A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD

NCT ID: NCT00138671

Last Updated: 2010-02-02

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-09-30

Brief Summary

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A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.

Detailed Description

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Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for study A2171030 was placed on hold. 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 A2171030 was terminated on June 17, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Conditions

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Diabetes Mellitus Chronic Obstructive Pulmonary Disease

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 short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.

Inhaled Insulin

Group Type EXPERIMENTAL

Inhaled Insulin

Intervention Type DRUG

Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.

Interventions

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Subcutaneous Insulin

Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.

Intervention Type DRUG

Inhaled Insulin

Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
* Prior smokers with a fixed airflow obstruction at screening (FEV1/FVC \< 70%) and FEV1 \< 80% predicted and/or a history of chronic productive cough.

Exclusion Criteria

* Poorly controlled, unstable or steroid-dependent COPD, insulin pump therapy, active smoking
Minimum Eligible Age

30 Years

Maximum Eligible Age

77 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

Glendale, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Jonesboro, Arkansas, United States

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Searcy, Arkansas, United States

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Berkeley, California, United States

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Fresno, California, United States

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Greenbrae, California, United States

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Huntington Beach, California, United States

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Los Angeles, California, United States

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Riverside, California, United States

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Tustin, California, United States

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Denver, Colorado, United States

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Waterbury, Connecticut, United States

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Chiefland, Florida, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Gainesville, Florida, United States

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Lake City, Florida, United States

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Melbourne, Florida, United States

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Miami, 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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Decatur, Georgia, United States

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Honolulu, Hawaii, United States

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Honululu, Hawaii, United States

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Chicago, Illinois, United States

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Normal, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Wichita, Kansas, United States

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Madisonville, Kentucky, United States

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New Orleans, Louisiana, United States

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Springfield, Massachusetts, United States

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Springfield, Massachusetts, United States

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Waltham, Massachusetts, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Butte, Montana, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Albany, New York, United States

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Albany, New York, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Spartanburg, South Carolina, United States

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Spartanburg, South Carolina, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Beaumont, Texas, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Fredericksburg, Virginia, United States

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Fredericksburg, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Huntington, West Virginia, United States

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Madison, Wisconsin, United States

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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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Edmonton, Alberta, Canada

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Red Deer, Alberta, Canada

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Burlington, Ontario, Canada

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Laval, Quebec, Canada

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Sherbrooke, Quebec, Canada

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San José, Provincia de San José, Costa Rica

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Neuss, , Germany

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Countries

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United States Brazil Canada Costa Rica Germany

Related Links

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Other Identifiers

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A2171030

Identifier Type: -

Identifier Source: org_study_id

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