Clinical Trial Details
| Trial ID: | L4229 |
| Source ID: | NCT00642616 |
| Associated Drug: | Technosphere® Insulin |
| Title: | Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00642616/results |
| Conditions: | Type 1 Diabetes Mellitus|Type 2 Diabetes Mellitus|Moderate Chronic Obstructive Pulmonary Disease|Asthma |
| Interventions: | DRUG: Technosphere® Insulin|DRUG: Usual Care |
| Outcome Measures: | Primary: Change in Post-bronchodilator FEV1 From Baseline to Week 52, Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory., 52 Weeks | Secondary: Number of Participants With Asthma Exacerbation by Treatment Arm, Number of participants who experienced worsening of asthma symptoms, Baseline to Week 52|Number of Participants With COPD Exacerbation by Treatment Arm, Number of participants who experienced worsening of COPD symptoms, Baseline to Week 52|Change in HbA1C From Baseline to Week 52, Baseline, week 52 |
| Sponsor/Collaborators: | Sponsor: Mannkind Corporation |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 34 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2009-03 |
| Completion Date: | 2014-11 |
| Results First Posted: | 2016-02-15 |
| Last Update Posted: | 2017-04-14 |
| Locations: | Mission Hills, California, 91345, United States|San Diego, California, 92117, United States|Palm Harbor, Florida, 34684, United States|Flint, Michigan, 48504, United States|Morehead City, North Carolina, 28557, United States|Medford, Oregon, 97504, United States|Greenville, South Carolina, 29615, United States|Spartanburg, South Carolina, 29302, United States|Dallas, Texas, 75225, United States|Dallas, Texas, 75231, United States|Federal Way, Washington, 98003, United States|Tacoma, Washington, 98405, United States|Yaroslavl, RUS, 150002, Russian Federation|Kemerovo, RU, 650066, Russian Federation|Moscow, RU, 105120, Russian Federation|St Petersburg, RU, 198013, Russian Federation|St. Petersburg, RU, 191015, Russian Federation|St. Petersburg, RU, 191119, Russian Federation|St. Petersburg, RU, 194354, Russian Federation|Kiev, UA, 04114, Ukraine|Kyiv, UA, 01021, Ukraine |
| URL: | https://clinicaltrials.gov/show/NCT00642616 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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