Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00136916
First received: August 25, 2005
Last updated: February 12, 2010
Last verified: December 2009
Results First Received: December 10, 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
Interventions: Drug: Inhaled Insulin
Drug: Subcutaneous 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At screening visit and during the 4-week run-in phase subjects received subcutaneous insulin regime of 2 to 3 daily doses (QD) of regular insulin-/short-acting insulin analog (lispro or aspart) and 1 or 2 doses QD of intermediate or long-acting insulin (neutral protamine hagedorn [NPH] insulin or Ultralente®) or insulin glargine QD at bedtime.

Reporting Groups
  Description
Inhaled Insulin (Exubera®) Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous Insulin Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.

Participant Flow:   Overall Study
    Inhaled Insulin (Exubera®)   Subcutaneous Insulin
STARTED   319   316 
Received Treatment   316   311 
COMPLETED   194 [1]   212 [1] 
NOT COMPLETED   125   104 
Never received study treatment                3                5 
Death                1                3 
Adverse Event                27                8 
Laboratory abnormality                0                1 
Lack of Efficacy                13                3 
Lost to Follow-up                12                14 
Withdrawal by Subject                44                46 
Unspecified                22                24 
Discontinued in follow up period                3                0 
[1] At study termination, active subjects completed end-of-study assessment and 3-month follow-up visit



  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®) Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous Insulin Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Total Total of all reporting groups

Baseline Measures
   Inhaled Insulin (Exubera®)   Subcutaneous Insulin   Total 
Overall Participants Analyzed 
[Units: Participants]
 316   311   627 
Age, Customized 
[Units: Participants]
     
Between 26 and 35 years   2   7   9 
Between 36 and 45 years   36   49   85 
Between 46 and 55 years   100   93   193 
Between 56 and 65 years   117   101   218 
Between 66 and 75 years   61   61   122 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.7  (9.2)   55.5  (9.9)   56.1  (9.6) 
Gender 
[Units: Participants]
     
Female   111   118   229 
Male   205   193   398 


  Outcome Measures
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1.  Primary:   Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Month 3 through extension Month 60 ]

2.  Primary:   Change From Baseline in FEV1   [ Time Frame: Baseline through extension follow up Month 3 ]

3.  Primary:   Annual Rate of Change in FEV1   [ Time Frame: Week -2 through extension follow up Month 3 or end of study ]

4.  Primary:   Summary of ≥ 15 % Decliners in FEV1   [ Time Frame: Month 3 through extension follow up Month 3 ]

5.  Primary:   Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)   [ Time Frame: Week -2 through extension follow up Month 3 or end of study ]

6.  Primary:   Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)   [ Time Frame: Baseline through extension follow up Month 3 ]

7.  Primary:   Summary of ≥ 20 % Decliners in DLco   [ Time Frame: Month 3 through extension follow up Month 3 ]

8.  Secondary:   Forced Vital Capacity (FVC)   [ Time Frame: Week -3 through extension follow up Month 3 or end of study ]

9.  Secondary:   Total Lung Capacity (TLC)   [ Time Frame: Baseline through extension follow up Month 3 ]

10.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline through extension follow up Month 3 ]

11.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG)   [ Time Frame: Baseline through extension follow up Month 3 ]

12.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline through extension follow up Month 3 ]

13.  Secondary:   Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)   [ Time Frame: Month 3 through extension Month 36 ]

14.  Secondary:   Total Daily Long-acting Insulin (Adjusted for Body Weight)   [ Time Frame: Month 3 through extension Month 36 ]

15.  Secondary:   Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)   [ Time Frame: Month 3 through extension Month 36 ]

16.  Secondary:   Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)   [ Time Frame: Month 3 through extension Month 36 ]

17.  Secondary:   Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides   [ Time Frame: Week -4 through Month 24 ]

18.  Secondary:   Hypoglycemic Event Rates   [ Time Frame: Month 1 through extension Month 36 ]

19.  Secondary:   Severe Hypoglycemic Event Rates   [ Time Frame: Month 1 through extension Month 36 ]

20.  Secondary:   Cough Questionnaire   [ Time Frame: Week 0 and if indicated through extension follow up Month 3 ]

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

22.  Secondary:   Transition Dyspnea Index (TDI)   [ Time Frame: Week 4 through extension follow up Month 3 or end of study ]

23.  Secondary:   High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits   [ Time Frame: Baseline, M12, M24, Ext M6, Ext M18, Ext M36 ]

24.  Secondary:   High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits   [ Time Frame: Baseline, M12, M24, Ext M6, Ext M18, Ext M36 ]

25.  Secondary:   Insulin Antibodies   [ Time Frame: Baseline through extension Month 36 ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00136916     History of Changes
Other Study ID Numbers: A2171029
Study First Received: August 25, 2005
Results First Received: December 10, 2009
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration