Follow-Up Study for Exubera (FUSE)

September 24, 2012 updated by: Pfizer

An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials

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.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

7439

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1426ABP
    - Pfizer Investigational Site
- Buenos Aires
  - Capital Federal, Buenos Aires, Argentina, C1181ACH
    - Pfizer Investigational Site
Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Pfizer Investigational Site
  - Wollongong, New South Wales, Australia, 2500
    - Pfizer Investigational Site
- Queensland
  - Herston, Queensland, Australia, 4029
    - Pfizer Investigational Site
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Pfizer Investigational Site
  - Melbourne, Victoria, Australia, 3004
    - Pfizer Investigational Site
Austria
- - Vienna, Austria, A-1130
    - Pfizer Investigational Site
  - Wien, Austria, A-1030
    - Pfizer Investigational Site
Belgium
- - Bornem, Belgium, 2880
    - Pfizer Investigational Site
  - Brussels, Belgium, 1070
    - Pfizer Investigational Site
  - Edegem, Belgium, 2650
    - Pfizer Investigational Site
  - Genk, Belgium, 3600
    - Pfizer Investigational Site
  - Leuven, Belgium, 3000
    - Pfizer Investigational Site
  - Liège 1, Belgium, 4000
    - Pfizer Investigational Site
Brazil
- MG
  - Belo Horizonte, MG, Brazil, 30150-221
    - Pfizer Investigational Site
- RS
  - Porto Alegre, RS, Brazil, 90035-170
    - Pfizer Investigational Site
- SP
  - Sao Paulo, SP, Brazil, 01244-030
    - Pfizer Investigational Site
  - Sao Paulo, SP, Brazil, 04025-011
    - Pfizer Investigational Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2L 1K8
    - Pfizer Investigational Site
  - Calgary, Alberta, Canada, T2T 5C7
    - Pfizer Investigational Site
  - Calgary, Alberta, Canada, T3B 0M3
    - Pfizer Investigational Site
  - Edmonton, Alberta, Canada, T5J 3N4
    - Pfizer Investigational Site
  - Edmonton, Alberta, Canada, T6G 2C8
    - Pfizer Investigational Site
  - Edmonton, Alberta, Canada, T6G 2S2
    - Pfizer Investigational Site
  - Red Deer, Alberta, Canada, T6N 6V7
    - Pfizer Investigational Site
- British Columbia
  - Victoria, British Columbia, Canada, V8R 1J8
    - Pfizer Investigational Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 3P4
    - Pfizer Investigational Site
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1A 2E2
    - Pfizer Investigational Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Pfizer Investigational Site
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - Pfizer Investigational Site
- Ontario
  - Corunna, Ontario, Canada, N0N 1G0
    - Pfizer Investigational Site
  - London, Ontario, Canada, N6A 4V2
    - Pfizer Investigational Site
  - Mississauga, Ontario, Canada, L5M 2V8
    - Pfizer Investigational Site
  - Oakville, Ontario, Canada, L6H 3P1
    - Pfizer Investigational Site
  - Ottawa, Ontario, Canada, K1H 1A2
    - Pfizer Investigational Site
  - Smiths Falls, Ontario, Canada, K7A 4W8
    - Pfizer Investigational Site
  - Thornhill, Ontario, Canada, L4J 8L7
    - Pfizer Investigational Site
  - Toronto, Ontario, Canada, M4N-3M5
    - Pfizer Investigational Site
  - Toronto, Ontario, Canada, M4R 2G4
    - Pfizer Investigational Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 5H6
    - Pfizer Investigational Site
  - Gatineau, Quebec, Canada, J8Y 6S9
    - Pfizer Investigational Site
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Pfizer Investigational Site
  - Laval, Quebec, Canada, H7T 2P5
    - Pfizer Investigational Site
  - Montreal, Quebec, Canada, H3A 1A1
    - Pfizer Investigational Site
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Pfizer Investigational Site
  - Trois Rivieres, Quebec, Canada, G8T 7A1
    - Pfizer Investigational Site
Croatia
- - Zagreb, Croatia, 10000
    - Pfizer Investigational Site
  - Zagreb, Croatia, 10 000
    - Pfizer Investigational Site
Denmark
- - Aarhus, Denmark, 8000
    - Pfizer Investigational Site
  - Copenhagen, Denmark, 2400
    - Pfizer Investigational Site
  - Herning, Denmark, 7400
    - Pfizer Investigational Site
