Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.
Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial
1 other identifier
interventional
320
2 countries
36
Brief Summary
To determine, in subjects with Type 1 Diabetes Mellitus:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 1999
Shorter than P25 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2000
CompletedFirst Submitted
Initial submission to the registry
January 17, 2007
CompletedFirst Posted
Study publicly available on registry
January 19, 2007
CompletedFebruary 13, 2007
February 1, 2007
January 17, 2007
February 9, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Primary outcome is 24 week change in baseline in HbA1c
Secondary Outcomes (10)
The secondary endpoints include the following efficacy assessments:
Incidence of hypoglycemia
Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)
Change from baseline in fasting lipid profile
Change from baseline in fasting plasma glucose level
- +5 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Type 1 Diabetes for more than 1 year
- Stable insulin regimen of at least 2 injections per day
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (36)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 17, 2007
First Posted
January 19, 2007
Study Start
September 1, 1999
Study Completion
September 1, 2000
Last Updated
February 13, 2007
Record last verified: 2007-02