Clinical Trial Details
| Trial ID: | L4634 |
| Source ID: | NCT00246623 |
| Associated Drug: | Exubera (Inhaled Insulin) |
| Title: | US Inhaled Insulin Dose Titration Study |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Exubera (inhaled insulin)|PROCEDURE: 8-point glucose diary (to assess pre- and post prandial glucoses)|PROCEDURE: Meal Tolerance Test|PROCEDURE: 24-hour continuous glucose monitoring (at select sites)|PROCEDURE: Pulmonary Function Testing|PROCEDURE: Hypoglycemic Event Monitoring|PROCEDURE: Laboratory Assessments|BEHAVIORAL: Nutritional Counseling and Diabetes Education |
| Outcome Measures: | Primary: Proportion of patients with type 2 diabetes (A1C 7.5-10% on >= 2 oral agents) in each study arm (Exubera dosage adjusted 'once weekly' or 'twice weekly') that attain an A1C of <=7% with forced dose titration of Exubera at 6 months. | Secondary: Secondary endpoints include change in A1C, fasting and 2 hr PP glucose, 24-hr mean glucose measured by continuous glucose monitoring, weight, lipids, and markers of oxidative stress. Hypoglycemia will also be assessed. |
| Sponsor/Collaborators: | Sponsor: Pfizer | Collaborators: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 120 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2005-11 |
| Completion Date: | 2007-03 |
| Results First Posted: | |
| Last Update Posted: | 2008-02-08 |
| Locations: | Pfizer Investigational Site, Birmingham, Alabama, United States|Pfizer Investigational Site, Los Angeles, California, United States|Pfizer Investigational Site, New Britain, Connecticut, United States|Pfizer Investigational Site, Norwalk, Connecticut, United States|Pfizer Investigational Site, Hollywood, Florida, United States|Pfizer Investigational Site, Atlanta, Georgia, United States|Pfizer Investigational Site, Boise, Idaho, United States|Pfizer Investigational Site, Hayden, Idaho, United States|Pfizer Investigational Site, Baton Rouge, Louisiana, United States|Pfizer Investigational Site, Boston, Massachusetts, United States|Pfizer Investigational Site, Albany, New York, United States|Pfizer Investigational Site, Syracuse, New York, United States|Pfizer Investigational Site, Dallas, Texas, United States|Pfizer Investigational Site, El Paso, Texas, United States|Pfizer Investigational Site, San Antonio, Texas, United States|Pfizer Investigational Site, Bennington, Vermont, United States |
| URL: | https://clinicaltrials.gov/show/NCT00246623 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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