Estonia
- - Pärnu, Estonia, 80018
    - Pfizer Investigational Site
  - Tallinn, Estonia, 10318
    - Pfizer Investigational Site
  - Tallinn, Estonia, 11625
    - Pfizer Investigational Site
  - Tallinn, Estonia, 13415
    - Pfizer Investigational Site
- Viljandi mk.
  - Viljandi, Viljandi mk., Estonia, 71024
    - Pfizer Investigational Site
Finland
- - Kuopio, Finland, 70210
    - Pfizer Investigational Site
  - Lahti, Finland, 15110
    - Pfizer Investigational Site
  - Lohja, Finland, 08200
    - Pfizer Investigational Site
  - Oulu, Finland, 90100
    - Pfizer Investigational Site
France
- - Amiens cedex 1, France, 80094
    - Pfizer Investigational Site
  - Armentieres, France, 59427
    - Pfizer Investigational Site
  - Besancon, France, 25030
    - Pfizer Investigational Site
  - Bondy Cedex, France, 93143
    - Pfizer Investigational Site
  - Brest CEDEX, France, 29609
    - Pfizer Investigational Site
  - Chartres, France, 28000
    - Pfizer Investigational Site
  - Corbeil-Essonnes, France, 91100
    - Pfizer Investigational Site
  - Lorient Cedex, France, 56322
    - Pfizer Investigational Site
  - Paris Cedex 10, France, 75475
    - Pfizer Investigational Site
  - Paris Cedex 18, France, 75877
    - Pfizer Investigational Site
  - Rennes Cedex 2, France, 35203
    - Pfizer Investigational Site
Germany
- - Altenburg, Germany, 04600
    - Pfizer Investigational Site
  - Aschaffenburg, Germany, 63739
    - Pfizer Investigational Site
  - Bad Doberan, Germany, 18209
    - Pfizer Investigational Site
  - Berlin, Germany, 10115
    - Pfizer Investigational Site
  - Berlin, Germany, 13355
    - Pfizer Investigational Site
  - Bonn, Germany, 53179
    - Pfizer Investigational Site
  - Chemnitz, Germany, 09130
    - Pfizer Investigational Site
  - Datteln, Germany, 45711
    - Pfizer Investigational Site
  - Dortmund, Germany, 44339
    - Pfizer Investigational Site
  - Eisenach, Germany, 99817
    - Pfizer Investigational Site
  - Emden, Germany, 26725
    - Pfizer Investigational Site
  - Essen, Germany, 45329
    - Pfizer Investigational Site
  - Falkensee, Germany, 14612
    - Pfizer Investigational Site
  - Friedberg, Germany, 86316
    - Pfizer Investigational Site
  - Fulda, Germany, 36037
    - Pfizer Investigational Site
  - Hamburg, Germany, 21073
    - Pfizer Investigational Site
  - Hohenmoelsen, Germany, 06679
    - Pfizer Investigational Site
  - Leipzig, Germany, 04103
    - Pfizer Investigational Site
  - Leverkusen, Germany, 51371
    - Pfizer Investigational Site
  - Marl, Germany, 45770
    - Pfizer Investigational Site
  - Meissen, Germany, 01662
    - Pfizer Investigational Site
  - Mittweida, Germany, 09648
    - Pfizer Investigational Site
  - Muenchen, Germany, D-80469
    - Pfizer Investigational Site
  - Muenster, Germany, 48145
    - Pfizer Investigational Site
  - Muenster, Germany, 48153
    - Pfizer Investigational Site
  - Neuss, Germany, 41460
    - Pfizer Investigational Site
  - Reinfeld, Germany, 23858
    - Pfizer Investigational Site
  - Riesa, Germany, 01587
    - Pfizer Investigational Site
  - Rossach, Germany, 96269
    - Pfizer Investigational Site
  - Schluechtern, Germany, 36381
    - Pfizer Investigational Site
  - Siegen, Germany, 57072
    - Pfizer Investigational Site
  - Suhl, Germany, 98529
    - Pfizer Investigational Site
  - Surwold, Germany, 26903
    - Pfizer Investigational Site
  - Villingen-Schwenningen, Germany, 78054
    - Pfizer Investigational Site
  - Wangen, Germany, 88239
    - Pfizer Investigational Site
  - Wangen / Allgaeu, Germany, 88239
    - Pfizer Investigational Site
  - Warburg, Germany, 34414
    - Pfizer Investigational Site
  - Wiesbaden, Germany, 65191
    - Pfizer Investigational Site
Greece
- - Athens, Greece, 11527
    - Pfizer Investigational Site
  - Athens, Greece, 15123
    - Pfizer Investigational Site
  - Thessaloniki, Greece, 546 36
    - Pfizer Investigational Site
Italy
- - Catania, Italy, 95122
    - Pfizer Investigational Site
  - Genova, Italy, 16132
    - Pfizer Investigational Site
  - Milano, Italy, 20132
    - Pfizer Investigational Site
  - Napoli, Italy, 80131
    - Pfizer Investigational Site
  - Padova, Italy, 35128
    - Pfizer Investigational Site
  - Palermo, Italy, 90127
    - Pfizer Investigational Site
  - Roma, Italy, 00133
    - Pfizer Investigational Site
  - Udine, Italy, 33100
    - Pfizer Investigational Site
Mexico
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44340
    - Pfizer Investigational Site
- Nuevo Leon
  - Monterrey, Nuevo Leon, Mexico, 64460
    - Pfizer Investigational Site
Netherlands
- - 's Hertogenbosch, Netherlands, 5211 RW
    - Pfizer Investigational Site
  - Amsterdam, Netherlands, 1105 AZ
    - Pfizer Investigational Site
  - Beek, Netherlands, 6191 JW
    - Pfizer Investigational Site
  - Eindhoven, Netherlands, 5631 BM
    - Pfizer Investigational Site
  - Venlo, Netherlands, 5912 BL
    - Pfizer Investigational Site
Norway
- - Fornebu, Norway, 1364
    - Pfizer Investigational Site
  - Honefoss, Norway, 3515
    - Pfizer Investigational Site
  - Skedsmokorset, Norway, N-2020
    - Pfizer Investigational Site
  - Stavanger, Norway, 4068
    - Pfizer Investigational Site
Poland
- - Lask, Poland, 98-100
    - Pfizer Investigational Site
  - Lodz, Poland, 93-338
    - Pfizer Investigational Site
  - Lublin, Poland, 20-536
    - Pfizer Investigational Site
  - Warszawa, Poland, 02-097
    - Pfizer Investigational Site
Portugal
- - Aveiro, Portugal, 3814-096
    - Pfizer Investigational Site
  - Lisboa, Portugal, 1250-203
    - Pfizer Investigational Site
  - Lisboa, Portugal, 1349-019
    - Pfizer Investigational Site
  - Porto, Portugal, 4099-001
    - Pfizer Investigational Site
  - Torres Vedras, Portugal, 2560-324
    - Pfizer Investigational Site
Slovakia
- - Banska Bystrica, Slovakia, 975 17
    - Pfizer Investigational Site
  - Bratislava, Slovakia, 811 08
    - Pfizer Investigational Site
  - Martin, Slovakia, 036 01
    - Pfizer Investigational Site
South Africa
- Gauteng
  - Houghton, Gauteng, South Africa, 2198
    - Pfizer Investigational Site
- KwaZulu Natal
  - Umhlanga Rocks, KwaZulu Natal, South Africa, 4320
    - Pfizer Investigational Site
Spain
- - Barcelona, Spain, 08036
    - Pfizer Investigational Site
  - Granada, Spain, 18012
    - Pfizer Investigational Site
  - Madrid, Spain, 28935
    - Pfizer Investigational Site
  - Malaga, Spain, 07300
    - Pfizer Investigational Site
  - Sevilla, Spain, 41014
    - Pfizer Investigational Site
  - Valencia, Spain, 46015
    - Pfizer Investigational Site
- A Coruña
  - Santiago de Compostela, A Coruña, Spain, 15706
    - Pfizer Investigational Site
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Pfizer Investigational Site
- Las Palmas de Gran Canaria
  - Las Palmas, Las Palmas de Gran Canaria, Spain, 35016
    - Pfizer Investigational Site
- Santa Cruz de Tenerife
  - La Laguna, Santa Cruz de Tenerife, Spain, 38320
    - Pfizer Investigational Site
- Valencia
  - Alzira, Valencia, Spain, 46600
    - Pfizer Investigational Site
- Vizcaya
  - Bilbao, Vizcaya, Spain, 48013
    - Pfizer Investigational Site
Sweden
- - Boras, Sweden, 503 30
    - Pfizer Investigational Site
  - Forshaga, Sweden, 667 32
    - Pfizer Investigational Site
  - Goteborg, Sweden, 412 55
    - Pfizer Investigational Site
  - Goteborg, Sweden, 41665
    - Pfizer Investigational Site
  - Göteborg, Sweden, 417 17
    - Pfizer Investigational Site
  - Harnosand, Sweden, 871 82
    - Pfizer Investigational Site
  - Helsingborg, Sweden, 251 87
    - Pfizer Investigational Site
  - Linkoping, Sweden, 581 85
    - Pfizer Investigational Site
  - Malmo, Sweden, 211 52
    - Pfizer Investigational Site
  - Stockholm, Sweden, 171 76
    - Pfizer Investigational Site
  - Vaxjo, Sweden, 351 85
    - Pfizer Investigational Site
United Kingdom
- - Bath, United Kingdom, BA2 3HT
    - Pfizer Investigational Site
  - Bath, United Kingdom, BA2 4BY
    - Pfizer Investigational Site
  - Birmingham, United Kingdom, B37 7TR
    - Pfizer Investigational Site
  - Birmingham, United Kingdom, B9 5SS
    - Pfizer Investigational Site
  - Bolton, United Kingdom, BL3 6TL
    - Pfizer Investigational Site
  - Canterbury, United Kingdom, CT1 3HX
    - Pfizer Investigational Site
  - Leicester, United Kingdom, LE1 5WW
