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Sponsored by: |
Mannkind Corporation |
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Information provided by: | Mannkind Corporation |
ClinicalTrials.gov Identifier: | NCT00570687 |
Twelve Type 2 diabetic subjects will each receive 2 different insulin medicinal products prior to a meal test and then, following an interim safety visit, receive the same 2 doses of insulin in the same order during a glucose clamp procedure.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: Technosphere Insulin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Estimated Enrollment: | 12 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Technosphere Insulin
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Drug: Technosphere Insulin
Inhalation 15U/30U
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This is a randomized, open label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit. Each treatment visit, meal challenge and glucose clamp, will have the subjects hospitalized in the clinical unit the night before initiation of treatment.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ingrid Zaunbrecher | 492 131 4018403 | klaus.rave@profil-research.de |
Germany, GER | |
Profil Institute for Metabolic Research | Recruiting |
Neuss, GER, Germany | |
Contact: Rave Klaus 4921314018403 |
Principal Investigator: | Klaus Rave, MD | Profil Institute for Metabolic Research |
Responsible Party: | MannKind Corporation ( Robert Baughman ) |
Study ID Numbers: | MKC-TI-118 |
Study First Received: | December 7, 2007 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00570687 |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
Inhaled Insulin |
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 |