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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials
Secondary ID [1] 0 0
A2171121
Universal Trial Number (UTN)
Trial acronym
FUSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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).

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Primary Lung Cancer Mortality - 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.
Timepoint [1] 0 0
Baseline from original trial up to Year 2 of this study
Secondary outcome [1] 0 0
Rate of Primary Lung Cancer Mortality Among Former Smokers - 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.
Timepoint [1] 0 0
Baseline from original trial up to Year 2 of this study
Secondary outcome [2] 0 0
Rate of All-cause Mortality - The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.
Timepoint [2] 0 0
Baseline from original trial up to Year 2 of this study
Secondary outcome [3] 0 0
Rate of Primary Lung Cancer Diagnosis - 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.
Timepoint [3] 0 0
Baseline from original trial up to Year 2 of this study

Eligibility
Key inclusion criteria
- Previously participated in an eligible Exubera clinical trial

- Willing to provide study doctor with at least one alternate contact person
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Wollongong
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Box Hill
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00734591
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications