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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 31, 2005

Last Updated Date

June 26, 2008

Start Date ^†

March 2003

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00143247 on ClinicalTrials.gov Archive Site

Current 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 ]

Original 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.

Descriptive Information

Brief Title ^†

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

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.

Brief Summary

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Condition ^†

Diabetes Mellitus

Intervention ^†

Drug: Inhaled insulin

Study Arms / Comparison Groups

Experimental: Open label, no comparator

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Estimated Enrollment ^†

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

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

Exclusion Criteria:

Smoking
Pregnancy

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00143247

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.