Diabetes MellitusFUSENCT00734591

Follow-Up Study for Exubera

An observational study of Diabetes Mellitus, run by Pfizer at 321 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus
What is being tested?: Exubera and Randomized diabetes therapy
Type of treatment: Injection or infusion
How many people: 7,439 participants
Where: 321 sitesin 25 countries
Study dates: Aug 2008to Jan 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

321 sites in 25 countries.

Country

City, postcode or hospital

321 sites in 25 countries

United States131 sites

Pfizer Investigational Site
Albany, New York, 12208
Pfizer Investigational Site
Albuquerque, New Mexico, 87106
Pfizer Investigational Site
Ann Arbor, Michigan, 48104
Pfizer Investigational Site
Asheboro, North Carolina, 27203
Pfizer Investigational Site
Atlanta, Georgia, 30318-2513
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Babylon, New York, 11702
Pfizer Investigational Site
Baltimore, Maryland, 21204
Pfizer Investigational Site
Bay Minette, Alabama, 36507
Pfizer Investigational Site
Beaumont, Texas, 77701
Pfizer Investigational Site
Belvidere, New Jersey, 07823
Pfizer Investigational Site
Berkeley, California, 94705
Pfizer Investigational Site
Boca Raton, Florida, 33433
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Brooklyn, New York, 11224
Pfizer Investigational Site
Burnsville, West Virginia, 26335
Pfizer Investigational Site
Charleston, South Carolina, 29412
Pfizer Investigational Site
Charlotte, North Carolina, 28227
Pfizer Investigational Site
Chiefland, Florida, 32626
Pfizer Investigational Site
Clinton, Michigan, 49236
Pfizer Investigational Site
Columbus, Ohio, 43207
Pfizer Investigational Site
Concord, California, 94520
Pfizer Investigational Site
Conyers, Georgia, 30013
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Dayton, Ohio, 45419
Pfizer Investigational Site
Decatur, Georgia, 30035
Pfizer Investigational Site
Denver, Colorado, 80206
Pfizer Investigational Site
Denver, Colorado, 80209
Pfizer Investigational Site
Denver, Colorado, 80220
Pfizer Investigational Site
Des Moines, Iowa, 50314
Pfizer Investigational Site
Des Moines, Iowa, 50315
Pfizer Investigational Site
Dubuque, Iowa, 52002
Pfizer Investigational Site
Durham, North Carolina, 27713
Pfizer Investigational Site
El Cajon, California, 92019
Pfizer Investigational Site
Elkton, Maryland, 21921
Pfizer Investigational Site
Encino, California, 91436
Pfizer Investigational Site
Federal Way, Washington, 98003
Pfizer Investigational Site
Fishers, Indiana, 46038
Pfizer Investigational Site
Flint, Michigan, 48532
Pfizer Investigational Site
Fogelsville, Pennsylvania, 18051
Pfizer Investigational Site
Forrest City, Arkansas, 72335
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Fullerton, California, 92835
Pfizer Investigational Site
Glen Burnie, Maryland, 21061
Pfizer Investigational Site
Glendale, Arizona, 85306
Pfizer Investigational Site
Golden, Colorado, 80401
Pfizer Investigational Site
Graysville, Alabama, 35073
Pfizer Investigational Site
Green Cove Springs, Florida, 32043
Pfizer Investigational Site
Greenville, Illinois, 62246
Pfizer Investigational Site
Hanover, Pennsylvania, 17331
Pfizer Investigational Site
Harrisburg, Pennsylvania, 17112
Pfizer Investigational Site
Hayden Lake, Idaho, 83835
Pfizer Investigational Site
Honolulu, Hawaii, 96813
Pfizer Investigational Site
Honolulu, Hawaii, 96814
Pfizer Investigational Site
Houston, Texas, 77008
Pfizer Investigational Site
Houston, Texas, 77079
Pfizer Investigational Site
Huntington Beach, California, 92648
Pfizer Investigational Site
Incline Village, Nevada, 89452
Pfizer Investigational Site
Indianapolis, Indiana, 46229
Pfizer Investigational Site
Indianapolis, Indiana, 46254-5472
