Metabolics Diabetes Nos Clinical Trial
Official title:
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Glyburide Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone
| Verified date | September 2007 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.
| Status | Completed |
| Enrollment | 534 |
| Est. completion date | November 2005 |
| Est. primary completion date | November 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Type 2 Diabetes, HbA1c > 7.0% and < 10.0%, mean serum triglyceride < 600 mg/dL, body mass index < 41 kg/m2, fasting c-peptide . 1.5 ng/mL. Exclusion Criteria: - History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution | Bahia Blanca | Buenas Aires |
| Argentina | Local Institution | Buenos Aires | |
| Argentina | Local Institution | Capital Federal | Buenos Aires |
| Argentina | Local Institution | Cordoba | |
| Argentina | Local Institution | Mendoza | |
| Australia | Local Institution | Brisbane | Queensland |
| Australia | Local Institution | Canberra | New South Wales |
| Australia | Local Institution | Wollongong | New South Wales |
| Brazil | Local Institution | Belem | Para |
| Brazil | Local Institution | Curitiba | Parana |
| Brazil | Local Institution | Marilia | Sao Paulo |
| Brazil | Local Institution | Porto Alegre | Rio Grande Do Sul |
| Canada | Local Institution | Corunna | Ontario |
| Canada | Local Institution | Gatineau | Quebec |
| Canada | Local Institution | Hawksbury | Ontario |
| Canada | Local Institution | Laval | Quebec |
| Canada | Local Institution | Sarnia | Ontario |
| Canada | Local Institution | St. Jerome | Quebec |
| Canada | Local Institution | St. John's | |
| France | Local Institution | Broglie | |
| France | Local Institution | Chartres | |
| France | Local Institution | Gemenos | |
| France | Local Institution | Husseren | Wesserling |
| France | Local Institution | Labarthe | Sur Leze |
| France | Local Institution | Rosiers | D'Egletons |
| Germany | Local Institution | Dresden | |
| Germany | Local Institution | Hamburg | |
| Germany | Local Institution | Nuernberg | |
| Germany | Local Institution | Viernheim | Schwenningen |
| Italy | Local Institution | Ravenna | |
| Mexico | Local Institution | Albuquerque | New Mexico |
| Mexico | Local Institution | Durango | |
| Mexico | Local Institution | Leon | Guanajuato |
| Mexico | Local Institution | Merida | Yucatan |
| Mexico | Local Institution | Mexico | Distrito Federal |
| Mexico | Local Institution | Monterrey | Nuevo Leon |
| Mexico | Local Institution | Tijuana | Baja California |
| Netherlands | Local Institution | Deurne | |
| Netherlands | Local Institution | Ewyk | |
| Netherlands | Local Institution | Hoogvliet | |
| Netherlands | Local Institution | Rijswijk | |
| Netherlands | Local Institution | S Gravenhage | |
| Netherlands | Local Institution | Zwijndrecht | |
| Peru | Local Institution | Arequipa | |
| Peru | Local Institution | Lima | |
| Puerto Rico | Local Institution | Carolina | |
| Puerto Rico | Local Institution | Guaynabo | |
| Puerto Rico | Local Institution | Ponce | |
| Puerto Rico | Local Institution | Rio Piedras | |
| Russian Federation | Local Institution | Moscow | |
| Russian Federation | Local Institution | Saratov | |
| Russian Federation | Local Institution | Smolensk | |
| Russian Federation | Local Institution | St. Petersburg | |
| Spain | Local Institution | A Coruna | |
| Spain | Local Institution | Alicante | |
| Spain | Local Institution | Cadiz | |
| Spain | Local Institution | Granada | |
| Spain | Local Institution | La Coruna | |
| Spain | Local Institution | Las Palmas | DE |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Oviedo | |
| Spain | Local Institution | Santiago | de Compostela |
| Spain | Local Institution | Tenerife | |
| Spain | Local Institution | Teruel | |
| Spain | Local Institution | Zaragoza | |
| United Kingdom | Local Institution | Aldershot | Hampshire |
| United Kingdom | Local Institution | Bath | Wiltshire |
| United Kingdom | Local Institution | Bexhill-on-Sea | East Sussex |
| United Kingdom | Local Institution | Blackpool | Lancashire |
| United Kingdom | Local Institution | Glasgow | Lanarkshire |
| United Kingdom | Local Institution | Harrow | Middlesex |
| United Kingdom | Local Institution | Hastings | Sussex |
| United Kingdom | Local Institution | Inkberrow | Worcestershire |
| United Kingdom | Local Institution | Soham | Cambridgeshire |
| United Kingdom | Local Institution | Sunbury on Thames | Greater London |
| United Kingdom | Local Institution | Swan Lane | |
| United States | Local Institution | Altoona | Pennsylvania |
| United States | Local Institution | Anderson | South Carolina |
| United States | Local Institution | Anniston | Alabama |
| United States | Local Institution | Arden Hills | Minnesota |
| United States | Local Institution | Berkley | Michigan |
| United States | Local Institution | Bluefield | West Virginia |
| United States | Local Institution | Bristol | Tennessee |
| United States | Local Institution | Charlotte | North Carolina |
| United States | Local Institution | Chester | Maryland |
| United States | Local Institution | Chicago | Illinois |
| United States | Local Institution | Chipley | Florida |
| United States | Local Institution | Cincinnati | Ohio |
| United States | Local Institution | Colorado Springs | Colorado |
| United States | Local Institution | Corvallis | Oregon |
| United States | Local Institution | Cranston | Rhode Island |
| United States | Local Institution | Dallas | Texas |
| United States | Local Institution | Denver | Colorado |
| United States | Local Institution | Detroit | Michigan |
| United States | Local Institution | Duncan | South Carolina |
| United States | Local Institution | Dunwoody | Georgia |
| United States | Local Institution | East Syracuse | New York |
| United States | Local Institution | Encinitas | California |
| United States | Local Institution | Eugene | Oregon |
| United States | Local Institution | Excelsior Springs | Missouri |
| United States | Local Institution | Greensboro | North Carolina |
| United States | Local Institution | Gulfport | Mississippi |
| United States | Local Institution | Hickory | North Carolina |
| United States | Local Institution | Hoover | Alabama |
| United States | Local Institution | Houston | Texas |
| United States | Local Institution | Huntersville | North Carolina |
| United States | Local Institution | Huntsville | Alabama |
| United States | Local Institution | Irving | Texas |
| United States | Local Institution | Kansas City | Missouri |
| United States | Local Institution | Kingsport | Tennessee |
| United States | Local Institution | Knoxville | Tennessee |
| United States | Local Institution | Lake Jackson | Texas |
| United States | Local Institution | Lexington | Kentucky |
| United States | Local Institution | Little Rock | Arkansas |
| United States | Local Institution | Long Beach | California |
| United States | Local Institution | Los Angeles | California |
| United States | Local Institution | Loveland | Colorado |
| United States | Local Institution | Marshfield | Wisconsin |
| United States | Local Institution | Memphis | Tennessee |
| United States | Local Institution | Mesa | Arizona |
| United States | Local Institution | Miami | Florida |
| United States | Local Institution | Mission Viejo | California |
| United States | Local Institution | Mobile | Alabama |
| United States | Local Institution | Morehead City | North Carolina |
| United States | Local Institution | New Port Richey | Florida |
| United States | Local Institution | Oklahoma City | Oklahoma |
| United States | Local Institution | Olympia | Washington |
| United States | Local Institution | Overland Park | Kansas |
| United States | Local Institution | Pasadena | California |
| United States | Local Institution | Philadelphia | Pennsylvania |
| United States | Local Institution | Phoenix | Arizona |
| United States | Local Institution | Pinellas Park | Florida |
| United States | Local Institution | Portland | Oregon |
| United States | Local Institution | San Antonio | Texas |
| United States | Local Institution | San Diego | California |
| United States | Local Institution | Silver Springs | Maryland |
| United States | Local Institution | Simpsonville | South Carolina |
| United States | Local Institution | Slidell | Louisiana |
| United States | Local Institution | Springfield | Massachusetts |
| United States | Local Institution | St. Louis | Missouri |
| United States | Local Institution | Summerville | South Carolina |
| United States | Local Institution | The Colony | Texas |
| United States | Local Institution | Tucson | Arizona |
| United States | Local Institution | Tulsa | Oklahoma |
| United States | Local Institution | Vero Beach | Florida |
| United States | Local Institution | Walnut Creek | California |
| United States | Local Institution | Westlake Village | California |
| United States | Local Institution | Wheat Ridge | Colorado |
| United States | Local Institution | Wilmington | North Carolina |
| United States | Local Institution | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Brazil, Canada, France, Germany, Italy, Mexico, Netherlands, Peru, Puerto Rico, Russian Federation, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide | |||
| Secondary | Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24 |