Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.
NCT ID: NCT00424437
Last Updated: 2007-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
320 participants
INTERVENTIONAL
1999-09-30
2000-09-30
Brief Summary
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1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin injections per day.
2. The toleration and safety of inhaled insulin therapy and its effects after 6 months, if any, on measures of pulmonary function.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Inhaled human insulin
Eligibility Criteria
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Inclusion Criteria
* Stable insulin regimen of at least 2 injections per day
Exclusion Criteria
* 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.
12 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Burlingame, California, United States
Pfizer Investigational Site
Irvine, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Tustin, California, United States
Pfizer Investigational Site
Hartford, Connecticut, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Stockbridge, Georgia, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Columbia, Missouri, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Albuquerque, New Mexico, United States
Pfizer Investigational Site
Buffalo, New York, United States
Pfizer Investigational Site
Manhasset, New York, United States
Pfizer Investigational Site
New Hyde Park, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Greenville, North Carolina, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Irving, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Charlottesville, Virginia, United States
Pfizer Investigational Site
Renton, Washington, United States
Pfizer Investigational Site
Calgary, Alberta, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, Canada
Pfizer Investigational Site
Halifax, Nova Scotia, Canada
Pfizer Investigational Site
London, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Laval, Quebec, Canada
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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217-106
Identifier Type: -
Identifier Source: org_study_id
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