Follow-Up Study for Exubera (FUSE)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00734591
First received: August 12, 2008
Last updated: September 24, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus |
Drug: Exubera Other: Randomized diabetes therapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Rate of Primary Lung Cancer Mortality [ Time Frame: Baseline from original trial up to Year 2 of this study ] [ Designated as safety issue: Yes ]Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.
Secondary Outcome Measures:
- Rate of Primary Lung Cancer Mortality Among Former Smokers [ Time Frame: Baseline from original trial up to Year 2 of this study ] [ Designated as safety issue: Yes ]Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.
- Rate of All-cause Mortality [ Time Frame: Baseline from original trial up to Year 2 of this study ] [ Designated as safety issue: Yes ]The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.
- Rate of Primary Lung Cancer Diagnosis [ Time Frame: Baseline from original trial up to Year 2 of this study ] [ Designated as safety issue: Yes ]The rate and rate ratio of lung cancer adjudicated as highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer) or likely (some information may have been missing for definite diagnosis) to be newly diagnosed primary lung cancer that occurred anytime from the start of the original trial to the end of FUSE.
| Enrollment: | 7439 |
| Study Start Date: | August 2008 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Previously treated with Exubera |
Drug: Exubera
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).
|
|
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.
|
Other: Randomized diabetes therapy
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). |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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)
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734591
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| Guadalajara, Jalisco, Mexico, 44340 | |
| Pfizer Investigational Site | |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| Netherlands | |
| Pfizer Investigational Site | |
| 's Hertogenbosch, Netherlands, 5211 RW | |
| Pfizer Investigational Site | |
| Amsterdam, Netherlands, 1105 AZ | |
| Pfizer Investigational Site | |
| Beek, Netherlands, 6191 JW | |
| Pfizer Investigational Site | |
| Eindhoven, Netherlands, 5631 BM | |
| Pfizer Investigational Site | |
| Venlo, Netherlands, 5912 BL | |
| Norway | |
| Pfizer Investigational Site | |
| Fornebu, Norway, 1364 | |
| Pfizer Investigational Site | |
| Honefoss, Norway, 3515 | |
| Pfizer Investigational Site | |
| Skedsmokorset, Norway, N-2020 | |
| Pfizer Investigational Site | |
| Stavanger, Norway, 4068 | |
| Poland | |
| Pfizer Investigational Site | |
| Lask, Poland, 98-100 | |
| Pfizer Investigational Site | |
| Lodz, Poland, 93-338 | |
| Pfizer Investigational Site | |
| Lublin, Poland, 20-536 | |
| Pfizer Investigational Site | |
| Warszawa, Poland, 02-097 | |
| Portugal | |
| Pfizer Investigational Site | |
| Aveiro, Portugal, 3814-096 | |
| Pfizer Investigational Site | |
| Lisboa, Portugal, 1349-019 | |
| Pfizer Investigational Site | |
| Lisboa, Portugal, 1250-203 | |
| Pfizer Investigational Site | |
| Porto, Portugal, 4099-001 | |
| Pfizer Investigational Site | |
| Torres Vedras, Portugal, 2560-324 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Banska Bystrica, Slovakia, 975 17 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 811 08 | |
| Pfizer Investigational Site | |
| Martin, Slovakia, 036 01 | |
| South Africa | |
| Pfizer Investigational Site | |
| Houghton, Gauteng, South Africa, 2198 | |
| Pfizer Investigational Site | |