Pfizer Investigational Site
Jeannette, Pennsylvania, 15644
Pfizer Investigational Site
Jersey Shore, Pennsylvania, 17740
Pfizer Investigational Site
Kansas City, Missouri, 64116
Pfizer Investigational Site
Kaufman, Texas, 75142
Pfizer Investigational Site
Kettering, Ohio, 45429
Pfizer Investigational Site
Kissimmee, Florida, 34743
Pfizer Investigational Site
Lake City, Florida, 32025
Pfizer Investigational Site
Lake Mary, Florida, 32746
Pfizer Investigational Site
Lansdale, Pennsylvania, 19446
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Long Beach, California, 90806
Pfizer Investigational Site
Longmont, Colorado, 80501
Pfizer Investigational Site
Los Angeles, California, 90073
Pfizer Investigational Site
Louisville, Kentucky, 40213
Pfizer Investigational Site
Louisville, Kentucky, 40258
Pfizer Investigational Site
Marietta, Ohio, 45750
Pfizer Investigational Site
Melrose Park, Pennsylvania, 19027
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Milford, Connecticut, 06460
Pfizer Investigational Site
Minneola, New York, 11501
Pfizer Investigational Site
Morehead City, North Carolina, 28557-3126
Pfizer Investigational Site
Mount Sterling, Kentucky, 40353
Pfizer Investigational Site
Muskegon, Michigan, 49444
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New Hartford, New York, 13413
Pfizer Investigational Site
Newark, Delaware, 19713
Pfizer Investigational Site
Normal, Illinois, 61761
Pfizer Investigational Site
North Myrtle Beach, South Carolina, 29582
Pfizer Investigational Site
Olympia Fields, Illinois, 60461
Pfizer Investigational Site
Opa-locka, Florida, 33054-3818
Pfizer Investigational Site
Pell City, Alabama, 35125
Pfizer Investigational Site
Pell City, Alabama, 35128
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19153-2326
Pfizer Investigational Site
Phoenix, Arizona, 85006
Pfizer Investigational Site
Phoenix, Arizona, 85016
Pfizer Investigational Site
Phoenix, Arizona, 85028
Pfizer Investigational Site
Phoenix, Arizona, 85051
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Portland, Oregon, 97232
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Richmond, Virginia, 23225-4017
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Rolling Hills Estates, California, 90274
Pfizer Investigational Site
Saint Cloud, Florida, 34769
Pfizer Investigational Site
Saint Cloud, Minnesota, 56301
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92120
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
San Jose, California, 95116
Pfizer Investigational Site
San Marcos, Texas, 78666
Pfizer Investigational Site
Santa Ana, California, 92704
Pfizer Investigational Site
Santa Barbara, California, 93105
Pfizer Investigational Site
South Burlington, Vermont, 05403
Pfizer Investigational Site
Spokane, Washington, 99204
Pfizer Investigational Site
Spokane, Washington, 99207
Pfizer Investigational Site
Springfield, Illinois, 62704
Pfizer Investigational Site
Springfield, Massachusetts, 01105
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
Stephenville, Texas, 76401
Pfizer Investigational Site
Syracuse, New York, 13210
Pfizer Investigational Site
Tabor City, North Carolina, 28463
Pfizer Investigational Site
Tampa, Florida, 33624
Pfizer Investigational Site
Tustin, California, 92780
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
Pfizer Investigational Site
Washington D.C., District of Columbia, 20307
Pfizer Investigational Site
Webster, Texas, 77598
Pfizer Investigational Site
West Palm Beach, Florida, 33401
Pfizer Investigational Site
Wheaton, Maryland, 20902
Pfizer Investigational Site
Wichita, Kansas, 67203
Pfizer Investigational Site
Williamsville, New York, 14221
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Germany38 sites

Pfizer Investigational Site
Altenburg, 04600
Pfizer Investigational Site
Aschaffenburg, 63739
Pfizer Investigational Site
Bad Doberan, 18209
Pfizer Investigational Site
Berlin, 10115
Pfizer Investigational Site
Berlin, 13355
Pfizer Investigational Site
Bonn, 53179
Pfizer Investigational Site
Chemnitz, 09130
Pfizer Investigational Site
Datteln, 45711
Pfizer Investigational Site
Dortmund, 44339
Pfizer Investigational Site
Eisenach, 99817
Pfizer Investigational Site
Emden, 26725
Pfizer Investigational Site
Essen, 45329
Pfizer Investigational Site
Falkensee, 14612
Pfizer Investigational Site
Friedberg, 86316
Pfizer Investigational Site
Fulda, 36037
Pfizer Investigational Site
Hamburg, 21073
Pfizer Investigational Site
Hohenmölsen, 06679
Pfizer Investigational Site
Leipzig, 04103
Pfizer Investigational Site
Leverkusen, 51371
Pfizer Investigational Site
Marl, 45770
Pfizer Investigational Site
Meissen, 01662
Pfizer Investigational Site
Mittweida, 09648
Pfizer Investigational Site
München, D-80469
Pfizer Investigational Site
Münster, 48145
Pfizer Investigational Site
Münster, 48153
Pfizer Investigational Site
Neuss, 41460
Pfizer Investigational Site
Reinfeld, 23858
Pfizer Investigational Site
Riesa, 01587
Pfizer Investigational Site
Rossach, 96269
Pfizer Investigational Site
Schlüchtern, 36381
Pfizer Investigational Site
Siegen, 57072
Pfizer Investigational Site
Suhl, 98529
Pfizer Investigational Site
Surwold, 26903
Pfizer Investigational Site
Villingen-Schwenningen, 78054
Pfizer Investigational Site
Wangen, 88239
Pfizer Investigational Site
Wangen / Allgaeu, 88239
Pfizer Investigational Site
Warburg, 34414
Pfizer Investigational Site
Wiesbaden, 65191

Other trials in Germany

Canada28 sites

Pfizer Investigational Site
Calgary, Alberta, T2L 1K8
Pfizer Investigational Site
Calgary, Alberta, T2T 5C7
Pfizer Investigational Site
Calgary, Alberta, T3B 0M3
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 5H6
Pfizer Investigational Site
Corunna, Ontario, N0N 1G0
Pfizer Investigational Site
Edmonton, Alberta, T5J 3N4
Pfizer Investigational Site
Edmonton, Alberta, T6G 2C8
Pfizer Investigational Site
Edmonton, Alberta, T6G 2S2
Pfizer Investigational Site
Gatineau, Quebec, J8Y 6S9
Pfizer Investigational Site
Greenfield Park, Quebec, J4V 2H1
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Pfizer Investigational Site
Laval, Quebec, H7T 2P5
Pfizer Investigational Site
London, Ontario, N6A 4V2
Pfizer Investigational Site
Mississauga, Ontario, L5M 2V8
Pfizer Investigational Site
Montreal, Quebec, H3A 1A1
Pfizer Investigational Site
Oakville, Ontario, L6H 3P1
Pfizer Investigational Site
Ottawa, Ontario, K1H 1A2
Pfizer Investigational Site
Red Deer, Alberta, T6N 6V7
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 5N4
Pfizer Investigational Site
Smiths Falls, Ontario, K7A 4W8
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1A 2E2
Pfizer Investigational Site
Thornhill, Ontario, L4J 8L7
Pfizer Investigational Site
Toronto, Ontario, M4N-3M5
Pfizer Investigational Site
Toronto, Ontario, M4R 2G4
Pfizer Investigational Site
Trois-Rivières, Quebec, G8T 7A1
Pfizer Investigational Site
Victoria, British Columbia, V8R 1J8
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

