Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00527397
First received: September 7, 2007
Last updated: October 5, 2009
Last verified: July 2009
Results First Received: July 15, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Intervention: Drug: CP-464,005

  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
10 centers in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
As a result of Pfizer's decision (18 Oct 2007) to return the worldwide rights for CP-464,005 (insulin human [rDNA origin] Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study before it had recruited targeted number of subjects.

Reporting Groups
  Description
All Subjects With Type 1 or Type 2 Diabetes Mellitus All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.

Participant Flow:   Overall Study
    All Subjects With Type 1 or Type 2 Diabetes Mellitus  
STARTED     24  
COMPLETED     0  
NOT COMPLETED     24  
Adverse Event                 3  
Lack of Efficacy                 1  
Protocol Violation                 1  
Withdrawal by Subject                 6  
Study terminated by sponsor                 13  



  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
All Subjects With Type 1 or Type 2 Diabetes Mellitus All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.

Baseline Measures
    All Subjects With Type 1 or Type 2 Diabetes Mellitus  
Number of Participants  
[units: participants]
  24  
Age  
[units: years]
Mean ± Standard Deviation
  55.2  ± 15.0  
Gender  
[units: participants]
 
Female     13  
Male     11  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Self-Monitoring Blood Glucose Levels: Change From Baseline   [ Time Frame: One year ]

2.  Secondary:   Daily Inhaled Insulin Dose   [ Time Frame: Up to 26 weeks ]

3.  Secondary:   The Values of Hemoglobin A1c:Change From Baseline   [ Time Frame: Baseline, Week 6, Week 12, Week 26, End of treatment ]

4.  Secondary:   The Value of Fasting Plasma Glucose:Change From Baseline   [ Time Frame: Baseline, Week 6, Week 12, Week 26 ]

5.  Secondary:   The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin   [ Time Frame: 0 month to 12 months ]

6.  Secondary:   The Values of Forced Expiratory Volume at 1 Second:Change From Baseline   [ Time Frame: Beseline, Week 1, Week 2, Week 6, Week 12, Week 26 ]

7.  Secondary:   The Values of Forced Vital Capacity:Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment ]

8.  Secondary:   The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline   [ Time Frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment ]

9.  Secondary:   Insulin Antibody Levels : Change From Baseline   [ Time Frame: Baseline, Week 6, Week 12, End of treatment ]


  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
As a result of Pfizer's decision (18 Oct 2007) to return the worldwide rights for CP-464,005 (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate 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: NCT00527397     History of Changes
Other Study ID Numbers: A2171105
Study First Received: September 7, 2007
Results First Received: July 15, 2009
Last Updated: October 5, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare