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Sponsored by: |
Mannkind Corporation |
---|---|
Information provided by: | Mannkind Corporation |
ClinicalTrials.gov Identifier: | NCT00754624 |
Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: Technosphere®/ Insulin and MedTone™ Inhaler |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Three-Year, Safety and Tolerability, Open-Label, 'Follow on' Trial Evaluating Technosphere /Insulin in Subjects With Type 2 Diabetes Mellitus. |
Enrollment: | 228 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | October 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Technosphere®/ Insulin and MedTone™ Inhaler
Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Anders Boss, MD | Mannkind Corporation |
Responsible Party: | MannKind Corporation ( Anders Boss, Chief Medical Officer & Senior Vice President ) |
Study ID Numbers: | MKC-TI-010 |
Study First Received: | September 16, 2008 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00754624 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |