August 31, 2005 |
June 26, 2008 |
March 2003 |
To observe, in subjects with long-term exposure to inhaled insulin, pulmonary function over time. [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00143247 on ClinicalTrials.gov Archive Site |
The following parameters will be observed: general safety, insulin antibodies, HbA1c, fasting plasma glucose, hypoglycemic episodes, mean daily insulin
doses, body weight, and fasting lipid profile. [ Designated as safety issue: No ] |
- The following parameters will be observed:
- general safety,
- insulin antibodies,
- HbA1c,
- fasting plasma glucose,
- hypoglycemic episodes,
- mean daily insulin doses,
- body weight, and
- fasting lipid profile.
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An Optional Roll-Over Extension of Previous Phase 2 Available to Patients Who Participated in Previous Phase 2 Studies. |
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. |
Long-term safety for Phase 2 subjects who choose to remain on inhaled insulin. |
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 due to lack of market performance and not for safety reasons. |
Phase II |
Interventional |
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Diabetes Mellitus |
Drug: Inhaled insulin |
Experimental: Open label, no comparator |
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Terminated |
85 |
January 2008 |
January 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2 extension protocols
Exclusion Criteria:
|
Both |
18 Years to 65 Years |
No |
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United States |
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NCT00143247 |
Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
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Pfizer |
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Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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Pfizer |
June 2008 |