Follow-Up Study for Exubera (FUSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00734591
First received: August 12, 2008
Last updated: September 24, 2012
Last verified: September 2012
Results First Received: September 24, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort
Condition: Diabetes Mellitus
Interventions: Drug: Exubera
Other: Randomized diabetes therapy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study had retrospective and prospective components. Individuals who participated in Exubera-controlled trials that were still active in 2003 or later participated in the retrospective part of this study (Follow-Up Study for Exubera; FUSE). Individuals from sites participating in the prospective part of FUSE were eligible.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Previously Randomized to Exubera Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
Previously Randomized to Comparator Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.

Participant Flow for 3 periods

Period 1:   Retrospective Period
    Previously Randomized to Exubera     Previously Randomized to Comparator  
STARTED     3875     3564  
COMPLETED     3875     3564  
NOT COMPLETED     0     0  

Period 2:   Screening for Prospective Period
    Previously Randomized to Exubera     Previously Randomized to Comparator  
STARTED     3875     3564  
COMPLETED     1358     1273  
NOT COMPLETED     2517     2291  
Site did not participate                 1604                 1488  
Patient at partic. site not enrolled                 913                 803  

Period 3:   Prospective Period
    Previously Randomized to Exubera     Previously Randomized to Comparator  
STARTED     1358     1273  
COMPLETED     1307     1229  
NOT COMPLETED     51     44  
Withdrawal by Subject                 11                 9  
Lost to Follow-up                 37                 33  
Study Terminated                 1                 0  
Unspecified                 2                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Previously Randomized to Exubera Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
Previously Randomized to Comparator Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
Total Total of all reporting groups

Baseline Measures
    Previously Randomized to Exubera     Previously Randomized to Comparator     Total  
Number of Participants  
[units: participants]
  3875     3564     7439  
Age [1]
[units: years]
Mean ± Standard Deviation
  54.8  ± 12.1     54.7  ± 12.6     54.8  ± 12.4  
Gender  
[units: participants]
     
Female     1677     1557     3234  
Male     2198     2007     4205  
Smoking status [2]
[units: participants]
     
Never-smoker     2194     2031     4225  
Ever-smoker     1681     1533     3214  
[1] Mean age at original trial
[2] Reported as number of participants who never smoked (never-smoker) and those who have ever smoked (ever-smoker) includes former smokers and current smokers.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Primary Lung Cancer Mortality   [ Time Frame: Baseline from original trial up to Year 2 of this study ]

2.  Secondary:   Rate of Primary Lung Cancer Mortality Among Former Smokers   [ Time Frame: Baseline from original trial up to Year 2 of this study ]

3.  Secondary:   Rate of All-cause Mortality   [ Time Frame: Baseline from original trial up to Year 2 of this study ]

4.  Secondary:   Rate of Primary Lung Cancer Diagnosis   [ Time Frame: Baseline from original trial up to Year 2 of this study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Detection and/or reporting bias possible in continuous analysis (presented here) of lung cancer mortality and lung cancer incidence endpoints. Study had insufficient power to draw clear statistical conclusions due to small number of events.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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