N/A
Completed N=7,439
Follow-Up Study for Exubera
Source: ClinicalTrials.gov NCT00734591 ↗Enrolled (actual)
7,439
Serious AEs
—
Results posted
Oct 2012
Primary outcomePrimary: Rate of Primary Lung Cancer Mortality — 0.48; 0.17 Deaths per 1000 patient years (PY)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Primary Lung Cancer Mortality |
0.48; 0.17 | — |
| SECONDARY Rate of Primary Lung Cancer Mortality Among Former Smokers |
0.94; 0.41 | — |
| SECONDARY Rate of All-cause Mortality |
6.03; 7.37 | — |
| SECONDARY Rate of Primary Lung Cancer Diagnosis |
1.07; 0.29 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00734591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.