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

NCT ID: NCT00139659

Last Updated: 2010-06-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-10-31

Brief Summary

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A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma

Detailed Description

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Conditions

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Asthma Diabetes Mellitus

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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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.

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.

Interventions

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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

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

Eligibility Criteria

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Inclusion Criteria

* Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
* Mild intermittent or mild to moderate persistent asthma

Exclusion Criteria

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

18 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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Beverly Hills, 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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San Diego, California, United States

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San Diego, California, United States

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Tustin, California, United States

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Boulder, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Waterbury, Connecticut, United States

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Newark, Delaware, 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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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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West Palm Beach, Florida, United States

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Augusta, 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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Dubuque, Iowa, United States

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Dubuque, Iowa, United States

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Wichita, Kansas, United States

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Bossier City, Louisiana, United States

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North Dartmouth, Massachusetts, 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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Brooklyn Center, Minnesota, United States

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St Louis, Missouri, United States

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Butte, Montana, 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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North Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Toledo, 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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Portland, Oregon, United States

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Lansdale, Pennsylvania, 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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Bartlett, Tennessee, 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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Dallas, Texas, United States

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Houstan, Texas, United States

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Houston, 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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Norfolk, 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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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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SP, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Red Deer, Alberta, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Burlington, Ontario, Canada

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London, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, 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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A2171028

Identifier Type: -

Identifier Source: org_study_id

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