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Sponsors and Collaborators: |
Eli Lilly and Company Alkermes |
---|---|
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00157339 |
Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month follow up period.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus Asthma Pulmonary Disease, Chronic Obstructive |
Drug: Human Insulin Inhalation Powder Drug: injected insulin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma |
Enrollment: | 299 |
Study Start Date: | August 2005 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 12 months
|
2: Active Comparator |
Drug: injected insulin
patient specific dose, injected, before meals, 12 months.
|
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 to 5 PM Eastern Time (UTC/GMT - 5 hour, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 7091, H7U-MC-IDAS |
Study First Received: | September 7, 2005 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00157339 |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Diabetes Mellitus Asthma Endocrine System Diseases Insulin Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases |
Lung Diseases Hypersensitivity, Immediate Chronic Disease Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity |
Disease Attributes Hypoglycemic Agents Pathologic Processes Immune System Diseases |
Bronchial Diseases Physiological Effects of Drugs Pharmacologic Actions |