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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: | NCT00325364 |
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: Human Insulin Inhalation Powder Drug: Injectable insulin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus. |
Enrollment: | 415 |
Study Start Date: | April 2006 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 24 months
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2: Active Comparator |
Drug: Injectable insulin
patient specific dose, injectable, before meals, 24 months
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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: | 9626, H7U-MC-IDAU |
Study First Received: | May 10, 2006 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00325364 |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |