Follow-Up Study for Exubera

Diabetes Mellitus Clinical Trial

— FUSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734591
• Other study ID #: A2171121
• Status: Completed
• Phase: N/A
• First received: August 12, 2008
• Last updated: September 24, 2012
• Start date: August 2008
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7439
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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).

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).

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Capital Federal	Buenos Aires
Australia	Pfizer Investigational Site	Box Hill	Victoria
Australia	Pfizer Investigational Site	Camperdown	New South Wales
Australia	Pfizer Investigational Site	Herston	Queensland
Australia	Pfizer Investigational Site	Melbourne	Victoria
Australia	Pfizer Investigational Site	Wollongong	New South Wales
Austria	Pfizer Investigational Site	Vienna
Austria	Pfizer Investigational Site	Wien
Belgium	Pfizer Investigational Site	Bornem
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Edegem
Belgium	Pfizer Investigational Site	Genk
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Liège 1
Brazil	Pfizer Investigational Site	Belo Horizonte	MG
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Chicoutimi	Quebec
Canada	Pfizer Investigational Site	Corunna	Ontario
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Gatineau	Quebec
Canada	Pfizer Investigational Site	Greenfield Park	Quebec
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Laval	Quebec
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Mississauga	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Oakville	Ontario
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Red Deer	Alberta
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	Smiths Falls	Ontario
Canada	Pfizer Investigational Site	St. John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Thornhill	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Trois Rivieres	Quebec
Canada	Pfizer Investigational Site	Victoria	British Columbia
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Croatia	Pfizer Investigational Site	Zagreb
Croatia	Pfizer Investigational Site	Zagreb
Denmark	Pfizer Investigational Site	Aarhus
Denmark	Pfizer Investigational Site	Copenhagen
Denmark	Pfizer Investigational Site	Herning
Estonia	Pfizer Investigational Site	Pärnu
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Viljandi	Viljandi mk.
Finland	Pfizer Investigational Site	Kuopio
Finland	Pfizer Investigational Site	Lahti
Finland	Pfizer Investigational Site	Lohja
Finland	Pfizer Investigational Site	Oulu
France	Pfizer Investigational Site	Amiens cedex 1
France	Pfizer Investigational Site	Armentieres
France	Pfizer Investigational Site	Besancon
France	Pfizer Investigational Site	Bondy Cedex
France	Pfizer Investigational Site	Brest CEDEX
France	Pfizer Investigational Site	Chartres
France	Pfizer Investigational Site	Corbeil-Essonnes
France	Pfizer Investigational Site	Lorient Cedex
France	Pfizer Investigational Site	Paris Cedex 10
France	Pfizer Investigational Site	Paris Cedex 18
France	Pfizer Investigational Site	Rennes Cedex 2
Germany	Pfizer Investigational Site	Altenburg
Germany	Pfizer Investigational Site	Aschaffenburg
Germany	Pfizer Investigational Site	Bad Doberan
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Bonn
Germany	Pfizer Investigational Site	Chemnitz
Germany	Pfizer Investigational Site	Datteln
Germany	Pfizer Investigational Site	Dortmund
Germany	Pfizer Investigational Site	Eisenach
Germany	Pfizer Investigational Site	Emden
Germany	Pfizer Investigational Site	Essen
Germany	Pfizer Investigational Site	Falkensee
Germany	Pfizer Investigational Site	Friedberg
Germany	Pfizer Investigational Site	Fulda
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Hohenmoelsen
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Leverkusen
Germany	Pfizer Investigational Site	Marl
Germany	Pfizer Investigational Site	Meissen
Germany	Pfizer Investigational Site	Mittweida
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Muenster
Germany	Pfizer Investigational Site	Muenster
Germany	Pfizer Investigational Site	Neuss
Germany	Pfizer Investigational Site	Reinfeld
Germany	Pfizer Investigational Site	Riesa
Germany	Pfizer Investigational Site	Rossach
Germany	Pfizer Investigational Site	Schluechtern
Germany	Pfizer Investigational Site	Siegen
Germany	Pfizer Investigational Site	Suhl
Germany	Pfizer Investigational Site	Surwold
Germany	Pfizer Investigational Site	Villingen-Schwenningen
Germany	Pfizer Investigational Site	Wangen
