Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6358
Source ID: NCT00295633
Associated Drug: Saxagliptin
Title: A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00295633/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Saxagliptin|DRUG: Saxagliptin|DRUG: Placebo|DRUG: pioglitazone|DRUG: rosiglitazone|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 Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD 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 achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value., Baseline, Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 565
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-03
Completion Date: 2008-10
Results First Posted: 2009-09-25
Last Update Posted: 2015-04-07
Locations: Winston Technology, Inc., Haleyville, Alabama, 35565, United States|Sunbelt Research Group, Llc, Mobile, Alabama, 36606, United States|Iicr, Inc., Ozark, Alabama, 36360, United States|Clinical Research Advantage, Inc, Mesa, Arizona, 85213, United States|Nea Clinic, Jonesboro, Arkansas, 72401, United States|Little Rock Family Practice Clinic, Little Rock, Arkansas, 72205, United States|Impact Clinical Trials, Beverly Hills, California, 90211, United States|Lovelace Scientific Resources, Inc., Beverly Hills, California, 90211, United States|Medical Group Of Encino, Encino, California, 91436, United States|Marin Endocrine Care And Research, Inc., Greenbrae, California, 94904, United States|Del Rosario Medical Clinic, Inc., Huntington Park, California, 90255, United States|Loma Linda Va Healthcare Systems, Loma Linda, California, 92357, United States|Peak Health Medical Group, Los Angeles, California, 90025, United States|Richard Cherlin, Md, Los Gatos, California, 95032, United States|Mission Internal Medical Group, Mission Viejo, California, 92691, United States|Desert Medical Advances, Palm Desert, California, 92260, United States|Denver Internal Medicine Group, Denver, Colorado, 80209, United States|Stamford Therapeutics Consortium, Stamford, Connecticut, 06905, United States|Phoenix Internal Medicine Associates, Llc, Waterbury, Connecticut, 06708, United States|Central Florida Clinical Trials, Inc., Altamonte Springs, Florida, 32714, United States|Southern Family Healthcare, Pa, Chipley, Florida, 32428, United States|Doctors Medical Center Of Walton County, Defuniak Springs, Florida, 32435, United States|Horizon Institute For Clinical Research, Hollywood, Florida, 33021, United States|Jacksonville Center For Clinical Research, Jacksonville, Florida, 32205, United States|Panhandle Family Care Associates, Marianna, Florida, 32446, United States|Nextphase Clinical Trials, Inc, Miami, Florida, 33145, United States|Baptist Diabetes Associates, Miami, Florida, 33156, United States|Heart & Vascular Center Research, Inc., Sarasota, Florida, 34239, United States|Alan B. Miller, Md, Dunwoody, Georgia, 30338, United States|Marietta Clinical Research, Inc., Marietta, Georgia, 30060, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|D. Thomas Rogers, Md, Facs, Kahului, Hawaii, 96732, United States|Southeast Idaho Family Practice, Idaho Falls, Idaho, 83404, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Physicians Research Group, Indianapolis, Indiana, 46250, United States|Northwest Indiana Center For Clinical Research, Valparaiso, Indiana, 46383, United States|Lipid Research Clinic, Iowa City, Iowa, 52242, United States|Professional Research Network Of Kansas, Wichita, Kansas, 67203, United States|Mouhaffel, Assad H., West Monroe, Louisiana, 71291, United States|Promed Physicians Family Practice, Portage, Michigan, 49024, United States|Olive Branch Family Medical Center, Olive Branch, Mississippi, 38654, United States|Radiant Research Las Vegas, Las Vegas, Nevada, 89146, United States|Nevada Alliance Against Diabetes, North Las Vegas, Nevada, 89030, United States|Office Of Ammar Bazerbashi, Md, Holmdel, New Jersey, 07733, United States|Urgentmed, P.C., South Bound Brook, New Jersey, 08880, United States|Medical Research Associates Of Charlotte, Inc., Charlotte, North Carolina, 28211, United States|Carolina Pharmaceutical Research, Statesville, North Carolina, 28625, United States|Community Health Care, Canal Fulton, Ohio, 44614, United States|Clinical Research Limited, Canton, Ohio, 44718, United States|Rapid Medical Research, Inc., Cleveland, Ohio, 44122, United States|Providence Health Partners - Center For Clinical Research, Dayton, Ohio, 45439, United States|Holzer Clinic, Gallipolis, Ohio, 45631, United States|Wells Institute For Health Awareness, Kettering, Ohio, 45429, United States|David Witkin, Md, Eugene, Oregon, 97401, United States|Harleysville Medical Associates, Harleysville, Pennsylvania, 19438, United States|Family Medical Associates, Levittown, Pennsylvania, 19056, United States|Banksville Medical Pc, Pittsburgh, Pennsylvania, 15216, United States|Three Rivers Medical Associates, Pa, Columbia, South Carolina, 29201, United States|Radiant Research, Greer, Greer, South Carolina, 29651, United States|Upstate Pharmaceutical Research, Simpsonville, South Carolina, 29681, United States|East Tennessee Medical Group, Alcoa, Tennessee, 37701, United States|Healthstar Physicians, Morristown, Tennessee, 37813, United States|Hayes Endocrine And Diabetes Center, Nashville, Tennessee, 37209, United States|Capital Medical Clinic, Llp, Austin, Texas, 78705, United States|Texas Diabetes And Endocrinology, P.A., Austin, Texas, 78731, United States|Radiant Research-Austin, Austin, Texas, 78752, United States|Priscilla Hollander, Md, Phd, Dallas, Texas, 75246, United States|The Medical Group Of Texas, Fort Worth, Texas, 76104, United States|Mobley Research Center, Houston, Texas, 77024, United States|Family Physician, Pa, Houston, Texas, 77074, United States|Mapleridge Medical Center, Houston, Texas, 77081, United States|Diabetes Center Of The Southwest, Midland, Texas, 79705, United States|Pearland Primary Care Associates, Llp, Pearland, Texas, 77584, United States|Med-Cure, Rosenberg, Texas, 77471, United States|Radiant Research San Antonio, San Antonio, Texas, 78229, United States|S.A.M. Clinical Research Center, San Antonio, Texas, 78229, United States|Collom And Carney Clinic, Texarkana, Texas, 75503, United States|National Clinical Research, Inc., Richmond, Virginia, 23294, United States|Tidewater Integrated Medical Research, Virginia Beach, Virginia, 23451, United States|Local Institution, Belgrano, Buenos Aires, C1426EGP, Argentina|Local Institution, Chacabuco, Buenos Aires, B6740CWC, Argentina|Local Institution, Ciudad Auton., Buenos Aires, C1505CWB, Argentina|Local Institution, La Plata, Buenos Aires, 1900, Argentina|Local Institution, Moron, Buenos Aires, B17081FF, Argentina|Local Institution, Ciudad De Mendoza, Mendoza, M5519XAC, Argentina|Local Institution, Rosario, Santa Fe, S2000CVD, Argentina|Local Institution, Lanus Este, Tucuman, 1824, Argentina|Local Institution, Buenos Aires, C1408INH, Argentina|Local Institution, Buenos Aires, C1425AGC, Argentina|Local Institution, St. Johns, Newfoundland and Labrador, A1E 2C2, Canada|Local Institution, Halifax, Nova Scotia, B3H 2Y9, Canada|Local Institution, Sarnia, Ontario, N7T 4X3, Canada|Local Institution, St Catharines, Ontario, L2R 7P3, Canada|Local Institution, St-Leonard, Quebec, H1S 3A9, Canada|Local Institution, Ste-Foy, Quebec, G1V 4G2, Canada|Local Institution, Saskatoon, Saskatchewan, S7K 3H3, Canada|Local Institution, Bangalore, 560010, India|Local Institution, Bangalore, 560054, India|Local Institution, Chennai, 600010, India|Local Institution, Chennai, 600013, India|Local Institution, Chennai, 600086, India|Local Institution, Chennai, 680004, India|Local Institution, Hariyana, 132001, India|Local Institution, Hyderabad, 500082, India|Local Institution, Indore, 452001, India|Local Institution, Maharashtra, 411011, India|Local Institution, Mangalore, 575001, India|Local Institution, Mumbai, 400021, India|Local Institution, Mumbai, 400067, India|Local Institution, Pune, 411011, India|Local Institution, Vellore, 632004, India|Local Institution, Chichuahua, Chihuahua, 31000, Mexico|Local Institution, Angeles Del Pedregal, Distrito Federal, 10700, Mexico|Local Institution, Zapopan, Jalisco, 45200, Mexico|Local Institution, Michoacan, Morelos, 58000, Mexico|Local Institution, Monterrey, Nuevo Leon, 66260, Mexico|Local Institution, Aguascalientes, 20232, Mexico|Local Institution, Cercado De Lima, Lima, 1, Peru|Local Institution, La Victoria, Lima, 13, Peru|Local Institution, Miraflores, Lima, 18, Peru|Local Institution, San Isidro, Lima, 27, Peru|Local Institution, San Martin De Porres, Lima, 31, Peru|Local Institution, Santiago De Surco, Lima, 33, Peru|Local Institution, Cebu City, 1600, Philippines|Local Institution, Cebu City, 6000, Philippines|Local Institution, Iloilo City, 5000, Philippines|Local Institution, Las Pinas, 1740, Philippines|Local Institution, Pasig City, 1600, Philippines|Local Institution, Carolina, 00983, Puerto Rico|Local Institution, Ponce, 00716, Puerto Rico|Local Institution, Ponce, 00717, Puerto Rico|Local Institution, Rio Piedras, 00926, Puerto Rico|Local Institution, San Juan, 00920, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT00295633

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D447 Saxagliptin small molecule DB06335 Details
D336 Pioglitazone small molecule DB01132 Details
D116 Rosiglitazone small molecule DB00412 Details
D089 Metformin small molecule DB00331 Details