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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Drug: Exubera
Other: Randomized diabetes therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 7439
Study Start Date: August 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Previously treated with Exubera 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).
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.
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).


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734591

  Show 321 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00734591     History of Changes
Other Study ID Numbers: A2171121
Study First Received: August 12, 2008
Results First Received: September 24, 2012
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Observational Study Exubera

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014