Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6842
Source ID: NCT02284893
Associated Drug: Saxagliptin
Title: Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02284893/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Saxagliptin|DRUG: Dapagliflozin|DRUG: Sitagliptin|DRUG: Placebo matching with Saxagliptin|DRUG: Placebo matching with Dapagliflozin|DRUG: Placebo matching with Sitagliptin
Outcome Measures: Primary: Mean Change in HbA1c, Baseline (randomization) to Week 26 | Secondary: Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, week 26|Mean Change in Total Body Weight, Baseline (randomization) to Week 26|Mean Change in Fasting Plasma Glucose (FPG), Baseline (randomization) to Week 26
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 461
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-09-09
Completion Date: 2016-09-20
Results First Posted: 2018-06-01
Last Update Posted: 2018-06-01
Locations: Research Site, Mesa, Arizona, 85206, United States|Research Site, Mesa, Arizona, 85213, United States|Research Site, Phoenix, Arizona, 85020, United States|Research Site, Little Rock, Arkansas, 72205, United States|Research Site, Huntington Beach, California, 92648, United States|Research Site, Huntington Park, California, 90255, United States|Research Site, Lomita, California, 90717, United States|Research Site, Los Angeles, California, 90057, United States|Research Site, Northridge, California, 91325, United States|Research Site, Norwalk, California, 90650, United States|Research Site, Paramount, California, 90723, United States|Research Site, Sacramento, California, 95823, United States|Research Site, Tarzana, California, 91356, United States|Research Site, Tustin, California, 92780, United States|Research Site, Golden, Colorado, 80401, United States|Research Site, Coral Gables, Florida, 33134, United States|Research Site, Kissimmee, Florida, 34744, United States|Research Site, Miami Beach, Florida, 33140, United States|Research Site, Miami, Florida, 33015, United States|Research Site, Miami, Florida, 33135, United States|Research Site, Miami, Florida, 33174, United States|Research Site, Palm Harbor, Florida, 34684, United States|Research Site, Pembroke Pines, Florida, 33026, United States|Research Site, Chicago, Illinois, 60634, United States|Research Site, Council Bluffs, Iowa, 51503, United States|Research Site, Crestview Hills, Kentucky, 41017, United States|Research Site, Charlotte, North Carolina, 28204, United States|Research Site, Morehead City, North Carolina, 28557, United States|Research Site, Salisbury, North Carolina, 28144, United States|Research Site, Norman, Oklahoma, 73069, United States|Research Site, Columbia, South Carolina, 29204, United States|Research Site, Bristol, Tennessee, 37620, United States|Research Site, Dallas, Texas, 75230, United States|Research Site, Houston, Texas, 77081, United States|Research Site, North Richland Hills, Texas, 76180, United States|Research Site, Pasadena, Texas, 77504, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Manassas, Virginia, 20110, United States|Research Site, Suffolk, Virginia, 23452, United States|Research Site, Kenosha, Wisconsin, 53142, United States|Research Site, Baja, 6500, Hungary|Research Site, Budapest, 1036, Hungary|Research Site, Budapest, 1097, Hungary|Research Site, Debrecen, 4032, Hungary|Research Site, Gyula, 5700, Hungary|Research Site, Nyíregyháza, 4405, Hungary|Research Site, Szekszárd, 7100, Hungary|Research Site, Aguascalientes, 20230, Mexico|Research Site, Chihuahua, 31217, Mexico|Research Site, Cuautla, 62746, Mexico|Research Site, Guadalajara, 44130, Mexico|Research Site, Guadalajara, 44160, Mexico|Research Site, Guadalajara, 44670, Mexico|Research Site, Monterrey, 64460, Mexico|Research Site, Białystok, 15-879, Poland|Research Site, Gdańsk, 80-546, Poland|Research Site, Kraków, 31-156, Poland|Research Site, Kraków, 31-261, Poland|Research Site, Opole, 45-367, Poland|Research Site, Poznań, 61-655, Poland|Research Site, Warszawa, 02-507, Poland|Research Site, Wroclaw, 50-349, Poland|Research Site, Wroclaw, 51-685, Poland|Research Site, Brasov, 500269, Romania|Research Site, Bucuresti, 011794, Romania|Research Site, Bucuresti, 020359, Romania|Research Site, Buzau, 120203, Romania|Research Site, Craiova, 200349, Romania|Research Site, Galati, 800098, Romania|Research Site, Oradea, 410169, Romania|Research Site, Satu-Mare, 440055, Romania|Research Site, Timisoara, 300736, Romania|Research Site, Boksburg North, 1460, South Africa|Research Site, Cape Town, 7700, South Africa|Research Site, Durban, 4091, South Africa|Research Site, Johannesburg, 1818, South Africa|Research Site, Lenasia, 1829, South Africa|Research Site, Moloto, 1022, South Africa|Research Site, Soweto, 2013, South Africa
URL: https://clinicaltrials.gov/show/NCT02284893

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