    - Pfizer Investigational Site
  - Newcastle-upon-Tyne, United Kingdom, NE15 6TQ
    - Pfizer Investigational Site
  - Salford, United Kingdom, M6 8HD
    - Pfizer Investigational Site
  - Westbury, United Kingdom, BA13 3JD
    - Pfizer Investigational Site
- Cornwall
  - Penzance, Cornwall, United Kingdom, TR18 4JH
    - Pfizer Investigational Site
  - St. Austell, Cornwall, United Kingdom, PL26 7RL
    - Pfizer Investigational Site
- Devon
  - Plymouth, Devon, United Kingdom, PL6 8BX
    - Pfizer Investigational Site
- Hertfordshire
  - Letchworth, Hertfordshire, United Kingdom, SG6 4UB
    - Pfizer Investigational Site
- Middlesex
  - Ashford, Middlesex, United Kingdom, TW15 3EA
    - Pfizer Investigational Site
- Oxford
  - Headington, Oxford, United Kingdom, OX3 7LJ
    - Pfizer Investigational Site
- Surrey
  - Weybridge, Surrey, United Kingdom, KT15 2BH
    - Pfizer Investigational Site
  - Woking, Surrey, United Kingdom, GU22 7EY
    - Pfizer Investigational Site
- Warwickshire
  - Rugby, Warwickshire, United Kingdom, CV22 5PX
    - Pfizer Investigational Site
- Wiltshire
  - Warminster, Wiltshire, United Kingdom, BA12 9AA
    - Pfizer Investigational Site
- Yorkshire
  - Sheffield, Yorkshire, United Kingdom, S7 2DW
    - Pfizer Investigational Site
United States
- Alabama
  - Bay Minette, Alabama, United States, 36507
    - Pfizer Investigational Site
  - Graysville, Alabama, United States, 35073
    - Pfizer Investigational Site
  - Pell City, Alabama, United States, 35125
    - Pfizer Investigational Site
  - Pell City, Alabama, United States, 35128
    - Pfizer Investigational Site
- Arizona
  - Glendale, Arizona, United States, 85306
    - Pfizer Investigational Site
  - Phoenix, Arizona, United States, 85006
    - Pfizer Investigational Site
  - Phoenix, Arizona, United States, 85016
    - Pfizer Investigational Site
  - Phoenix, Arizona, United States, 85028
    - Pfizer Investigational Site
  - Phoenix, Arizona, United States, 85051
    - Pfizer Investigational Site
- Arkansas
  - Forrest City, Arkansas, United States, 72335
    - Pfizer Investigational Site
- California
  - Berkeley, California, United States, 94705
    - Pfizer Investigational Site
  - Concord, California, United States, 94520
    - Pfizer Investigational Site
  - El Cajon, California, United States, 92019
    - Pfizer Investigational Site
  - Encino, California, United States, 91436
    - Pfizer Investigational Site
  - Fresno, California, United States, 93720
    - Pfizer Investigational Site
  - Fullerton, California, United States, 92835
    - Pfizer Investigational Site
  - Huntington Beach, California, United States, 92648
    - Pfizer Investigational Site
  - Long Beach, California, United States, 90806
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90073
    - Pfizer Investigational Site
  - Rolling Hills Estates, California, United States, 90274
    - Pfizer Investigational Site
  - San Diego, California, United States, 92120
    - Pfizer Investigational Site
  - San Diego, California, United States, 92128
    - Pfizer Investigational Site
  - San Jose, California, United States, 95116
    - Pfizer Investigational Site
  - Santa Ana, California, United States, 92704
    - Pfizer Investigational Site
  - Santa Barbara, California, United States, 93105
    - Pfizer Investigational Site
  - Tustin, California, United States, 92780
    - Pfizer Investigational Site
- Colorado
  - Denver, Colorado, United States, 80220
    - Pfizer Investigational Site
  - Denver, Colorado, United States, 80209
    - Pfizer Investigational Site
  - Denver, Colorado, United States, 80206
    - Pfizer Investigational Site
  - Golden, Colorado, United States, 80401
    - Pfizer Investigational Site
  - Longmont, Colorado, United States, 80501
    - Pfizer Investigational Site
- Connecticut
  - Milford, Connecticut, United States, 06460
    - Pfizer Investigational Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Pfizer Investigational Site
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Pfizer Investigational Site
  - Washington, District of Columbia, United States, 20307
    - Pfizer Investigational Site
