Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2118
Source ID: NCT00316082
Associated Drug: Saxagliptin
Title: Study of BMS-477118 as Monotherapy With Titration 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/NCT00316082/results
Conditions: Diabetes
Interventions: DRUG: Saxagliptin|DRUG: Saxagliptin|DRUG: Saxagliptin|DRUG: Saxagliptin|DRUG: Placebo|DRUG: metformin
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1 (A1C) at Week 24, Mean change from baseline in A1C at Week 24, adjusted for baseline value., Baseline, Week 24 | Secondary: Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM, Mean change from baseline in A1C at Week 24, adjusted for baseline value., Baseline, Week 24|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, 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, Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo 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, Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value., Baseline, Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 365
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-06
Completion Date: 2008-11
Results First Posted: 2009-09-25
Last Update Posted: 2015-04-29
Locations: Tomac, Inc., Columbiana, Alabama, 35051, United States|Winston Technology, Inc., Haleyville, Alabama, 35565, United States|Clinical Reseacrh Advantage/ Brown Family Medicine, Mesa, Arizona, 85213, United States|Strategos Medical Group, Bakersfield, California, 93311, United States|Providence Clinical Research, Burbank, California, 91505, United States|Rx For Life, Inc, Cudahy, California, 90201, United States|Medical Group Of Encino, Encino, California, 91436, United States|Southland Clinical Research Center, Inc., Fountain Valley, California, 92708, United States|Valley Research, Fresno, California, 93720, United States|Diabetes Medical Center Of California, Northridge, California, 91325, United States|In Private Prictice Clinic, Pico Rivera, California, 90660, United States|San Jose Clinical Research, Inc., San Jose, California, 95128, United States|Central Florida Clinical Trials, Inc., Altamonte Springs, Florida, 32714, United States|Accelovance, Melbourne, Florida, 32935, United States|University Family Healthcare, Pa, Sarasota, Florida, 34243, United States|Premier Healthcare, St. Petersburg, Florida, 33707, United States|Pinnacle Medical Research, Overland Park, Kansas, 66215, United States|Kansas City University Of Medicine And Biosciences, Kansas City, Missouri, 64106, United States|Primary Care Physicians, Pc, Wentzville, Missouri, 63385, United States|Physicians Research Center, Toms River, New Jersey, 08755, United States|Hudson Valley Clinical Research Center, Kingston, New York, 12401, United States|Neem Research Group Of Charlotte, Charlotte, North Carolina, 28262, United States|Diabetes Center- East Carolina University, Greenville, North Carolina, 27834, United States|Crescent Medical Research, Salisbury, North Carolina, 28144, United States|Community Health Care, Inc., Barberton, Ohio, 44203, United States|Clinical Research Limited, Canton, Ohio, 44718, United States|Wells Institute For Health Awareness, Kettering, Ohio, 45429, United States|Clinical Research Source, Inc, Perrysburg, Ohio, 43551, United States|Accelovance, Oklahoma City, Oklahoma, 73112, United States|Integris Family Care South, Oklahoma City, Oklahoma, 73170, United States|The Office Of Patricia Buchanan, Eugene, Oregon, 97404, United States|Cumberland Valley Endocrinology Center, Llc, Carlisle, Pennsylvania, 17015, United States|Fleetwood Clinical Research, Fleetwood, Pennsylvania, 19522, United States|Banksville Medical, Pc, Pittsburgh, Pennsylvania, 15216, United States|Biomedical Research Associates, Llc, Shippensburg, Pennsylvania, 17257, United States|Middle Tyger Family Medicine, Duncan, South Carolina, 29334, United States|Southeastern Research Assoc, Taylors, South Carolina, 29687, United States|Versoza & Ungab Internal Medicine Associates, Bartlett, Tennessee, 38134, United States|Collierville Medical Specialist, Collierville, Tennessee, 38017, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Med-South Research, Memphis, Tennessee, 38116, United States|Southwind Medical Specialist, Memphis, Tennessee, 38125, United States|Precision Family Medicine, Carrollton, Texas, 75010, United States|Alpha Therapy Research Center, Corpus Christi, Texas, 78411, United States|Village Family Practice, Houston, Texas, 77024, United States|Texas Center For Drug Development, P.A., Houston, Texas, 77081, United States|Abbott Clinical Research Group, Inc, San Antonio, Texas, 78224, United States|Taylor/Wade Medical, Bountiful, Utah, 84010, United States|Optimum Clinical Research, Salt Lake City, Utah, 84102, United States|Tidewater Integrated Medical Research, Virginia Beach, Virginia, 23451, United States|Spokane Internal Medicine, Spokane, Washington, 99216, United States|Local Institution, Manipal, Karnataka, 576104, India|Local Institution, Kochi, Kerala, 682026, India|Local Institution, Attavar, Mangalore, 575001, India|Local Institution, Sarita Vihar, New Delhi, 110076, India|Local Institution, Bangalore, 560034, India|Local Institution, Mumbai, 400007, India|Local Institution, Mumbai, 400021, India|Local Institution, Nagpur, 440012, India|Local Institution, Moscov, 118089, Russian Federation|Local Institution, Moscow, 115487, Russian Federation|Local Institution, Nizhniy Novgorod, 603126, Russian Federation|Local Institution, Saint Petersburg, 198013, Russian Federation|Local Institution, Saratov, 410018, Russian Federation|Local Institution, Saratov, 410054, Russian Federation|Local Institution, Smolensk, 214018, Russian Federation|Local Institution, St.Petersburg, 194156, Russian Federation|Local Institution, Volgograd, 400138, Russian Federation|Local Institution, Changhua, 500, Taiwan|Local Institution, Kaohsiung County, 833, Taiwan|Local Institution, Taichung City, 407, Taiwan|Local Institution, Taichung, 402, Taiwan|Local Institution, Taipei City, 114, Taiwan|Local Institution, Tao-Yuan County, 333, Taiwan
URL: https://clinicaltrials.gov/show/NCT00316082

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