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Clinical Trial Details

Trial ID: L7163
Source ID: NCT00424333
Associated Drug: Inhaled Human Insulin
Title: Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Inhaled human insulin
Outcome Measures: Primary: Primary outcome is 24 week change in baseline in HbA1c. | Secondary: 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|Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)|Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).|Change from baseline in body weight|Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments).|Patient satisfaction and preference.
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 320
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 1999-05
Completion Date: 2000-10
Results First Posted:
Last Update Posted: 2007-02-13
Locations: 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, Bronx, New York, 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, 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
URL: https://clinicaltrials.gov/show/NCT00424333

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress