Clinical trial NCT00359801: Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety
Official title: An International, Multicenter, Large Simple Trial To Evaluate The Long-Term Pulmonary And Cardiovascular Safety Of Exubera In Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: Large Simple Trial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-02
Enrollment: 1976
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline
timeFrame: Baseline, Month 6, Year 1, Year 2, Index Visit
measure: Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects
timeFrame: Baseline, Month 6, Year 1, Year 2, Index Visit
measure: Time to Persistent Decline in FEV1 Exceeding 20% From Baseline
timeFrame: Baseline to 5 years
Secondary outcomes:
measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline, Week 26, Week 52, Week 104, Index Visit
measure: Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis
timeFrame: Baseline through End of Study
measure: Time to Event for Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis
timeFrame: Baseline to 5 years
measure: All-cause Mortality: Number of Deaths
timeFrame: Baseline through End of Study
measure: Time to Event: All-cause Mortality
timeFrame: Baseline to 5 years
measure: Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
timeFrame: Baseline through End of Study
measure: Time to Event for Cardiovascular Serious Adverse Event (SAE) Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction, or Non-fatal Stroke
timeFrame: Baseline to 5 years
measure: Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm
timeFrame: Baseline through End of Study
measure: Time to Event for Allergic Response Serious Adverse Event (SAE) Composite, Including: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm
timeFrame: Baseline to 5 years
measure: Change in Glycosylated Hemoglobin (HbA1c) From Baseline
timeFrame: Baseline, Month 6, Year 1, Year 2, Index Visit
measure: Change in Glycosylated Hemoglobin (HbA1c) From Baseline
timeFrame: Baseline to 5 years
Other outcomes:
Locations:
city: Bay Minette
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Fairhope
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Graysville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Pell City
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Forrest City
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Searcy
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Cudahy
country: United States
facility: Pfizer Investigational Site
state: California
city: El Cajon
country: United States
facility: Pfizer Investigational Site
state: California
city: Huntington Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Rolling Hills Estates
country: United States
facility: Pfizer Investigational Site
state: California
city: San Jose
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: Westminster
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Wilmington
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Debary
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Green Cove Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Marianna
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Merritt Island
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Niceville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Opa Locka
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Port Charlotte
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Conyers
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Warner Robins
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Libertyville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Fishers
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Mount Sterling
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Bossier City
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Auburn
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Elkton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Glen Burnie
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Wheaton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Plymouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Battle Creek
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Battle Creek
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Clinton
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Flint
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Muskegon
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Sterling Heights
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Troy
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Warren
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Saint Cloud
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Grand Island
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Incline Village
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Belleville
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Belvidere
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Glendora
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Babylon
country: United States
facility: Pfizer Investigational Site
state: New York
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: New Hartford
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
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state: New York
city: Williamsville
country: United States
facility: Pfizer Investigational Site
state: New York
city: Asheboro
country: United States
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state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Morehead City
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
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state: North Carolina
city: Shelby
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Tabor City
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Ashtabula
country: United States
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state: Ohio
city: Canton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
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state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: McConnelsville
country: United States
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state: Ohio
city: Zanesville
country: United States
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city: Clinton
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state: Oklahoma
city: Bend
