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Clinical Trial Details

Trial ID: L2040
Source ID: NCT02681094
Associated Drug: Dapagliflozin
Title: A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02681094/results
Conditions: Type 2 Diabetes Mellitus|Inadequate Glycaemic Control
Interventions: DRUG: Dapagliflozin|DRUG: Placebo for Dapagliflozin|DRUG: Saxagliptin|DRUG: Placebo for Saxagliptin
Outcome Measures: Primary: Change From Baseline in HbA1c at Week 24, To demonstrate the superiority of the change from baseline HbA1c achieved with the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually after 24 weeks. Results were presented for the modified full analysis set. Note: Baseline was defined as the last assessment on or prior to the date of the first dose of the study medication., Baseline and week 24 | Secondary: Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks, To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually on proportion of participants achieving therapeutic glycaemic response after 24 weeks. Therapeutic glycaemic response was defined as an HbA1c value at Week 24 \<7.0% irrespective of whether participant received rescue medication. Risk difference for each treatment was calculated as adjusted response rate. Participants who did not had an HbA1c measurement at Week 24 were regarded as non-responders. Results were presented for the modified full analysis set., Baseline and week 24|Change in Fasting Plasma Glucose at 24 Weeks, To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5mg to either agent individually on fasting plasma glucose after 24 weeks. Results were presented for the modified full analysis set., Baseline and week 24|Change in Total Body Weight at 24 Weeks, To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to saxagliptin 5 mg on total body weight after 24 weeks. Results were presented for the modified full analysis set., Baseline and week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 905
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-02-26
Completion Date: 2017-07-15
Results First Posted: 2018-10-10
Last Update Posted: 2018-10-10
Locations: Research Site, Saraland, Alabama, 36571, United States|Research Site, Fresno, California, 93702, United States|Research Site, Harbor City, California, 90710, United States|Research Site, Hawaiian Gardens, California, 90716, United States|Research Site, Lancaster, California, 93534, United States|Research Site, Los Angeles, California, 90057, United States|Research Site, Montclair, California, 91763, United States|Research Site, Pomona, California, 91767, United States|Research Site, Spring Valley, California, 91978, United States|Research Site, Vallejo, California, 94592, United States|Research Site, Denver, Colorado, 80220, United States|Research Site, Northglenn, Colorado, 80234, United States|Research Site, Wheat Ridge, Colorado, 80033, United States|Research Site, Waterbury, Connecticut, 06708, United States|Research Site, Cooper City, Florida, 33024, United States|Research Site, Doral, Florida, 33166, United States|Research Site, Hialeah, Florida, 33012, United States|Research Site, Miami Lakes, Florida, 33016, United States|Research Site, Miami, Florida, 33176, United States|Research Site, Miami, Florida, 33186, United States|Research Site, Buford, Georgia, 30518, United States|Research Site, Chicago, Illinois, 60607, United States|Research Site, Hazel Crest, Illinois, 60429, United States|Research Site, New Orleans, Louisiana, 70115, United States|Research Site, Zachary, Louisiana, 70791, United States|Research Site, Biloxi, Mississippi, 39531, United States|Research Site, Florissant, Missouri, 63031, United States|Research Site, Albany, New York, 12203, United States|Research Site, Bronx, New York, 10459, United States|Research Site, Asheville, North Carolina, 28801, United States|Research Site, Mooresville, North Carolina, 28117, United