Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose

NCT00150410 | Completed Phase 3

• 1 other identifier: A2171017
• Study Type: interventional
• Target: 626
• Locations: 5 countries
• Sites: 119

Brief Summary

• Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug.
• Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glycosylated hemoglobin

Secondary Outcomes (4)

• Change from baseline in fasting plasma glucose. Other secondary efficacy

• endpoints include, body weight, patient reported outcomes, incidence and severity

• of hypoglycemic episodes, cough questionnaire, and discontinuation rate due to

• insufficient clinical response.

Interventions

Inhaled insulin DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Currently treated and on a stable doses of drugs for the preceding two (2) months

You may not qualify if:

• Type 1 Diabetes
• Smoking

Sponsors & Collaborators

• Pfizer: lead
• Sanofi: collaborator

Study Sites (119)

Pfizer Investigational Site

Mesa, Arizona, 85205, United States

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Phoenix, Arizona, 85012, United States

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Tucson, Arizona, 85715, United States

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Searcy, Arkansas, 72143, United States

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Alhambra, California, 91801, United States

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Concord, California, 94520, United States

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Huntington Beach, California, 92647, United States

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Huntington Beach, California, 92648, United States

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La Jolla, California, 92037, United States

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Long Beach, California, 90805, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90048, United States

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Riverside, California, 92506, United States

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Santa Barbara, California, 93105, United States

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Tustin, California, 92780, United States

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Westminster, California, 92683, United States

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Denver, Colorado, 80209, United States

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Wheat Ridge, Colorado, 80033, United States

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Waterbury, Connecticut, 06708, United States

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Washington D.C., District of Columbia, 20010, United States

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Washington D.C., District of Columbia, 20307, United States

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Hollywood, Florida, 33021, United States

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West Palm Beach, Florida, 33401, United States

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Winter Park, Florida, 32789, United States

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Atlanta, Georgia, 30309, United States

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Augusta, Georgia, 30909, United States

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Savannah, Georgia, 31405, United States

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Savannah, Georgia, 31419, United States

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Honolulu, Hawaii, 96813, United States

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‘Ewa Beach, Hawaii, 96706, United States

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Idaho Falls, Idaho, 83404-6370, United States

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Idaho Falls, Idaho, 83404-7542, United States

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Chicago Heights, Illinois, 60411, United States

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Indianapolis, Indiana, 46202, United States

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Des Moines, Iowa, 50314, United States

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Wichita, Kansas, 67203, United States

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Lexington, Kentucky, 40503, United States

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Louisville, Kentucky, 40213, United States

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Baton Rouge, Louisiana, 70808, United States

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New Orleans, Louisiana, 70112, United States

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Baltimore, Maryland, 21204, United States

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Springfield, Massachusetts, 01103, United States

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Springfield, Massachusetts, 01199, United States

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Waltham, Massachusetts, 02453, United States

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West Saint Paul, Minnesota, 55118, United States

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North Kansas City, Missouri, 64116, United States

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St Louis, Missouri, 63141, United States

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Butte, Montana, 59701, United States

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Lincoln, Nebraska, 68521, United States

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New Brunswick, New Jersey, 08901, United States

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New Brunswick, New Jersey, 08903, United States

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Albuquerque, New Mexico, 87106, United States

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Albany, New York, 12208, United States

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Flushing, New York, 11365, United States

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Mineola, New York, 11501, United States

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New Hyde Park, New York, 11042, United States

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Rochester, New York, 14642, United States

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Raleigh, North Carolina, 27609, United States

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Cincinnati, Ohio, 45229, United States

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Cleveland, Ohio, 44195, United States

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Lakewood, Ohio, 44107, United States

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Oklahoma City, Oklahoma, 73104, United States

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Portland, Oregon, 97210, United States

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Pittsburgh, Pennsylvania, 15235, United States

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Charleston, South Carolina, 29401-5799, United States

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Charleston, South Carolina, 29425, United States

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Duncan, South Carolina, 29334, United States

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Spartanburg, South Carolina, 29303, United States

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Spartanburg, South Carolina, 29307, United States

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Sumter, South Carolina, 29150, United States

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Kingsport, Tennessee, 37660, United States

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Knoxville, Tennessee, 37909, United States

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Memphis, Tennessee, 38119, United States

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Nashville, Tennessee, 37232, United States

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Corpus Christi, Texas, 78411, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75246, United States

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El Paso, Texas, 79925, United States

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El Paso, Texas, 79935, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78237, United States

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Ogden, Utah, 84403, United States

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Fredericksburg, Virginia, 22401, United States

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Richmond, Virginia, 23221, United States

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Richmond, Virginia, 23294, United States

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Renton, Washington, 98055, United States

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Tukwila, Washington, 98188, United States

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Milwaukee, Wisconsin, 53209, United States

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Camperdown, New South Wales, 2050, Australia

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Wollongong, New South Wales, 2500, Australia

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Herston, Queensland, 4029, Australia

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Woolloongabba, Queensland, 4102, Australia

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Keswick, South Australia, 5035, Australia

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Box Hill, Victoria, 3128, Australia

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Caulfield, Victoria, 3162, Australia

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Porto Alegre, Rio Grande do Sul, 90035-170, Brazil

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São Paulo, São Paulo, 01244-030, Brazil

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São Paulo, São Paulo, 04231-030, Brazil

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Winnipeg, Manitoba, R3E 3P4, Canada

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London, Ontario, N6A 4V2, Canada

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Mississauga, Ontario, L5M2V8, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Thornhill, Ontario, L4J 1V8, Canada

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Toronto, Ontario, M4N-3M5, Canada

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Toronto, Ontario, M4R 2G4, Canada

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Laval, Quebec, H7T 2P5, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Saint-Jérôme, Quebec, J7Z 5T3, Canada

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Vaudreuil, Quebec, J7V 8P9, Canada

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St. John's, A1E 2E2, Canada

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Guadalajara, Jalisco, 44340, Mexico

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Guadalajara, Jalisco, 44349, Mexico

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Guadalajara, Jalisco, 44660, Mexico

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Guadalajara, Jalisco/Mexico, 44347, Mexico

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Mexico City, Mexico City, 02990, Mexico

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Mexico City, Mexico City, 03100, Mexico

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Monterrey, Nuevo León, 64060, Mexico

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Jalapa, Veracruz, 91020, Mexico

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Mexico City, CP 14000, Mexico

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: January 1, 2003
• Study Completion: June 1, 2007
• Last Updated: October 31, 2008

Record last verified: 2008-10

Locations

CA (12); US (88); ME (9); AU (7); BR (3)