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.
- Previously participated in an eligible Exubera clinical trial
- Willing to provide study doctor with at least one alternate contact person
- Participated in an investigational study of an unapproved drug since completing the
Exubera trial
- Ever used an other (non-Exubera) inhaled insulin
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Follow-Up Study for Exubera | |||
| Official Title | An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials | |||
| 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | All subjects who participated in a controlled trial of Exubera active within the last five years (17 protocols total) | |||
| Condition | Diabetes Mellitus | |||
| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 7439 | |||
| Original Estimated Enrollment | 2400 | |||
| Actual Study Completion Date | January 2012 | |||
| Actual Primary Completion Date | January 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | 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 | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00734591 | |||
| Other Study ID Numbers | A2171121 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2012 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
