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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bay Minette, Alabama, 36507-4185 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Pregnant or lactating

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

NCT00359801
Pfizer
Completed
Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety

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Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety
An International, Multicenter, Large Simple Trial To Evaluate The Long-Term Pulmonary And Cardiovascular Safety Of Exubera In Patients With Diabetes Mellitus
The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus
  • 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.
  • Drug: 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).
    Other Name: Non-Exubera
  • Experimental: Exubera
    Intervention: Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
  • Active Comparator: Usual Diabetes Care
    Intervention: Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1976
April 2009
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Puerto Rico,   Sweden,   United Kingdom,   United States
 
 
NCT00359801
A2171069
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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