Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes

NCT00424333

Last updated date
Study Location
Pfizer Investigational Site
Duarte, California, , United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 1 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Type 1 Diabetes for more than 1 year

- Stable insulin regimen of at least 2 injections per day

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


- Any smoking within the last 6 months. Smoking is not permitted at any time during this
study.


- Subjects on insulin pump during 2 months prior to screening.


- Subjects with poorly-controlled asthma, clinically significant chronic obstructive
pulmonary disease, or other significant respiratory disease.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Type 1 Diabetes MellitusSafety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents NCT00479258
  1. Buffalo, New York
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Type 1 Diabetes MellitusA Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes NCT02038764
  1. San Diego, California
  2. San Diego, California
  3. San Francisco, California
  4. Aurora, Colorado
  5. New Haven, Connecticut
  6. New Haven, Connecticut
  7. New Haven, Connecticut
  8. Atlanta, Georgia
  9. Chicago, Illinois
  10. Chicago, Illinois
  11. Chicago, Illinois
  12. Chicago, Illinois
  13. Worcester, Massachusetts
  14. Worcester, Massachusetts
  15. Minneapolis, Minnesota
  16. Minneapolis, Minnesota
  17. Saint Louis, Missouri
  18. Saint Louis, Missouri
  19. Saint Louis, Missouri
  20. Durham, North Carolina
  21. Durham, North Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Type 1 Diabetes MellitusSix Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes NCT00424333
  1. Duarte, California
  2. Long Beach, California
  3. Los Angeles, California
  4. Stanford, California
  5. Denver, Colorado
  6. New Haven, Connecticut
  7. Gainesville, Florida
  8. Hollywood, Florida
  9. Miami, Florida
  10. Tallahassee, Florida
  11. Peoria, Illinois
  12. Skokie, Illinois
  13. Lutherville, Maryland
  14. Waltham, Massachusetts
  15. Minneapolis, Minnesota
  16. Columbia, Missouri
  17. Bronx, New York
  18. New Hyde Park, New York
  19. Rochester, New York
  20. Syracuse, New York
  21. Durham, North Carolina
  22. Winston-salem, North Carolina
  23. Portland, Oregon
  24. Pittsburgh, Pennsylvania
  25. Dallas, Texas
  26. Houston, Texas
  27. Burlington, Vermont
  28. Charlottesville, Virginia
  29. Charlottsville, Virginia
  30. Seattle, Washington
  31. Edmonton, Alberta
  32. Hamilton, Ontario
  33. Mississauga, Ontario
  34. Toronto, Ontario
  35. Montreal, Quebec
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Type 1 Diabetes MellitusSix Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus. NCT00424437
  1. Burlingame, California
  2. Irvine, California
  3. Newport Beach, California
  4. San Diego, California
  5. San Francisco, California
  6. Tustin, California
  7. Hartford, Connecticut
  8. Washington, District of Columbia
  9. Atlanta, Georgia
  10. Stockbridge, Georgia
  11. Chicago, Illinois
  12. Lexington, Kentucky
  13. Columbia, Missouri
  14. St Louis, Missouri
  15. St. Louis, Missouri
  16. Omaha, Nebraska
  17. Albuquerque, New Mexico
  18. Buffalo, New York
  19. Manhasset, New York
  20. New Hyde Park, New York
  21. New York, New York
  22. Greenville, North Carolina
  23. Cleveland, Ohio
  24. Portland, Oregon
  25. Austin, Texas
  26. Dallas, Texas
  27. Irving, Texas
  28. San Antonio, Texas
  29. Charlottesville, Virginia
  30. Renton, Washington
  31. Calgary, Alberta
  32. Winnipeg, Manitoba
  33. St John's, Newfoundland and Labrador
  34. Halifax, Nova Scotia
  35. London, Ontario
  36. Toronto, Ontario
  37. Laval, Quebec
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes
Official Title  ICMJE Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin in an Intensive Insulin Regimen for Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial
Brief Summary

To determine in subjects with Type 1 Diabetes Mellitus:

  1. Whether glycemic control can be achieved at least as effectively with a) an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens differ only by the route of delivery of the short acting insulin.
  2. The toleration and safety of inhaled insulin therapy and its effects after 6months, if any, on measures of pulmonary function.
Detailed Description Not Provided
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, Type 1
Intervention  ICMJE Drug: Inhaled human insulin
Study Arms  ICMJE Not Provided
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 Completed
Enrollment  ICMJE
 (submitted: January 17, 2007)
320
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2000
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 1 Diabetes for more than 1 year
  • Stable insulin regimen of at least 2 injections per day

Exclusion Criteria:

  • Any smoking within the last 6 months. Smoking is not permitted at any time during this study.
  • Subjects on insulin pump during 2 months prior to screening.
  • Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years to 65 Years   (Child, 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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00424333
Other Study ID Numbers  ICMJE 217-107
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2007

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