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Clinical Trial Details

Trial ID: L3414
Source ID: NCT02558296
Associated Drug: Bexagliflozin
Title: Bexagliflozin Efficacy and Safety Trial
Acronym: BEST
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02558296/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Bexagliflozin|DRUG: Placebo
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 24, The primary efficacy objective of this trial is to evaluate the placebo-adjusted change in HbA1c from baseline after 24 weeks of treatment with 20 mg bexagliflozin tablets in type 2 diabetic subjects with increased risk of cardiovascular adverse events., 24 weeks | Secondary: Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin, To evaluate the effect of 20 mg bexagliflozin on the change in HbA1c from baseline to week 24 in randomized subjects who have been prescribed insulin to control their diabetes, 24 weeks|Change in Body Weight From Baseline to Week 48, To evaluate the effect of 20 mg bexagliflozin on the change in body weight from baseline to week 48 in randomized subjects with a BMI ≥ 25 kg/m2 compared to placebo, 48 weeks|Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline, To evaluate the effect of 20 mg bexagliflozin on the change in systolic blood pressure (SBP) from baseline to week 24 in subjects with baseline systolic blood pressure ≥ 140 mmHg compared to placebo, 24 weeks | Other: Change in HbA1c From Baseline Over Time, To assess the effect of 20 mg bexagliflozin treatment on the change in HbA1c from baseline versus placebo over time up to 168 weeks, Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168|Change in Fasting Plasma Glucose Over Time, To evaluate the effect of bexagliflozin treatment on the change in fasting plasma glucose (FPG) versus placebo over time up to 168 weeks, Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168|Proportion of Subjects Requiring an Intensification of Hypoglycemic Agent and Time to First Intensification, To measure the proportion of subjects requiring an intensification of hypoglycemic agent in the bexagliflozin arm versus placebo during 24 week period, 24 week|Proportion of Subjects Requiring an Intensification of Hypoglycemic Agent and Time to First Intensification, To measure the proportion of subjects requiring an intensification of hypoglycemic agent in the bexagliflozin arm versus placebo during the entire study period, Duration of study (168 weeks)|Proportion of Subjects Requiring a Relaxation of Hypoglycemic Agent, To measure the proportion of subjects requiring a relaxation of hypoglycemic agent in the bexagliflozin arm versus placebo during 24 week period, 24 weeks|Proportion of Subjects Requiring a Relaxation of Hypoglycemic Agent, To measure the proportion of subjects requiring a relaxation of hypoglycemic agent in the bexagliflozin arm versus placebo during the entire study, Duration of study (168 weeks)|Proportion of Participants With Incidence of Hospitalization for Heart Failure, To measure the incidence of hospitalization for heart failure among all subjects and among subjects who have a history of heart failure at baseline, Duration of study (168 weeks)
Sponsor/Collaborators: Sponsor: Theracos
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1700
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-10
Completion Date: 2019-10-23
Results First Posted: 2021-07-07
Last Update Posted: 2021-07-14
Locations: Research Site 1090, Gilbert, Arizona, 85295, United States|Research Site 1041, Little Rock, Arkansas, 72204, United States|Research Site 1073, Azusa, California, 91773, United States|Research Site 1076, Concord, California, 94520, United States|Research Site 1078, Fresno, California, 93720, United States|Research Site 1089, Harbor City, California, 90710, United States|Research Site 1058, Lincoln, California, 95821, United States|Research Site 1051, Los Angeles, California, 90022, United States|Research Site 1004, Los Angeles, California, 90057, United States|Research Site 1068, Montclair, California, 91763, United States|Research Site 1077, Orange, California, 92868, United States|Research Site 1218, Denver, Colorado, 80209, United States|Research Site 1092, Golden, Colorado, 80401, United States|Research Site 1216, Norwalk, Connecticut, 06851, United States|Research Site 1083, Newark, Delaware, 19713, United States|Research Site 1057, Boca Raton, Florida, 33434, United States|Research Site 1059, Brooksville, Florida, 34601, United States|Research Site 1050, Panama City, Florida, 32401, United States|Research Site 1099, Port Charlotte, Florida, 33952, United States|Research Site 1066, Tampa, Florida, 33634, United States|Research Site 1072, Augusta, Georgia, 30909, United States|Research Site 1082, Pocatello, Idaho, 83201, United States|Research Site 1258, Champaign, Illinois, 61822, United States|Research Site 1043, Anderson, Indiana, 46011, United States|Research Site 1071, Avon, Indiana, 46123, United States|Research Site 1086, Des Moines, Iowa, 50314, United States|Research Site 1224, Covington, Kentucky, 41011, United States|Research Site 1228, Annapolis, Maryland, 21401, United States|Research Site 1221, Baltimore, Maryland, 21202, United States|Research Site 1079, Hyattsville, Maryland, 20782, United States|Research Site 1223, Midland, Michigan, 48670, United States|Research Site 1217, Petoskey, Michigan, 49770, United States|Research Site 1254, Ypsilanti, Michigan, 48197, United States|Research Site 1054, Saint Louis, Missouri, 63136, United States|Research Site 1060, Saint Louis, Missouri, 63141, United States|Research Site 1252, Kalispell, Montana, 59901, United States|Research Site 1052, Omaha, Nebraska, 68131, United States|Research Site 1263, Omaha, Nebraska, 68198, United States|Research Site 1080, Las Vegas, Nevada, 89123, United States|Research Site 1219, Somerset, New Jersey, 08873, United States|Research Site 1044, Albuquerque, New Mexico, 87102, United States|Research Site 1264, Bronx, New York, 10468, United States|Research Site 1220, Saratoga Springs, New York, 12866, United States|Research Site 1049, West Seneca, New York, 14224, United States|Research Site 1085, Chapel Hill, North Carolina, 27517, United States|Research Site 1074, Charlotte, North Carolina, 28204, United States|Research Site 1056, Morehead City, North Carolina, 28557, United States|Research Site 1229, Wilmington, North Carolina, 28401, United States|Research Site 1064, Winston-Salem, North Carolina, 27103, United States|Research Site 1075, Fargo, North Dakota, 58103, United States|Research Site 1266, Lindsay, Oklahoma, 73052, United States|Research Site 1055, Oklahoma City, Oklahoma, 73119, United States|Research Site 1265, Oklahoma City, Oklahoma, 73134, United States|Research Site 1046, Oklahoma City, Oklahoma, 73135, United States|Research Site 1260, Lancaster, Pennsylvania, 17601, United States|Research Site 1042, Cumberland, Rhode Island, 02864, United States|Research Site 1225, Austin, Texas, 78758, United States|Research Site 1259, Dallas, Texas, 75235, United States|Research Site 1048, Kingwood, Texas, 77339, United States|Research Site 1070, Lampasas, Texas, 76550, United States|Research Site 1222, Lewisville, Texas, 75067, United States|Research Site 1081, North Richland Hills, Texas, 76180, United States|Research Site 1226, San Antonio, Texas, 78212, United States|Research Site 1053, San Antonio, Texas, 78218, United States|Research Site 1063, Salt Lake City, Utah, 84124, United States|Research Site 1230, Salem, Virginia, 24153, United States|Research Site 5013, Vancouver, British Columbia, V5Z1M9, Canada|Research Site 5015, Cambridge, Ontario, N1R 6V6, Canada|Research Site 5012, Hamilton, Ontario, L8L5G8, Canada|Research Site 5023, London, Ontario, N6A 4V2, Canada|Research Site 5016, Peterborough, Ontario, K9J 0B2, Canada|Research Site 5005, Sudbury, Ontario, P3C 5K7, Canada|Research Site 5022, Toronto, Ontario, M5B 1W8, Canada|Research Site 5014, Toronto, Ontario, M5G 1XS, Canada|Research Site 5008, Gatineau, Quebec, J8Y 6S8, Canada|Research Site 5007, St-Charles-Borromee, Quebec, J6E 6J2, Canada|Research Site 