- Florida
  - Boca Raton, Florida, United States, 33433
    - Pfizer Investigational Site
  - Chiefland, Florida, United States, 32626
    - Pfizer Investigational Site
  - Green Cove Springs, Florida, United States, 32043
    - Pfizer Investigational Site
  - Kissimmee, Florida, United States, 34743
    - Pfizer Investigational Site
  - Lake City, Florida, United States, 32025
    - Pfizer Investigational Site
  - Lake Mary, Florida, United States, 32746
    - Pfizer Investigational Site
  - Miami, Florida, United States, 33136
    - Pfizer Investigational Site
  - Opa Locka, Florida, United States, 33054-3818
    - Pfizer Investigational Site
  - St. Cloud, Florida, United States, 34769
    - Pfizer Investigational Site
  - Tampa, Florida, United States, 33624
    - Pfizer Investigational Site
  - West Palm Beach, Florida, United States, 33401
    - Pfizer Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Pfizer Investigational Site
  - Atlanta, Georgia, United States, 30318-2513
    - Pfizer Investigational Site
  - Conyers, Georgia, United States, 30013
    - Pfizer Investigational Site
  - Decatur, Georgia, United States, 30035
    - Pfizer Investigational Site
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Pfizer Investigational Site
  - Honolulu, Hawaii, United States, 96814
    - Pfizer Investigational Site
- Idaho
  - Hayden Lake, Idaho, United States, 83835
    - Pfizer Investigational Site
- Illinois
  - Greenville, Illinois, United States, 62246
    - Pfizer Investigational Site
  - Normal, Illinois, United States, 61761
    - Pfizer Investigational Site
  - Olympia Fields, Illinois, United States, 60461
    - Pfizer Investigational Site
  - Springfield, Illinois, United States, 62704
    - Pfizer Investigational Site
- Indiana
  - Fishers, Indiana, United States, 46038
    - Pfizer Investigational Site
  - Indianapolis, Indiana, United States, 46229
    - Pfizer Investigational Site
  - Indianapolis, Indiana, United States, 46254-5472
    - Pfizer Investigational Site
- Iowa
  - Des Moines, Iowa, United States, 50314
    - Pfizer Investigational Site
  - Des Moines, Iowa, United States, 50315
    - Pfizer Investigational Site
  - Dubuque, Iowa, United States, 52002
    - Pfizer Investigational Site
- Kansas
  - Wichita, Kansas, United States, 67203
    - Pfizer Investigational Site
- Kentucky
  - Louisville, Kentucky, United States, 40213
    - Pfizer Investigational Site
  - Louisville, Kentucky, United States, 40258
    - Pfizer Investigational Site
  - Mount Sterling, Kentucky, United States, 40353
    - Pfizer Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21204
    - Pfizer Investigational Site
  - Elkton, Maryland, United States, 21921
    - Pfizer Investigational Site
  - Glen Burnie, Maryland, United States, 21061
    - Pfizer Investigational Site
  - Wheaton, Maryland, United States, 20902
    - Pfizer Investigational Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Pfizer Investigational Site
  - Springfield, Massachusetts, United States, 01105
    - Pfizer Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States, 48104
    - Pfizer Investigational Site
  - Clinton, Michigan, United States, 49236
    - Pfizer Investigational Site
  - Flint, Michigan, United States, 48532
    - Pfizer Investigational Site
  - Muskegon, Michigan, United States, 49444
    - Pfizer Investigational Site
- Minnesota
  - Saint Cloud, Minnesota, United States, 56301
    - Pfizer Investigational Site
- Missouri
  - Kansas City, Missouri, United States, 64116
    - Pfizer Investigational Site
  - Springfield, Missouri, United States, 65807
    - Pfizer Investigational Site
- Nevada
  - Incline Village, Nevada, United States, 89452
    - Pfizer Investigational Site
  - Las Vegas, Nevada, United States, 89128
    - Pfizer Investigational Site
- New Jersey
  - Belvidere, New Jersey, United States, 07823
    - Pfizer Investigational Site
  - New Brunswick, New Jersey, United States, 08901
    - Pfizer Investigational Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - Pfizer Investigational Site
- New York
  - Albany, New York, United States, 12208
    - Pfizer Investigational Site
