Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1700 participants
INTERVENTIONAL
2015-10-31
2019-10-23
Brief Summary
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The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.
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Detailed Description
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An estimated 1650 subjects with inadequately controlled T2DM and an elevated risk of cardiovascular adverse events will be randomized to bexagliflozin tablets, 20 mg, or placebo in a ratio of 2:1 in addition to the background anti-diabetic medications.
The study is an event-driven trial. The treatment period will end when the last randomized subject has completed at least 52 weeks of treatment and a total of at least 134 subjects have experienced a cardiac event.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bexagliflozin tablets, 20 mg
Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.
Bexagliflozin
20 mg, tablet
Placebo tablets
Each subject will receive placebo (inactive tablet) once daily for the duration of the study.
Placebo
20 mg tablet to match active comparator
Interventions
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Bexagliflozin
20 mg, tablet
Placebo
20 mg tablet to match active comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who have had a stable treatment regimen for T2DM for the past 3 months
* Subjects who present with at least one of the following 3 histories:
Group 1: A history of atherosclerotic vascular disease Group 2: A history of heart failure Group 3: Age ≥ 55 years with diabetes for ≥ 10 years, uncontrolled hypertension, currently smoking, reduced kidney function, or cholesterol problems
Exclusion Criteria
* History of genitourinary tract infections
* Evidence of abnormal liver function
* History of MI, stroke or hospitalization for heart failure in the past 3 months
* Prior kidney transplant or evidence of kidney problems
* Prior or planned pace maker implantation
* Pregnant or nursing
40 Years
ALL
No
Sponsors
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Theracos
INDUSTRY
Responsible Party
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Principal Investigators
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J. Paul Lock, MD
Role: STUDY_DIRECTOR
Theracos
Locations
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Research Site 1090
Gilbert, Arizona, United States
Research Site 1041
Little Rock, Arkansas, United States
Research Site 1073
Azusa, California, United States
Research Site 1076
Concord, California, United States
Research Site 1078
Fresno, California, United States
Research Site 1089
Harbor City, California, United States
Research Site 1058
Lincoln, California, United States
Research Site 1051
Los Angeles, California, United States
Research Site 1004
Los Angeles, California, United States
Research Site 1068
Montclair, California, United States
Research Site 1077
Orange, California, United States
Research Site 1218
Denver, Colorado, United States
Research Site 1092
Golden, Colorado, United States
Research Site 1216
Norwalk, Connecticut, United States
Research Site 1083
Newark, Delaware, United States
Research Site 1057
Boca Raton, Florida, United States
Research Site 1059
Brooksville, Florida, United States
Research Site 1050
Panama City, Florida, United States
Research Site 1099
Port Charlotte, Florida, United States
Research Site 1066
Tampa, Florida, United States
Research Site 1072
Augusta, Georgia, United States
Research Site 1082
Pocatello, Idaho, United States
Research Site 1258
Champaign, Illinois, United States
Research Site 1043
Anderson, Indiana, United States
Research Site 1071
Avon, Indiana, United States
Research Site 1086
Des Moines, Iowa, United States
Research Site 1224
Covington, Kentucky, United States
Research Site 1228
Annapolis, Maryland, United States
Research Site 1221
Baltimore, Maryland, United States
Research Site 1079
Hyattsville, Maryland, United States
Research Site 1223
Midland, Michigan, United States
Research Site 1217
Petoskey, Michigan, United States
Research Site 1254
Ypsilanti, Michigan, United States
Research Site 1054
St Louis, Missouri, United States
Research Site 1060
St Louis, Missouri, United States
Research Site 1252
Kalispell, Montana, United States
Research Site 1052
Omaha, Nebraska, United States
Research Site 1263
Omaha, Nebraska, United States
Research Site 1080
Las Vegas, Nevada, United States
Research Site 1219
Somerset, New Jersey, United States
Research Site 1044
Albuquerque, New Mexico, United States
Research Site 1220
Saratoga Springs, New York, United States
Research Site 1264
The Bronx, New York, United States
Research Site 1049
West Seneca, New York, United States
Research Site 1085
Chapel Hill, North Carolina, United States
Research Site 1074
Charlotte, North Carolina, United States
Research Site 1056
Morehead City, North Carolina, United States
Research Site 1229
Wilmington, North Carolina, United States
