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

NCT ID: NCT00143247

Last Updated: 2010-04-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2008-01-31

Brief Summary

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This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin).

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exubera® (inhaled insulin)

Open label, no comparator

Group Type EXPERIMENTAL

Exubera® (inhaled insulin)

Intervention Type DRUG

Treatment of type 1 and type 2 diabetes with short-acting insulin

Interventions

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Exubera® (inhaled insulin)

Treatment of type 1 and type 2 diabetes with short-acting insulin

Intervention Type DRUG

Other Intervention Names

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Exubera®

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Smoking
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Chicago, Illinois, United States

Site Status

Pfizer Investigational Site

Albuquerque, New Mexico, United States

Site Status

Pfizer Investigational Site

Durham, North Carolina, United States

Site Status

Pfizer Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Pfizer Investigational Site

Austin, Texas, United States

Site Status

Pfizer Investigational Site

Austin, Texas, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A2171036

Identifier Type: -

Identifier Source: org_study_id

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