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A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00282971
First received: January 26, 2006
Last updated: September 11, 2009
Last verified: July 2009
Results First Received: February 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus Type 2
Interventions: Other: Standard of Care
Drug: Inhaled Insulin (Exubera)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total subjects enrolled=354. Total subjects given study drug=351. (ie, 3 subjects withdrew after enrollment/randomization, but prior to receiving study drug)

Reporting Groups
  Description
Inhaled Insulin Inhaled insulin plus oral therapy
Standard of Care Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

Participant Flow:   Overall Study
    Inhaled Insulin     Standard of Care  
STARTED     180     171  
COMPLETED     146     149  
NOT COMPLETED     34     22  



  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 Inhaled insulin plus oral therapy
Standard of Care Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Total Total of all reporting groups

Baseline Measures
    Inhaled Insulin     Standard of Care     Total  
Number of Participants  
[units: participants]
  180     171     351  
Age, Customized  
[units: participants]
     
<18 years     0     0     0  
Between 18 and 44 years     12     6     18  
Between 45 and 64 years     112     113     225  
>=65 years     56     52     108  
Gender  
[units: participants]
     
Female     76     80     156  
Male     104     91     195  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24   [ Time Frame: 4, 12 and 24 weeks ]

2.  Secondary:   Percentage of Participants Achieving Glycemic Control by Visit   [ Time Frame: 4, 12 and 24 weeks ]

3.  Secondary:   Change From Baseline in FEV1 at Week 24 LOCF   [ Time Frame: 24 weeks ]


  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
Study terminated prematurely since the sponsor stopped marketing and manufacturing of EXUBERA and withdrew Market Authorization in Europe in September 2008. No efficacy, safety, or quality reason was associated with the premature halt of this study.


  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: NCT00282971     History of Changes
Other Study ID Numbers: A2171063, EXACTA
Study First Received: January 26, 2006
Results First Received: February 11, 2009
Last Updated: September 11, 2009
Health Authority: United States: Food and Drug Administration