Follow-Up Study for Exubera (FUSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00734591
First received: August 12, 2008
Last updated: September 24, 2012
Last verified: September 2012

August 12, 2008
September 24, 2012
August 2008
January 2012   (final data collection date for primary outcome measure)
Rate of Primary Lung Cancer Mortality [ Time Frame: Baseline from original trial up to Year 2 of this study ] [ Designated as safety issue: Yes ]
Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.
Primary lung cancer mortality [ Time Frame: Within 2 years of enrollment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00734591 on ClinicalTrials.gov Archive Site
  • Rate of Primary Lung Cancer Mortality Among Former Smokers [ Time Frame: Baseline from original trial up to Year 2 of this study ] [ Designated as safety issue: Yes ]
    Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.
  • Rate of All-cause Mortality [ Time Frame: Baseline from original trial up to Year 2 of this study ] [ Designated as safety issue: Yes ]
    The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.
  • Rate of Primary Lung Cancer Diagnosis [ Time Frame: Baseline from original trial up to Year 2 of this study ] [ Designated as safety issue: Yes ]
    The rate and rate ratio of lung cancer adjudicated as highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer) or likely (some information may have been missing for definite diagnosis) to be newly diagnosed primary lung cancer that occurred anytime from the start of the original trial to the end of FUSE.
All cause mortality [ Time Frame: wihtin two years of enrollment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   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
 
NCT00734591
A2171121
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP