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

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

ChemIDplus related topics:

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
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 October 10, 2008

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