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Sponsors and Collaborators: |
Eli Lilly and Company Alkermes |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00063128 |
This is a research study of a study drug known as LY041001 or human insulin inhalation powder (HIIP). HIIP is a powder form of insulin made to be inhaled through the mouth and into the lungs using a special handheld device.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 1 |
Drug: insulin Drug: human insulin inhalation powder (HIIP) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus |
Enrollment: | 119 |
Study Start Date: | April 2003 |
Study Completion Date: | April 2004 |
Arms | Assigned Interventions |
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A: Experimental |
Drug: insulin
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B: Active Comparator |
Drug: human insulin inhalation powder (HIIP)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 6944, H7U-MC-IDAI |
Study First Received: | June 20, 2003 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00063128 |
Health Authority: | United States: Food and Drug Administration |
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 |