| Trial ID: | L5520 |
| Source ID: | NCT00747006
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| Associated Drug: |
Ti Inhalation Powder And Humalog (Amendment 1)
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| Title: |
Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake
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| Acronym: |
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| Status: |
TERMINATED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT00747006/results
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| Conditions: |
Diabetes Mellitus, Type 2|Diabetes Mellitus, Type 1
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| Interventions: |
DRUG: TI Inhalation Powder and Humalog (Amendment 1)|DRUG: TI Inhalation Powder (original protocol)
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| Outcome Measures: |
Primary: Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects), AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC, 0 to 240 minutes|Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects), AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC, 0 to 240 minutes|Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects), AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC, 0 to 240 minutes|Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects), AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC, 0 to 240 minutes|Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects), Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch, 0 to 240 minutes|Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects), Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast, 0 to 240 minutes|Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects), Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch, 0 to 240 minutes|Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects), Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch, 0 to 240 minutes | Secondary: Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects), Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch, 0 to 240 minutes|Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects), Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast, 0 to 240 minutes|Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects), Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch, 0 to 240 minutes|Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects), Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch, 0 to 240 minutes
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| Sponsor/Collaborators: |
Sponsor: Mannkind Corporation
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
18
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2008-09
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| Completion Date: |
2011-05
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| Results First Posted: |
2014-10-21
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| Last Update Posted: |
2014-10-30
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| Locations: |
Sansum Medical Research Institute, Santa Barbara, California, 93105, United States
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| URL: |
https://clinicaltrials.gov/show/NCT00747006
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