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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 Treatment

Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment

Secondary outcome:

Change in Glycosylated Hemoglobin by Duration of Exubera Treatment

Hypoglycemic 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

Page last updated: August 20, 2015

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