  - Babylon, New York, United States, 11702
    - Pfizer Investigational Site
  - Brooklyn, New York, United States, 11224
    - Pfizer Investigational Site
  - Minneola, New York, United States, 11501
    - Pfizer Investigational Site
  - New Hartford, New York, United States, 13413
    - Pfizer Investigational Site
  - Syracuse, New York, United States, 13210
    - Pfizer Investigational Site
  - Williamsville, New York, United States, 14221
    - Pfizer Investigational Site
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - Pfizer Investigational Site
  - Charlotte, North Carolina, United States, 28227
    - Pfizer Investigational Site
  - Durham, North Carolina, United States, 27713
    - Pfizer Investigational Site
  - Morehead City, North Carolina, United States, 28557-3126
    - Pfizer Investigational Site
  - Raleigh, North Carolina, United States, 27609
    - Pfizer Investigational Site
  - Tabor City, North Carolina, United States, 28463
    - Pfizer Investigational Site
  - Winston-Salem, North Carolina, United States, 27103
    - Pfizer Investigational Site
- Ohio
  - Columbus, Ohio, United States, 43207
    - Pfizer Investigational Site
  - Dayton, Ohio, United States, 45419
    - Pfizer Investigational Site
  - Kettering, Ohio, United States, 45429
    - Pfizer Investigational Site
  - Marietta, Ohio, United States, 45750
    - Pfizer Investigational Site
- Oregon
  - Portland, Oregon, United States, 97210
    - Pfizer Investigational Site
  - Portland, Oregon, United States, 97232
    - Pfizer Investigational Site
- Pennsylvania
  - Fogelsville, Pennsylvania, United States, 18051
    - Pfizer Investigational Site
  - Hanover, Pennsylvania, United States, 17331
    - Pfizer Investigational Site
  - Harrisburg, Pennsylvania, United States, 17112
    - Pfizer Investigational Site
  - Jeannette, Pennsylvania, United States, 15644
    - Pfizer Investigational Site
  - Jersey Shore, Pennsylvania, United States, 17740
    - Pfizer Investigational Site
  - Lansdale, Pennsylvania, United States, 19446
    - Pfizer Investigational Site
  - Melrose Park, Pennsylvania, United States, 19027
    - Pfizer Investigational Site
  - Philadelphia, Pennsylvania, United States, 19153-2326
    - Pfizer Investigational Site
- South Carolina
  - Charleston, South Carolina, United States, 29412
    - Pfizer Investigational Site
  - North Myrtle Beach, South Carolina, United States, 29582
    - Pfizer Investigational Site
- Texas
  - Beaumont, Texas, United States, 77701
    - Pfizer Investigational Site
  - Dallas, Texas, United States, 75246
    - Pfizer Investigational Site
  - Houston, Texas, United States, 77008
    - Pfizer Investigational Site
  - Houston, Texas, United States, 77079
    - Pfizer Investigational Site
  - Kaufman, Texas, United States, 75142
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78229
    - Pfizer Investigational Site
  - San Marcos, Texas, United States, 78666
    - Pfizer Investigational Site
  - Stephenville, Texas, United States, 76401
    - Pfizer Investigational Site
  - Webster, Texas, United States, 77598
    - Pfizer Investigational Site
- Vermont
  - South Burlington, Vermont, United States, 05403
    - Pfizer Investigational Site
- Virginia
  - Richmond, Virginia, United States, 23225-4017
    - Pfizer Investigational Site
  - Richmond, Virginia, United States, 23294
    - Pfizer Investigational Site
- Washington
  - Federal Way, Washington, United States, 98003
    - Pfizer Investigational Site
  - Spokane, Washington, United States, 99204
    - Pfizer Investigational Site
  - Spokane, Washington, United States, 99207
    - Pfizer Investigational Site
- West Virginia
  - Burnsville, West Virginia, United States, 26335
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All subjects who participated in a controlled trial of Exubera active within the last five years (17 protocols total)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Previously treated with Exubera	Drug: 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).
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.	Other: 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).