| Umhlanga Rocks, KwaZulu Natal, South Africa, 4320 | |
| Spain | |
| Pfizer Investigational Site | |
| Santiago de Compostela, A Coruña, Spain, 15706 | |
| Pfizer Investigational Site | |
| Badalona, Barcelona, Spain, 08916 | |
| Pfizer Investigational Site | |
| Las Palmas, Las Palmas de Gran Canaria, Spain, 35016 | |
| Pfizer Investigational Site | |
| La Laguna, Santa Cruz de Tenerife, Spain, 38320 | |
| Pfizer Investigational Site | |
| Alzira, Valencia, Spain, 46600 | |
| Pfizer Investigational Site | |
| Bilbao, Vizcaya, Spain, 48013 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08036 | |
| Pfizer Investigational Site | |
| Granada, Spain, 18012 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28935 | |
| Pfizer Investigational Site | |
| Malaga, Spain, 07300 | |
| Pfizer Investigational Site | |
| Sevilla, Spain, 41014 | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46015 | |
| Sweden | |
| Pfizer Investigational Site | |
| Boras, Sweden, 503 30 | |
| Pfizer Investigational Site | |
| Forshaga, Sweden, 667 32 | |
| Pfizer Investigational Site | |
| Goteborg, Sweden, 41665 | |
| Pfizer Investigational Site | |
| Goteborg, Sweden, 412 55 | |
| Pfizer Investigational Site | |
| Göteborg, Sweden, 417 17 | |
| Pfizer Investigational Site | |
| Harnosand, Sweden, 871 82 | |
| Pfizer Investigational Site | |
| Helsingborg, Sweden, 251 87 | |
| Pfizer Investigational Site | |
| Linkoping, Sweden, 581 85 | |
| Pfizer Investigational Site | |
| Malmo, Sweden, 211 52 | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 171 76 | |
| Pfizer Investigational Site | |
| Vaxjo, Sweden, 351 85 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Penzance, Cornwall, United Kingdom, TR18 4JH | |
| Pfizer Investigational Site | |
| St. Austell, Cornwall, United Kingdom, PL26 7RL | |
| Pfizer Investigational Site | |
| Plymouth, Devon, United Kingdom, PL6 8BX | |
| Pfizer Investigational Site | |
| Letchworth, Hertfordshire, United Kingdom, SG6 4UB | |
| Pfizer Investigational Site | |
| Ashford, Middlesex, United Kingdom, TW15 3EA | |
| Pfizer Investigational Site | |
| Headington, Oxford, United Kingdom, OX3 7LJ | |
| Pfizer Investigational Site | |
| Weybridge, Surrey, United Kingdom, KT15 2BH | |
| Pfizer Investigational Site | |
| Woking, Surrey, United Kingdom, GU22 7EY | |
| Pfizer Investigational Site | |
| Rugby, Warwickshire, United Kingdom, CV22 5PX | |
| Pfizer Investigational Site | |
| Warminster, Wiltshire, United Kingdom, BA12 9AA | |
| Pfizer Investigational Site | |
| Sheffield, Yorkshire, United Kingdom, S7 2DW | |
| Pfizer Investigational Site | |
| Bath, United Kingdom, BA2 4BY | |
| Pfizer Investigational Site | |
| Bath, United Kingdom, BA2 3HT | |
| Pfizer Investigational Site | |
| Birmingham, United Kingdom, B37 7TR | |
| Pfizer Investigational Site | |
| Birmingham, United Kingdom, B9 5SS | |
| Pfizer Investigational Site | |
| Bolton, United Kingdom, BL3 6TL | |
| Pfizer Investigational Site | |
| Canterbury, United Kingdom, CT1 3HX | |
| Pfizer Investigational Site | |
| Leicester, United Kingdom, LE1 5WW | |
| Pfizer Investigational Site | |
| Newcastle-upon-Tyne, United Kingdom, NE15 6TQ | |
| Pfizer Investigational Site | |
| Salford, United Kingdom, M6 8HD | |
| Pfizer Investigational Site | |
| Westbury, United Kingdom, BA13 3JD | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00734591 History of Changes |
| Other Study ID Numbers: | A2171121 |
| Study First Received: | August 12, 2008 |
| Results First Received: | September 24, 2012 |
| Last Updated: | September 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Pfizer:
|
Observational Study Exubera |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013