Follow-Up Study for Exubera

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Exubera
* Other: Randomized diabetes therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previously treated with Exubera<br> | Drug: Exubera<br>* 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).<br>|
| Previously treated with comparator<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline from original trial up to Year 2 of this study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline from original trial up to Year 2 of this study | 
| 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. | Baseline from original trial up to Year 2 of this study | 
| 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. | Baseline from original trial up to Year 2 of this study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Observational Study Exubera