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Sponsored by: |
Mannkind Corporation |
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Information provided by: | Mannkind Corporation |
ClinicalTrials.gov Identifier: | NCT00642538 |
20 eligible subjects will be enrolled into the treatment phase of the trial.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: MKC253 Inhalation Powder Drug: Technosphere Inhalation Powder Drug: subcutaneous injection |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1, Repeated Single-Dose, Double Blind, Randomized, Five Treatment Controlled Safety and Pharmacological Response Evaluation Trial of MKC253 Inhalation Powder in Adult Male and Postmenopausal Female Subjects With Type 2 Diabetes Mellitus |
Estimated Enrollment: | 20 |
Study Start Date: | February 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
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Drug: MKC253 Inhalation Powder
Inhalation Powder, prandial
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2: Experimental
1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
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Drug: MKC253 Inhalation Powder
Inhalation Powder, prandial
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3: Experimental
1.5 mg dose of GLP-1 as MKC253 Inhalation Powder
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Drug: MKC253 Inhalation Powder
Inhalation Powder, prandial
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4: Placebo Comparator
TIP (placebo comparison)
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Drug: Technosphere Inhalation Powder
Inhalation Powder, prandial
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5: Active Comparator
10 ug subcutaneous control
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Drug: subcutaneous injection
10µg Exenatide, prandial
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Trial objectives are to determine the safety & pharmacological response of MKC253 Inhalation Powder.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | MannKind Corporation ( Cheif Medical Officer ) |
Study ID Numbers: | MKC-253-002, EudraCT #: 2007-003430-42 |
Study First Received: | March 3, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00642538 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Diabetic adult male, diabetic postmenopausal women |
Metabolic Diseases Exenatide Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |