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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00391027 |
To compare efficacy and safety of Exubera vs Lantus in patients with type 2 diabetes mellitus.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: Inhaled Human Insulin (Exubera) Drug: Insulin Glargine (Lantus) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | A Six Month, Open-Label Outpatient, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control Compared To Insulin Glargine (Lantus®) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents |
Enrollment: | 260 |
Study Start Date: | December 2006 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Insulin Glargine (Lantus): Active Comparator |
Drug: Insulin Glargine (Lantus)
Patient will be randomized to Lantus while remaining on pre-study oral hypoglycemic agents.
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Inhaled Human Insulin (Exubera): Active Comparator |
Drug: Inhaled Human Insulin (Exubera)
Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.
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Ages Eligible for Study: | 30 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: | A2171084 |
Study First Received: | October 19, 2006 |
Last Updated: | February 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00391027 History of Changes |
Health Authority: | United States: Food and Drug Administration |
type 2 diabetes, insulin, glycemic control |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Glargine |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |