| Follow-Up Study for Exubera |
| An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials |
| 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. |
| 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. |
| Observational |
| Observational Model: Cohort |
| Not Provided |
| Not Provided |
| Non-Probability Sample |
| All subjects who participated in a controlled trial of Exubera active within the last five years (17 protocols total) |
| Diabetes Mellitus |
|
|
- Previously treated with Exubera
Intervention: Drug: 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.
Intervention: Other: Randomized diabetes therapy
|
| Not Provided |
| |
| Completed |
| 7439 |
| January 2012 |
| January 2012 (Final data collection date for primary outcome measure) |
|
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
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, United Kingdom, United States |
| |
| |
| NCT00734591 |
| A2171121 |
| No |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| September 2012 |
