Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00479258
First received: May 24, 2007
Last updated: October 31, 2008
Last verified: October 2008
Results First Received: October 29, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 1
Interventions: Drug: Inhaled insulin (Exubera)
Drug: Subcutaneous Insulin (subject's prescribed)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Two subjects completed the informed consent/assent process and entered the A2171083 study but none received treatment. The first subject withdrew consent during the Baseline Run-in period which was prior to Randomization. The second subject screen failed at Visit 1. Location = UNITED STATES.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Pfizer announced in Oct 2007 that it would stop marketing Exubera. At that time recruitment was placed on hold. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. As a result, study A2171083 was terminated and no further recruitment took place.

Reporting Groups
  Description
Inhaled Insulin (Exubera) No subjects received study medication.
Subcutaneous Insulin (Subject's Prescribed) No subjects received study medication.

Participant Flow:   Overall Study
    Inhaled Insulin (Exubera)     Subcutaneous Insulin (Subject's Prescribed)  
STARTED     0     0  
COMPLETED     0     0  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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
Inhaled Insulin (Exubera) No subjects received study medication.
Subcutaneous Insulin (Subject's Prescribed) No subjects received study medication.
Total Total of all reporting groups

Baseline Measures
    Inhaled Insulin (Exubera)     Subcutaneous Insulin (Subject's Prescribed)     Total  
Number of Participants  
[units: participants]
  0     0     0  
Age, Customized [1]
[units: subjects]
  0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     0     0     0  
[1] <18 years



  Outcome Measures

1.  Primary:   To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period   [ Time Frame: 12 months ]

2.  Secondary:   Change From Baseline in Other PFT Parameters   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Treatment Preferences.   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change From Baseline in FVC   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Slope for Other PFT Parameters;   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Change From Baseline in Insulin Antibodies (microU/mL);   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

9.  Secondary:   Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Hypoglycemic Event Rates;   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

11.  Secondary:   7 Point Home Glucose   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Pfizer announced Oct07 it would stop marketing Exubera; recruitment placed on hold. Nektar, from which Pfizer licensed Exubera, announced April 9, 2008 it had stopped its search for a new marketing partner. Study terminated; no further recruitment.


  More Information
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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.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00479258     History of Changes
Other Study ID Numbers: A2171083
Study First Received: May 24, 2007
Results First Received: October 29, 2008
Last Updated: October 31, 2008
Health Authority: United States: Food and Drug Administration