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Clinical Trial Details

Trial ID: L3302
Source ID: NCT00370565
Associated Drug: Inhaled Human Insulin
Title: Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Inhaled Human Insulin
Outcome Measures: Primary: The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.|HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values. | Secondary: Secondary: Efficacy: change in fasting plasma glucose and meal glucose response (2-h postprandial increment in plasma glucose)Fasting plasma glucose measured at Weeks -4, -1, 0, and 12 (the Weeks -1 and 12 measurements will be part of the meal studies)|Meal glucose response measured at Week -1 and at Week 12;|These results for efficacy are measured in the lab using plasma samples collected during clinic visits,|not the subject's home glucose monitoring results.|Comparison of 24-hour home glucose profiles.|Proportion of subjects with acceptable or good glycemic control (e.g., HbA1c < 8.0% or <7.0%) at the end of treatment, incidence and severity of hypoglycemic episodes, discontinuation rate, change in fasting lipid profile, and change in body weight.|A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.
Sponsor/Collaborators: Sponsor: Pfizer | Collaborators: Sanofi|Nektar Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 345
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 1999-06
Completion Date: 2000-09
Results First Posted:
Last Update Posted: 2007-02-13
Locations: Pfizer Investigational Site, Irvine, California, 92618, United States|Pfizer Investigational Site, Long Beach, California, 90806, United States|Pfizer Investigational Site, Los Angeles, California, 90059, United States|Pfizer Investigational Site, Los Angeles, California, 90073, United States|Pfizer Investigational Site, Newport Beach, California, 92663, United States|Pfizer Investigational Site, San Diego, California, 92108, United States|Pfizer Investigational Site, Tustin, California, 92780, United States|Pfizer Investigational Site, New Britain, Connecticut, 06050, United States|Pfizer Investigational Site, New Haven, Connecticut, 06510, United States|Pfizer Investigational Site, New Haven, Connecticut, 06519, United States|Pfizer Investigational Site, Washington, District of Columbia, 20007, United States|Pfizer Investigational Site, Clearwater, Florida, 33761, United States|Pfizer Investigational Site, Hollywood, Florida, 33021, United States|Pfizer Investigational Site, Miami, Florida, 33136, United States|Pfizer Investigational Site, Tampa, Florida, 33607, United States|Pfizer Investigational Site, Louisville, Kentucky, 40202, United States|Pfizer Investigational Site, New Orleans, Louisiana, 70121, United States|Pfizer Investigational Site, Minneapolis, Minnesota, 55416, United States|Pfizer Investigational Site, Columbia, Missouri, 65212, United States|Pfizer Investigational Site, St. Louis, Missouri, 63141, United States|Pfizer Investigational Site, Omaha, Nebraska, 68131, United States|Pfizer Investigational Site, New York, New York, 10016, United States|Pfizer Investigational Site, New York, New York, 10025, United States|Pfizer Investigational Site, Rochester, New York, 14642, United States|Pfizer Investigational Site, Greenville, North Carolina, 27858, United States|Pfizer Investigational Site, Winston-salem, North Carolina, 27157, United States|Pfizer Investigational Site, Cleveland, Ohio, 44195, United States|Pfizer Investigational Site, Portland, Oregon, 97201-3098, United States|Pfizer Investigational Site, Philadelphia, Pennsylvania, 19104, United States|Pfizer Investigational Site, Austin, Texas, 78758, United States|Pfizer Investigational Site, Dallas, Texas, 75230, United States|Pfizer Investigational Site, Dallas, Texas, 75235-8858, United States|Pfizer Investigational Site, Dallas, Texas, 75246, United States|Pfizer Investigational Site, Irving, Texas, 75061, United States|Pfizer Investigational Site, San Antonio, Texas, 78229, United States|Pfizer Investigational Site, Burlington, Vermont, 05401, United States|Pfizer Investigational Site, Renton, Washington, 98055, United States|Pfizer Investigational Site, Calgary, Alberta, T3B 0M3, Canada|Pfizer Investigational Site, Edmonton, Alberta, T5H 3V9, Canada|Pfizer Investigational Site, Edmonton, Alberta, T6G 2C8, Canada|Pfizer Investigational Site, Edmonton, Alberta, T6G 2S2, Canada|Pfizer Investigational Site, Red Deer, Alberta, T4N 6V7, Canada|Pfizer Investigational Site, Winnipeg, Manitoba, R3A 1R9, Canada|Pfizer Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|Pfizer Investigational Site, St John's, Newfoundland and Labrador, A1B 3V6, Canada|Pfizer Investigational Site, Halifax, Nova Scotia, B3H 2Y9, Canada|Pfizer Investigational Site, Ottawa, Ontario, K1Y 4E9, Canada|Pfizer Investigational Site, Toronto, Ontario, M5B 1WB, Canada|Pfizer Investigational Site, Toronto, Ontario, M5C 2T2, Canada|Pfizer Investigational Site, Toronto, Ontario, M5G 1X5, Canada|Pfizer Investigational Site, Toronto, Ontario, M5G 2C4, Canada|Pfizer Investigational Site, Laval, Quebec, H7T 2P5, Canada
URL: https://clinicaltrials.gov/show/NCT00370565

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress