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Sponsored by: |
Mannkind Corporation |
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Information provided by: | Mannkind Corporation |
ClinicalTrials.gov Identifier: | NCT00662857 |
28 subjects to be enrolled for a screening period, 3 dosing visits & a follow-up visit. Visits 2 and 3 dosing of TI Inhalation powder, will be either two 15U cartridges or one 30U cartridge. Visit 4 dosing will be a sc injection of 10IU of RAA.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 1 |
Drug: Technosphere Insulin A Drug: Technosphere Insulin B Drug: Humalog |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Phase 2, Open-Label, Randomized, 2-Way Crossover, Clinical Trial to Compare the Pharmacokinetics of 2 Formulations of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder and to Determine the Bioavailability of a 30 Unit Cartridge of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder Versus a 10 Unit Subcutaneous Injection of Insulin Lispro in Subjects With Type 1 Diabetes Mellitus |
Estimated Enrollment: | 28 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Technosphere Insulin Inhalation Powder
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Drug: Technosphere Insulin A
Inhalation Powder, two 15U cartridges
Drug: Technosphere Insulin B
Inhalation Powder, one 30U cartridge
Drug: Humalog
A single subcutaneous 10IU of Rapid Acting Analogue
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28 eligible subjects will be enrolled to determine bioequivalence and safety parameters of two 15U TI Inhalation Powder cartridges (TIA) vs. one 30U TI Inhalation Powder cartridge (TIB), according to a randomized, 2-way crossover design. Additionally, bioavailability of one 30U TI Inhalation Powder cartridge to a single subcutaneous injection of 10IU of RAA will be compared.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | MannKind Corporation ( Anders H. Boss, MD, MFPM ) |
Study ID Numbers: | MKC-TI-116 |
Study First Received: | April 16, 2008 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00662857 |
Health Authority: | United States: Food and Drug Administration |
Diabetic adult male, diabetic adult female |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Insulin LISPRO |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |