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

Condition(s) targeted: Diabetes Mellitus

Intervention: Inhaled insulin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CTgov Call Center, Phone: 1-800-718-1021

- 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.

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

Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Glycosylated hemoglobin

Secondary outcome:

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Pfizer CTgov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Mesa, Arizona, United States; No longer recruiting

Pfizer Investigational Site, PHOENIX, Arizona, United States; Completed

Pfizer Investigational Site, Tucson, Arizona, United States; No longer recruiting

Pfizer Investigational Site, Searcy, Arkansas, United States; Completed

Pfizer Investigational Site, Long Beach, California, United States; No longer recruiting

Pfizer Investigational Site, Tustin, California, United States; No longer recruiting

Pfizer Investigational Site, LOS ANGELES, California, United States; No longer recruiting

Pfizer Investigational Site, La Jolla, California, United States; No longer recruiting

Pfizer Investigational Site, ALHAMBRA, California, United States; No longer recruiting

Pfizer Investigational Site, Santa Barbara, California, United States; No longer recruiting

Pfizer Investigational Site, Concord, California, United States; No longer recruiting

Pfizer Investigational Site, CONCORD, California, United States; No longer recruiting

Pfizer Investigational Site, Long Beach, California, United States; Completed

Pfizer Investigational Site, Riverside, California, United States; Completed

Pfizer Investigational Site, Huntington Beach, California, United States; No longer recruiting

Pfizer Investigational Site, Westminster, California, United States; No longer recruiting

Pfizer Investigational Site, Wheat Ridge, Colorado, United States; No longer recruiting

Pfizer Investigational Site, Denver, Colorado, United States; No longer recruiting

Pfizer Investigational Site, Waterbury, Connecticut, United States; No longer recruiting

Pfizer Investigational Site, Mexico, DF, Mexico; No longer recruiting

Pfizer Investigational Site, WASHINGTON, District of Columbia, United States; No longer recruiting

Pfizer Investigational Site, West Palm Beach, Florida, United States; No longer recruiting

Pfizer Investigational Site, Winter Park, Florida, United States; No longer recruiting

Pfizer Investigational Site, Hollywood, Florida, United States; Completed

Pfizer Investigational Site, ATLANTA, Georgia, United States; No longer recruiting

Pfizer Investigational Site, Savannah, Georgia, United States; No longer recruiting

Pfizer Investigational Site, Augusta, Georgia, United States; No longer recruiting

Pfizer Investigational Site, Mexico Df, Mexico; Completed

Pfizer Investigational Site, St. John's, Canada; Completed

Pfizer Investigational Site, Ewa Beach, Hawaii, United States; No longer recruiting

Pfizer Investigational Site, Honolulu, Hawaii, United States; No longer recruiting

Pfizer Investigational Site, Idaho Falls, Idaho, United States; No longer recruiting

Pfizer Investigational Site, IDAHO FALLS, Idaho, United States; No longer recruiting

Pfizer Investigational Site, Idaho Falls,, Idaho, United States; No longer recruiting

Pfizer Investigational Site, Chicago Heights, Illinois, United States; Completed

Pfizer Investigational Site, CHICAGO HEIGHTS, Illinois, United States; Completed

Pfizer Investigational Site, Indianapolis, Indiana, United States; No longer recruiting

Pfizer Investigational Site, Des Moines, Iowa, United States; No longer recruiting

Pfizer Investigational Site, Guadalajara, Jalisco, Mexico; No longer recruiting

Pfizer Investigational Site, Guadalajara, Jalisco/Mexico, Mexico; No longer recruiting

Pfizer Investigational Site, Wichita, Kansas, United States; No longer recruiting

Pfizer Investigational Site, LOUISVILLE, Kentucky, United States; Completed

Pfizer Investigational Site, Lexington, Kentucky, United States; Completed

Pfizer Investigational Site, LEXINGTON, Kentucky, United States; Completed

Pfizer Investigational Site, Baton Rouge, Louisiana, United States; No longer recruiting

Pfizer Investigational Site, Baton Rouge, Louisiana, United States; Completed

Pfizer Investigational Site, New Orleans, Louisiana, United States; Completed

Pfizer Investigational Site, Winnipeg, Manitoba, Canada; No longer recruiting

Pfizer Investigational Site, Baltimore, Maryland, United States; No longer recruiting

Pfizer Investigational Site, BALTIMORE, Maryland, United States; No longer recruiting

Pfizer Investigational Site, SPRINGFIELD, Massachusetts, United States; Completed

Pfizer Investigational Site, Waltham, Massachusetts, United States; Completed

Pfizer Investigational Site, Springfield, Massachusetts, United States; Completed

Pfizer Investigational Site, WEST ST. PAUL, Minnesota, United States; No longer recruiting

Pfizer Investigational Site, NORTH KANSAS CITY, Missouri, United States; No longer recruiting

Pfizer Investigational Site, St. Louis, Missouri, United States; No longer recruiting

Pfizer Investigational Site, BUTTE, Montana, United States; No longer recruiting

Pfizer Investigational Site, Lincoln, Nebraska, United States; No longer recruiting

Pfizer Investigational Site, New Brunswick, New Jersey, United States; No longer recruiting

Pfizer Investigational Site, ALBUQUERQUE, New Mexico, United States; No longer recruiting

Pfizer Investigational Site, CAMPERDOWN, New South Wales, Australia; Completed

Pfizer Investigational Site, Wollongong, New South Wales, Australia; Completed

Pfizer Investigational Site, ALBANY, New York, United States; No longer recruiting

Pfizer Investigational Site, ROCHESTER, New York, United States; No longer recruiting

Pfizer Investigational Site, FLUSHING, New York, United States; No longer recruiting

Pfizer Investigational Site, NEW HYDE PARK, New York, United States; No longer recruiting

Pfizer Investigational Site, Mineola, New York, United States; Completed

Pfizer Investigational Site, RALEIGH, North Carolina, United States; Completed

Pfizer Investigational Site, Monterrey, Nuevo Leon, Mexico; Recruiting

Pfizer Investigational Site, CLEVELAND, Ohio, United States; No longer recruiting

Pfizer Investigational Site, Lakewood, Ohio, United States; No longer recruiting

Pfizer Investigational Site, Cincinnati, Ohio, United States; No longer recruiting

Pfizer Investigational Site, OKLAHOMA CITY, Oklahoma, United States; No longer recruiting

Pfizer Investigational Site, Toronto, Ontario, Canada; Completed

Pfizer Investigational Site, Mississauga, Ontario, Canada; No longer recruiting

Pfizer Investigational Site, London, Ontario, Canada; No longer recruiting

Pfizer Investigational Site, Thornhill, Ontario, Canada; Completed

Pfizer Investigational Site, Oakville, Ontario, Canada; No longer recruiting

Pfizer Investigational Site, PORTLAND, Oregon, United States; Completed

Pfizer Investigational Site, Pittsburgh, Pennsylvania, United States; No longer recruiting

Pfizer Investigational Site, Laval, Quebec, Canada; Completed

Pfizer Investigational Site, Montreal, Quebec, Canada; Completed

Pfizer Investigational Site, Vaudreuil, Quebec, Canada; No longer recruiting

Pfizer Investigational Site, St Jerome, Quebec, Canada; No longer recruiting

Pfizer Investigational Site, Herston, Queensland, Australia; No longer recruiting

Pfizer Investigational Site, Woolloongabba, Queensland, Australia; Completed

Pfizer Investigational Site, Porto Alegre, RS, Brazil; No longer recruiting

Pfizer Investigational Site, Sao Paulo, SP, Brazil; No longer recruiting

Pfizer Investigational Site, Keswick, South Australia, Australia; Completed

Pfizer Investigational Site, Sumter, South Carolina, United States; Completed

Pfizer Investigational Site, Charleston, South Carolina, United States; No longer recruiting

Pfizer Investigational Site, CHARLESTON, South Carolina, United States; No longer recruiting

Pfizer Investigational Site, Duncan, South Carolina, United States; No longer recruiting

Pfizer Investigational Site, Spartanburg, South Carolina, United States; No longer recruiting

Pfizer Investigational Site, KNOXVILLE, Tennessee, United States; No longer recruiting

Pfizer Investigational Site, Memphis, Tennessee, United States; Completed

Pfizer Investigational Site, MEMPHIS, Tennessee, United States; Completed

Pfizer Investigational Site, Nashville, Tennessee, United States; No longer recruiting

Pfizer Investigational Site, Kingsport, Tennessee, United States; No longer recruiting

Pfizer Investigational Site, Dallas, Texas, United States; Completed

Pfizer Investigational Site, Dallas, Texas, United States; No longer recruiting

Pfizer Investigational Site, El Paso, Texas, United States; No longer recruiting

Pfizer Investigational Site, San Antonio, Texas, United States; No longer recruiting

Pfizer Investigational Site, Corpus Christi, Texas, United States; No longer recruiting

Pfizer Investigational Site, Ogden, Utah, United States; No longer recruiting

Pfizer Investigational Site, Jalapa, Veracruz, Mexico; No longer recruiting

Pfizer Investigational Site, Box Hill, Victoria, Australia; Completed

Pfizer Investigational Site, Caulfield, Victoria, Australia; Completed

Pfizer Investigational Site, Richmond, Virginia, United States; No longer recruiting

Pfizer Investigational Site, Fredericksburg, Virginia, United States; No longer recruiting

Pfizer Investigational Site, Renton, Washington, United States; No longer recruiting

Pfizer Investigational Site, Tukwila, Washington, United States; No longer recruiting

Pfizer Investigational Site, Milwaukee, Wisconsin, United States; No longer recruiting

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

Starting date: January 2003
Last updated: May 1, 2007