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An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials


N/A
18 Years
N/A
Not Enrolling
Both
Diabetes Mellitus

Thank you

Trial Information

An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

Rate of Primary Lung Cancer Mortality

Outcome Description:

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.

Outcome Time Frame:

Baseline from original trial up to Year 2 of this study

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Institutional Review Board

Study ID:

A2171121

NCT ID:

NCT00734591

Start Date:

August 2008

Completion Date:

January 2012

Related Keywords:

  • Diabetes Mellitus
  • Observational Study Exubera
  • Diabetes Mellitus

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteSanta Fe, New Mexico  87505
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteWashington, District of Columbia  20007-2197
Pfizer Investigational SiteBurlington, Vermont  05401-3456
Pfizer Investigational SiteLewistown, Idaho  83501
Pfizer Investigational SiteNewark, Delaware  19713
Pfizer Investigational SiteHonolulu, Hawaii  96813
Pfizer Investigational SiteMorgantown, West Virginia  26506