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Clinical Trial Details

Trial ID: L5486
Source ID: NCT01619059
Associated Drug: Saxagliptin
Title: Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01619059/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Saxagliptin|DRUG: Dapagliflozin|DRUG: Metformin IR|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., From Baseline to 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, 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 double-blind period, including observations prior to rescue., From Baseline to Week 24|Adjusted Mean Change From Baseline in Fasting Plasma Glucose 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 double-blind period, including observations prior to rescue., From Baseline to Week 24|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., From Baseline to Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 315
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-06
Completion Date: 2015-01
Results First Posted: 2016-03-17
Last Update Posted: 2016-04-22
Locations: University Of Alabama At Birmingham, Birmingham, Alabama, 35294, United States|Terence T. Hart, Md, Muscle Shoals, Alabama, 35662, United States|Mesa Family Medical Center, Mesa, Arizona, 85203, United States|Clinical Research Advantage Inc/Desert Clinical Research Llc, Mesa, Arizona, 85213, United States|Clinical Research Advantage, Inc, Phoenix, Arizona, 85020, United States|Clinical Research Advantage, Inc./ Stonecreek Medical Associates, Pc, Phoenix, Arizona, 85028, United States|Beach Physicians Clinical Research Corp., Huntington Beach, California, 92647, United States|Torrance Clinical Research, Lomita, California, 90717, United States|Randall G. Shue, Do, Inc., Los Angeles, California, 90023, United States|National Research Institute, Los Angeles, California, 90057, United States|Cassidy Medical Group/Clinical Research Advantage, Vista, California, 92083, United States|Infosphere Clinical Research, Inc., West Hills, California, 91307, United States|New West Physicians, Pc, Golden, Colorado, 80401, United States|Southeast Clinical Research, Llc, Chiefland, Florida, 32626, United States|Clinical Therapeutics Corporation, Coral Gables, Florida, 33134, United States|Medical Research Unlimited, Llc, Hialeah, Florida, 33012, United States|University Of Florida Endocrinology & Diabetes, Jacksonville, Florida, 32207, United States|Care Partners Clinical Research, Llc, Jacksonville, Florida, 32277, United States|Clinical Research Of Miami, Inc., Miami, Florida, 33126, United States|Clinical Research Advantage, Inc., Evansville, Indiana, 47725, United States|Clinical Research Advantage, Evansville, Indiana, 7714, United States|Mercy Health Research, Saint Louis, Missouri, 63141, United States|Clinical Research Advantage, Inc., Las Vegas, Nevada, 89128, United States|Joslin Diabetes Center Affiliate Of Snhmc, Nashua, New Hampshire, 03063, United States|N. Shore Diabetes & Endoc Assoc, New Hyde Park, New York, 11042, United States|Digiovanna Institute For Medical Education & Research, North Massapequa, New York, 11758, United States|Barat Research Group, Inc., Charlotte, North Carolina, 28262, United States|Sterling Research Grp, Ltd., Cincinnati, Ohio, 45219, United States|Physicians Research, Inc., Zanesville, Ohio, 43701, United States|Tlm Medical Services, Columbia, South Carolina, 29204, United States|Family Medicine Of Sayebrook, Myrtle Beach, South Carolina, 29588, United States|Holston Medical Group, Bristol, Tennessee, 37620, United States|Vanderbilt Diabetes Center, Nashville, Tennessee, 37232, United States|Padre Coast Clinical Research, Corpus Christi, Texas, 78404, United States|Local Institution, Moncton, New Brunswick, E1G 1A7, Canada|Local Institution, St-john, Newfoundland and Labrador, A1E 2E2, Canada|Local Institution, Halifax, Nova Scotia, B3K2M5, Canada|Local Institution, Brampton, Ontario, L6T-0G1, Canada|Local Institution, Sarnia, Ontario, N7T 4X3, Canada|Local Institution, Montreal, Quebec, H2R 1V6, Canada|Local Institution, Quebec, G3K 2P8, Canada|Local Institution, Hradec Kralove, 500 05, Czech Republic|Local Institution, Karlovy Vary, 360 01, Czech Republic|Local Institution, Praha 5, 150 98, Czech Republic|Local Institution, Balatonfured, H-8230, Hungary|Local Institution, Budaors, 2040, Hungary|Local Institution, Budapest, 1138, Hungary|Local Institution, Zalaegerszeg, 8900, Hungary|Local Institution, Guadalajara, Jalisco, 44600, Mexico|Local Institution, Guadalajara, Jalisco, 44650, Mexico|Local Institution, Guadalajara, Jalisco, 44670, Mexico|Local Institution, Morelia, Michioacan, 58070, Mexico|Local Institution, Monterrey, Nuevo Leon, 64460, Mexico|Local Institution, Del. Benito Juarez, 03100, Mexico|Local Institution, Veracruz, 91910, Mexico|Local Institution, Bialystok, 15-435, Poland|Local Institution, Katowice, 40-750, Poland|Local Institution, Katowice, 40954, Poland|Local Institution, Krakow, 31-530, Poland|Local Institution, Pszczyna, 43-200, Poland|Local Institution, Pulawy, 24-100, Poland|Local Institution, Szczecin, 70-376, Poland|Local Institution, Warszawa, 01-868, Poland|Local Institution, Wegrow, 07-100, Poland|Local Institution, Wroclaw, 50-349, Poland|Research & Cardiovascular Corp, Ponce, 00717, Puerto Rico|Local Institution, Brasov, 500365, Romania|Local Institution, Bucharest, 070208, Romania|Local Institution, Bucharest, 77108, Romania|Local Institution, Bucuresti, 020045, Romania|Local Institution, Constanta, 900591, Romania|Local Institution, Craiova, 200349, Romania|Local Institution, Galati, 800098, Romania|Local Institution, Ploiesti, 100097, Romania|Local Institution, Kursk, 305035, Russian Federation|Local Institution, Moscow, 119034, Russian Federation|Local Institution, Saint-petersburg, 194044, Russian Federation|Local Institution, St. Petersburg, 194044, Russian Federation|Local Institution, St. Petersburg, 195257, Russian Federation|Local Institution, St. Petersburg, 197136, Russian Federation|Local Institution, St. Petersburg, 197341, Russian Federation|Local Institution, St.petersburg, 195112, Russian Federation|Local Institution, St.petersburg, 197022, Russian Federation|Local Institution, Yaroslaval, 150062, Russian Federation
URL: https://clinicaltrials.gov/show/NCT01619059

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