Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of 12-Week Administration Of PF-00734200 To Subjects With Type 2 Diabetes Mellitus And Insufficient Glycemic Control On Metformin Treatment
| Verified date | June 2011 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving metformin
| Status | Completed |
| Enrollment | 289 |
| Est. completion date | August 2008 |
| Est. primary completion date | August 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: Men or women between 18-80 years of age with poorly controlled Type 2 diabetes Exclusion Criteria: Type 1 or secondary forms of diabetes Currently using insulin |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Pfizer Investigational Site | Coquitlam | British Columbia |
| Canada | Pfizer Investigational Site | Laval | Quebec |
| Canada | Pfizer Investigational Site | Pointe-Claire | Quebec |
| Canada | Pfizer Investigational Site | Quebec | |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Korea, Republic of | Pfizer Investigational Site | Seoul | |
| Korea, Republic of | Pfizer Investigational Site | Seoul | |
| Korea, Republic of | Pfizer Investigational Site | Seoul | |
| Korea, Republic of | Pfizer Investigational Site | Seoul | |
| Puerto Rico | Pfizer Investigational Site | San Juan | |
| United States | Pfizer Investigational Site | Aiken | South Carolina |
| United States | Pfizer Investigational Site | Albuquerque | New Mexico |
| United States | Pfizer Investigational Site | Ann Arbor | Michigan |
| United States | Pfizer Investigational Site | Artesia | California |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Bay City | Michigan |
| United States | Pfizer Investigational Site | Bennington | Vermont |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Canton | Michigan |
| United States | Pfizer Investigational Site | Cerritos | California |
| United States | Pfizer Investigational Site | Chandler | Arizona |
| United States | Pfizer Investigational Site | Conyers | Georgia |
| United States | Pfizer Investigational Site | Cumberland | Rhode Island |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | DeFuniak Springs | Florida |
| United States | Pfizer Investigational Site | El Paso | Texas |
| United States | Pfizer Investigational Site | Elizabeth | New Jersey |
| United States | Pfizer Investigational Site | Ettrick | Virginia |
| United States | Pfizer Investigational Site | Eugene | Oregon |
| United States | Pfizer Investigational Site | Florence | South Carolina |
| United States | Pfizer Investigational Site | Fresno | California |
| United States | Pfizer Investigational Site | Greenbrea | California |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Huntington Beach | California |
| United States | Pfizer Investigational Site | Hurst | Texas |
| United States | Pfizer Investigational Site | Idaho Falls | Idaho |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Jackson | Mississippi |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Kenosha | Wisconsin |
| United States | Pfizer Investigational Site | Kingsport | Tennessee |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Litchfield Park | Arizona |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Madisonville | Kentucky |
| United States | Pfizer Investigational Site | Marion | Ohio |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | National City | California |
| United States | Pfizer Investigational Site | New Port Richey | Florida |
| United States | Pfizer Investigational Site | Ocala | Florida |
| United States | Pfizer Investigational Site | Odessa | Texas |
| United States | Pfizer Investigational Site | Oxon Hill | Maryland |
| United States | Pfizer Investigational Site | Pearland | Texas |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Picayune | Mississippi |
| United States | Pfizer Investigational Site | Pinecrest | Florida |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Roseville | California |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | Scarborough | Maine |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | St. Peters | Missouri |
| United States | Pfizer Investigational Site | St. Petersburg | Florida |
| United States | Pfizer Investigational Site | Syracuse | New York |
| United States | Pfizer Investigational Site | Trenton | New Jersey |
| United States | Pfizer Investigational Site | Troy | Michigan |
| United States | Pfizer Investigational Site | Valley Village | California |
| United States | Pfizer Investigational Site | Virginia Beach | Virginia |
| United States | Pfizer Investigational Site | Virginia Beach | Virginia |
| United States | Pfizer Investigational Site | West Covina | California |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Canada, Korea, Republic of, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | 12 weeks | No | |
| Secondary | Fasting Glucose | 12 weeks | No | |
| Secondary | Fasting Insulin | 12 weeks | No |
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