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Sponsored by: |
Mannkind Corporation |
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Information provided by: | Mannkind Corporation |
ClinicalTrials.gov Identifier: | NCT00309244 |
The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.
Condition | Intervention | Phase |
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Diabetes Type 2 |
Drug: Technosphere/Insulin Drug: Comparator Treatment |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Ty0pe 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere /Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up |
Estimated Enrollment: | 676 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (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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2: Active Comparator
Comparator Treatment
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Drug: Comparator Treatment
BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Type 2 diabetes currently receiving pre-/self mixed insulin therapy 2 to 3 times daily where fast acting component is either regular or rapid acting insulin non-smoking Body mass index 40 kg/m2 HbA1c > 7.0% < 11.0% FEV1 > or = 70% predicted (NHANES III); DLco > or = 70% predicted (Miller) Total Lung Capacity > or = 80% predicted (ITS)
Exclusion Criteria:
Concomitant sulphonylureas, meglitinide, or other non-sulfonylurea secretagogues, pramlintide acetate (Symlin®), and/or any incretin (eg, Byetta®) within the preceding 6 weeks History of viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes history of chronic obstructive pulmonary disease, asthma (any history of bronchospasm or asthma after the age of 14), and/or any other clinically important pulmonary disease Evidence of severe complications of diabetes
Responsible Party: | MannKind Corporation ( Anders Boss, MD, MFPM, Chief Medical Officer ) |
Study ID Numbers: | MKC-TI-102 |
Study First Received: | March 27, 2006 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00309244 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |