Follow-Up Study for Exubera (FUSE)

Pfizer

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Drug: Exubera; Other: Randomized diabetes therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT00734591

A2171121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,439 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

7,439 participants in 2 patient groups

Previously treated with Exubera

Treatment:

Drug: Exubera

Previously treated with comparator

Description:

Subjects who had been treated with a comparator (other diabetes treatment such as injected insulin) in a prior Exubera controlled trial.

Treatment:

Other: Randomized diabetes therapy