Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5936
Source ID: NCT00313313
Associated Drug: Saxagliptin
Title: A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00313313/results
Conditions: Diabetes
Interventions: DRUG: Saxagliptin|DRUG: Saxagliptin|DRUG: Glyburide|DRUG: Placebo|DRUG: Glyburide|DRUG: Metformin
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (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 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 plus glyburide versus placebo plus upward titrated glyburide 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 values., Baseline, Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 768
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-04
Completion Date: 2008-09
Results First Posted: 2009-09-25
Last Update Posted: 2015-05-04
Locations: Reserach Solutions, Llc, Jonesboro, Arkansas, 72401, United States|Searcy Medical Center, Searcy, Arkansas, 72143, United States|Stewart Medical Group, Alhambra, California, 91801, United States|Southland Clinical Research Center, Inc., Fountain Valley, California, 92708, United States|Valley Research, Fresno, California, 93720, United States|Randall Shue, D.O., Los Angeles, California, 90023, United States|Clinical Trials Research, Roseville, California, 95661, United States|New West Physicians, Golden, Colorado, 80401, United States|Phoenix Internal Medicine Associates, Llc, Waterbury, Connecticut, 06708, United States|Christiana Care Research Institute, Newark, Delaware, 19713, United States|Central Florida Clinical Trials, Altamonte Springs, Florida, 32714, United States|Family Care Assoc & Emerald Care Res Grp, Chipley, Florida, 32428, United States|Clinical Therapeutics Corporation, Coral Gables, Florida, 33134, United States|Fpa Clinical Research, Kissimmee, Florida, 34741, United States|Emerald Coast Research Group, Marianna, Florida, 32446, United States|University Of Miami Diabetes Research Inst., Miami, Florida, 33136, United States|Atlanta Pharmaceutical Research Center, Inc, Dunwoody, Georgia, 30338, United States|Cedar-Crosse Research Ctr, Chicago, Illinois, 60607, United States|Family Medical Center Of Hart Co., Munfordville, Kentucky, 42765, United States|Columbia Medical Practice, Columbia, Maryland, 21045, United States|Va Medical Center, Kansas City, Missouri, 64128, United States|St. Louis Center For Clinical Research, St. Louis, Missouri, 63128, United States|Nevada Alliance Against Diabetes, North Las Vegas, Nevada, 89030, United States|Physicians Research Center, Toms River, New Jersey, 08755, United States|Cny Family Care, East Syracuse, New York, 13057, United States|Metrolina Internal Medicine, Charlotte, North Carolina, 28204, United States|Med Res Assoc Charlotte, Charlotte, North Carolina, 28211, United States|Regional Physicians Research, High Point, North Carolina, 27262, United States|Diabetes & Endocrinology Consultants, Pc, Morehead City, North Carolina, 28557, United States|Mountain Top Clinical Research Center, Sparta, North Carolina, 28675, United States|Daystar Clinical Research, Inc., Akron, Ohio, 44313, United States|Community Health Care, Canal Fulton, Ohio, 44614, United States|Triphase Research, Ltd., Franklin, Ohio, 45005, United States|Albert J Weisbrot,Md&Assoc Inc, Mason, Ohio, 45040, United States|Dr Bahagwan Dass Md, Youngstown, Ohio, 44507, United States|Oklahoma Cardiovascular And Hypertension Center, Oklahoma City, Oklahoma, 73132, United States|Utica Park Clinic, Tulsa, Oklahoma, 74104, United States|Integris Family Care Yukon, Yukon, Oklahoma, 73109, United States|Coordinators Plus, Llc, Eugene, Oregon, 97401, United States|Oregon Clinical Research, Portland, Oregon, 97220, United States|Pearl Clinical Research, Norristown, Pennsylvania, 19401, United States|Banksville Medical Pc, Pittsburgh, Pennsylvania, 15216, United States|Guthrie Clinic, Ltd, Sayre, Pennsylvania, 18840, United States|Upstate Pharmaceutical Research, Simsonville, South Carolina, 29681, United States|Spartanburg Medical Research, Spartanburg, South Carolina, 29303, United States|Southeastern Research Assoc, Taylors, South Carolina, 29687, United States|Capital Medical Clinic, Llp, Austin, Texas, 78705, United States|Texas Center For Drug Development, P.A., Houston, Texas, 77081, United States|Breath Of Life Research Institute, Katy, Texas, 77450, United States|Diabetes & Glandular Disease Research Assoc, Pa, San Antonio, Texas, 78229, United States|S.A.M. Clinical Research Center, San Antonio, Texas, 78229, United States|Tidewater Integrated Medical Research, Virginia Beach, Virginia, 23451, United States|Office Of Dr. Gray, Spokane, Washington, 99216, United States|Advanced Healthcare S.C., Milwaukee, Wisconsin, 53209, United States|Local Institution, Mar Del Plata, Buenos Aires, 7600, Argentina|Local Institution, Buenos Aires, C1406FEQ, Argentina|Local Institution, Buenos Aires, C1425AGC, Argentina|Local Institution, Cordoba, 5000, Argentina|Local Institution, B. Rodolfo Teofilo, Ceara, 60430, Brazil|Local Institution, Fortaleza, Ceara, 60021, Brazil|Local Institution, Belo Horizonte, Minas Gerais, 30150, Brazil|Local Institution, Belem, Para, 66073, Brazil|Local Institution, Porto Alegre, Rio Grande Do Sul, 90035003, Brazil|Local Institution, Porto Alegre, Rio Grande Do Sul, 90610, Brazil|Local Institution, Campinas, Sao Paulo, 13059, Brazil|Local Institution, Marília, Sao Paulo, 17519, Brazil|Local Institution, Sao Paulo - Sp, Sao Paulo, 04231, Brazil|Local Institution, Vila Mariana, Sao Paulo, 04020, Brazil|Local Institution, Hong Kong, SAR, Hong Kong|Local Institution, Kowloon, Hong Kong|Local Institution, Givatayim, 53583, Israel|Local Institution, Haifa, 31096, Israel|Local Institution, Holon, 58100, Israel|Local Institution, Jerusalem, 91120, Israel|Local Institution, Rishon Le-Zion, 75650, Israel|Local Institution, Tel Aviv, 64353, Israel|Local Institution, Zefat, 13100, Israel|Local Institution, Zerifin, 70300, Israel|Local Institution, Kyunggi-Do, 420-717, Korea, Republic of|Local Institution, Kyunggi-Do, 463-707, Korea, Republic of|Local Institution, Seoul, 120-752, Korea, Republic of|Local Institution, Seoul, 130-702, Korea, Republic of|Local Institution, Seoul, 135-710, Korea, Republic of|Local Institution, Seoul, 135-720, Korea, Republic of|Local Institution, Seoul, 137040, Korea, Republic of|Local Institution, Suwon, 443721, Korea, Republic of|Local Institution, Tijuana, B.C., Baja California, 22320, Mexico|Local Institution, Df, Distrito Federal, 11800, Mexico|Local Institution, Guadalajara, Jalisco, 44340, Mexico|Local Institution, Guadalajara, Jalisco, 44670, Mexico|Local Institution, Cuernavaca, Morelos, 62250, Mexico|Local Institution, Monterrey, Nuevo Leon, 64060, Mexico|Local Institution, Monterrey, Nuevo Leon, 64710, Mexico|Local Institution, Merida, Yucatan, 97210, Mexico|Local Institution, Durango, 64710, Mexico|Local Institution, San Isidro, Lima, 27, Peru|Local Institution, Lima, 18, Peru|Local Institution, Lima, LIMA 1, Peru|Local Institution, Lima, LIMA 31, Peru|Local Institution, Cebu, 6000, Philippines|Local Institution, Manila, 1000, Philippines|Local Institution, Quezon, 1102, Philippines|Local Institution, Carolina, 00983, Puerto Rico|Local Institution, Guaynabo, 00966, Puerto Rico|Local Institution, Ponce, 00716, Puerto Rico|Local Institution, Ponce, 00717, Puerto Rico|Local Institution, Singapore, 119074, Singapore|Local Institution, Umhlanga Rocks, Kwa Zulu Natal, 4319, South Africa|Local Institution, Kimberley, Northern Cape, 8301, South Africa|Local Institution, Tygerberg, Western Cape, 7505, South Africa|Local Institution, Cape Town, 7008, South Africa|Local Institution, Johannesburg, 2196, South Africa|Local Institution, Changhua, 500, Taiwan|Local Institution, Taichung, 402, Taiwan|Local Institution, Taipei, 112, Taiwan
URL: https://clinicaltrials.gov/show/NCT00313313

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