Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes
NCT ID: NCT00424411
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
300 participants
INTERVENTIONAL
1999-09-30
2000-12-31
Brief Summary
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1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day.
2. The toleration and safety of EXUBERA™ (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 (EXUBERA™)
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.
35 Years
80 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
Los Angeles, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
Pfizer Investigational Site
Orange, 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
New Haven, Connecticut, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
New Orleans, Louisiana, 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
New Hyde Park, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Greenville, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, 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
Burlington, Vermont, 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
Edmonton, Alberta, Canada
Pfizer Investigational Site
Red Deer, 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
Mississauga, Ontario, Canada
Pfizer Investigational Site
Ottawa, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Chomedy, Quebec, 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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217-108
Identifier Type: -
Identifier Source: org_study_id
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