Germany	Pfizer Investigational Site	Wangen / Allgaeu
Germany	Pfizer Investigational Site	Warburg
Germany	Pfizer Investigational Site	Wiesbaden
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Thessaloniki
Italy	Pfizer Investigational Site	Catania
Italy	Pfizer Investigational Site	Genova
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Napoli
Italy	Pfizer Investigational Site	Padova
Italy	Pfizer Investigational Site	Palermo
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Udine
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Netherlands	Pfizer Investigational Site	's Hertogenbosch
Netherlands	Pfizer Investigational Site	Amsterdam
Netherlands	Pfizer Investigational Site	Beek
Netherlands	Pfizer Investigational Site	Eindhoven
Netherlands	Pfizer Investigational Site	Venlo
Norway	Pfizer Investigational Site	Fornebu
Norway	Pfizer Investigational Site	Honefoss
Norway	Pfizer Investigational Site	Skedsmokorset
Norway	Pfizer Investigational Site	Stavanger
Poland	Pfizer Investigational Site	Lask
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Lublin
Poland	Pfizer Investigational Site	Warszawa
Portugal	Pfizer Investigational Site	Aveiro
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Porto
Portugal	Pfizer Investigational Site	Torres Vedras
Slovakia	Pfizer Investigational Site	Banska Bystrica
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Martin
South Africa	Pfizer Investigational Site	Houghton	Gauteng
South Africa	Pfizer Investigational Site	Umhlanga Rocks	KwaZulu Natal
Spain	Pfizer Investigational Site	Alzira	Valencia
Spain	Pfizer Investigational Site	Badalona	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Bilbao	Vizcaya
Spain	Pfizer Investigational Site	Granada
Spain	Pfizer Investigational Site	La Laguna	Santa Cruz de Tenerife
Spain	Pfizer Investigational Site	Las Palmas	Las Palmas de Gran Canaria
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Malaga
Spain	Pfizer Investigational Site	Santiago de Compostela	A Coruña
Spain	Pfizer Investigational Site	Sevilla
Spain	Pfizer Investigational Site	Valencia
Sweden	Pfizer Investigational Site	Boras
Sweden	Pfizer Investigational Site	Forshaga
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Göteborg
Sweden	Pfizer Investigational Site	Harnosand
Sweden	Pfizer Investigational Site	Helsingborg
Sweden	Pfizer Investigational Site	Linkoping
Sweden	Pfizer Investigational Site	Malmo
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Vaxjo
United Kingdom	Pfizer Investigational Site	Ashford	Middlesex
United Kingdom	Pfizer Investigational Site	Bath
United Kingdom	Pfizer Investigational Site	Bath
United Kingdom	Pfizer Investigational Site	Birmingham
United Kingdom	Pfizer Investigational Site	Birmingham
United Kingdom	Pfizer Investigational Site	Bolton
United Kingdom	Pfizer Investigational Site	Canterbury
United Kingdom	Pfizer Investigational Site	Headington	Oxford
United Kingdom	Pfizer Investigational Site	Leicester
United Kingdom	Pfizer Investigational Site	Letchworth	Hertfordshire
United Kingdom	Pfizer Investigational Site	Newcastle-upon-Tyne
United Kingdom	Pfizer Investigational Site	Penzance	Cornwall
United Kingdom	Pfizer Investigational Site	Plymouth	Devon
United Kingdom	Pfizer Investigational Site	Rugby	Warwickshire
United Kingdom	Pfizer Investigational Site	Salford
United Kingdom	Pfizer Investigational Site	Sheffield	Yorkshire
United Kingdom	Pfizer Investigational Site	St. Austell	Cornwall
United Kingdom	Pfizer Investigational Site	Warminster	Wiltshire
United Kingdom	Pfizer Investigational Site	Westbury
United Kingdom	Pfizer Investigational Site	Weybridge	Surrey
United Kingdom	Pfizer Investigational Site	Woking	Surrey
United States	Pfizer Investigational Site	Albany	New York
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Asheboro	North Carolina
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Babylon	New York
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bay Minette	Alabama
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Belvidere	New Jersey
United States	Pfizer Investigational Site	Berkeley	California
United States	Pfizer Investigational Site	Boca Raton	Florida
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Burnsville	West Virginia
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Chiefland	Florida
United States	Pfizer Investigational Site	Clinton	Michigan
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Concord	California
United States	Pfizer Investigational Site	Conyers	Georgia
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Des Moines	Iowa
United States	Pfizer Investigational Site	Des Moines	Iowa
United States	Pfizer Investigational Site	Dubuque	Iowa
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	El Cajon	California
United States	Pfizer Investigational Site	Elkton	Maryland
United States	Pfizer Investigational Site	Encino	California
United States	Pfizer Investigational Site	Federal Way	Washington
United States	Pfizer Investigational Site	Fishers	Indiana
United States	Pfizer Investigational Site	Flint	Michigan
United States	Pfizer Investigational Site	Fogelsville	Pennsylvania
United States	Pfizer Investigational Site	Forrest City	Arkansas
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Fullerton	California
United States	Pfizer Investigational Site	Glen Burnie	Maryland
United States	Pfizer Investigational Site	Glendale	Arizona
United States	Pfizer Investigational Site	Golden	Colorado
United States	Pfizer Investigational Site	Graysville	Alabama
United States	Pfizer Investigational Site	Green Cove Springs	Florida
United States	Pfizer Investigational Site	Greenville	Illinois
United States	Pfizer Investigational Site	Hanover	Pennsylvania
United States	Pfizer Investigational Site	Harrisburg	Pennsylvania
United States	Pfizer Investigational Site	Hayden Lake	Idaho
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Huntington Beach	California
United States	Pfizer Investigational Site	Incline Village	Nevada
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Jeannette	Pennsylvania
United States	Pfizer Investigational Site	Jersey Shore	Pennsylvania
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kaufman	Texas
United States	Pfizer Investigational Site	Kettering	Ohio
United States	Pfizer Investigational Site	Kissimmee	Florida
United States	Pfizer Investigational Site	Lake City	Florida
United States	Pfizer Investigational Site	Lake Mary	Florida
United States	Pfizer Investigational Site	Lansdale	Pennsylvania
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Longmont	Colorado
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Marietta	Ohio
United States	Pfizer Investigational Site	Melrose Park	Pennsylvania
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Milford	Connecticut
United States	Pfizer Investigational Site	Minneola	New York
United States	Pfizer Investigational Site	Morehead City	North Carolina
United States	Pfizer Investigational Site	Mount Sterling	Kentucky
United States	Pfizer Investigational Site	Muskegon	Michigan
United States	Pfizer Investigational Site	New Brunswick	New Jersey
United States	Pfizer Investigational Site	New Hartford	New York
United States	Pfizer Investigational Site	Newark	Delaware
United States	Pfizer Investigational Site	Normal	Illinois
United States	Pfizer Investigational Site	North Myrtle Beach	South Carolina
United States	Pfizer Investigational Site	Olympia Fields	Illinois
United States	Pfizer Investigational Site	Opa Locka	Florida
United States	Pfizer Investigational Site	Pell City	Alabama
United States	Pfizer Investigational Site	Pell City	Alabama
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Rolling Hills Estates	California
United States	Pfizer Investigational Site	Saint Cloud	Minnesota
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Jose	California
United States	Pfizer Investigational Site	San Marcos	Texas
United States	Pfizer Investigational Site	Santa Ana	California
United States	Pfizer Investigational Site	Santa Barbara	California
United States	Pfizer Investigational Site	South Burlington	Vermont
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Springfield	Missouri
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Springfield	Massachusetts
United States	Pfizer Investigational Site	St. Cloud	Florida
United States	Pfizer Investigational Site	Stephenville	Texas
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Tabor City	North Carolina
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tustin	California
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Webster	Texas
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	Wheaton	Maryland
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Williamsville	New York
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline from original trial up to Year 2 of this study	Yes
Secondary	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.	Baseline from original trial up to Year 2 of this study	Yes
Secondary	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.	Baseline from original trial up to Year 2 of this study	Yes
Secondary	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.	Baseline from original trial up to Year 2 of this study	Yes

External Links

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