Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety

NCT ID: NCT00359801

Last Updated: 2010-02-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1976 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.

Detailed Description

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Pfizer announced in October 2007 that it would stop marketing Exubera. At that time, Pfizer committed to continued marketing until it returned the licensing rights for the technology to Nektar. Following the announcement, enrollment was halted. Subjects already enrolled and receiving treatment at the time of the halt in enrollment could continue in the study in accordance with the protocol. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, an amendment was filed on April 16, 2008 specifying that all subjects randomized to Exubera had to be transitioned to usual diabetes care, and all study subjects followed for serious adverse events for 6 months. In accordance with this amendment, study A2171069 was terminated on April 29, 2009. Neither safety nor efficacy reasons were the cause of the study termination.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exubera

Group Type EXPERIMENTAL

Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care

Intervention Type DRUG

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.

Intervention Type DRUG

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).

Intervention Type DRUG

Other Intervention Names

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Non-Exubera

Eligibility Criteria

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Inclusion Criteria

* Eligible for receiving Exubera treatment based on the approved local label

Exclusion Criteria

* Pregnant or lactating
* Have a progressive fatal disease or a life expectancy that prohibits them from participating in a five-year research study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

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

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Countries

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United States Germany Puerto Rico Sweden United Kingdom

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.

Reference Type DERIVED
PMID: 32478195 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31799472 (View on PubMed)

Related Links

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Other Identifiers

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A2171069

Identifier Type: -

Identifier Source: org_study_id

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