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Clinical Trial Details

Trial ID: L4063
Source ID: NCT02229396
Associated Drug: Exantide With Dapagliflozin
Title: Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02229396/results
Conditions: Diabetes Mellitus
Interventions: DRUG: Exantide with Dapagliflozin|DRUG: Exentide|DRUG: Dapagliflozin
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 28, To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone., Baseline to Week 28 | Secondary: Change in Body Weight From Baseline to Week 28, To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone., Baseline to Week 28|Change in Fasting Plasma Glucose From Baseline to Week 28, To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone., Baseline to Week 28|Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test, To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone., Baseline to Week 28|Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28, To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone., Baseline to Week 28|Change in Fasting Plasma Glucose From Baseline to Week 2, To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone., Baseline to Week 2|Percentage of Patients Achieving HbA1c <7% at Week 28, To compare the percentage of patients achieving HbA1c \<7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone., Baseline to Week 28|Change in Systolic Blood Pressure From Baseline to Week 28, To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone., Baseline to Week 28
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 695
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-09-04
Completion Date: 2017-12-28
Results First Posted: 2017-09-08
Last Update Posted: 2018-12-31
Locations: Research Site, Birmingham, Alabama, 35235, United States|Research Site, Huntsville, Alabama, 35801, United States|Research Site, Tuscumbia, Alabama, 35674, United States|Research Site, Glendale, Arizona, 85306, United States|Research Site, Tempe, Arizona, 85283, United States|Research Site, Anaheim, California, 92801, United States|Research Site, Chula Vista, California, 91911, United States|Research Site, El Cajon, California, 92020, United States|Research Site, Fresno, California, 93720, United States|Research Site, La Mesa, California, 91942, United States|Research Site, Long Beach, California, 90807, United States|Research Site, Los Angeles, California, 90057, United States|Research Site, Mission Hills, California, 91345, United States|Research Site, Montclair, California, 91763, United States|Research Site, Oceanside, California, 92056, United States|Research Site, San Diego, California, 92103, United States|Research Site, San Diego, California, 92114, United States|Research Site, Tustin, California, 92780, United States|Research Site, Van Nuys, California, 91405, United States|Research Site, Boynton Beach, Florida, 33437, United States|Research Site, Clearwater, Florida, 33765, United States|Research Site, Coral Gables, Florida, 33134, United States|Research Site, Fort Lauderdale, Florida, 33316, United States|Research Site, Hialeah, Florida, 33012, United States|Research Site, Jacksonville, Florida, 32256, United States|Research Site, Jacksonville, Florida, 32277, United States|Research Site, Miami, Florida, 33126, United States|Research Site, Miami, Florida, 33133, United States|Research Site, Miami, Florida, 33135, United States|Research Site, Miami, Florida, 33142, United States|Research Site, Miami, Florida, 33165, United States|Research Site, Miami, Florida, 33175, United States|Research Site, Miami, Florida, 33186, United States|Research Site, North Miami Beach, Florida, 33162, United States|Research Site, Orlando, Florida, 32801, United States|Research Site, Orlando, Florida, 32806, United States|Research Site, Tampa, Florida, 33603, United States|Research Site, Williston, Florida, 32696, United States|Research Site, Chicago, Illinois, 60607, United States|Research Site, Avon, Indiana, 46123, United States|Research Site, Evansville, Indiana, 47714, United States|Research Site, Franklin, Indiana, 46131, United States|Research Site, Muncie, Indiana, 47304, United States|Research Site, Newton, Kansas, 67114, United States|Research