United Kingdom21 sites

Pfizer Investigational Site
Ashford, Middlesex, TW15 3EA
Pfizer Investigational Site
Bath, BA2 3HT
Pfizer Investigational Site
Bath, BA2 4BY
Pfizer Investigational Site
Birmingham, B37 7TR
Pfizer Investigational Site
Birmingham, B9 5SS
Pfizer Investigational Site
Bolton, BL3 6TL
Pfizer Investigational Site
Canterbury, CT1 3HX
Pfizer Investigational Site
Headington, Oxford, OX3 7LJ
Pfizer Investigational Site
Leicester, LE1 5WW
Pfizer Investigational Site
Letchworth Garden City, Hertfordshire, SG6 4UB
Pfizer Investigational Site
Newcastle upon Tyne, NE15 6TQ
Pfizer Investigational Site
Penzance, Cornwall, TR18 4JH
Pfizer Investigational Site
Plymouth, Devon, PL6 8BX
Pfizer Investigational Site
Rugby, Warwickshire, CV22 5PX
Pfizer Investigational Site
Salford, M6 8HD
Pfizer Investigational Site
Sheffield, Yorkshire, S7 2DW
Pfizer Investigational Site
St Austell, Cornwall, PL26 7RL
Pfizer Investigational Site
Warminster, Wiltshire, BA12 9AA
Pfizer Investigational Site
Westbury, BA13 3JD
Pfizer Investigational Site
Weybridge, Surrey, KT15 2BH
Pfizer Investigational Site
Woking, Surrey, GU22 7EY

Other trials in United Kingdom

Spain12 sites

Pfizer Investigational Site
Alzira, Valencia, 46600
Pfizer Investigational Site
Badalona, Barcelona, 08916
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
Bilbao, Vizcaya, 48013
Pfizer Investigational Site
Granada, Granada, 18012
Pfizer Investigational Site
Las Palmas, Las Palmas de Gran Canaria, 35016
Pfizer Investigational Site
Madrid, Madrid, 28935
Pfizer Investigational Site
Málaga, Malaga, 07300
Pfizer Investigational Site
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
Pfizer Investigational Site
Santiago de Compostela, A Coruña, 15706
Pfizer Investigational Site
Seville, Sevilla, 41014
Pfizer Investigational Site
Valencia, Valencia, 46015

Other trials in Spain

France11 sites

Pfizer Investigational Site
Amiens, 80094
Pfizer Investigational Site
Armentières, 59427
Pfizer Investigational Site
Besançon, 25030
Pfizer Investigational Site
Bondy, 93143
Pfizer Investigational Site
Brest, 29609
Pfizer Investigational Site
Chartres, 28000
Pfizer Investigational Site
Corbeil-Essonnes, France, 91100
Pfizer Investigational Site
Lorient, 56322
Pfizer Investigational Site
Paris, 75475
Pfizer Investigational Site
Paris, 75877
Pfizer Investigational Site
Rennes, 35203

Other trials in France

Sweden11 sites

Pfizer Investigational Site
Borås, 503 30
Pfizer Investigational Site
Forshaga, 667 32
Pfizer Investigational Site
Gothenburg, 412 55
Pfizer Investigational Site
Gothenburg, 41665
Pfizer Investigational Site
Gothenburg, 417 17
Pfizer Investigational Site
Härnösand, 871 82
Pfizer Investigational Site
Helsingborg, 251 87
Pfizer Investigational Site
Linköping, 581 85
Pfizer Investigational Site
Malmö, 211 52
Pfizer Investigational Site
Stockholm, 171 76
Pfizer Investigational Site
Vaxjo, 351 85

Other trials in Sweden

Italy8 sites

Pfizer Investigational Site
Catania, 95122
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Milan, 20132
Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Padova, 35128
Pfizer Investigational Site
Palermo, 90127
Pfizer Investigational Site
Roma, 00133
Pfizer Investigational Site
Udine, 33100

Other trials in Italy

Belgium6 sites

Pfizer Investigational Site
Bornem, 2880
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Edegem, 2650
Pfizer Investigational Site
Genk, 3600
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Liège, 4000

Other trials in Belgium

Australia5 sites

Pfizer Investigational Site
Box Hill, Victoria, 3128
Pfizer Investigational Site
Camperdown, New South Wales, 2050
Pfizer Investigational Site
Herston, Queensland, 4029
Pfizer Investigational Site
Melbourne, Victoria, 3004
Pfizer Investigational Site
Wollongong, New South Wales, 2500

Other trials in Australia

Estonia5 sites

Pfizer Investigational Site
Pärnu, 80018
Pfizer Investigational Site
Tallinn, 10318
Pfizer Investigational Site
Tallinn, 11625
Pfizer Investigational Site
Tallinn, 13415
Pfizer Investigational Site
Viljandi, Viljandi Mk., 71024

Other trials in Estonia

Netherlands5 sites

Pfizer Investigational Site
's-Hertogenbosch, 5211 RW
Pfizer Investigational Site
Amsterdam, 1105 AZ
Pfizer Investigational Site
Beek, 6191 JW
Pfizer Investigational Site
Eindhoven, 5631 BM
Pfizer Investigational Site
Venlo, 5912 BL

Other trials in Netherlands

Portugal5 sites

Pfizer Investigational Site
Aveiro, 3814-096
Pfizer Investigational Site
Lisbon, 1250-203
Pfizer Investigational Site
Lisbon, 1349-019
Pfizer Investigational Site
Porto, 4099-001
Pfizer Investigational Site
Torres Vedras, 2560-324

Other trials in Portugal

Brazil4 sites

Pfizer Investigational Site
Belo Horizonte, Minas Gerais, 30150-221
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-170
Pfizer Investigational Site
São Paulo, São Paulo, 01244-030
Pfizer Investigational Site
São Paulo, São Paulo, 04025-011

Other trials in Brazil

Finland4 sites

Pfizer Investigational Site
Kuopio, 70210
Pfizer Investigational Site
Lahti, 15110
Pfizer Investigational Site
Lohja, 08200
Pfizer Investigational Site
Oulu, 90100

Other trials in Finland

Norway4 sites

Pfizer Investigational Site
Fornebu, 1364
Pfizer Investigational Site
Hønefoss, 3515
Pfizer Investigational Site
Skedsmokorset, N-2020
Pfizer Investigational Site
Stavanger, 4068

Other trials in Norway

Poland4 sites

Pfizer Investigational Site
Łask, 98-100
Pfizer Investigational Site
Lodz, 93-338
Pfizer Investigational Site
Lublin, 20-536
Pfizer Investigational Site
Warsaw, 02-097

Other trials in Poland

Denmark3 sites

Pfizer Investigational Site
Aarhus, 8000
Pfizer Investigational Site
Copenhagen, 2400
Pfizer Investigational Site
Herning, 7400

Other trials in Denmark

Greece3 sites

Pfizer Investigational Site
Athens, 11527
Pfizer Investigational Site
Athens, 15123
Pfizer Investigational Site
Thessaloniki, 546 36

Other trials in Greece

Slovakia3 sites

Pfizer Investigational Site
Banská Bystrica, 975 17
Pfizer Investigational Site
Bratislava, 811 08
Pfizer Investigational Site
Martin, 036 01

Other trials in Slovakia

Argentina2 sites

Pfizer Investigational Site
Buenos Aires, C1426ABP
Pfizer Investigational Site
Capital Federal, Buenos Aires, C1181ACH

Other trials in Argentina

Austria2 sites

Pfizer Investigational Site
Vienna, A-1030
Pfizer Investigational Site
Vienna, A-1130

Other trials in Austria

Croatia2 sites

Pfizer Investigational Site
Zagreb, 10 000
Pfizer Investigational Site
Zagreb, 10000

Other trials in Croatia

Mexico2 sites

Pfizer Investigational Site
Guadalajara, Jalisco, 44340
Pfizer Investigational Site
Monterrey, Nuevo León, 64460

Other trials in Mexico

South Africa2 sites

Pfizer Investigational Site
Houghton Estate, Gauteng, 2198
Pfizer Investigational Site
Umhlanga, KwaZulu-Natal, 4320

Other trials in South Africa

About this study

Official title: 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.

Read the 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.

Conditions: Diabetes Mellitus
Being tested: Exubera, Randomized diabetes therapy
Keywords: Observational Study Exubera
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExuberaDrug
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).
Randomized diabetes therapyOther
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).

Study groups in NCT00734591
Study group	Role	What they receive
Previously treated with Exubera		Not described Receives: Drug: Exubera
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. Receives: Other: Randomized diabetes therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Primary Lung Cancer Mortality
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.
Measured: Baseline from original trial up to Year 2 of this study

Secondary outcomes (3)

Rate of Primary Lung Cancer Mortality Among Former Smokers
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.
Measured: Baseline from original trial up to Year 2 of this study
Rate of All-cause Mortality
The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.
Measured: Baseline from original trial up to Year 2 of this study
Rate of Primary Lung Cancer Diagnosis
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.
Measured: Baseline from original trial up to Year 2 of this study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Jan 2012

First posted14 Aug 2008 (estimated)
Study startAug 2008
Primary completionJan 2012
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Enrolment: 7,439 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00734591
Sponsor's protocol ID: A2171121
Acronym: FUSE
Status last verified: Sep 2012
First submitted: 12 Aug 2008
Last updated: 23 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 31331907

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials
ClinicalTrials.gov ID: NCT00734591
Acronym / sponsor ID: FUSE / A2171121
Conditions: Diabetes Mellitus
Keywords: Observational Study Exubera
Study type: Observational
Recruitment status: Completed
Enrolment: 7,439 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 14 Aug 2008 (estimated)
Results: Posted 23 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Number of arms: 2

Arm	Type	Receives
Previously treated with Exubera	–	Drug: Exubera
Previously treated with comparator	–	Other: Randomized diabetes therapySubjects who had been treated with a comparator (other diabetes treatment such as injected insulin) in a prior Exubera controlled trial.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All subjects who participated in a controlled trial of Exubera active within the last five years (17 protocols total)

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExuberaSubjects 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).	Drug	Previously treated with Exubera
Randomized diabetes therapySubjects 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).	Other	Previously treated with comparator

Primary outcome

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.

3 secondary outcomes

Rate of Primary Lung Cancer Mortality Among Former Smokers
Time frame: 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
Rate of Primary Lung Cancer Diagnosis
Time frame: Baseline from original trial up to Year 2 of this study

Results and safety

Results posted to the registry on 23 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Previously Randomized to Exubera	3,875	3,875
Previously Randomized to Comparator	3,564	3,564

Primary outcome: Rate of Primary Lung Cancer Mortality

Time frame: Baseline from original trial up to Year 2 of this study. Number (95% Confidence Interval). Unit: Deaths per 1000 patient years (PY)

Measure	Previously Randomized to Exubera n = 3875	Previously Randomized to Comparator n = 3654
Value	0.48 (0.17 to 1.04)	0.17 (0.02 to 0.61)

Previously Randomized to Exubera vs Previously Randomized to Comparator: Exact method: 2.81 (95% CI 0.50 to 28.46)

Population analysed: Entire study population: all randomized participants (retrospective).

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Previously Randomized to Exubera	0 of 0	0 of 0	Not reported
Previously Randomized to Comparator	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Detection and/or reporting bias possible in continuous analysis (presented here) of lung cancer mortality and lung cancer incidence endpoints. Study had insufficient power to draw clear statistical conclusions due to small number of events.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31331907Gatto 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

321 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by Pfizer at 321 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 321 sites in United States, Germany, Canada, United Kingdom, Spain and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Primary Lung Cancer Mortality (time frame: Baseline from original trial up to Year 2 of this study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00734591, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2012.