Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00150410
Collaborator
Sanofi (Industry)
626
120
53
5.2
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
626 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date
:
Jan 1, 2003
Actual Study Completion Date
:
Jun 1, 2007
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Mesa | Arizona | United States | 85205 |
| 2 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85012 |
| 3 | Pfizer Investigational Site | Tucson | Arizona | United States | 85715 |
| 4 | Pfizer Investigational Site | Searcy | Arkansas | United States | 72143 |
| 5 | Pfizer Investigational Site | Alhambra | California | United States | 91801 |
| 6 | Pfizer Investigational Site | Concord | California | United States | 94520 |
| 7 | Pfizer Investigational Site | Huntington Beach | California | United States | 92647 |
| 8 | Pfizer Investigational Site | Huntington Beach | California | United States | 92648 |
| 9 | Pfizer Investigational Site | La Jolla | California | United States | 92037 |
| 10 | Pfizer Investigational Site | Long Beach | California | United States | 90805 |
| 11 | Pfizer Investigational Site | Long Beach | California | United States | 90806 |
| 12 | Pfizer Investigational Site | Los Angeles | California | United States | 90048 |
| 13 | Pfizer Investigational Site | Riverside | California | United States | 92506 |
| 14 | Pfizer Investigational Site | Santa Barbara | California | United States | 93105 |
| 15 | Pfizer Investigational Site | Tustin | California | United States | 92780 |
| 16 | Pfizer Investigational Site | Westminster | California | United States | 92683 |
| 17 | Pfizer Investigational Site | Denver | Colorado | United States | 80209 |
| 18 | Pfizer Investigational Site | Wheat Ridge | Colorado | United States | 80033 |
| 19 | Pfizer Investigational Site | Waterbury | Connecticut | United States | 06708 |
| 20 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20010 |
| 21 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20307 |
| 22 | Pfizer Investigational Site | Hollywood | Florida | United States | 33021 |
| 23 | Pfizer Investigational Site | West Palm Beach | Florida | United States | 33401 |
| 24 | Pfizer Investigational Site | Winter Park | Florida | United States | 32789 |
| 25 | Pfizer Investigational Site | Atlanta | Georgia | United States | 30309 |
| 26 | Pfizer Investigational Site | Augusta | Georgia | United States | 30909 |
| 27 | Pfizer Investigational Site | Savannah | Georgia | United States | 31405 |
| 28 | Pfizer Investigational Site | Savannah | Georgia | United States | 31419 |
| 29 | Pfizer Investigational Site | Ewa Beach | Hawaii | United States | 96706 |
| 30 | Pfizer Investigational Site | Honolulu | Hawaii | United States | 96813 |
| 31 | Pfizer Investigational Site | Idaho Falls, | Idaho | United States | 83404-7542 |
| 32 | Pfizer Investigational Site | Idaho Falls | Idaho | United States | 83404-6370 |
| 33 | Pfizer Investigational Site | Idaho Falls | Idaho | United States | 83404-7542 |
| 34 | Pfizer Investigational Site | Chicago Heights | Illinois | United States | 60411 |
| 35 | Pfizer Investigational Site | Indianapolis | Indiana | United States | 46202 |
| 36 | Pfizer Investigational Site | Des Moines | Iowa | United States | 50314 |
| 37 | Pfizer Investigational Site | Wichita | Kansas | United States | 67203 |
| 38 | Pfizer Investigational Site | Lexington | Kentucky | United States | 40503 |
| 39 | Pfizer Investigational Site | Louisville | Kentucky | United States | 40213 |
| 40 | Pfizer Investigational Site | Baton Rouge | Louisiana | United States | 70808 |
| 41 | Pfizer Investigational Site | New Orleans | Louisiana | United States | 70112 |
| 42 | Pfizer Investigational Site | Baltimore | Maryland | United States | 21204 |
| 43 | Pfizer Investigational Site | Springfield | Massachusetts | United States | 01103 |
| 44 | Pfizer Investigational Site | Springfield | Massachusetts | United States | 01199 |
| 45 | Pfizer Investigational Site | Waltham | Massachusetts | United States | 02453 |
| 46 | Pfizer Investigational Site | West St. Paul | Minnesota | United States | 55118 |
| 47 | Pfizer Investigational Site | North Kansas City | Missouri | United States | 64116 |
| 48 | Pfizer Investigational Site | St. Louis | Missouri | United States | 63141 |
| 49 | Pfizer Investigational Site | Butte | Montana | United States | 59701 |
| 50 | Pfizer Investigational Site | Lincoln | Nebraska | United States | 68521 |
| 51 | Pfizer Investigational Site | New Brunswick | New Jersey | United States | 08901 |
| 52 | Pfizer Investigational Site | New Brunswick | New Jersey | United States | 08903 |
| 53 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87106 |
| 54 | Pfizer Investigational Site | Albany | New York | United States | 12208 |
| 55 | Pfizer Investigational Site | Flushing | New York | United States | 11365 |
| 56 | Pfizer Investigational Site | Mineola | New York | United States | 11501 |
| 57 | Pfizer Investigational Site | New Hyde Park | New York | United States | 11042 |
| 58 | Pfizer Investigational Site | Rochester | New York | United States | 14642 |
| 59 | Pfizer Investigational Site | Raleigh | North Carolina | United States | 27609 |
