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This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00418522
First received: January 3, 2007
Last updated: September 8, 2009
Last verified: July 2009
History of Changes
Results First Received: July 30, 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 2
Interventions: Drug: Insulin glargine
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Inhaled Human Insulin Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
Insulin Glargine Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

Participant Flow:   Overall Study
    Inhaled Human Insulin     Insulin Glargine  
STARTED     219     194  
Received Treatment     212     190  
COMPLETED     136     152  
NOT COMPLETED     83     42  
Adverse Event                 7                 1  
Lack of Efficacy                 1                 3  
Lost to Follow-up                 10                 4  
Withdrawal by Subject                 31                 7  
Unknown                 27                 23  
Randomized but did not receive treatment                 7                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Inhaled Human Insulin Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
Insulin Glargine Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Total Total of all reporting groups

Baseline Measures
    Inhaled Human Insulin     Insulin Glargine     Total  
Number of Participants  
[units: participants]
 		  212     190     402  
Age, Customized  
[units: participants]
 		     
18 to 44 years     27     26     53  
45 to 65 years     151     125     276  
>=65 years     34     39     73  
Gender  
[units: participants]
 		     
Female     92     84     176  
Male     120     106     226  



  Outcome Measures
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1.  Primary:   Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population   [ Time Frame: Baseline, Week 26 ]
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2.  Secondary:   Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26   [ Time Frame: Week 26 ]
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3.  Secondary:   Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26   [ Time Frame: Week 26 ]
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4.  Secondary:   Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26   [ Time Frame: Week 26 ]
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5.  Secondary:   Change From Baseline in Fasting Plasma Glucose at Week 26   [ Time Frame: Baseline, Week 26 ]
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6.  Secondary:   Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26   [ Time Frame: Baseline, Week 26 ]
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7.  Secondary:   Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26   [ Time Frame: Baseline, Week 26 ]
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8.  Secondary:   Change From Baseline in Lipids at Week 26   [ Time Frame: Baseline, Week 26 ]
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9.  Secondary:   Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26   [ Time Frame: Baseline, Week 26 ]
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10.  Secondary:   Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26   [ Time Frame: Baseline, Week 26 ]
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11.  Secondary:   Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26   [ Time Frame: Baseline, Week 26 ]
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12.  Secondary:   Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26   [ Time Frame: Baseline, Week 26 ]
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13.  Secondary:   Number of Subjects With Hypoglycemic Events   [ Time Frame: Months 1 to 7 ]
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14.  Secondary:   Number of Total Hypoglycemic Events   [ Time Frame: Months 1 to 7 ]
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15.  Secondary:   Number of Total Subject Months of Treatment   [ Time Frame: Months 1 to 7 ]
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16.  Secondary:   Crude Hypoglycemic Event Rate   [ Time Frame: Months 1 to 7 ]
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17.  Secondary:   Number of Nocturnal Hypoglycemic Events   [ Time Frame: Months 1 to 7 ]
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18.  Secondary:   Change From Baseline in Body Weight at Week 26   [ Time Frame: Baseline, Week 26 ]
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19.  Secondary:   Change From Baseline in Body Mass Index (BMI) at Week 26   [ Time Frame: Baseline, Week 26 ]
  Show Outcome Measure 19

20.  Other Pre-specified:   Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS   [ Time Frame: Baseline, Week 26 ]
  Show Outcome Measure 20

21.  Secondary:   Change From Baseline in Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 Vitality Domain Questionnaire   [ Time Frame: Baseline, Week 26 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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 cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data were not summarized, and no statistical analyses were performed.  


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: NCT00418522     History of Changes
Other Study ID Numbers: A2171095
Study First Received: January 3, 2007
Results First Received: July 30, 2009
Last Updated: September 8, 2009
Health Authority: United States: Food and Drug Administration