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Sponsored by: |
Mannkind Corporation |
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Information provided by: | Mannkind Corporation |
ClinicalTrials.gov Identifier: | NCT00511602 |
Primary objective to evaluate the effect of a 12-week treatment period with prandial administration of Technosphere Insulin on glucose control in subjects with T2 DM. Secondary objective is to Evaluate the safety and tolerability of a 12-week treatment period of Technosphere Insulin and Technosphere Placebo.
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Drug: Technosphere Insulin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Inhaled Technosphere Insulin Compared to Technosphere Placebo in Patients With Type 2 Diabetes Mellitus Following Diabetes Education |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | PDC-INS-0008 |
Study First Received: | August 3, 2007 |
Last Updated: | August 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00511602 |
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 |