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| Sponsors and Collaborators: |
Eli Lilly and Company Alkermes |
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00063128 |
Purpose
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 |
|
Diabetes Mellitus, Type 1 |
Drug: insulin Drug: human insulin inhalation powder (HIIP) |
Phase II |
| MedlinePlus related topics: | Diabetes Diabetes Type 1 |
| Drug Information available for: | Insulin Insulin lispro |
| 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 |
| A: Experimental |
Drug: insulin
|
| B: Active Comparator |
Drug: human insulin inhalation powder (HIIP)
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 25 Study Locations |
| Eli Lilly and Company |
| Alkermes |
| 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 |
More Information
Lilly Clinical Trial Registry 
  |
| Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 6944, H7U-MC-IDAI |
| First Received: | June 20, 2003 |
| Last Updated: | December 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00063128 |
| Health Authority: | United States: Food and Drug Administration |
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