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NCT00359801 Clinical Trial

Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety

Diabetes Mellitus Clinical Trial

— VOLUME  

Official title:
An International, Multicenter, Large Simple Trial To Evaluate The Long-Term Pulmonary And Cardiovascular Safety Of Exubera In Patients With Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00359801
Other study ID # A2171069
Secondary ID
Status Completed
Phase Phase 4
First received July 31, 2006
Last updated January 29, 2010
Start date July 2006
Est. completion date April 2009

Study information
Verified date September 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1976
Est. completion date April 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for Exubera to guide prescribing and treatment decisions.
• Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Subjects are randomized to use usual diabetes care. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).

Locations
Country Name City State
Germany Pfizer Investigational Site Aschaffenburg
Germany Pfizer Investigational Site Bad Doberan
Germany Pfizer Investigational Site Bad Groenenbach
Germany Pfizer Investigational Site Bad Oeynhausen
Germany Pfizer Investigational Site Bad Staffelstein
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 Dortmund
Germany Pfizer Investigational Site Eisenach
Germany Pfizer Investigational Site Emden
Germany Pfizer Investigational Site Essen
Germany Pfizer Investigational Site Esslingen
Germany Pfizer Investigational Site Falkensee
Germany Pfizer Investigational Site Friedberg
Germany Pfizer Investigational Site Fulda
Germany Pfizer Investigational Site Hagen
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Hohenmoelsen
Germany Pfizer Investigational Site Jena
Germany Pfizer Investigational Site Koeln
Germany Pfizer Investigational Site Leverkusen
Germany Pfizer Investigational Site Mahlberg
Germany Pfizer Investigational Site Mannheim
Germany Pfizer Investigational Site Markdorf
Germany Pfizer Investigational Site Marl
Germany Pfizer Investigational Site Meissen
Germany Pfizer Investigational Site Muenster
Germany Pfizer Investigational Site Muenster
Germany Pfizer Investigational Site Neuwied
Germany Pfizer Investigational Site Nuernberg
Germany Pfizer Investigational Site Reinfeld
Germany Pfizer Investigational Site Riesa
Germany Pfizer Investigational Site Schluechtern
Germany Pfizer Investigational Site Siegen
Germany Pfizer Investigational Site Suhl
Germany Pfizer Investigational Site Villingen-Schwenningen
Germany Pfizer Investigational Site Wangen
Germany Pfizer Investigational Site Wangen I. Allgaeu
Germany Pfizer Investigational Site Warburg
Puerto Rico Pfizer Investigational Site Manati
Sweden Pfizer Investigational Site Boras
Sweden Pfizer Investigational Site Forshaga
Sweden Pfizer Investigational Site Goteborg
Sweden Pfizer Investigational Site Lilla Edet
United Kingdom Pfizer Investigational Site Airdrie
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 Chesterfield Derbyshire
United Kingdom Pfizer Investigational Site Dronfield Sheffield
United Kingdom Pfizer Investigational Site Leicester
United Kingdom Pfizer Investigational Site Newcastle Upon Tyne
United Kingdom Pfizer Investigational Site Newcastle Upon Tyne
United Kingdom Pfizer Investigational Site Rugby Warwickshire
United Kingdom Pfizer Investigational Site Sheffield Yorkshire
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 Albuquerque New Mexico
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Asheboro North Carolina
United States Pfizer Investigational Site Ashtabula Ohio
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Auburn Maine
United States Pfizer Investigational Site Babylon New York
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Battle Creek Michigan
United States Pfizer Investigational Site Battle Creek Michigan
United States Pfizer Investigational Site Bay Minette Alabama
United States Pfizer Investigational Site Belleville New Jersey
United States Pfizer Investigational Site Belvidere New Jersey
United States Pfizer Investigational Site Bend Oregon
United States Pfizer Investigational Site Bismarck North Dakota
United States Pfizer Investigational Site Boca Raton Florida
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Bossier City Louisiana
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Brooklyn New York
United States Pfizer Investigational Site Broomall Pennsylvania
United States Pfizer Investigational Site Burnsville West Virginia
United States Pfizer Investigational Site Canton Ohio
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Charleston West Virginia
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Chesapeake Virginia
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Clinton Oklahoma
United States Pfizer Investigational Site Clinton Michigan
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Conyers Georgia
United States Pfizer Investigational Site Corpus Christi Texas
United States Pfizer Investigational Site Cudahy California
United States Pfizer Investigational Site Dauphin Pennsylvania
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Debary Florida
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Des Moines Iowa
United States Pfizer Investigational Site El Cajon California
United States Pfizer Investigational Site Elkton Maryland
United States Pfizer Investigational Site Ettrick Virginia
United States Pfizer Investigational Site Fairhope Alabama
United States Pfizer Investigational Site Fishers Indiana
United States Pfizer Investigational Site Flint Michigan
United States Pfizer Investigational Site Florence South Carolina
United States Pfizer Investigational Site Fogelsville Pennsylvania
United States Pfizer Investigational Site Forrest City Arkansas
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Garland Texas
United States Pfizer Investigational Site Germantown Tennessee
United States Pfizer Investigational Site Glen Burnie Maryland
United States Pfizer Investigational Site Glendora New Jersey
United States Pfizer Investigational Site Grand Island Nebraska
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 Greer South Carolina
United States Pfizer Investigational Site Hanover Pennsylvania
United States Pfizer Investigational Site Harrisburg Pennsylvania
United States Pfizer Investigational Site Hollywood Florida
United States Pfizer Investigational Site Huntington Beach California
United States Pfizer Investigational Site Hurst Texas
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 Jenkintown Pennsylvania
United States Pfizer Investigational Site Jersey Shore Pennsylvania
United States Pfizer Investigational Site Kaufman Texas
United States Pfizer Investigational Site Kissimmee Florida
United States Pfizer Investigational Site Kissimmee Florida
United States Pfizer Investigational Site Layton Utah
United States Pfizer Investigational Site Libertyville Illinois
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Lubbock Texas
United States Pfizer Investigational Site Marianna Florida
United States Pfizer Investigational Site McConnelsville Ohio
United States Pfizer Investigational Site Merritt Island Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Midland Texas
United States Pfizer Investigational Site Milford Connecticut
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 Hartford New York
United States Pfizer Investigational Site Niceville Florida
United States Pfizer Investigational Site Norristown Pennsylvania
United States Pfizer Investigational Site North Myrtle Beach South Carolina
United States Pfizer Investigational Site Opa Locka Florida
United States Pfizer Investigational Site Orange City Florida
United States Pfizer Investigational Site Ormond Beach Florida
United States Pfizer Investigational Site Pell City Alabama
United States Pfizer Investigational Site Pembroke Pines Florida
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 Plantation Florida
United States Pfizer Investigational Site Plymouth Massachusetts
United States Pfizer Investigational Site Plymouth Meeting Pennsylvania
United States Pfizer Investigational Site Port Charlotte Florida
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Rochester New York
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 Jose California
United States Pfizer Investigational Site San Marcos Texas
United States Pfizer Investigational Site Santa Ana California
United States Pfizer Investigational Site Searcy Arkansas
United States Pfizer Investigational Site Shelby North Carolina
United States Pfizer Investigational Site Stephenville Texas
United States Pfizer Investigational Site Sterling Heights Michigan
United States Pfizer Investigational Site Tabor City North Carolina
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tipton Pennsylvania
United States Pfizer Investigational Site Troy Michigan
United States Pfizer Investigational Site Warner Robins Georgia
United States Pfizer Investigational Site Warren Michigan
United States Pfizer Investigational Site Webster Texas
United States Pfizer Investigational Site Westminster California
United States Pfizer Investigational Site Wheaton Maryland
United States Pfizer Investigational Site Williamsville New York
United States Pfizer Investigational Site Wilmington Delaware
United States Pfizer Investigational Site Winston-Salem North Carolina
United States Pfizer Investigational Site Zanesville Ohio