| 60 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45229 |
| 61 | Pfizer Investigational Site | Cleveland | Ohio | United States | 44195 |
| 62 | Pfizer Investigational Site | Lakewood | Ohio | United States | 44107 |
| 63 | Pfizer Investigational Site | Oklahoma City | Oklahoma | United States | 73104 |
| 64 | Pfizer Investigational Site | Portland | Oregon | United States | 97210 |
| 65 | Pfizer Investigational Site | Pittsburgh | Pennsylvania | United States | 15235 |
| 66 | Pfizer Investigational Site | Charleston | South Carolina | United States | 29401-5799 |
| 67 | Pfizer Investigational Site | Charleston | South Carolina | United States | 29425 |
| 68 | Pfizer Investigational Site | Duncan | South Carolina | United States | 29334 |
| 69 | Pfizer Investigational Site | Spartanburg | South Carolina | United States | 29303 |
| 70 | Pfizer Investigational Site | Spartanburg | South Carolina | United States | 29307 |
| 71 | Pfizer Investigational Site | Sumter | South Carolina | United States | 29150 |
| 72 | Pfizer Investigational Site | Kingsport | Tennessee | United States | 37660 |
| 73 | Pfizer Investigational Site | Knoxville | Tennessee | United States | 37909 |
| 74 | Pfizer Investigational Site | Memphis | Tennessee | United States | 38119 |
| 75 | Pfizer Investigational Site | Nashville | Tennessee | United States | 37232 |
| 76 | Pfizer Investigational Site | Corpus Christi | Texas | United States | 78411 |
| 77 | Pfizer Investigational Site | Dallas | Texas | United States | 75230 |
| 78 | Pfizer Investigational Site | Dallas | Texas | United States | 75246 |
| 79 | Pfizer Investigational Site | El Paso | Texas | United States | 79925 |
| 80 | Pfizer Investigational Site | El Paso | Texas | United States | 79935 |
| 81 | Pfizer Investigational Site | San Antonio | Texas | United States | 78229 |
| 82 | Pfizer Investigational Site | San Antonio | Texas | United States | 78237 |
| 83 | Pfizer Investigational Site | Ogden | Utah | United States | 84403 |
| 84 | Pfizer Investigational Site | Fredericksburg | Virginia | United States | 22401 |
| 85 | Pfizer Investigational Site | Richmond | Virginia | United States | 23221 |
| 86 | Pfizer Investigational Site | Richmond | Virginia | United States | 23294 |
| 87 | Pfizer Investigational Site | Renton | Washington | United States | 98055 |
| 88 | Pfizer Investigational Site | Tukwila | Washington | United States | 98188 |
| 89 | Pfizer Investigational Site | Milwaukee | Wisconsin | United States | 53209 |
| 90 | Pfizer Investigational Site | Camperdown | New South Wales | Australia | 2050 |
| 91 | Pfizer Investigational Site | Wollongong | New South Wales | Australia | 2500 |
| 92 | Pfizer Investigational Site | Herston | Queensland | Australia | 4029 |
| 93 | Pfizer Investigational Site | Woolloongabba | Queensland | Australia | 4102 |
| 94 | Pfizer Investigational Site | Keswick | South Australia | Australia | 5035 |
| 95 | Pfizer Investigational Site | Box Hill | Victoria | Australia | 3128 |
| 96 | Pfizer Investigational Site | Caulfield | Victoria | Australia | 3162 |
| 97 | Pfizer Investigational Site | Porto Alegre | RS | Brazil | 90035-170 |
| 98 | Pfizer Investigational Site | Sao Paulo | SP | Brazil | 01244-030 |
| 99 | Pfizer Investigational Site | Sao Paulo | SP | Brazil | 04231-030 |
| 100 | Pfizer Investigational Site | Winnipeg | Manitoba | Canada | R3E 3P4 |
| 101 | Pfizer Investigational Site | London | Ontario | Canada | N6A 4V2 |
| 102 | Pfizer Investigational Site | Mississauga | Ontario | Canada | L5M2V8 |
| 103 | Pfizer Investigational Site | Oakville | Ontario | Canada | L6H 3P1 |
| 104 | Pfizer Investigational Site | Thornhill | Ontario | Canada | L4J 1V8 |
| 105 | Pfizer Investigational Site | Toronto | Ontario | Canada | M4N-3M5 |
| 106 | Pfizer Investigational Site | Toronto | Ontario | Canada | M4R 2G4 |
| 107 | Pfizer Investigational Site | Laval | Quebec | Canada | H7T 2P5 |
| 108 | Pfizer Investigational Site | Montreal | Quebec | Canada | H1T 2M4 |
| 109 | Pfizer Investigational Site | St Jerome | Quebec | Canada | J7Z 5T3 |
| 110 | Pfizer Investigational Site | Vaudreuil | Quebec | Canada | J7V 8P9 |
| 111 | Pfizer Investigational Site | St. John's | Canada | A1E 2E2 | |
| 112 | Pfizer Investigational Site | Mexico | DF | Mexico | 02990 |
| 113 | Pfizer Investigational Site | Mexico | DF | Mexico | 03100 |
| 114 | Pfizer Investigational Site | Guadalajara | Jalisco/Mexico | Mexico | 44347 |
| 115 | Pfizer Investigational Site | Guadalajara | Jalisco | Mexico | 44340 |
| 116 | Pfizer Investigational Site | Guadalajara | Jalisco | Mexico | 44349 |
| 117 | Pfizer Investigational Site | Guadalajara | Jalisco | Mexico | 44660 |
| 118 | Pfizer Investigational Site | Monterrey | Nuevo Leon | Mexico | 64060 |
| 119 | Pfizer Investigational Site | Jalapa | Veracruz | Mexico | 91020 |
| 120 | Pfizer Investigational Site | Mexico Df | Mexico | CP 14000 |
Sponsors and Collaborators
- Pfizer
- Sanofi
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00150410
Other Study ID Numbers:
- A2171017
First Posted:
Sep 8, 2005
Last Update Posted:
Oct 31, 2008
Last Verified:
Oct 1, 2008
Additional relevant MeSH terms: