Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137046
First received: August 26, 2005
Last updated: February 3, 2010
Last verified: December 2009
Results First Received: December 7, 2009  
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: Subcutaneous Insulin
Drug: Inhaled Insulin

  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
A total of 64 centers took part in the study between 09 May 2002 and 08 December 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At the screening visit and during the 4-week run-in phase all subjects received a subcutaneous insulin regimen consisting of 2 to 3 doses per day of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 doses daily of intermediate-/long-acting insulin (NPH insulin or Ultralente), or insulin glargine once daily at bedtime.

Reporting Groups
  Description
Inhaled Insulin Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous Insulin Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.

Participant Flow:   Overall Study
    Inhaled Insulin     Subcutaneous Insulin  
STARTED     291 [1]   291 [2]
Received Study Treatment     290     290  
COMPLETED     192 [3]   198  
NOT COMPLETED     99     93  
Death                 2                 1  
Adverse Event                 16                 5  
Laboratory Abnormality                 2                 0  
Lack of Efficacy                 13                 1  
Lost to Follow-up                 8                 24  
Unspecified                 23                 19  
Withdrawal by Subject                 33                 42  
Adverse Event 4 Days after Last Dose                 1                 0  
Withdrew prior to study treatment                 1                 1  
[1] One subject was randomized to inhaled insulin but never received treatment.
[2] One subject was randomized to subcutaneous insulin but never received treatment.
[3] Completed subjects were those subjects who did not discontinue while on active drug.



  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 (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous Insulin Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Total Total of all reporting groups

Baseline Measures
    Inhaled Insulin     Subcutaneous Insulin     Total  
Number of Participants  
[units: participants]
  290     290     580  
Age, Customized  
[units: years]
     
18 to 25     48     53     101  
26 to 35     81     96     177  
36 to 45     94     71     165  
46 to 55     52     48     100  
56 to 65     15     22     37  
Gender  
[units: participants]
     
Female     121     129     250  
Male     169     161     330  



  Outcome Measures
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1.  Primary:   Change From Baseline in Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Baseline through Extension Follow-up Month 3 ]

2.  Primary:   Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Month 3 through Extension Follow-up 3 ]

3.  Primary:   Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)   [ Time Frame: Baseline through Extension Follow-up Month 3 ]

4.  Primary:   Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).   [ Time Frame: Month 3 through Extension Follow-up Month 3 ]

5.  Primary:   Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Week -2 through Extension Follow-up Month 6 or end of study ]

6.  Primary:   Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)   [ Time Frame: Week -2 through Extension Follow-up Month 6 or end of study ]

7.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline through Extension Follow-up Month 3 ]

8.  Secondary:   Hypoglycemic Event Rates   [ Time Frame: Month 1 through Extension Month 39 ]

9.  Secondary:   Severe Hypoglycemic Event Rates   [ Time Frame: Month 1 through Extension Month 39 ]

10.  Secondary:   Change From Baseline in Fasting Plasma Glucose   [ Time Frame: Baseline through Extension Follow-up Month 3 ]

11.  Secondary:   Change From Baseline Body Weight   [ Time Frame: Baseline through Extension Follow-up Month 3 ]

12.  Secondary:   Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)   [ Time Frame: Month 3 through Extension Month 39 ]

13.  Secondary:   Total Daily Long-Acting Insulin Dose Adjusted for Body Weight   [ Time Frame: Month 3 through Extension Month 39 ]

14.  Secondary:   Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)   [ Time Frame: Month 3 through Extension Month 39 ]

15.  Secondary:   Total Daily Short-Acting Insulin Dose Adjusted for Body Weight   [ Time Frame: Month 3 through Extension Month 39 ]

16.  Secondary:   Baseline Dyspnea Index (BDI)   [ Time Frame: Week - 1 ]

17.  Secondary:   Transition Dyspnea Index (TDI)   [ Time Frame: Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study ]

18.  Secondary:   Lipids   [ Time Frame: Week -4 through Month 24 ]

19.  Secondary:   Cough Questionnaire   [ Time Frame: Week 0 and if indicated through Extension Follow up Month 3 ]

20.  Secondary:   Forced Vital Capacity (FVC)   [ Time Frame: Week -3 through Extension Follow-up Month 6 or End of Study ]

21.  Secondary:   Total Lung Capacity (TLC)   [ Time Frame: Week -3 through Extension Follow-up Month 6 or End of Study ]

22.  Secondary:   Insulin Antibodies   [ Time Frame: Baseline through Extension Month 39 ]


  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
Due to early termination of study, none of the subjects completed the study as planned. Subjects active at the time of study termination completed an end-of-study assessment and a 3-month follow-up visit.


  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: NCT00137046     History of Changes
Other Study ID Numbers: A2171022
Study First Received: August 26, 2005
Results First Received: December 7, 2009
Last Updated: February 3, 2010
Health Authority: United States: Food and Drug Administration