A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD

NCT00138671

Last updated date
Study Location
Pfizer Investigational Site
Glendale, Arizona, 85306, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus, Chronic Obstructive Pulmonary Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-77 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin

- Prior smokers with a fixed airflow obstruction at screening (FEV1/FVC < 70%) and FEV1 < 80% predicted and/or a history of chronic productive cough.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Poorly controlled, unstable or steroid-dependent COPD, insulin pump therapy, active
smoking

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Diabetes Mellitus, Chronic Obstructive Pulmonary DiseaseA One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD NCT00138671
  1. Glendale, Arizona
  2. Peoria, Arizona
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Phoenix, Arizona
  6. Tucson, Arizona
  7. Jonesboro, Arkansas
  8. Searcy, Arkansas
  9. Berkeley, California
  10. Fresno, California
  11. Greenbrae, California
  12. Huntington Beach, California
  13. Los Angeles, California
  14. Riverside, California
  15. Tustin, California
  16. Denver, Colorado
  17. Waterbury, Connecticut
  18. Chiefland, Florida
  19. Clearwater, Florida
  20. Clearwater, Florida
  21. DeLand, Florida
  22. Gainesville, Florida
  23. Lake City, Florida
  24. Melbourne, Florida
  25. Miami, Florida
  26. West Palm Beach, Florida
  27. Winter Park, Florida
  28. Decatur, Georgia
  29. Honolulu, Hawaii
  30. Honululu, Hawaii
  31. Chicago, Illinois
  32. Normal, Illinois
  33. Evansville, Indiana
  34. Indianapolis, Indiana
  35. Des Moines, Iowa
  36. Wichita, Kansas
  37. Madisonville, Kentucky
  38. New Orleans, Louisiana
  39. Springfield, Massachusetts
  40. Springfield, Massachusetts
  41. Waltham, Massachusetts
  42. Kansas City, Missouri
  43. St. Louis, Missouri
  44. Butte, Montana
  45. Omaha, Nebraska
  46. Henderson, Nevada
  47. Las Vegas, Nevada
  48. Las Vegas, Nevada
  49. Albany, New York
  50. Albany, New York
  51. Cincinnati, Ohio
  52. Cincinnati, Ohio
  53. Toledo, Ohio
  54. Oklahoma City, Oklahoma
  55. Medford, Oregon
  56. Portland, Oregon
  57. Pittsburgh, Pennsylvania
  58. Spartanburg, South Carolina
  59. Spartanburg, South Carolina
  60. Memphis, Tennessee
  61. Nashville, Tennessee
  62. Beaumont, Texas
  63. Beaumont, Texas
  64. Dallas, Texas
  65. Houston, Texas
  66. San Antonio, Texas
  67. San Antonio, Texas
  68. Fredericksburg, Virginia
  69. Fredericksburg, Virginia
  70. Richmond, Virginia
  71. Richmond, Virginia
  72. Richmond, Virginia
  73. Richmond, Virginia
  74. Spokane, Washington
  75. Spokane, Washington
  76. Huntington, West Virginia
  77. Madison, Wisconsin
  78. Porto Alegre, RS
  79. Campinas, SP
  80. Sao Paulo, SP
  81. São Paulo, SP
  82. Edmonton, Alberta
  83. Red Deer, Alberta
  84. Burlington, Ontario
  85. Laval, Quebec
  86. Sherbrooke, Quebec
  87. San Jose,
  88. Neuss,
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD
Official Title  ICMJE Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Obstructive Pulmonary Disease: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial
Brief Summary A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.
Detailed Description Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for study A2171030 was placed on hold. 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 A2171030 was terminated on June 17, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: Subcutaneous Insulin
    Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.
  • Drug: Inhaled Insulin
    Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.
Study Arms  ICMJE
  • Active Comparator: Subcutaneous Insulin
    Intervention: Drug: Subcutaneous Insulin
  • Experimental: Inhaled Insulin
    Intervention: Drug: Inhaled Insulin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 6, 2009)
105
Original Enrollment  ICMJE
 (submitted: August 26, 2005)
250
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
  • Prior smokers with a fixed airflow obstruction at screening (FEV1/FVC < 70%) and FEV1 < 80% predicted and/or a history of chronic productive cough.

Exclusion Criteria:

  • Poorly controlled, unstable or steroid-dependent COPD, insulin pump therapy, active smoking
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years to 77 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Canada,   Costa Rica,   Germany,   United States
Removed Location Countries Mexico
 
Administrative Information
NCT Number  ICMJE NCT00138671
Other Study ID Numbers  ICMJE A2171030
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP