Diabetes Mellitus Clinical Trial
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
| Verified date | October 2008 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
- 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.
| Status | Completed |
| Enrollment | 626 |
| Est. completion date | June 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Pfizer Investigational Site | Box Hill | Victoria |
| Australia | Pfizer Investigational Site | Camperdown | New South Wales |
| Australia | Pfizer Investigational Site | Caulfield | Victoria |
| Australia | Pfizer Investigational Site | Herston | Queensland |
| Australia | Pfizer Investigational Site | Keswick | South Australia |
| Australia | Pfizer Investigational Site | Wollongong | New South Wales |
| Australia | Pfizer Investigational Site | Woolloongabba | Queensland |
| Brazil | Pfizer Investigational Site | Porto Alegre | RS |
| Brazil | Pfizer Investigational Site | Sao Paulo | SP |
| Brazil | Pfizer Investigational Site | Sao Paulo | SP |
| Canada | Pfizer Investigational Site | Laval | Quebec |
| Canada | Pfizer Investigational Site | London | Ontario |
| Canada | Pfizer Investigational Site | Mississauga | Ontario |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Oakville | Ontario |
| Canada | Pfizer Investigational Site | St Jerome | Quebec |
| Canada | Pfizer Investigational Site | St. John's | |
| Canada | Pfizer Investigational Site | Thornhill | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Vaudreuil | Quebec |
| Canada | Pfizer Investigational Site | Winnipeg | Manitoba |
| Mexico | Pfizer Investigational Site | Guadalajara | Jalisco/Mexico |
| Mexico | Pfizer Investigational Site | Guadalajara | Jalisco |
| Mexico | Pfizer Investigational Site | Guadalajara | Jalisco |
| Mexico | Pfizer Investigational Site | Guadalajara | Jalisco |
| Mexico | Pfizer Investigational Site | Jalapa | Veracruz |
| Mexico | Pfizer Investigational Site | Mexico | DF |
| Mexico | Pfizer Investigational Site | Mexico | DF |
| Mexico | Pfizer Investigational Site | Mexico Df | |
| Mexico | Pfizer Investigational Site | Monterrey | Nuevo Leon |
| United States | Pfizer Investigational Site | Albany | New York |
| United States | Pfizer Investigational Site | Albuquerque | New Mexico |
| United States | Pfizer Investigational Site | Alhambra | California |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Augusta | Georgia |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baton Rouge | Louisiana |
| United States | Pfizer Investigational Site | Butte | Montana |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Chicago Heights | Illinois |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Concord | California |
| United States | Pfizer Investigational Site | Corpus Christi | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Des Moines | Iowa |
| United States | Pfizer Investigational Site | Duncan | South Carolina |
| United States | Pfizer Investigational Site | El Paso | Texas |
| United States | Pfizer Investigational Site | El Paso | Texas |
| United States | Pfizer Investigational Site | Ewa Beach | Hawaii |
| United States | Pfizer Investigational Site | Flushing | New York |
| United States | Pfizer Investigational Site | Fredericksburg | Virginia |
| United States | Pfizer Investigational Site | Hollywood | Florida |
| United States | Pfizer Investigational Site | Honolulu | Hawaii |
| United States | Pfizer Investigational Site | Huntington Beach | California |
| United States | Pfizer Investigational Site | Huntington Beach | California |
| United States | Pfizer Investigational Site | Idaho Falls | Idaho |
| United States | Pfizer Investigational Site | Idaho Falls | Idaho |
| United States | Pfizer Investigational Site | Idaho Falls, | Idaho |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Kingsport | Tennessee |
| United States | Pfizer Investigational Site | Knoxville | Tennessee |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | Lakewood | Ohio |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Lincoln | Nebraska |
| United States | Pfizer Investigational Site | Long Beach | California |
| United States | Pfizer Investigational Site | Long Beach | California |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Mesa | Arizona |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | Mineola | New York |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | New Brunswick | New Jersey |
| United States | Pfizer Investigational Site | New Brunswick | New Jersey |
| United States | Pfizer Investigational Site | New Hyde Park | New York |
| United States | Pfizer Investigational Site | New Orleans | Louisiana |
| United States | Pfizer Investigational Site | North Kansas City | Missouri |
| United States | Pfizer Investigational Site | Ogden | Utah |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Renton | Washington |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Riverside | California |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | Santa Barbara | California |
| United States | Pfizer Investigational Site | Savannah | Georgia |
| United States | Pfizer Investigational Site | Savannah | Georgia |
| United States | Pfizer Investigational Site | Searcy | Arkansas |
| United States | Pfizer Investigational Site | Spartanburg | South Carolina |
| United States | Pfizer Investigational Site | Spartanburg | South Carolina |
| United States | Pfizer Investigational Site | Springfield | Massachusetts |
| United States | Pfizer Investigational Site | Springfield | Massachusetts |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | Sumter | South Carolina |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Tukwila | Washington |
| United States | Pfizer Investigational Site | Tustin | California |
| United States | Pfizer Investigational Site | Waltham | Massachusetts |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| United States | Pfizer Investigational Site | Waterbury | Connecticut |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| United States | Pfizer Investigational Site | West St. Paul | Minnesota |
| United States | Pfizer Investigational Site | Westminster | California |
| United States | Pfizer Investigational Site | Wheat Ridge | Colorado |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer | Sanofi |
United States, Australia, Brazil, Canada, Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glycosylated hemoglobin | |||
| Secondary | Change from baseline in fasting plasma glucose. Other secondary efficacy | |||
| Secondary | endpoints include, body weight, patient reported outcomes, incidence and severity | |||
| Secondary | of hypoglycemic episodes, cough questionnaire, and discontinuation rate due to | |||
| Secondary | insufficient clinical response. |
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