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Sponsored by: |
Mannkind Corporation |
---|---|
Information provided by: | Mannkind Corporation |
ClinicalTrials.gov Identifier: | NCT00308308 |
To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes
Condition | Intervention | Phase |
---|---|---|
Diabetes, Type I |
Drug: Technosphere Insulin Drug: Human insulin aspart |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up |
Enrollment: | 570 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | January 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Technosphere Insulin
|
Drug: Technosphere Insulin
Inhalation Powder, three to four times per day before meals
|
2: Active Comparator
Human insulin aspart
|
Drug: Human insulin aspart
Subcutaneous injection, three (3) to four times per day before meals
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Anders Boss | Mannkind Corporation |
Responsible Party: | MannKind Corporation ( Anders Boss, MC, MFPM, Chief Medical Officer ) |
Study ID Numbers: | MKC-TI-009 |
Study First Received: | March 27, 2006 |
Last Updated: | February 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00308308 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Insulin, Asp(B28)- Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |