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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00356421 |
To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 1 |
Drug: Inhaled Human Insulin (Exubera®) Drug: Insulin lispro (Humalog) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus |
Enrollment: | 58 |
Study Start Date: | November 2006 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control: Active Comparator |
Drug: Insulin lispro (Humalog)
Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.
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Experimental: Experimental |
Drug: Inhaled Human Insulin (Exubera®)
Preprandial inhaled insulin regimen and administration of insulin glargine QD
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Pfizer announced in October 2007 that it would stop marketing Exubera®. At that time recruitment for study, A2171035 was placed on hold. Nektar, the company from which Pfizer licensed Exubera®, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera®. As a result, study A2171035 was terminated on May 12, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A2171035 |
Study First Received: | July 24, 2006 |
Results First Received: | June 24, 2009 |
Last Updated: | August 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00356421 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Insulin LISPRO Diabetes Mellitus Type 1 Insulin |
Hypoglycemic Agents Diabetes Mellitus, Type 1 Glargine Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Autoimmune Diseases Immune System Diseases Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Insulin LISPRO |
Insulin Pharmacologic Actions Hypoglycemic Agents Diabetes Mellitus, Type 1 Glargine Glucose Metabolism Disorders |