Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose
This study has been completed.
Sponsor:
Pfizer
Collaborator:
Sanofi
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150410
First received: September 6, 2005
Last updated: October 28, 2008
Last verified: October 2008
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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:
Drug Information available for:
Metformin
Metformin hydrochloride
Insulin human
Rosiglitazone
Rosiglitazone Maleate
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150410
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| 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 | |
| Pfizer Investigational Site | |
| Riverside, California, United States, 92506 | |
| Pfizer Investigational Site | |
| Santa Barbara, California, United States, 93105 | |
| Pfizer Investigational Site | |
| Tustin, California, United States, 92780 | |
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| Westminster, California, United States, 92683 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Denver, Colorado, United States, 80209 | |
| Pfizer Investigational Site | |
| Wheat Ridge, Colorado, United States, 80033 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, District of Columbia | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States, 20010 | |
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| Washington, District of Columbia, United States, 20307 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| 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 | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30309 | |
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| Augusta, Georgia, United States, 30909 | |
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| Savannah, Georgia, United States, 31405 | |
| Pfizer Investigational Site | |
| Savannah, Georgia, United States, 31419 | |
| United States, Hawaii | |
| Pfizer Investigational Site | |
| Ewa Beach, Hawaii, United States, 96706 | |
| Pfizer Investigational Site | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Idaho | |
| Pfizer Investigational Site | |
| Idaho Falls, Idaho, United States, 83404-7542 | |
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| Idaho Falls, Idaho, United States, 83404-6370 | |
| Pfizer Investigational Site | |
| Idaho Falls,, Idaho, United States, 83404-7542 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago Heights, Illinois, United States, 60411 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Pfizer Investigational Site | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Wichita, Kansas, United States, 67203 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40503 | |
| Pfizer Investigational Site | |
| 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 | |
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| 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 | |
| Pfizer Investigational Site | |
| Butte, Montana, United States, 59701 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Lincoln, Nebraska, United States, 68521 | |
| United States, New Jersey | |
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| New Brunswick, New Jersey, United States, 08901 | |
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| New Brunswick, New Jersey, United States, 08903 | |
| United States, New Mexico | |
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| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
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| Albany, New York, United States, 12208 | |
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| Flushing, New York, United States, 11365 | |
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| Mineola, New York, United States, 11501 | |
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| New Hyde Park, New York, United States, 11042 | |
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| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45229 | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44195 | |
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| Lakewood, Ohio, United States, 44107 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
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| Pittsburgh, Pennsylvania, United States, 15235 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29401-5799 | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29425 | |
| Pfizer Investigational Site | |
| 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 | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23294 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Renton, Washington, United States, 98055 | |
| Pfizer Investigational Site | |
| 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 | |
| Pfizer Investigational Site | |
| Keswick, South Australia, Australia, 5035 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| Box Hill, Victoria, Australia, 3128 | |
| Pfizer Investigational Site | |
| Caulfield, Victoria, Australia, 3162 | |
| Brazil | |
| Pfizer Investigational Site | |
| Porto Alegre, RS, Brazil, 90035-170 | |
| Pfizer Investigational Site | |
| Sao Paulo, SP, Brazil, 01244-030 | |
| Pfizer Investigational Site | |
| Sao Paulo, SP, Brazil, 04231-030 | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| 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 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M4N-3M5 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| 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 | |
| Pfizer Investigational Site | |
| St. John's, Canada, A1E 2E2 | |
| Mexico | |
| Pfizer Investigational Site | |
| Mexico, DF, Mexico, 02990 | |
| Pfizer Investigational Site | |
| Mexico, DF, Mexico, 03100 | |
| 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 Rosiglitazone |
Insulin Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013