Florida, United States
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Orange City, Florida, United States
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Ormond Beach, Florida, United States
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Pembroke Pines, Florida, United States
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Plantation, Florida, United States
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Port Charlotte, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Conyers, Georgia, United States
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Decatur, Georgia, United States
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Warner Robins, Georgia, United States
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Boise, Idaho, United States
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Greenville, Illinois, United States
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Libertyville, Illinois, United States
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Fishers, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Louisville, Kentucky, United States
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Mount Sterling, Kentucky, United States
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Bossier City, Louisiana, United States
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Auburn, Maine, United States
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Baltimore, Maryland, United States
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Elkton, Maryland, United States
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Glen Burnie, Maryland, United States
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Wheaton, Maryland, United States
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Boston, Massachusetts, United States
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Plymouth, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Battle Creek, Michigan, United States
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Battle Creek, Michigan, United States
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Clinton, Michigan, United States
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Flint, Michigan, United States
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Muskegon, Michigan, United States
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Sterling Heights, Michigan, United States
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Troy, Michigan, United States
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Warren, Michigan, United States
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Saint Cloud, Minnesota, United States
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Grand Island, Nebraska, United States
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Incline Village, Nevada, United States
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Belleville, New Jersey, United States
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Belvidere, New Jersey, United States
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Glendora, New Jersey, United States
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Albuquerque, New Mexico, United States
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Babylon, New York, United States
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Brooklyn, New York, United States
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New Hartford, New York, United States
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Rochester, New York, United States
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Williamsville, New York, United States
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Asheboro, North Carolina, United States
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Charlotte, North Carolina, United States
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Morehead City, North Carolina, United States
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Raleigh, North Carolina, United States
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Raleigh, North Carolina, United States
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Shelby, North Carolina, United States
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Tabor City, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Ashtabula, Ohio, United States
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Canton, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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McConnelsville, Ohio, United States
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Zanesville, Ohio, United States
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Clinton, Oklahoma, United States
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Bend, Oregon, United States
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Broomall, Pennsylvania, United States
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Dauphin, Pennsylvania, United States
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Fogelsville, Pennsylvania, United States
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Hanover, Pennsylvania, United States
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Harrisburg, Pennsylvania, United States
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Jeannette, Pennsylvania, United States
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Jenkintown, Pennsylvania, United States
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Jersey Shore, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Plymouth Meeting, Pennsylvania, United States
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Tipton, Pennsylvania, United States
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Charleston, South Carolina, United States
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Florence, South Carolina, United States
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Greer, South Carolina, United States
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North Myrtle Beach, South Carolina, United States
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Germantown, Tennessee, United States
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Corpus Christi, Texas, United States
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Garland, Texas, United States
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Hurst, Texas, United States
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Kaufman, Texas, United States
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Lubbock, Texas, United States
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Midland, Texas, United States
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San Antonio, Texas, United States
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San Marcos, Texas, United States
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Stephenville, Texas, United States
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Webster, Texas, United States
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Layton, Utah, United States
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Chesapeake, Virginia, United States
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Ettrick, Virginia, United States
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Burnsville, West Virginia, United States
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Charleston, West Virginia, United States
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Aschaffenburg, , Germany
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Bad Doberan, , Germany
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Bad Grönenbach, , Germany
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Bad Oeynhausen, , Germany
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Bad Staffelstein, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Chemnitz, , Germany
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Cologne, , Germany
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Datteln, , Germany
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Dortmund, , Germany
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Dortmund, , Germany
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Eisenach, , Germany
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Emden, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Falkensee, , Germany
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Friedberg, , Germany
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Fulda, , Germany
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Hagen, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hohenmölsen, , Germany
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Jena, , Germany
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Leverkusen, , Germany
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Mahlberg, , Germany
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Mannheim, , Germany
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Markdorf, , Germany
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Marl, , Germany
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Meissen, , Germany
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Münster, , Germany
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Münster, , Germany
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Neuwied, , Germany
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Nuremberg, , Germany
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Reinfeld, , Germany
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Riesa, , Germany
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Schlüchtern, , Germany
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Siegen, , Germany
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Suhl, , Germany
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Villingen-Schwenningen, , Germany
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Wangen, , Germany
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Wangen I. Allgaeu, , Germany
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Warburg, , Germany
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Manatí, , Puerto Rico
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Borås, , Sweden
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Forshaga, , Sweden
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Gothenburg, , Sweden
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Lilla Edet, , Sweden
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Chesterfield, Derbyshire, United Kingdom
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Ashford, Middlesex, United Kingdom
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Dronfield, Sheffield, United Kingdom
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Weybridge, SURREY, United Kingdom
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Woking, Surrey, United Kingdom
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Rugby, Warwickshire, United Kingdom
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Warminster, WILTSHIRE, United Kingdom
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Sheffield, Yorkshire, United Kingdom
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Airdrie, , United Kingdom
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Bath, , United Kingdom
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Bath, , United Kingdom
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Birmingham, , United Kingdom
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Leicester, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Westbury, , United Kingdom
Countries
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References
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Gatto NM, Bracken MB, Kolitsopoulos F, Duggan WT, Koch GG, Wise RA, Jackson NC. Pulmonary and cardiovascular safety of inhaled insulin in routine practice: The Exubera Large Simple Trial (VOLUME). Contemp Clin Trials Commun. 2019 Aug 13;18:100427. doi: 10.1016/j.conctc.2019.100427. eCollection 2020 Jun.
Kolitsopoulos FM, Gatto NM, Sweetland K, Bracken MB, Jackson N. Implications of product withdrawal on a post-approval pragmatic trial: The VOLUME study experience. Contemp Clin Trials Commun. 2019 Oct 28;16:100477. doi: 10.1016/j.conctc.2019.100477. eCollection 2019 Dec.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A2171069
Identifier Type: -
Identifier Source: org_study_id
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