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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150410
First received: September 6, 2005
Last updated: October 28, 2008
Last verified: October 2008
  Purpose
  • 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.

Condition Intervention Phase
Diabetes Mellitus
Drug: Inhaled insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A One-Year, Open, Randomized, Parallel, Three-Arm Study Comparing Exubera® (Insulin Dry Powder Pulmonary Inhaler) vs. Avandia® (Rosiglitazone Maleate) as Add-On Therapy vs. Exubera® Substitution of Sulfonylurea in Patients With Type 2 Diabetes, Poorly Controlled on Combination Sulfonylurea and Metformin Treatment

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Glycosylated hemoglobin

Secondary Outcome Measures:
  • 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.

Enrollment: 626
Study Start Date: January 2003
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Type 1 Diabetes
  • Smoking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150410

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Locations
United States, Arizona
Pfizer Investigational Site
Mesa, Arizona, United States, 85205
Pfizer Investigational Site
Phoenix, Arizona, United States, 85012
Pfizer Investigational Site
Tucson, Arizona, United States, 85715
United States, Arkansas
Pfizer Investigational Site
Searcy, Arkansas, United States, 72143
United States, California
Pfizer Investigational Site
Alhambra, California, United States, 91801
Pfizer Investigational Site
Concord, California, United States, 94520
Pfizer Investigational Site
Huntington Beach, California, United States, 92648
Pfizer Investigational Site
Huntington Beach, California, United States, 92647
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
Long Beach, California, United States, 90805
Pfizer Investigational Site
Long Beach, California, United States, 90806
Pfizer Investigational Site
Los Angeles, California, United States, 90048
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Riverside, California, United States, 92506
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Santa Barbara, California, United States, 93105
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Tustin, California, United States, 92780
Pfizer Investigational Site
Westminster, California, United States, 92683
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80209
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Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Pfizer Investigational Site
Waterbury, Connecticut, United States, 06708
United States, District of Columbia
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Washington, District of Columbia, United States, 20010
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Washington, District of Columbia, United States, 20307
United States, Florida
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Hollywood, Florida, United States, 33021
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West Palm Beach, Florida, United States, 33401
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Winter Park, Florida, United States, 32789
United States, Georgia
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Atlanta, Georgia, United States, 30309
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Augusta, Georgia, United States, 30909
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Savannah, Georgia, United States, 31419
Pfizer Investigational Site
Savannah, Georgia, United States, 31405
United States, Hawaii
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Ewa Beach, Hawaii, United States, 96706
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Honolulu, Hawaii, United States, 96813
United States, Idaho
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Idaho Falls, Idaho, United States, 83404-7542
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Idaho Falls, Idaho, United States, 83404-6370
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Idaho Falls,, Idaho, United States, 83404-7542
United States, Illinois
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Chicago Heights, Illinois, United States, 60411
United States, Indiana
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Indianapolis, Indiana, United States, 46202
United States, Iowa
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Des Moines, Iowa, United States, 50314
United States, Kansas
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Wichita, Kansas, United States, 67203
United States, Kentucky
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Lexington, Kentucky, United States, 40503
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Louisville, Kentucky, United States, 40213
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70808
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70112
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01199
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01103
Pfizer Investigational Site
Waltham, Massachusetts, United States, 02453
United States, Minnesota
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West St. Paul, Minnesota, United States, 55118
United States, Missouri
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North Kansas City, Missouri, United States, 64116
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St. Louis, Missouri, United States, 63141
United States, Montana
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Butte, Montana, United States, 59701
United States, Nebraska
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Lincoln, Nebraska, United States, 68521
United States, New Jersey
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New Brunswick, New Jersey, United States, 08901
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, New York
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Albany, New York, United States, 12208
Pfizer Investigational Site
Flushing, New York, United States, 11365
Pfizer Investigational Site
Mineola, New York, United States, 11501
Pfizer Investigational Site
New Hyde Park, New York, United States, 11042
Pfizer Investigational Site
Rochester, New York, United States, 14642
United States, North Carolina
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Raleigh, North Carolina, United States, 27609
United States, Ohio
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Cincinnati, Ohio, United States, 45229
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Cleveland, Ohio, United States, 44195
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Lakewood, Ohio, United States, 44107
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
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Portland, Oregon, United States, 97210
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15235
United States, South Carolina
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Charleston, South Carolina, United States, 29401-5799
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Charleston, South Carolina, United States, 29425
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Duncan, South Carolina, United States, 29334
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Spartanburg, South Carolina, United States, 29303
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Spartanburg, South Carolina, United States, 29307
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Sumter, South Carolina, United States, 29150
United States, Tennessee
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Kingsport, Tennessee, United States, 37660
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Knoxville, Tennessee, United States, 37909
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Memphis, Tennessee, United States, 38119
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Nashville, Tennessee, United States, 37232
United States, Texas
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Corpus Christi, Texas, United States, 78411
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Dallas, Texas, United States, 75246
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Dallas, Texas, United States, 75230
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El Paso, Texas, United States, 79935
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El Paso, Texas, United States, 79925
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78237
United States, Utah
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Ogden, Utah, United States, 84403
United States, Virginia
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Fredericksburg, Virginia, United States, 22401
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Richmond, Virginia, United States, 23221
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Richmond, Virginia, United States, 23294
United States, Washington
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Renton, Washington, United States, 98055
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Tukwila, Washington, United States, 98188
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53209
Australia, New South Wales
Pfizer Investigational Site
Camperdown, New South Wales, Australia, 2050
Pfizer Investigational Site
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Pfizer Investigational Site
Herston, Queensland, Australia, 4029
Pfizer Investigational Site
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
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Keswick, South Australia, Australia, 5035
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Caulfield, Victoria, Australia, 3162
Brazil
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-170
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Sao Paulo, SP, Brazil, 01244-030
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Sao Paulo, SP, Brazil, 04231-030
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
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London, Ontario, Canada, N6A 4V2
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Mississauga, Ontario, Canada, L5M2V8
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Oakville, Ontario, Canada, L6H 3P1
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Thornhill, Ontario, Canada, L4J 1V8
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Toronto, Ontario, Canada, M4R 2G4
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Toronto, Ontario, Canada, M4N-3M5
Canada, Quebec
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Laval, Quebec, Canada, H7T 2P5
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Montreal, Quebec, Canada, H1T 2M4
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St Jerome, Quebec, Canada, J7Z 5T3
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Vaudreuil, Quebec, Canada, J7V 8P9
Canada
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St. John's, Canada, A1E 2E2
Mexico
Pfizer Investigational Site
Mexico, DF, Mexico, 03100
Pfizer Investigational Site
Mexico, DF, Mexico, 02990
Pfizer Investigational Site
Guadalajara, Jalisco/Mexico, Mexico, 44347
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44660
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44349
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44340
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64060
Pfizer Investigational Site
Jalapa, Veracruz, Mexico, 91020
Pfizer Investigational Site
Mexico Df, Mexico, CP 14000
Sponsors and Collaborators
Pfizer
Sanofi
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00150410     History of Changes
Other Study ID Numbers: A2171017
Study First Received: September 6, 2005
Last Updated: October 28, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014