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

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ClinicalTrials.gov Identifier: NCT00136916
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : August 29, 2005
Results First Posted : January 18, 2010
Last Update Posted : February 18, 2010
Sponsor:
Information provided by:
Pfizer

Brief Summary:

This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®.

This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Inhaled Insulin Drug: Subcutaneous insulin Phase 3

Detailed Description:
Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171029 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 635 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 2 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial
Study Start Date : June 2002
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inhaled Insulin
Inhalable short-acting insulin
Drug: Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose
Other Name: Exubera

Active Comparator: Subcutaneous insulin Drug: Subcutaneous insulin
Subcutaneous insulin with dose adjusted according to premeal blood glucose




Primary Outcome Measures :
  1. Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Month 3 through extension Month 60 ]
  2. Change From Baseline in FEV1 [ Time Frame: Baseline through extension follow up Month 3 ]
  3. Annual Rate of Change in FEV1 [ Time Frame: Week -2 through extension follow up Month 3 or end of study ]
  4. Summary of ≥ 15 % Decliners in FEV1 [ Time Frame: Month 3 through extension follow up Month 3 ]
  5. 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. Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) [ Time Frame: Baseline through extension follow up Month 3 ]
  7. Summary of ≥ 20 % Decliners in DLco [ Time Frame: Month 3 through extension follow up Month 3 ]

Secondary Outcome Measures :
  1. Forced Vital Capacity (FVC) [ Time Frame: Week -3 through extension follow up Month 3 or end of study ]
  2. Total Lung Capacity (TLC) [ Time Frame: Baseline through extension follow up Month 3 ]
  3. Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline through extension follow up Month 3 ]
  4. Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline through extension follow up Month 3 ]
  5. Change From Baseline in Body Weight [ Time Frame: Baseline through extension follow up Month 3 ]
  6. Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Month 3 through extension Month 36 ]
  7. Total Daily Long-acting Insulin (Adjusted for Body Weight) [ Time Frame: Month 3 through extension Month 36 ]
  8. Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Month 3 through extension Month 36 ]
  9. Total Daily Short-acting Insulin Dose (Adjusted for Body Weight) [ Time Frame: Month 3 through extension Month 36 ]
  10. Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides [ Time Frame: Week -4 through Month 24 ]
  11. Hypoglycemic Event Rates [ Time Frame: Month 1 through extension Month 36 ]
  12. Severe Hypoglycemic Event Rates [ Time Frame: Month 1 through extension Month 36 ]
  13. Cough Questionnaire [ Time Frame: Week 0 and if indicated through extension follow up Month 3 ]
  14. Baseline Dyspnea Index (BDI) [ Time Frame: Week -1 ]
  15. Transition Dyspnea Index (TDI) [ Time Frame: Week 4 through extension follow up Month 3 or end of study ]
  16. 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 ]
  17. 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 ]
  18. Insulin Antibodies [ Time Frame: Baseline through extension Month 36 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus

Exclusion Criteria:

  • COPD
  • Asthma
  • Smoking Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136916


  Show 92 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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
First Posted: August 29, 2005    Key Record Dates
Results First Posted: January 18, 2010
Last Update Posted: February 18, 2010
Last Verified: December 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs