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Clinical Trial Details

Trial ID: L6733
Source ID: NCT01606007
Associated Drug: Saxagliptin
Title: Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01606007/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Saxagliptin|DRUG: Metformin XR|DRUG: Dapagliflozin|DRUG: Placebo matching with Dapagliflozin|DRUG: Placebo matching with Saxagliptin
Outcome Measures: Primary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24, HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue., Baseline (Week 0) and at Week 24 | Secondary: Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF]), Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue., Baseline (Week 0) and at Week 24|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue., Baseline (Week 0) and at Week 24|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]), Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin., At Week 24|Adjusted Mean Change From Baseline in Body Weight at Week 24, Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue., Baseline (Week 0) and at Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1282
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-07
Completion Date: 2014-01
Results First Posted: 2015-10-20
Last Update Posted: 2017-05-15
Locations: Central Alabama Research, Birmingham, Alabama, 35209, United States|Central Alabama Research, Homewood, Alabama, 35244, United States|Terence T. Hart, Md, Muscle Shoals, Alabama, 35662, United States|International Institute Of Clinical Research, Ozark, Alabama, 36360, United States|Clinical Research Advantage, Mesa, Arizona, 85206, United States|Elite Clinical Studies, Llc, Phoenix, Arizona, 85018, United States|Genova Clinical Research, Tucson, Arizona, 85704, United States|Medical Investigations, Inc., Little Rock, Arkansas, 72205, United States|Aureus Research, Inc., Little Rock, Arkansas, 72211, United States|Southland Clinical Research Center, Inc., Fountain Valley, California, 92708, United States|Torrance Clinical Research, Lomita, California, 90717, United States|National Research Inst, Los Angeles, California, 90057, United States|Providence Clinical Research, North Hollywood, California, 91606, United States|Diabetes Medical Center Of California, Northridge, California, 91325, United States|Mehrdad Kevin Ariani Md, Inc., Northridge, California, 91325, United States|Lucita M. Cruz,Md.,Inc., Norwalk, California, 90650, United States|Center For Clinical Trials, Llc., Paramount, California, 90723, United States|Center For Clinical Trials Of Sacramento, Inc., Sacramento, California, 95823, United States|Trinitas Research, Inc, San Jose, California, 95116, United States|Orange County Research Center, Tustin, California, 92780, United States|Clinical Research Advantage, Colorado Springs, Colorado, 80906, United States|Infocus Clinical Research, Denver, Colorado, 80211, United States|Lynn Institute Of Denver, Denver, Colorado, 80246, United States|Southeast Clinical Research, Llc, Chiefland, Florida, 32626, United States|Clinical Therapeutics Corporation, Coral Gables, Florida, 33134, United States|Southeast Clinical Research, Llc, Jacksonville, Florida, 32216, United States|Fpa Clinical Research, Kissimmee, Florida, 34741, United States|Newphase Clinical Trials, Inc., Miami Beach, Florida, 33140, United States|Clinical Research Of Miami, Inc., Miami, Florida, 33126, United States|Advanced Pharma Cr, Llc, Miami, Florida, 33136, United States|Omega Research Consultants, Llc, Orlando, Florida, 32804, United States|Palm Harbor Medical Associates, Palm Harbor, Florida, 34684, United States|Andres Patron, Do Pa, Pembroke Pines, Florida, 33026, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607-4559, United States|Deerbrook Medical Associates, Vernon Hills, Illinois, 60061, United States|Clinical Research Advantage, Council Bluffs, Iowa, 51503, United States|Horizon Research Group Of Opelousas, Llc, Eunice, Louisiana, 70535, United States|Associated Internal Medicine Specialists, Battle Creek, Michigan, 49015, United States|Harris And Associates, P.C., Detroit, Michigan, 48235, United States|Patterson Medical Clinic, Florissant, Missouri, 63031, United States|Bellevue Family Practice, Bellevue, Nebraska, 68005, United States|Clinical Research Advantage, Elkhorn, Nebraska, 68022, United States|Clinical Research Advantage, Fremont, Nebraska, 68025, United States|Clinical Research Advantage, Omaha, Nebraska, 68130, United States|South Jersey Medical Associates, P.A., Blackwood, New Jersey, 08012, United States|Central Jersey Health And Medical Research, Elizabeth, New Jersey, 07205, United States|Southgate Medical Group, West Seneca, New York, 14224, United States|Metrolina Internal Medicine, Charlotte, North Carolina, 28204, United States|Triad Clinical Trials, Llc, Greensboro, North Carolina, 27410, United States|Diabetes & Endocrinology Consultants, Morehead City, North Carolina, 28557, United States|Pmg Research Of Winston-Salem, Llc, Winston-salem, North Carolina, 27103, United States|Daystar Clinical Resarch, Inc., Akron, Ohio, 44313, United States|Sterling Research Grp, Ltd., Cincinnati, Ohio, 45246, United States|Rapid Medical Research, Inc., Cleveland, Ohio, 44122, United States|Primed Clinical Research, Dayton, Ohio, 45419, United States|Physicians Research, Inc., Zanesville, Ohio, 43701, United States|Lynn Institute Of Norman, Norman, Oklahoma, 73069, United States|Willamette Valley Clinical Studies, Eugene, Oregon, 97404, United States|Oregon Clinical Research, Portland, Oregon, 97220, United States|Heritage Valley Medical Group, Beaver, Pennsylvania, 15009, United States|Wellmon Family Practice, Shippensburg, Pennsylvania, 17257, United States|Tlm Medical Services, Columbia, South Carolina, 29204, United States|Palmetto Clinical Trial Services Llc, Fountain Inn, South Carolina, 29644, United States|Holston Medical Group, Bristol, Tennessee, 37620, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Pmg Research Of Knoxville, Knoxville, Tennessee, 37912, United States|Arlington Family Research Center, Inc., Arlington, Texas, 76012, United States|Padre Coast Clinical Research, Corpus Christi, Texas, 78404, United States|Dallas Diabetes & Endocrine Center, Dallas, Texas, 75230-2548, United States|Excel Clinical Research, Llc, Houston, Texas, 77035, United States|North Hills Medical Research, Inc., North Richland Hills, Texas, 76180, United States|Med-Olam Clinical Research, Pasadena, Texas, 77504, United States|Sam Clinical Research Center, San Antoinio, Texas, 78229, United States|Covenant Clinical Research, Pa, San Antonio, Texas, 78229, United States|Hillcrest Family Health Center, Waco, Texas, 76710, United States|Val R. Hansen, M.D., Bountiful, Utah, 84010, United States|Highland Clinical Research, Salt Lake City, Utah, 84124, United States|Southwestern Vermont Med Cntr, Bennington, Vermont, 05201, United States|Hampton Roads Center For Clinical Research, Inc., Suffolk, Virginia, 23435, United States|Local Institution, Coquitlam, British Columbia, V3K 3V9, Canada|Local Institution, Winnipeg, Manitoba, R3E3P4, Canada|Local Institution, Brampton, Ontario, L6T 0G1, Canada|Local Institution, Smiths Falls, Ontario, K7A 4W8, Canada|Local Institution, Toronto, Ontario, M9W 4L6, Canada|Local Institution, Granby, Quebec, J2G 8Z9, Canada|Local Institution, Saskatoon, Saskatchewan, S7K 3H3, Canada|Local Institution, Quebec, G1N 4V3, Canada|Local Institution, Bucheon, Gyeonggi-do, 420-717, Korea, Republic of|Local Institution, Sungnam-si, Gyeonggi-do, 463-712, Korea, Republic of|Local Institution, Daegu, 700-721, Korea, Republic of|Local Institution, Incheon, 405-760, Korea, Republic of|Local Institution, Seoul, 110-774, Korea, Republic of|Local Institution, Seoul, 120-752, Korea, Republic of|Local Institution, Seoul, 137-701, Korea, Republic of|Local Institution, Guadalajara, Jalisco, 44670, Mexico|Local Institution, Cuautla, Morelos, 62744, Mexico|Local Institution, Monterrey, Nuevo Leon, 64460, Mexico|Local Institution, Monterrey, Nuevo Leon, 64710, Mexico|Local Institution, Merida, Yucatan, 97070, Mexico|Local Institution, Aguascalientes, 20230, Mexico|Local Institution, Chihuahua, 31217, Mexico|Local Institution, Durango, 34000, Mexico|Local Institution, Gdansk, 80-546, Poland|Local Institution, Katowice, 40-057, Poland|Local Institution, Katowice, 40954, Poland|Local Institution, Krakow, 30-015, Poland|Local Institution, Lodz, 90-242, Poland|Local Institution, Opole, 45-367, Poland|Local Institution, Poznan, 61-655, Poland|Local Institution, Pulawy, 24-100, Poland|Local Institution, Warszawa, 03-580, Poland|Local Institution, Cidra, 00739, Puerto Rico|Local Institution, Manati, 00674, Puerto Rico|Local Institution, Ponce, 00716, Puerto Rico|Local Institution, San Juan, 00909, Puerto Rico|Local Institution, San Juan, 00926, Puerto Rico|Local Institution, San Juan, 00935, Puerto Rico|Local Institution, Villa Fontana, 00983, Puerto Rico|Local Institution, Ploiesti, Prahova, 100018, Romania|Local Institution, Ploiesti, Prahova, 100163, Romania|Local Institution, Timisoara, Timis, 300736, Romania|Local Institution, Bucharest, 050538, Romania|Local Institution, Bucuresti, 020359, Romania|Local Institution, Bucuresti, 020475, Romania|Local Institution, Bucuresti, 11794, Romania|Local Institution, Cluj Napoca Cluj, 400006, Romania|Local Institution, Craiova, 200349, Romania|Local Institution, Galati, 800098, Romania|Local Institution, Soweto, Gauteng, 2013, South Africa|Local Institution, Gauteng, Johannesburg, 1818, South Africa|Local Institution, Durban, Kwa-Zulu Natal, 4001, South Africa|Local Institution, Cape Town, Western Cape, 7500, South Africa|Local Institution, Goodwood, Western Cape, 7460, South Africa|Local Institution, Paarl, Western Cape, 7646, South Africa|Local Institution, Rondebosch, Western Cape, 7700, South Africa|Local Institution, Somerset West, Western Cape, 7130, South Africa|Local Institution, Johannesburg, 1829, South Africa|Local Institution, Johannesburg, 2129, South Africa
URL: https://clinicaltrials.gov/show/NCT01606007

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D447 Saxagliptin small molecule DB06335 Details
D445 Dapagliflozin small molecule DB06292 Details