Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes
NCT ID: NCT00424333
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
1999-05-31
2000-10-31
Brief Summary
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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.
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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
Duarte, California, United States
Pfizer Investigational Site
Long Beach, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Stanford, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Gainesville, Florida, United States
Pfizer Investigational Site
Hollywood, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Tallahassee, Florida, United States
Pfizer Investigational Site
Peoria, Illinois, United States
Pfizer Investigational Site
Skokie, Illinois, United States
Pfizer Investigational Site
Lutherville, Maryland, United States
Pfizer Investigational Site
Waltham, Massachusetts, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
Columbia, Missouri, United States
Pfizer Investigational Site
New Hyde Park, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Syracuse, New York, United States
Pfizer Investigational Site
The Bronx, New York, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Burlington, Vermont, United States
Pfizer Investigational Site
Charlottesville, Virginia, United States
Pfizer Investigational Site
Charlottsville, Virginia, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Edmonton, Alberta, Canada
Pfizer Investigational Site
Hamilton, Ontario, Canada
Pfizer Investigational Site
Mississauga, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Montreal, 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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217-107
Identifier Type: -
Identifier Source: org_study_id
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