5009, St. Georges, Quebec, G5Y4T8, Canada|Research Site 5006, Quebec, G1V 4G5, Canada|Research Site 3116, Benesov, 256 01, Czechia|Research Site 3106, Brandys nad Labem, 250 01, Czechia|Research Site 3107, Brno, 60200, Czechia|Research Site 3118, Brno, 639 00, Czechia|Research Site 3109, Cesky Krumlov, 381 01, Czechia|Research Site 3114, Havirov, 736 01, Czechia|Research Site 3103, Hradec Kralove, 50005, Czechia|Research Site 3110, Krnov, 794 01, Czechia|Research Site 3102, Kromeriz, 767 01, Czechia|Research Site 3105, Marianske Lazne, 353 01, Czechia|Research Site 3113, Plzen, 326 00, Czechia|Research Site 3104, Praha, 128 08, Czechia|Research Site 3111, Praha, 149 00, Czechia|Research Site 3112, Praha, 181 00, Czechia|Research Site 3115, Uherske Hradiste, 686 68, Czechia|Research Site 6104, Copenhagen, 2100, Denmark|Research Site 6103, Copenhagen, 2300S, Denmark|Research Site 6105, Copenhagen, 2400, Denmark|Research Site 7007, Chuncheon, Gangwon-Do, 200-722, Korea, Republic of|Research Site 7001, Wonju, Gangwon-Do, 220-701, Korea, Republic of|Research Site 7004, Anyang, Gyeonggi-do, 431-070, Korea, Republic of|Research Site 7005, Guri, Gyeonggi-do, 471-701, Korea, Republic of|Research Site 7006, Busan, 602-739, Korea, Republic of|Research Site 7002, Gwangju, 501-757, Korea, Republic of|Research Site 7008, Incheon, 400-711, Korea, Republic of|Research Site 2015, Guadalajara, Jalisco, 44160, Mexico|Research Site 2013, Culiacan, Sinaloa, 80230, Mexico|Research Site 2008, Tampico, Tamaulipas, 89000, Mexico|Research Site 2012, Merida, Yucatan, 97218, Mexico|Research Site 2011, Aguascalientes, 20230, Mexico|Research Site 2009, Chihuahua, 31217, Mexico|Research Site 2014, Mexico, 80230, Mexico|Research Site 2016, Queretaro, Mexico|Research Site 2010, Veracruz, 91910, Mexico|Research Site 5110, Amsterdam, 2545CH, Netherlands|Research Site 5113, Harderwijk, 3844DG, Netherlands|Research Site 5101, Hertogenbosch, 5223GZ, Netherlands|Research Site 5112, Hoofddorp, Netherlands|Research Site 5102, Hoogeveen, 7909AA, Netherlands|Research Site 5106, Rotterdam, 3O45 PM, Netherlands|Research Site 5103, Zwijndrecht, 3331EV, Netherlands|Research Site 7122, Aleksandrow Lodzki, 95-070, Poland|Research Site 7113, Gdansk, 80-126, Poland|Research Site 7119, Gdynia, 81-338, Poland|Research Site 7109, Grodzisk Mazowiecki, 05-825, Poland|Research Site 7115, Katowice, 20-060, Poland|Research Site 7106, Katowice, 40-752, Poland|Research Site 7121, Katowice, 40-954, Poland|Research Site 7111, Kutno, 99-300, Poland|Research Site 7104, Lodz, 90-368, Poland|Research Site 7135, Lodz, 94-255, Poland|Research Site 7120, Lublin, 20-362, Poland|Research Site 7108, Olawa, 55-200, Poland|Research Site 7118, Otwock, 05-402, Poland|Research Site 7107, Pulawy, 24-100, Poland|Research Site 7105, Sobotka, 55-050, Poland|Research Site 7112, Sochaczew, 96-500, Poland|Research Site 7123, Warsaw, 00-465, Poland|Research Site 7117, Warszawa, 01-868, Poland|Research Site 7116, Warszawa, 04-730, Poland|Research Site 9309, Lomonosov, Russian Federation|Research Site 9303, Moscow, Russian Federation|Research Site 9315, Moscow, Russian Federation|Research Site 9314, Novosibirsk, 630099, Russian Federation|Research Site 9318, Novosibirsk, 630099, Russian Federation|Research Site 9301, Novosibirsk, Russian Federation|Research Site 9310, Saint Petersburg, 1199044, Russian Federation|Research Site 9304, Saint Petersburg, Russian Federation|Research Site 9307, Saint Petersburg, Russian Federation|Research Site 9311, Saint Petersburg, Russian Federation|Research Site 9312, Saint Petersburg, Russian Federation|Research Site 9302, Tomsk, 6340, Russian Federation|Research Site 8001, Kaohsiung, 807, Taiwan|Research Site 8002, New Taipei, 231, Taiwan|Research Site 8006, Taichung, 404, Taiwan|Research Site 8005, Tainan, 704, Taiwan|Research Site 8007, Taipei, 100, Taiwan|Research Site 8004, Taipei, 111, Taiwan|Research Site 8003, Taipei, 112, Taiwan
URL: https://clinicaltrials.gov/show/NCT02558296

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D517 Bexagliflozin small molecule DB12236 Details