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Clinical Trial Details

Trial ID: L6161
Source ID: NCT00327015
Associated Drug: Saxagliptin
Title: A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00327015/results
Conditions: Diabetes
Interventions: DRUG: Saxagliptin|DRUG: Saxagliptin|DRUG: Metformin|DRUG: Placebo|DRUG: pioglitazone
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy, Mean change from baseline in A1C at Week 24, adjusted for baseline value., Baseline, Week 24|Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy, Mean change from baseline in A1C at Week 24, adjusted for baseline value., Baseline, Week 24 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy, Mean change from baseline in FPG at Week 24, adjusted for baseline value., Baseline, Week 24|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy, Mean change from baseline in FPG at Week 24, adjusted for baseline value., Baseline, Week 24|Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy, Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24., Week 24|Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy, Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24., Week 24|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy, Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value., Baseline, Week 24|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy, Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value., Baseline, Week 24|Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy, Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24., Week 24|Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy, Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24., Week 24|Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy, Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone., Week 24|Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy, Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone., Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1306
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-05
Completion Date: 2008-12
Results First Posted: 2009-09-25
Last Update Posted: 2015-04-29
Locations: East Bay Clinical Trial Center, Concord, California, 94520, United States|Encompass Clinical Research, Encinitas, California, 92024, United States|Community Clinical Trials, Orange, California, 92868, United States|Coastal Biomedical Research Inc, Santa Monica, California, 90404, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|St. Joseph'S Medical Associates, Stockton, California, 95204, United States|Clinical Therapeutics Corporation, Coral Gables, Florida, 33134, United States|Florida Research Network, Llc, Gainesville, Florida, 32605, United States|Fpa Clinical Research, Kissimmee, Florida, 34741, United States|Emerald Coast Research Group, Marianna, Florida, 32446, United States|Baptist Diabetes Associates, Miami, Florida, 33156, United States|Middle Georgia Drug Study Center, Llc, Perry, Georgia, 31069, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|Adviso Medical Research, Llc, Chicago, Illinois, 60617, United States|Deerbrook Medical Associates, Vernon Hills, Illinois, 60061, United States|Physicians Research Group, Indianapolis, Indiana, 46250, United States|Professional Network Research Of Kansas, Wichita, Kansas, 67203, United States|Medical Arts Research Collaborative, Llc, Excelsior Springs, Missouri, 64024, United States|Nevada Alliance Against Diabetes, N. Las Vegas, Nevada, 89030, United States|Metrolina Medical Research, Charlotte, North Carolina, 28209, United States|Durham Internal Medicine Assoc., Durham, North Carolina, 27704, United States|Down East Medical Associates, Morehead City, North Carolina, 28557, United States|Midwest Regional Research, Inc., Bellbrook, Ohio, 45305, United States|Massillon Family Practice, Massillon, Ohio, 44646, United States|Your Diabetes Endocrine Nutrition Group, Mentor, Ohio, 44060, United States|Newark Physician Associates, Newark, Ohio, 43055, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|Safe Harbor Clinical Research, E. Providence, Rhode Island, 02914, United States|Internal Medicine Of Greer, Greer, South Carolina, 29651, United States|Middle Tennessee Clinical Research, Fayetteville, Tennessee, 37334, United States|Frontier Clinical Research, Llc., Memphis, Tennessee, 38103, United States|Capital Medical Clinic, Llp, Austin, Texas, 78705, United States|Endocrine Associates, Houston, Texas, 77004, United States|Advances In Health,Inc, Houston, Texas, 77030, United States|Juno Research, Llc, Houston, Texas, 77036, United States|Non Invasive Cardiovascular Pa, Houston, Texas, 77074, United States|Tiena Health Research, Irving, Texas, 75039, United States|Diabetes Center Of The Southwest, Midland, Texas, 79705, United States|Hill Country Medical Associates, New Braunfels, Texas, 78130, United States|Pearland Primary Care Associates, Llp, Pearland, Texas, 77584, United States|Med-Cure Primary Care Physicians, Rosenberg, Texas, 77471, United States|Gsa Research, San Antonio, Texas, 78213, United States|Covenant Clinical Research, Pa, San Antonio, Texas, 78229, United States|S.A.M. Clinical Research Center, San Antonio, Texas, 78229, United States|Seven Corners Medical Research Center, Falls Church, Virginia, 22044, United States|Salem Va Medical Ctr Research & Devlopment, Salem, Virginia, 24153, United States|Physicians Clinic Of Spokane, Spokane, Washington, 99204, United States|Local Institution, Belgrano, Buenos Aires, C1426EGP, Argentina|Local Institution, Capital Federal, Buenos Aires, 1221, Argentina|Local Institution, Capital Federal, Buenos Aires, C1406GWY, Argentina|Local Institution, Chacabuco, Buenos Aires, 6740, Argentina|Local Institution, La Plata, Buenos Aires, B1902COS, Argentina|Local Institution, Moron, Buenos Aires, B1708IFF, Argentina|Local Institution, San Martin, Buenos Aires, CP1405, Argentina|Local Institution, San Pedro, Buenos Aires, B2930DGO, Argentina|Local Institution, Zarate, Buenos Aires, 2800, Argentina|Local Institution, Rosario, Santa Fe, CP2000, Argentina|Local Institution, Lanus Este, Tucuman, 1824, Argentina|Local Institution, Buenos Aires, 1121, Argentina|Local Institution, Buenos Aires, B7602CBM, Argentina|Local Institution, Buenos Aires, C1117ABH, Argentina|Local Institution, Buenos Aires, C1408INH, Argentina|Local Institution, Buenos Aires, C1425AGC, Argentina|Local Institution, Buenos Aires, C1505CWB, Argentina|Local Institution, Mendoza, CP5500, Argentina|Local Institution, Salta, 4406, Argentina|Local Institution, Salta, A4400EMI, Argentina|Local Institution, San Juan, 5400, Argentina|Local Institution, Fortaleza, Ceara, 60021, Brazil|Local Institution, Fortaleza, Ceara, 60430, Brazil|Local Institution, Goiania, Goias, 74110, Brazil|Local Institution, Belem, Para, 66073, Brazil|Local Institution, Recife, Pe, 52051, Brazil|Local Institution, Porto Alegre, Rio Grande Do Sul, 90035, Brazil|Local Institution, Campinas, Sao Paulo, 13059, Brazil|Local Institution, Marília, Sao Paulo, 17519, Brazil|Local Institution, Sao Paulo, 01244, Brazil|Local Institution, Sao Paulo, 04020, Brazil|Local Institution, Aschaffenburg, 63739, Germany|Local Institution, Bad, 37431, Germany|Local Institution, Dresden, 01307, Germany|Local Institution, Dresden, O1219, Germany|Local Institution, Duisburg, 47051, Germany|Local Institution, Heidelberg, 69120, Germany|Local Institution, Kuenzing, 94550, Germany|Local Institution, Ludwigshafen, 67073, Germany|Local Institution, Magdeburg, 39112, Germany|Local Institution, Mainz, 55116, Germany|Local Institution, Mannheim, 68161, Germany|Local Institution, Saarbrücken, 66119, Germany|Local Institution, Vellmar, 34246, Germany|Local Institution, Wangen Im Allgau, 88239, Germany|Local Institution, Eger, 3300, Hungary|Local Institution, Gyula, 5700, Hungary|Local Institution, Szentes, 6600, Hungary|Local Institution, Szigetvár, 7900, Hungary|Local Institution, Érd, 2030, Hungary|Local Institution, Panjagutta, Hyderabad, Andhra Pradesh, 500082, India|Local Institution, Vasanth Nagar, Bangalore, 560052, India|Local Institution, Bangalore, Karnataka, 560010, India|Local Institution, Pune, Maharashtra, 411011, India|Local Institution, Kandivili West, Mumbai, 400067, India|Local Institution, Sarita Vihar, New Delhi, 110076, India|Local Institution, Chennai, Tamil Nadu, 680086, India|Local Institution, Bangalore, 560054, India|Local Institution, Chennai, 680004, India|Local Institution, Haryana, 132001, India|Local Institution, Rajasthan, 302001, India|Local Institution, Rajasthan, 334 003, India|Local Institution, Vellore, Tamilnadu, 632004, India|Local Institution, Catania, 20099, Italy|Local Institution, Genova, 16132, Italy|Local Institution, Milano, 20132, Italy|Local Institution, Perugia, 06124, Italy|Local Institution, Ravenna, 48100, Italy|Local Institution, Mexico, Distrito Federal, 06700, Mexico|Local Institution, Guadalajara, Jalisco, 44340, Mexico|Local Institution, Guadalajara, Jalisco, 44650, Mexico|Local Institution, Guadalajara, Jalisco, 44670, Mexico|Local Institution, Guadalajara, Jalisco, 45030, Mexico|Local Institution, Guadalajara, Jalisco, 45200, Mexico|Local Institution, Cuernavaca, Morelos, 62250, Mexico|Local Institution, Garza Garcia, Nuevo Leon, 66260, Mexico|Local Institution, Monterrey, Nuevo Leon, 64020, Mexico|Local Institution, Monterrey, Nuevo Leon, 64460, Mexico|Local Institution, Monterrey, Nuevo Leon, 64570, Mexico|Local Institution, Merida, Yucatan, 