Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase 2a, Randomized, Placebo-Controlled, Parallel Group, Multiple-Dose Study To Evaluate The Efficacy, Safety, And Tolerability Of 12-Week Oral Administration Of PF-00734200 Tablets To Subjects With Type 2 Diabetes Mellitus On Stable Treatment With Metformin
| Verified date | June 2010 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.
| Status | Completed |
| Enrollment | 303 |
| Est. completion date | June 2008 |
| Est. primary completion date | June 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of type 2 diabetes - Hb1AC >7%-11% inclusive - Male and females 18-70; females must be post-menopausal - On a stable dose of metformin hydrochloride Exclusion Criteria: - Medical history of stroke, unstable angina, heart attack within one year of enrollment, and alcohol dependency or recent drug abuse. - Women of childbearing potential, pregnant or nursing - Evidence of diabetic complications with significant end-organ damage |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Colombia | Pfizer Investigational Site | Bogota | Cundinamarca |
| Colombia | Pfizer Investigational Site | Bogota | Cundinamarca |
| Colombia | Pfizer Investigational Site | Floridablanca | Santander |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Giengen | |
| Germany | Pfizer Investigational Site | Hamburg | |
| Germany | Pfizer Investigational Site | Muenchen | |
| Italy | Pfizer Investigational Site | Roma | |
| Spain | Pfizer Investigational Site | Alcala de Henares | Madrid |
| Spain | Pfizer Investigational Site | Santiago de Compostela | La Coruña |
| Spain | Pfizer Investigational Site | Valencia | |
| Spain | Pfizer Investigational Site | Valencia | |
| Sweden | Pfizer Investigational Site | Goteborg | |
| Sweden | Pfizer Investigational Site | Malmo | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| United States | Pfizer Investigational Site | Ann Arbor | Michigan |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Bartlett | Tennessee |
| United States | Pfizer Investigational Site | Biloxi | Mississippi |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Brockton | Massachusetts |
| United States | Pfizer Investigational Site | Canton | Michigan |
| United States | Pfizer Investigational Site | Carmichael | California |
| United States | Pfizer Investigational Site | Carnegie | Pennsylvania |
| United States | Pfizer Investigational Site | Cary | North Carolina |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Chula Vista | California |
| United States | Pfizer Investigational Site | Collierville | Tennessee |
| United States | Pfizer Investigational Site | Conyers | Georgia |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | DeFuniak Springs | Florida |
| United States | Pfizer Investigational Site | Destin | Florida |
| United States | Pfizer Investigational Site | East Providence | Rhode Island |
| United States | Pfizer Investigational Site | Fair Oaks | California |
| United States | Pfizer Investigational Site | Flint | Michigan |
| United States | Pfizer Investigational Site | Gilbert | Arizona |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Irving | Texas |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Jonesboro | Arkansas |
| United States | Pfizer Investigational Site | Kingsport | Tennessee |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Little Rock | Arkansas |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Marion | Ohio |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | National City | California |
| United States | Pfizer Investigational Site | New Port Richey | Florida |
| United States | Pfizer Investigational Site | New Port Richey | Florida |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Palm Harbor | Florida |
| United States | Pfizer Investigational Site | Paramount | California |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Picayune | Mississippi |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Roseville | California |
| United States | Pfizer Investigational Site | Sacramento | California |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | Skokie | Illinois |
| United States | Pfizer Investigational Site | Skokie | Illinois |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | Trenton | New Jersey |
| United States | Pfizer Investigational Site | Virginia Beach | Virginia |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| United States | Pfizer Investigational Site | Wheeling | Illinois |
| United States | Pfizer Investigational Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Colombia, Germany, Italy, Spain, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1C levels (%) | 12 weeks | No | |
| Primary | Evaluation of Dose Response in HbA1c (%) | 12 weeks | No | |
| Secondary | Insulin and Glucose AUC following a mixed meal tolerance test | 12 weeks | No | |
| Secondary | Proportion of subjects achieving ADA glycemic goal of Hb A1c <7% | 12 weeks | No | |
| Secondary | Incidence of Adverse Events | 12 weeks | Yes |
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