Group / Cohort

Intervention / Treatment

Previously treated with Exubera

Drug: 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).

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.

Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Primary Lung Cancer Mortality Time Frame: Baseline from original trial up to Year 2 of this study	Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.	Baseline from original trial up to Year 2 of this study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Primary Lung Cancer Mortality Among Former Smokers Time Frame: Baseline from original trial up to Year 2 of this study	Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.	Baseline from original trial up to Year 2 of this study
Rate of All-cause Mortality Time Frame: Baseline from original trial up to Year 2 of this study	The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.	Baseline from original trial up to Year 2 of this study
Rate of Primary Lung Cancer Diagnosis Time Frame: Baseline from original trial up to Year 2 of this study	The rate and rate ratio of lung cancer adjudicated as highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer) or likely (some information may have been missing for definite diagnosis) to be newly diagnosed primary lung cancer that occurred anytime from the start of the original trial to the end of FUSE.	Baseline from original trial up to Year 2 of this study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

October 23, 2012

Last Update Submitted That Met QC Criteria

September 24, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Observational Study Exubera

Other Study ID Numbers

A2171121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Follow-Up Study for Exubera (FUSE)

An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Clinical Trials on Diabetes Mellitus

Clinical Trials on Exubera

Search Similar Trials

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Drug Interventions

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Conditions

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Sponsor/Collaborators

Locations