At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials
In Brief
An observational study evaluating Exubera and Randomized diabetes therapy for Diabetes Mellitus. Completed, enrolled 7,439 participants across 321 sites in 25 countries.
Detailed 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.
Study Details
Timeline
Interventions
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).
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).