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Clinical Trial Details

Trial ID: L7111
Source ID: NCT00143247
Associated Drug: Exubera® (Inhaled Insulin)
Title: Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00143247/results
Conditions: Diabetes Mellitus
Interventions: DRUG: Exubera® (inhaled insulin)
Outcome Measures: Primary: Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment, Change from Baseline: mean of (value of observed forced expiratory volume in 1 second (FEV1) (liters) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements., Baseline to 126 months|Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment, Change from Baseline: mean of (value of observed Carbon Monoxide Diffusing Capacity (mL/min/mm Hg) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements., baseline to 126 months | Secondary: Change in Glycosylated Hemoglobin by Duration of Exubera Treatment, Change from Baseline: mean of (value of observed glycosylated hemoglobin (HbA1C) (percent) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements., Baseline to 126 months|Hypoglycemic Event Rates by Interval of Exubera Treatment, Number of hypoglycemic events per subject-month. Subject-month determined by time on treatment. Interval of treatment based on elapsed duration of treatment in the controlled \& uncontrolled studies.Overall represents entire duration of treatment. Hypoglycemia: Characteristic symptoms of hypoglycemia with no blood glucose check. Clinical picture must include prompt resolution with food intake, subcutaneous glucagon or intravenous glucose.OR,Characteristic symptoms of hypoglycemia with blood glucose check showing glucose \<=59 mg/dl.OR,Any glucose measurement \<=49 mg/dl,with or without symptoms., 0 to 132 months|Severe Hypoglycemic Event Rates by Interval of Exubera Treatment, Number of severe hypoglycemic events per 100 subject-months.Subject-month determined by time on treatment.Interval of treatment based on elapsed duration of treatment in controlled \& uncontrolled studies.Overall represents entire duration of treatment.A severe hypoglycemic event must have met all 3of following:1.subject unable to treat self.2.subject exhibited 1 or more of neurological symptoms defined in protocol.3.blood glucose must be \<=49 mg/dl if measured.If not measured,clinical manifestations must have been reversed by oral carbohydrates,subcutaneous glucagon,or intravenous glucose., 0-132 months|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes, Observed values by duration of treatment., 36 months to 126 months|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry), observed values by duration of treatment., 36 to 126 months|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry), Observed values by duration of treatment., 6 to 120 months|Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment, Decliners = decline of ≥15% in forced expiratory volume or ≥20% in carbon monoxide diffusing capacity., 3 to >=108 months|Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment, Decliners at particular timepoint were defined as any decline of ≥15% in forced expiratory volume., 3 to >=108 months|Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment, Decliners at particular timepoint were defined as any decline of ≥20% in carbon monoxide diffusing capacity., 6 to >=108 months
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 173
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2003-03
Completion Date: 2008-01
Results First Posted: 2009-11-09
Last Update Posted: 2010-04-15
Locations: Pfizer Investigational Site, San Diego, California, 92123, United States|Pfizer Investigational Site, New Haven, Connecticut, 06504, United States|Pfizer Investigational Site, Miami, Florida, 33136, United States|Pfizer Investigational Site, Chicago, Illinois, 60610, United States|Pfizer Investigational Site, Albuquerque, New Mexico, 87131-5666, United States|Pfizer Investigational Site, Durham, North Carolina, 27710, United States|Pfizer Investigational Site, Winston Salem, North Carolina, 27157, United States|Pfizer Investigational Site, Austin, Texas, 78752, United States|Pfizer Investigational Site, Austin, Texas, 78758, United States|Pfizer Investigational Site, Dallas, Texas, 75230, United States|Pfizer Investigational Site, Dallas, Texas, 75243, United States|Pfizer Investigational Site, San Antonio, Texas, 78229, United States
URL: https://clinicaltrials.gov/show/NCT00143247