- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00143247
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
April 10, 2010 updated by: Pfizer
An Open-Label, Phase 2, 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 Participating in Extension Protocols 217-102, 103, or 104
This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The study was terminated on Oct. 18, 2007.
This study is not a post approval commitment study.
Pfizer decided to cancel new trials because of the decision to withdraw Exubera® (inhaled insulin) due to lack of market performance and not for safety reasons.
Study Type
Interventional
Enrollment (Actual)
173
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92123
- Pfizer Investigational Site
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Connecticut
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New Haven, Connecticut, United States, 06504
- Pfizer Investigational Site
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Florida
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Miami, Florida, United States, 33136
- Pfizer Investigational Site
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Illinois
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Chicago, Illinois, United States, 60610
- Pfizer Investigational Site
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New Mexico
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Albuquerque, New Mexico, United States, 87131-5666
- Pfizer Investigational Site
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North Carolina
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Durham, North Carolina, United States, 27710
- Pfizer Investigational Site
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Winston Salem, North Carolina, United States, 27157
- Pfizer Investigational Site
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Texas
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Austin, Texas, United States, 78758
- Pfizer Investigational Site
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Austin, Texas, United States, 78752
- Pfizer Investigational Site
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Dallas, Texas, United States, 75230
- Pfizer Investigational Site
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Dallas, Texas, United States, 75243
- Pfizer Investigational Site
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San Antonio, Texas, United States, 78229
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2 extension protocols
Exclusion Criteria:
- Smoking
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exubera® (inhaled insulin)
Open label, no comparator
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Treatment of type 1 and type 2 diabetes with short-acting insulin
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment
Time Frame: Baseline to 126 months
|
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.
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Baseline to 126 months
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Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment
Time Frame: baseline to 126 months
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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.
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baseline to 126 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Glycosylated Hemoglobin by Duration of Exubera Treatment
Time Frame: Baseline to 126 months
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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.
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Baseline to 126 months
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Hypoglycemic Event Rates by Interval of Exubera Treatment
Time Frame: 0 to 132 months
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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.
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0 to 132 months
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Severe Hypoglycemic Event Rates by Interval of Exubera Treatment
Time Frame: 0-132 months
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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.
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0-132 months
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Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes
Time Frame: 36 months to 126 months
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Observed values by duration of treatment.
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36 months to 126 months
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Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry)
Time Frame: 36 to 126 months
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observed values by duration of treatment.
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36 to 126 months
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Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)
Time Frame: 6 to 120 months
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Observed values by duration of treatment.
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6 to 120 months
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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
Time Frame: 3 to >=108 months
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Decliners = decline of ≥15% in forced expiratory volume or ≥20% in carbon monoxide diffusing capacity.
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3 to >=108 months
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Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment
Time Frame: 3 to >=108 months
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Decliners at particular timepoint were defined as any decline of ≥15% in forced expiratory volume.
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3 to >=108 months
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Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment
Time Frame: 6 to >=108 months
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Decliners at particular timepoint were defined as any decline of ≥20% in carbon monoxide diffusing capacity.
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6 to >=108 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
August 31, 2005
First Submitted That Met QC Criteria
August 31, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Estimate)
April 15, 2010
Last Update Submitted That Met QC Criteria
April 10, 2010
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A2171036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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