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facility: Pfizer Investigational Site
state: Oregon
city: Broomall
country: United States
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city: Dauphin
country: United States
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city: Fogelsville
country: United States
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state: Pennsylvania
city: Hanover
country: United States
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city: Jeannette
country: United States
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state: Pennsylvania
city: Jenkintown
country: United States
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state: Pennsylvania
city: Jersey Shore
country: United States
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state: Pennsylvania
city: Norristown
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Plymouth Meeting
country: United States
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state: Pennsylvania
city: Tipton
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Florence
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: North Myrtle Beach
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Germantown
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Garland
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Hurst
country: United States
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state: Texas
city: Kaufman
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lubbock
country: United States
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state: Texas
city: Midland
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
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country: United States
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country: United States
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country: United States
facility: Pfizer Investigational Site
state: Utah
city: Chesapeake
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Ettrick
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state: Virginia
city: Burnsville
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Aschaffenburg
country: Germany
facility: Pfizer Investigational Site
city: Bad Doberan
country: Germany
facility: Pfizer Investigational Site
city: Bad Groenenbach
country: Germany
facility: Pfizer Investigational Site
city: Bad Oeynhausen
country: Germany
facility: Pfizer Investigational Site
city: Bad Staffelstein
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Chemnitz
country: Germany
facility: Pfizer Investigational Site
city: Datteln
country: Germany
facility: Pfizer Investigational Site
city: Dortmund
country: Germany
facility: Pfizer Investigational Site
city: Dortmund
country: Germany
facility: Pfizer Investigational Site
city: Eisenach
country: Germany
facility: Pfizer Investigational Site
city: Emden
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Esslingen
country: Germany
facility: Pfizer Investigational Site
city: Falkensee
country: Germany
facility: Pfizer Investigational Site
city: Friedberg
country: Germany
facility: Pfizer Investigational Site
city: Fulda
country: Germany
facility: Pfizer Investigational Site
city: Hagen
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hohenmoelsen
country: Germany
facility: Pfizer Investigational Site
city: Jena
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: Leverkusen
country: Germany
facility: Pfizer Investigational Site
city: Mahlberg
country: Germany
facility: Pfizer Investigational Site
city: Mannheim
country: Germany
facility: Pfizer Investigational Site
city: Markdorf
country: Germany
facility: Pfizer Investigational Site
city: Marl
country: Germany
facility: Pfizer Investigational Site
city: Meissen
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Neuwied
country: Germany
facility: Pfizer Investigational Site
city: Nuernberg
country: Germany
facility: Pfizer Investigational Site
city: Reinfeld
country: Germany
facility: Pfizer Investigational Site
city: Riesa
country: Germany
facility: Pfizer Investigational Site
city: Schluechtern
country: Germany
facility: Pfizer Investigational Site
city: Siegen
country: Germany
facility: Pfizer Investigational Site
city: Suhl
country: Germany
facility: Pfizer Investigational Site
city: Villingen-Schwenningen
country: Germany
facility: Pfizer Investigational Site
city: Wangen I. Allgaeu
country: Germany
facility: Pfizer Investigational Site
city: Wangen
country: Germany
facility: Pfizer Investigational Site
city: Warburg
country: Germany
facility: Pfizer Investigational Site
city: Manati
country: Puerto Rico
facility: Pfizer Investigational Site
city: Boras
country: Sweden
facility: Pfizer Investigational Site
city: Forshaga
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Lilla Edet
country: Sweden
facility: Pfizer Investigational Site
city: Chesterfield
country: United Kingdom
facility: Pfizer Investigational Site
state: Derbyshire
city: Ashford
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Dronfield
country: United Kingdom
facility: Pfizer Investigational Site
state: Sheffield
city: Weybridge
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Woking
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Rugby
country: United Kingdom
facility: Pfizer Investigational Site
state: Warwickshire
city: Warminster
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
state: Yorkshire
city: Airdrie
country: United Kingdom
facility: Pfizer Investigational Site
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Leicester
country: United Kingdom
facility: Pfizer Investigational Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Pfizer Investigational Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Pfizer Investigational Site
city: Westbury
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Gatto NM, Bracken MB, Kolitsopoulos F, Duggan WT, Koch GG, Wise RA, Jackson NC. Pulmonary and cardiovascular safety of inhaled insulin in routine practice: The Exubera Large Simple Trial (VOLUME). Contemp Clin Trials Commun. 2019 Aug 13;18:100427. doi: 10.1016/j.conctc.2019.100427. eCollection 2020 Jun.
citation: Kolitsopoulos FM, Gatto NM, Sweetland K, Bracken MB, Jackson N. Implications of product withdrawal on a post-approval pragmatic trial: The VOLUME study experience. Contemp Clin Trials Commun. 2019 Oct 28;16:100477. doi: 10.1016/j.conctc.2019.100477. eCollection 2019 Dec.