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Germany,  Puerto Rico,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline Baseline, Month 6, Year 1, Year 2, Index Visit Yes
Primary Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects Baseline, Month 6, Year 1, Year 2, Index Visit Yes
Primary Time to Persistent Decline in FEV1 Exceeding 20% From Baseline Baseline to 5 years Yes
Secondary Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Baseline, Week 26, Week 52, Week 104, Index Visit Yes
Secondary Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis Baseline through End of Study Yes
Secondary Time to Event for Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis Baseline to 5 years Yes
Secondary All-cause Mortality: Number of Deaths Baseline through End of Study Yes
Secondary Time to Event: All-cause Mortality Baseline to 5 years Yes
Secondary Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke Baseline through End of Study Yes
Secondary Time to Event for Cardiovascular Serious Adverse Event (SAE) Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction, or Non-fatal Stroke Baseline to 5 years Yes
Secondary Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm Baseline through End of Study Yes
Secondary Time to Event for Allergic Response Serious Adverse Event (SAE) Composite, Including: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm Baseline to 5 years Yes
Secondary Change in Glycosylated Hemoglobin (HbA1c) From Baseline Baseline, Month 6, Year 1, Year 2, Index Visit No
Secondary Change in Glycosylated Hemoglobin (HbA1c) From Baseline Baseline to 5 years No
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