Follow-Up Study for Exubera

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NCT00734591

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Study Location
Pfizer Investigational Site
Bay Minette, Alabama, 36507, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title Follow-Up Study for Exubera
Official Title An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials
Brief 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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All subjects who participated in a controlled trial of Exubera active within the last five years (17 protocols total)
Condition 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).

Study Groups/Cohorts
  • 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
Publications * Gatto NM, Koralek DO, Bracken MB, Duggan WT, Lem J, Klioze S, Koch GG, Wise RA, Cohen RB, Jackson NC. Lung Cancer-Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results. Diabetes Care. 2019 Sep;42(9):1708-1715. doi: 10.2337/dc18-2529. Epub 2019 Jul 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 25, 2012)		7439
Original Estimated Enrollment
 (submitted: August 12, 2008)		2400
Actual Study Completion Date January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries 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
Removed Location Countries  
 
Administrative Information
NCT Number NCT00734591
Other Study ID Numbers A2171121
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2012