97070, Mexico|Local Institution, Aguascalientes, 20230, Mexico|Local Institution, Aguascalientes, 20232, Mexico|Local Institution, Cebu City, 6000, Philippines|Local Institution, Iloilo City, 5000, Philippines|Local Institution, Manila City, 1000, Philippines|Local Institution, Marikina City, 1800, Philippines|Local Institution, Pasig City, 1605, Philippines|Local Institution, Quezon City, 1100, Philippines|Local Institution, Gniewkowo, 88-140, Poland|Local Institution, Gorzow Wielkopolski, 66-400, Poland|Local Institution, Izabelin, 05-080, Poland|Local Institution, Krakow, 31-159, Poland|Local Institution, Lublin, 20-538, Poland|Local Institution, Michalow-Regionow, 05-119, Poland|Local Institution, Warszawa, 03-563, Poland|Local Institution, Wroclaw, 50-127, Poland|Local Institution, Zabrze, 41-800, Poland|Local Institution, Carolina, 00983, Puerto Rico|Local Institution, Ponce, 00716, Puerto Rico|Local Institution, Ponce, 00717, Puerto Rico|Local Institution, Rio Pieoras, 00926, Puerto Rico|Local Institution, San Juan, 00909, Puerto Rico|Local Institution, San Juan, 00920, Puerto Rico|Local Institution, Kemerovo, Russia, 650066, Russian Federation|Local Institution, Moscow, Russia, 117593, Russian Federation|Local Institution, Moscow, Russia, 123056, Russian Federation|Local Institution, Moscow, Russia, 125299, Russian Federation|Local Institution, Nizhniy Novgorod, Russia, 603018, Russian Federation|Local Institution, Izhevsk, 426000, Russian Federation|Local Institution, Kirov, 610030, Russian Federation|Local Institution, Krasnodar, 350012, Russian Federation|Local Institution, Krasnodar, 350042, Russian Federation|Local Institution, Kursk, 305035, Russian Federation|Local Institution, Moscow, 105229, Russian Federation|Local Institution, Moscow, 115093, Russian Federation|Local Institution, Moscow, 115280, Russian Federation|Local Institution, Moscow, 117292, Russian Federation|Local Institution, Moscow, 119034, Russian Federation|Local Institution, Moscow, 11992, Russian Federation|Local Institution, Moscow, 123423, Russian Federation|Local Institution, Moscow, 125315, Russian Federation|Local Institution, Moscow, 127486, Russian Federation|Local Institution, Moscow, 127644, Russian Federation|Local Institution, Moscow, 129010, Russian Federation|Local Institution, Moscow, 129119, Russian Federation|Local Institution, Moscow, 129327, Russian Federation|Local Institution, Nizhniy Novgorod, 603126, Russian Federation|Local Institution, Novosibirsk, 630047, Russian Federation|Local Institution, Novosibirsk, 630087, Russian Federation|Local Institution, Perm, 614095, Russian Federation|Local Institution, Rostov-Na-Donu, 344022, Russian Federation|Local Institution, Rostov-Na-Donu, 344029, Russian Federation|Local Institution, Saint Petersburg, 198013, Russian Federation|Local Institution, Saratov, 410024, Russian Federation|Local Institution, Saratov, 410028, Russian Federation|Local Institution, Saratov, 410053, Russian Federation|Local Institution, Saratov, 410054, Russian Federation|Local Institution, Smolensk, 214018, Russian Federation|Local Institution, St Petersburg, 193015, Russian Federation|Local Institution, St-Petersburg, 197022, Russian Federation|Local Institution, St. Peterburg, 195257, Russian Federation|Local Institution, St. Petersburg, 193312, Russian Federation|Local Institution, St. Petersburg, 195112, Russian Federation|Local Institution, St. Petersburg, 197198, Russian Federation|Local Institution, St.Petersburg, 191119, Russian Federation|Local Institution, St.Petersburg, 192177, Russian Federation|Local Institution, St.Petersburg, 194354, Russian Federation|Local Institution, St.Petersburg, 195176, Russian Federation|Local Institution, Tuymen, 625023, Russian Federation|Local Institution, Vladimir, 600023, Russian Federation|Local Institution, Volgograd, 400001, Russian Federation|Local Institution, Volgograd, 400107, Russian Federation|Local Institution, Yaroslaval, 150003, Russian Federation|Local Institution, Yaroslavl, 150003, Russian Federation|Local Institution, Dniepropetrovsk, 49044, Ukraine|Local Institution, Kharkiv, 61039, Ukraine|Local Institution, Kharkiv, 61176, Ukraine|Local Institution, Kyiv, 03680, Ukraine|Local Institution, Kyiv, 4050, Ukraine|Local Institution, Lutsk, 43024, Ukraine|Local Institution, Lviv, 790015, Ukraine|Local Institution, Lviv, 79013, Ukraine|Local Institution, Odessa, 65025, Ukraine|Local Institution, Ternopil, 46001, Ukraine
URL: https://clinicaltrials.gov/show/NCT00327015

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D447 Saxagliptin small molecule DB06335 Details
D089 Metformin small molecule DB00331 Details
D336 Pioglitazone small molecule DB01132 Details