Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes

NCT ID: NCT00137046

Last Updated: 2010-02-18

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

582 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2008-12-31

Brief Summary

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This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).

This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.

Detailed Description

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Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171022 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subcutaneous Insulin

Group Type ACTIVE_COMPARATOR

Subcutaneous Insulin

Intervention Type DRUG

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Inhaled Insulin

Group Type EXPERIMENTAL

Inhaled Insulin

Intervention Type DRUG

Inhaled insulin with dose adjusted according to premeal blood glucose

Interventions

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Subcutaneous Insulin

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Intervention Type DRUG

Inhaled Insulin

Inhaled insulin with dose adjusted according to premeal blood glucose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes mellitus

Exclusion Criteria

* severe asthma or COPD
* smoking
* brittle diabetes
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

Fullerton, California, United States

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Long Beach, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Santa Barbara, California, United States

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Santa Rosa, California, United States

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Tustin, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Longmont, Colorado, United States

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Hamden, Connecticut, United States

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Madison, Connecticut, United States

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Newark, Delaware, United States

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Coral Gables, Florida, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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Tallahassee, Florida, United States

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West Palm Beach, Florida, United States

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Winter Park, Florida, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Wilmette, Illinois, United States

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Bethesda, Maryland, United States

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St Louis, Missouri, United States

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Butte, Montana, United States

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New Hyde Park, New York, United States

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Durham, North Carolina, United States

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Portland, Oregon, United States

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Lansdale, Pennsylvania, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Burlington, Vermont, United States

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Richmond, Virginia, United States

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Renton, Washington, United States

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Milwaukee, Wisconsin, United States

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Capital Federal, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Belo Horizonte, Minas Gerais, Brazil

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Campinas, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Calgary, Alberta, Canada

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Victoria, British Columbia, Canada

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Winnepeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Oakville, Ontario, Canada

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Ottawa, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Mexico City, COL LAS Americas, Mexico

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Countries

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United States Argentina Brazil Canada Mexico

Related Links

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Other Identifiers

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A2171022

Identifier Type: -

Identifier Source: org_study_id

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