Site, Monroe, Louisiana, 71201, United States|Research Site, Hazelwood, Missouri, 63042, United States|Research Site, Bellevue, Nebraska, 68005, United States|Research Site, Las Vegas, Nevada, 89109, United States|Research Site, Haddon Heights, New Jersey, 08035, United States|Research Site, Burlington, North Carolina, 27215, United States|Research Site, Greensboro, North Carolina, 27408, United States|Research Site, Mooresville, North Carolina, 28117, United States|Research Site, Morehead City, North Carolina, 28557, United States|Research Site, Cincinnati, Ohio, 45242, United States|Research Site, Vandalia, Ohio, 45377, United States|Research Site, Medford, Oregon, 97504, United States|Research Site, Philadelphia, Pennsylvania, 91307, United States|Research Site, Charleston, South Carolina, 29407, United States|Research Site, Greer, South Carolina, 29651, United States|Research Site, Spartanburg, South Carolina, 29303, United States|Research Site, Summerville, South Carolina, 29485, United States|Research Site, Dakota Dunes, South Dakota, 57049, United States|Research Site, Memphis, Tennessee, 38119, United States|Research Site, Dallas, Texas, 75218, United States|Research Site, Dallas, Texas, 75230, United States|Research Site, Houston, Texas, 77074, United States|Research Site, Houston, Texas, 77079, United States|Research Site, Houston, Texas, 77090, United States|Research Site, Pearland, Texas, 77584, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Tomball, Texas, 77375, United States|Research Site, Clinton, Utah, 84015, United States|Research Site, Salt Lake City, Utah, 84102, United States|Research Site, Burke, Virginia, 22015, United States|Research Site, Manassas, Virginia, 20110, United States|Research Site, Richmond, Virginia, 23294, United States|Research Site, Baja, 6500, Hungary|Research Site, Balatonfüred, 8230, Hungary|Research Site, Budapest, 1033, Hungary|Research Site, Budapest, 1083, Hungary|Research Site, Budapest, 1088, Hungary|Research Site, Budaörs, 2040, Hungary|Research Site, Debrecen, 4025, Hungary|Research Site, Eger, 3300, Hungary|Research Site, Godollo, 2100, Hungary|Research Site, Gyula, 5700, Hungary|Research Site, Gödöllő, 2100, Hungary|Research Site, Kecskemét, 6000, Hungary|Research Site, Komárom, 2921, Hungary|Research Site, Létavértes, 4281, Hungary|Research Site, Nyíregyháza, 4405, Hungary|Research Site, Pécs, 7623, Hungary|Research Site, Szeged, 6722, Hungary|Research Site, Szekszárd, 7100, Hungary|Research Site, Lodz, 94-255, Poland|Research Site, Lublin, 20-538, Poland|Research Site, Oświęcim, 32-600, Poland|Research Site, Parczew, 21-200, Poland|Research Site, Poznań, 61-655, Poland|Research Site, Torun, 87-100, Poland|Research Site, Zgierz, 95-100, Poland|Research Site, Łódź, 94-048, Poland|Research Site, Baia Mare, 430222, Romania|Research Site, Bucuresti, 010192, Romania|Research Site, Bucuresti, 010825, Romania|Research Site, Bucuresti, 020475, Romania|Research Site, Galati, 800578, Romania|Research Site, Oradea, 410032, Romania|Research Site, Oradea, 410169, Romania|Research Site, Oradea, 410469, Romania|Research Site, Ploiesti, 100342, Romania|Research Site, Timișoara, 300456, Romania|Research Site, Banska Bystrica, 97517, Slovakia|Research Site, Bardejov, 085 01, Slovakia|Research Site, Bratislava, 81108, Slovakia|Research Site, Bratislava, 82106, Slovakia|Research Site, Bratislava, 85101, Slovakia|Research Site, Dolny Kubin, 026 01, Slovakia|Research Site, Kosice, 04001, Slovakia|Research Site, Levice, 934 01, Slovakia|Research Site, Levice, 93401, Slovakia|Research Site, Lucenec, 984 01, Slovakia|Research Site, Nitra, 94911, Slovakia|Research Site, Pezinok, 90201, Slovakia|Research Site, Sturovo, 943 01, Slovakia|Research Site, Trebišov, 07501, Slovakia|Research Site, Bloemfontein, 9301, South Africa|Research Site, Cape Town, 7925, South Africa|Research Site, Johannesburg, 1818, South Africa|Research Site, Kempton Park, 1619, South Africa|Research Site, Middelburg, 1055, South Africa|Research Site, Parow, 7505, South Africa|Research Site, Port Elizabeth, 6014, South Africa|Research Site, Pretoria, 0001, South Africa
URL: https://clinicaltrials.gov/show/NCT02229396

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