States|Research Site, Fargo, North Dakota, 58103, United States|Research Site, Columbus, Ohio, 43201, United States|Research Site, Maumee, Ohio, 43537, United States|Research Site, East Providence, Rhode Island, 02914, United States|Research Site, West Columbia, South Carolina, 29169, United States|Research Site, Dallas, Texas, 75208, United States|Research Site, Dallas, Texas, 75230, United States|Research Site, El Paso, Texas, 79935, United States|Research Site, Fort Worth, Texas, 76132, United States|Research Site, Houston, Texas, 77004, United States|Research Site, Houston, Texas, 77036, United States|Research Site, Houston, Texas, 77040, United States|Research Site, Odessa, Texas, 79761, United States|Research Site, Sugar Land, Texas, 77479, United States|Research Site, Waco, Texas, 76710, United States|Research Site, Salt Lake City, Utah, 84102, United States|Research Site, Norfolk, Virginia, 23510, United States|Research Site, Moncton, New Brunswick, E1G 1A7, Canada|Research Site, Bridgewater, Nova Scotia, B4V 3N2, Canada|Research Site, Brampton, Ontario, L7A 3P1, Canada|Research Site, Etobicoke, Ontario, M9W 4L6, Canada|Research Site, London, Ontario, N5W 6A2, Canada|Research Site, Scarborough, Ontario, M1P 2T7, Canada|Research Site, Sudbury, Ontario, P3E 6C3, Canada|Research Site, Toronto, Ontario, M3J 2C5, Canada|Research Site, Chicoutimi, Quebec, G7H 7K9, Canada|Research Site, Levis, Quebec, G6W 0M5, Canada|Research Site, Mirabel, Quebec, J7J 2K8, Canada|Research Site, Pointe-Claire, Quebec, H9R 3J1, Canada|Research Site, Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada|Research Site, Ceske Budejovice, 370 01, Czechia|Research Site, Chrudim III, 537 01, Czechia|Research Site, Jilove u Prahy, 254 01, Czechia|Research Site, Ostrava, 710 00, Czechia|Research Site, Pardubice, 530 02, Czechia|Research Site, Plzen, 301 66, Czechia|Research Site, Praha - Klanovice, 190 14, Czechia|Research Site, Praha 10, 100 00, Czechia|Research Site, Praha 4, 140 46, Czechia|Research Site, Praha 4, 149 00, Czechia|Research Site, Praha 8, 181 00, Czechia|Research Site, Uherske Hradiste, 686 01, Czechia|Research Site, Berlin, 10787, Germany|Research Site, Bünde, 32257, Germany|Research Site, Essen, 45359, Germany|Research Site, Giengen, 89537, Germany|Research Site, Grossheirath, 96269, Germany|Research Site, Hof, 95030, Germany|Research Site, Hohenmölsen, 06679, Germany|Research Site, Karlsruhe, 76199, Germany|Research Site, Lichtenfels, 96215, Germany|Research Site, Meine, 38527, Germany|Research Site, Münster, 48153, Germany|Research Site, Rehburg Loccum, 31547, Germany|Research Site, Stolberg, 52222, Germany|Research Site, Villingen-Schwenningen, 78048, Germany|Research Site, Guadalajara, 44160, Mexico|Research Site, Guadalajara, 44600, Mexico|Research Site, Guadalajara, 44670, Mexico|Research Site, Mexico, 03800, Mexico|Research Site, Monterrey, 64460, Mexico|Research Site, Monterrey, 64465, Mexico|Research Site, Zapopan, 45116, Mexico|Research Site, Arkhangelsk, 163001, Russian Federation|Research Site, Ekaterinburg, 620039, Russian Federation|Research Site, Ekaterinburg, 620219, Russian Federation|Research Site, Izhevsk, 426063, Russian Federation|Research Site, Kazan, 420008, Russian Federation|Research Site, Moscow, 119991, Russian Federation|Research Site, Moscow, 127473, Russian Federation|Research Site, Perm, 614056, Russian Federation|Research Site, Perm, 6144090, Russian Federation|Research Site, Rostov-on-Don, 344022, Russian Federation|Research Site, Saint Petersburg, 196601, Russian Federation|Research Site, Saint-Petersburg, 196143, Russian Federation|Research Site, St.Petersburg, 198013, Russian Federation|Research Site, Tver, 170036, Russian Federation|Research Site, Ufa, 450071, Russian Federation|Research Site, Vladikavkaz, 362007, Russian Federation
URL: https://clinicaltrials.gov/show/NCT02681094

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