An Optional Roll-Over Extension of Previous Phase 2 Available to Patients Who Participated in Previous Phase 2 Studies. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00143247

Purpose

Long-term safety for Phase 2 subjects who choose to remain on inhaled insulin.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Inhaled insulin	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

To observe, in subjects with long-term exposure to inhaled insulin, pulmonary function over time. [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	85
Study Start Date:	March 2003
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Inhaled insulin: Experimental Open label, no comparator	Drug: Inhaled insulin Treatment of type 1 and type 2 diabetes with short-acting insulin

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 due to lack of market performance and not for safety reasons.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2 extension protocols

Exclusion Criteria:

Smoking
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143247

Locations

United States, California
Pfizer Investigational Site
San Diego, California, United States, 92123
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06504
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33136
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60610
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87131-5666
United States, North Carolina
Pfizer Investigational Site
Winston Salem, North Carolina, United States, 27157
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
Austin, Texas, United States, 78752
Pfizer Investigational Site
Austin, Texas, United States, 78758
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
Dallas, Texas, United States, 75243

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2171036
Study First Received:	August 31, 2005
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00143247
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009