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Follow-Up Study for Exubera

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bay Minette, Alabama, 36507 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

- Previously participated in an eligible Exubera clinical trial

- Willing to provide study doctor with at least one alternate contact person

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

- Participated in an investigational study of an unapproved drug since completing the
Exubera trial

- Ever used an other (non-Exubera) inhaled insulin

NCT00734591
Pfizer
Completed
Follow-Up Study for Exubera

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Pfizer Clinical Trials Contact Center

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[email protected]

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Follow-Up Study for Exubera
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.
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.
Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample
All subjects who participated in a controlled trial of Exubera active within the last five years (17 protocols total)
Diabetes Mellitus
  • 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).

  • Previously treated with Exubera
    Intervention: 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.
    Intervention: Other: Randomized diabetes therapy
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7439
January 2012
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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,   United States
 
 
NCT00734591
A2171121
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

FOR MORE INFORMATION

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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