Follow-Up Study for Exubera

Completed

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.

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Participated in an investigational study of an unapproved drug since completing the Exubera trial
Ever used an other (non-Exubera) inhaled insulin

Arm && Interventions

Group	Intervention	Description
Previously treated with comparator	Randomized diabetes therapy	Subjects who had been treated with a comparator (other diabetes treatment such as injected insulin) in a prior Exubera controlled trial.
Previously treated with Exubera	Exubera	-

Primary Outcome Measures

Name	Time	Method
Rate of Primary Lung Cancer Mortality	Baseline from original trial up to Year 2 of this study	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

Name	Time	Method
Rate of Primary Lung Cancer Mortality Among Former Smokers	Baseline from original trial up to Year 2 of this study	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	Baseline from original trial up to Year 2 of this study	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	Baseline from original trial up to Year 2 of this study	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.