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Clinical Trial Details

Trial ID: L6857
Source ID: NCT00424411
Associated Drug: Inhaled Human Insulin (Exubera™)
Title: Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Inhaled human insulin (EXUBERA™)
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: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 1999-09
Completion Date: 2000-12
Results First Posted:
Last Update Posted: 2007-02-13
Locations: 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, 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, 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
URL: https://clinicaltrials.gov/show/NCT00424411

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress