Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes
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
1 other identifier
interventional
320
2 countries
35
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.
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 May 1999
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
October 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 (35)
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
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
May 1, 1999
Study Completion
October 1, 2000
Last Updated
February 13, 2007
Record last verified: 2007-02