| Trial ID: | L2439 |
| Source ID: | NCT00662857
|
| Associated Drug: |
Technosphere® Insulin Inhalation Powder
|
| Title: |
A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00662857/results
|
| Conditions: |
Diabetes Mellitus: Type 1
|
| Interventions: |
DRUG: Technosphere® Insulin Inhalation Powder|DRUG: Technosphere Insulin® Inhalation Powder|DRUG: RAA Population
|
| Outcome Measures: |
Primary: Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360, Dose-normalized baseline-corrected area under the serum insulin vs. time curve, 0 to 360 minutes post-dose|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax., Maximum observed baseline-corrected serum insulin concentration, 0 to 360 minutes post-dose|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax, 0 to 360 minutes post-dose|Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro, Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose), 0 to 360 minutes post-dose |
|
| Sponsor/Collaborators: |
Sponsor: Mannkind Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
29
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-04
|
| Completion Date: |
2008-12
|
| Results First Posted: |
2014-10-16
|
| Last Update Posted: |
2014-10-16
|
| Locations: |
Profil Institute for Clinical Research Inc., Chula Vista, California, 91911, United States|Diabetes & Glandular Disease Research Assoc PA, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00662857
|
