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Follow-Up Study for Exubera

NCT ID: NCT00734591

Last Updated: 2012-10-23

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

Total Enrollment

7439 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-01-31

Brief Summary

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In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All subjects diagnosed with lung cancer had a history of smoking and the number of lung cancer cases observed fell within the expected range based on population-based data. There is currently not enough information to determine if any of the observed lung cancer cases were related to Exubera use, therefore, the study is being conducted to further investigate whether Exubera use makes the appearance of lung cancer more likely.

Detailed Description

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Both retrospective and prospective components All subjects who participated in one of the 17 included Exubera clinical trials will be invited to participate in the current study.

Conditions

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Diabetes Mellitus

Keywords

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Observational Study Exubera

Study Design

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Observational Model Type

COHORT

Study Groups

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Previously treated with Exubera

Exubera

Intervention Type DRUG

Subjects who had been treated with Exubera in a prior Exubera controlled trial. Following initial use of randomized treatment, physicians and subjects were free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).

Previously treated with comparator

Subjects who had been treated with a comparator (other diabetes treatment such as injected insulin) in a prior Exubera controlled trial.

Randomized diabetes therapy

Intervention Type OTHER

Subjects who had been treated with a comparator (other diabetes treatment including one or more of: subcutaneous insulin, sulfonylureas, biguanides, or thiazolinediones) in a prior Exubera controlled trial.

Following initial use of randomized treatment, physicians and subjects were free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).

Interventions

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Exubera

Subjects who had been treated with Exubera in a prior Exubera controlled trial. Following initial use of randomized treatment, physicians and subjects were free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).

Intervention Type DRUG

Randomized diabetes therapy

Subjects who had been treated with a comparator (other diabetes treatment including one or more of: subcutaneous insulin, sulfonylureas, biguanides, or thiazolinediones) in a prior Exubera controlled trial.

Following initial use of randomized treatment, physicians and subjects were free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Previously participated in an eligible Exubera clinical trial
* Willing to provide study doctor with at least one alternate contact person

Exclusion Criteria

* Participated in an investigational study of an unapproved drug since completing the Exubera trial
* Ever used an other (non-Exubera) inhaled insulin
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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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Bay Minette, Alabama, United States

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Graysville, Alabama, United States

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Pell City, Alabama, United States

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Pell City, Alabama, United States

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Glendale, Arizona, 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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Phoenix, Arizona, United States

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Forrest City, Arkansas, United States

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Berkeley, California, United States

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Concord, California, United States

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El Cajon, California, United States

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Encino, California, United States

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Fresno, California, United States

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Fullerton, California, United States

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Huntington Beach, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Rolling Hills Estates, California, United States

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San Diego, California, United States

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San Diego, 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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Santa Barbara, California, United States

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Tustin, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Golden, Colorado, United States

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Longmont, Colorado, United States

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Milford, Connecticut, United States

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Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Boca Raton, Florida, United States

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Chiefland, Florida, United States

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Green Cove Springs, Florida, United States

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Kissimmee, Florida, United States

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Lake City, Florida, United States

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Lake Mary, Florida, United States

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Miami, Florida, United States

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Opa-locka, Florida, United States

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Saint Cloud, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, 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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Honolulu, Hawaii, United States

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Honolulu, Hawaii, United States

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Hayden Lake, Idaho, United States

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Greenville, Illinois, United States

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Normal, Illinois, United States

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Olympia Fields, Illinois, United States

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Springfield, 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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Des Moines, Iowa, United States

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Dubuque, Iowa, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Mount Sterling, Kentucky, 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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Springfield, Massachusetts, United States

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Ann Arbor, 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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Saint Cloud, Minnesota, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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Incline Village, Nevada, United States

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Las Vegas, Nevada, United States

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Belvidere, New Jersey, United States

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New Brunswick, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Babylon, New York, United States

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Brooklyn, New York, United States

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Minneola, New York, United States

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New Hartford, New York, United States

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Syracuse, 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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Durham, 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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Tabor City, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Marietta, Ohio, United States

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Portland, Oregon, United States

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Portland, Oregon, 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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Jersey Shore, Pennsylvania, United States

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Lansdale, Pennsylvania, United States

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Melrose Park, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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North Myrtle Beach, South Carolina, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Kaufman, 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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South Burlington, Vermont, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Federal Way, Washington, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Burnsville, West Virginia, United States

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Capital Federal, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Camperdown, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Herston, Queensland, Australia

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Box Hill, Victoria, Australia

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Melbourne, Victoria, Australia

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Vienna, , Austria

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Vienna, , Austria

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Bornem, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Genk, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Belo Horizonte, Minas Gerais, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Red Deer, Alberta, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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Corunna, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Oakville, Ontario, Canada

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Ottawa, Ontario, Canada

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Smiths Falls, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Gatineau, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Zagreb, , Croatia

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Zagreb, , Croatia

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Aarhus, , Denmark

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Copenhagen, , Denmark

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Herning, , Denmark

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Viljandi, Viljandi Mk., Estonia

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Pärnu, , Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Kuopio, , Finland

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Lahti, , Finland

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Lohja, , Finland

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Oulu, , Finland

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Corbeil-Essonnes, France, France

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Amiens, , France

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Armentières, , France

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Besançon, , France

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Bondy, , France

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Brest, , France

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Chartres, , France

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Lorient, , France

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Paris, , France

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Paris, , France

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Rennes, , France

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Altenburg, , Germany

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Aschaffenburg, , Germany

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Bad Doberan, , 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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Datteln, , 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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Falkensee, , Germany

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Friedberg, , Germany

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Fulda, , Germany

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Hamburg, , Germany

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Hohenmölsen, , Germany

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Leipzig, , Germany

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Leverkusen, , Germany

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Marl, , Germany

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Meissen, , Germany

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Mittweida, , Germany

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München, , Germany

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Münster, , Germany

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Münster, , Germany

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Neuss, , Germany

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Reinfeld, , Germany

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Riesa, , Germany

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Rossach, , Germany

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Schlüchtern, , Germany

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Siegen, , Germany

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Suhl, , Germany

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Surwold, , Germany

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Villingen-Schwenningen, , Germany

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Wangen, , Germany

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Wangen / Allgaeu, , Germany

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Warburg, , Germany

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Wiesbaden, , Germany

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Athens, , Greece

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Athens, , Greece

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Thessaloniki, , Greece

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Catania, , Italy

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Genova, , Italy

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Milan, , Italy

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Napoli, , Italy

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Padua, , Italy

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Palermo, , Italy

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Roma, , Italy

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Udine, , Italy

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Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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's-Hertogenbosch, , Netherlands

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Amsterdam, , Netherlands

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Beek, , Netherlands

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Eindhoven, , Netherlands

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Venlo, , Netherlands

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Fornebu, , Norway

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Hønefoss, , Norway

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Skedsmokorset, , Norway

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Stavanger, , Norway

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Lodz, , Poland

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Lublin, , Poland

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Warsaw, , Poland

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Łask, , Poland

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Aveiro, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Torres Vedras, , Portugal

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Martin, , Slovakia

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Houghton Estate, Gauteng, South Africa

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Umhlanga, KwaZulu-Natal, South Africa

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Santiago de Compostela, A Coruña, Spain

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Badalona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Granada, Granada, Spain

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Las Palmas, Las Palmas de Gran Canaria, Spain

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Madrid, Madrid, Spain

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Málaga, Malaga, Spain

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San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

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Seville, Sevilla, Spain

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Alzira, Valencia, Spain

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Valencia, Valencia, Spain

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Bilbao, Vizcaya, Spain

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Borås, , Sweden

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Forshaga, , Sweden

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Härnösand, , Sweden

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Helsingborg, , Sweden

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Linköping, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Vaxjo, , Sweden

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Penzance, Cornwall, United Kingdom

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St Austell, Cornwall, United Kingdom

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Plymouth, Devon, United Kingdom

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Letchworth Garden City, Hertfordshire, United Kingdom

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Ashford, Middlesex, United Kingdom

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Headington, Oxford, 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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Bath, , United Kingdom

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Bath, , United Kingdom

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Birmingham, , United Kingdom

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Birmingham, , United Kingdom

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Bolton, , United Kingdom

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Canterbury, , United Kingdom

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Leicester, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Salford, , United Kingdom

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Westbury, , United Kingdom

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Countries

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United States Argentina Australia Austria Belgium Brazil Canada Croatia Denmark Estonia Finland France Germany Greece Italy Mexico Netherlands Norway Poland Portugal Slovakia South Africa Spain Sweden United Kingdom

References

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Gatto NM, Koralek DO, Bracken MB, Duggan WT, Lem J, Klioze S, Koch GG, Wise RA, Cohen RB, Jackson NC. Lung Cancer-Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results. Diabetes Care. 2019 Sep;42(9):1708-1715. doi: 10.2337/dc18-2529. Epub 2019 Jul 22.

Reference Type DERIVED
PMID: 31331907 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171121&StudyName=Follow-Up%20Study%20for%20Exubera

To obtain contact information for a study center near you, click here.

Other Identifiers

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A2171121

Identifier Type: -

Identifier Source: org_study_id