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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00734591
Registration number
NCT00734591
Ethics application status
Date submitted
12/08/2008
Date registered
14/08/2008
Date last updated
23/10/2012
Titles & IDs
Public title
Follow-Up Study for Exubera
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Scientific title
An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials
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Secondary ID [1]
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0
A2171121
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Universal Trial Number (UTN)
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Trial acronym
FUSE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus
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0
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Exubera
Other interventions - Randomized diabetes therapy
Previously treated with 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.
Treatment: Drugs: 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 interventions: 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).
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of Primary Lung Cancer Mortality
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline from original trial up to Year 2 of this study
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Secondary outcome [1]
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Rate of Primary Lung Cancer Mortality Among Former Smokers
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline from original trial up to Year 2 of this study
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Secondary outcome [2]
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Rate of All-cause Mortality
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Assessment method [2]
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The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.
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Timepoint [2]
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Baseline from original trial up to Year 2 of this study
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Secondary outcome [3]
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Rate of Primary Lung Cancer Diagnosis
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline from original trial up to Year 2 of this study
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Eligibility
Key inclusion criteria
- Previously participated in an eligible Exubera clinical trial
- Willing to provide study doctor with at least one alternate contact person
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2012
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Sample size
Target
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Accrual to date
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Final
7439
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - Camperdown
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Pfizer Investigational Site - Wollongong
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Recruitment hospital [3]
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Pfizer Investigational Site - Herston
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Recruitment hospital [4]
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Pfizer Investigational Site - Box Hill
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Recruitment hospital [5]
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Pfizer Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Westbury
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Pfizer
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00734591
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Pfizer CT.gov Call Center
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Pfizer
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00734591
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