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
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus
Intervention: Exubera® (inhaled insulin) (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera®
(inhaled insulin).
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera TreatmentChange in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment
Secondary outcome: Change in Glycosylated Hemoglobin by Duration of Exubera TreatmentHypoglycemic Event Rates by Interval of Exubera Treatment Severe Hypoglycemic Event Rates by Interval of Exubera Treatment Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry) Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry) 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 Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2
extension protocols
Exclusion Criteria:
- Smoking
- Pregnancy
Locations and Contacts
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
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: March 2003
Last updated: April 10, 2010
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