Research Site 1064
Winston-Salem, North Carolina, United States
Research Site 1075
Fargo, North Dakota, United States
Research Site 1266
Lindsay, Oklahoma, United States
Research Site 1055
Oklahoma City, Oklahoma, United States
Research Site 1265
Oklahoma City, Oklahoma, United States
Research Site 1046
Oklahoma City, Oklahoma, United States
Research Site 1260
Lancaster, Pennsylvania, United States
Research Site 1042
Cumberland, Rhode Island, United States
Research Site 1225
Austin, Texas, United States
Research Site 1259
Dallas, Texas, United States
Research Site 1048
Kingwood, Texas, United States
Research Site 1070
Lampasas, Texas, United States
Research Site 1222
Lewisville, Texas, United States
Research Site 1081
North Richland Hills, Texas, United States
Research Site 1226
San Antonio, Texas, United States
Research Site 1053
San Antonio, Texas, United States
Research Site 1063
Salt Lake City, Utah, United States
Research Site 1230
Salem, Virginia, United States
Research Site 5013
Vancouver, British Columbia, Canada
Research Site 5015
Cambridge, Ontario, Canada
Research Site 5005
Greater Sudbury, Ontario, Canada
Research Site 5012
Hamilton, Ontario, Canada
Research Site 5023
London, Ontario, Canada
Research Site 5016
Peterborough, Ontario, Canada
Research Site 5022
Toronto, Ontario, Canada
Research Site 5014
Toronto, Ontario, Canada
Research Site 5008
Gatineau, Quebec, Canada
Research Site 5007
Saint-Charles-Borromée, Quebec, Canada
Research Site 5009
Saint-Georges, Quebec, Canada
Research Site 5006
Québec, , Canada
Research Site 3116
Benešov, , Czechia
Research Site 3106
Brandýs nad Labem, , Czechia
Research Site 3107
Brno, , Czechia
Research Site 3118
Brno, , Czechia
Research Site 3109
Český Krumlov, , Czechia
Research Site 3114
Havířov, , Czechia
Research Site 3103
Hradec Králové, , Czechia
Research Site 3110
Krnov, , Czechia
Research Site 3102
Kroměříž, , Czechia
Research Site 3105
Mariánské Lázně, , Czechia
Research Site 3113
Pilsen, , Czechia
Research Site 3104
Prague, , Czechia
Research Site 3111
Prague, , Czechia
Research Site 3112
Prague, , Czechia
Research Site 3115
Uherské Hradiště, , Czechia
Research Site 6104
Copenhagen, , Denmark
Research Site 6103
Copenhagen, , Denmark
Research Site 6105
Copenhagen, , Denmark
Research Site 2015
Guadalajara, Jalisco, Mexico
Research Site 2013
Culiacán, Sinaloa, Mexico
Research Site 2008
Tampico, Tamaulipas, Mexico
Research Site 2012
Mérida, Yucatán, Mexico
Research Site 2011
Aguascalientes, , Mexico
Research Site 2009
Chihuahua City, , Mexico
Research Site 2014
México, , Mexico
Research Site 2016
Querétaro, , Mexico
Research Site 2010
Veracruz, , Mexico
Research Site 5101
's-Hertogenbosch, , Netherlands
Research Site 5110
Amsterdam, , Netherlands
Research Site 5113
Harderwijk, , Netherlands
Research Site 5112
Hoofddorp, , Netherlands
Research Site 5102
Hoogeveen, , Netherlands
Research Site 5106
Rotterdam, , Netherlands
Research Site 5103
Zwijndrecht, , Netherlands
Research Site 7122
Aleksandrów Łódzki, , Poland
Research Site 7113
Gdansk, , Poland
Research Site 7119
Gdynia, , Poland
Research Site 7109
Grodzisk Mazowiecki, , Poland
Research Site 7115
Katowice, , Poland
Research Site 7106
Katowice, , Poland
Research Site 7121
Katowice, , Poland
Research Site 7111
Kutno, , Poland
Research Site 7104
Lodz, , Poland
Research Site 7135
Lodz, , Poland
Research Site 7120
Lublin, , Poland
Research Site 7118
Otwock, , Poland
Research Site 7108
Oława, , Poland
Research Site 7107
Puławy, , Poland
Research Site 7105
Sobótka, , Poland
Research Site 7112
Sochaczew, , Poland
Research Site 7123
Warsaw, , Poland
Research Site 7117
Warsaw, , Poland
Research Site 7116
Warsaw, , Poland
Research Site 9309
Lomonosov, , Russia
Research Site 9303
Moscow, , Russia
Research Site 9315
Moscow, , Russia
Research Site 9314
Novosibirsk, , Russia
Research Site 9318
Novosibirsk, , Russia
Research Site 9301
Novosibirsk, , Russia
Research Site 9310
Saint Petersburg, , Russia
Research Site 9304
Saint Petersburg, , Russia
Research Site 9307
Saint Petersburg, , Russia
Research Site 9311
Saint Petersburg, , Russia
Research Site 9312
Saint Petersburg, , Russia
Research Site 9302
Tomsk, , Russia
Research Site 7007
Chuncheon, Gangwon-do, South Korea
Research Site 7001
Wŏnju, Gangwon-do, South Korea
Research Site 7004
Anyang-si, Gyeonggi-do, South Korea
Research Site 7005
Guri-si, Gyeonggi-do, South Korea
Research Site 7006
Busan, , South Korea
Research Site 7002
Gwangju, , South Korea
Research Site 7008
Incheon, , South Korea
Research Site 8001
Kaohsiung City, , Taiwan
Research Site 8002
New Taipei City, , Taiwan
Research Site 8006
Taichung, , Taiwan
Research Site 8005
Tainan City, , Taiwan
Research Site 8007
Taipei, , Taiwan
Research Site 8004
Taipei, , Taiwan
Research Site 8003
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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THR-1442-C-476
Identifier Type: -
Identifier Source: org_study_id
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