Heart FailurePhase 3SCOREDNCT03315143
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
A Phase 3 study testing Sotagliflozin in people with Heart Failure and Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 754 sites in 45 countries.
Trial summary
The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Type 2 Diabetes Mellitus, Chronic Kidney Diseases
- What is being tested?
- Sotagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10,584 participants
- Where
- 754 sitesin 45 countries
- Study dates
- 19 Dec 2017to 8 Jul 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) ≥7%.
- Estimated glomerular filtration rate (eGFR) ≥25 and ≤60 milliliter/minute (mL/min)/1.73 square meter (m^2).
- Age 18 years or older with at least one major cardiovascular risk factor or age 55 years or older with at least two minor cardiovascular risk factors.
- Signed written informed consent.
Who cannot join
- Antihyperglycemic treatment has not been stable within 12 weeks prior to screening.
- Planned coronary procedure or surgery after randomization.
- Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization.
- Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
754 sites in 45 countries.
754 sites in 45 countries
United States119 sites
Investigational Site Number 8400101
Albany, New York, 12206
Investigational Site Number 8400064
Anderson, South Carolina, 29621
Investigational Site Number 8400114
Arlington, Texas, 76015
Investigational Site Number 8400085
Arlington Heights, Illinois, 60005
Investigational Site Number 8400123
Atlanta, Georgia, 30303
Investigational Site Number 8400080
Bangor, Maine, 04401
Investigational Site Number 8400047
Beaver, Pennsylvania, 15009
Investigational Site Number 8400109
Bend, Oregon, 97702
Investigational Site Number 8400093
Bennington, Vermont, 05201
Investigational Site Number 8400039
Beverly Hills, California, 90211
Investigational Site Number 8400017
Birmingham, Alabama, 35205
Investigational Site Number 8400065
Bountiful, Utah, 84010-7717
Investigational Site Number 8400095
Bradenton, Florida, 34209
Investigational Site Number 8400104
Chicago, Illinois, 60611
Investigational Site Number 8400027
Chicago, Illinois, 60612
Investigational Site Number 8400124
Chicago, Illinois, 60612
Investigational Site Number 8400001
Chicago, Illinois, 60616
Investigational Site Number 8400038
Cincinnati, Ohio, 45219
Investigational Site Number 8400007
Cincinnati, Ohio, 45241
Investigational Site Number 8400090
Clearwater, Florida, 33756
Investigational Site Number 8400121
Clearwater, Florida, 33756
Investigational Site Number 8400015
Columbus, Ohio, 43210
Investigational Site Number 8400042
Concord, California, 94520
Investigational Site Number 8400049
Cooper City, Florida, 33024
Investigational Site Number 8400067
Corpus Christi, Texas, 78814
Investigational Site Number 8400052
Crystal Lake, Illinois, 60012
Investigational Site Number 8400082
Dallas, Texas, 75231
Investigational Site Number 8400133
Danville, Virginia, 24541-2834
Investigational Site Number 8400003
Des Moines, Iowa, 50314
Investigational Site Number 8400022
El Paso, Texas, 79935
Investigational Site Number 8400054
Fairfax, Virginia, 22039
Investigational Site Number 8400132
Falls Church, Virginia, 22044
Investigational Site Number 8400072
Fargo, North Dakota, 58103
Investigational Site Number 8400083
Federal Way, Washington, 98003
Investigational Site Number 8400002
Flint, Michigan, 48504
Investigational Site Number 8400069
Flint, Michigan, 48532-3447
Investigational Site Number 8400089
Fresno, California, 93720
Investigational Site Number 8400019
Greensburg, Pennsylvania, 15601
Investigational Site Number 8400079
Greenville, North Carolina, 27834-5704
Investigational Site Number 8400030
Greer, South Carolina, 29651
Investigational Site Number 8400092
Hialeah, Florida, 33012
Investigational Site Number 8400026
Hollywood, Florida, 33024
Investigational Site Number 8400033
Honolulu, Hawaii, 96814
Investigational Site Number 8400099
Houston, Texas, 77043
Investigational Site Number 8400103
Houston, Texas, 77070
Investigational Site Number 8400006
Huntington Park, California, 90255
Investigational Site Number 8400097
Indiana, Pennsylvania, 15701-3578
Investigational Site Number 8400134
Jacksonville, Florida, 32204
Investigational Site Number 8400055
Jacksonville, Florida, 32207-4966
Investigational Site Number 8400056
Jacksonville, Florida, 32216
Investigational Site Number 8400031
Jacksonville, Florida, 32277
Investigational Site Number 8400066
Kansas City, Missouri, 64111
Investigational Site Number 8400086
Katy, Texas, 77450
Investigational Site Number 8400009
Las Vegas, Nevada, 89148
Investigational Site Number 8400061
Laurelton, New York, 11413
Investigational Site Number 8400032
Levittown, Pennsylvania, 19056-2404
Investigational Site Number 8400071
Little Rock, Arkansas, 72211
Investigational Site Number 8400036
Long Beach, California, 90807
Investigational Site Number 8400113
Lorain, Ohio, 44053
Investigational Site Number 8400073
Los Angeles, California, 90017
Investigational Site Number 8400084
Los Angeles, California, 90022-4302
Investigational Site Number 8400035
Los Gatos, California, 95032
Investigational Site Number 8400041
Louisville, Kentucky, 40213
Investigational Site Number 8400037
Maitland, Florida, 32751
Investigational Site Number 8400034
Manassas, Virginia, 20110
Investigational Site Number 8400040
Memphis, Tennessee, 38163
Investigational Site Number 8400011
Mentor, Ohio, 44060
Investigational Site Number 8400004
Mesa, Arizona, 85206
Investigational Site Number 8400059
Mesa, Arizona, 85210
Investigational Site Number 8400100
Mesquite, Texas, 75150
Investigational Site Number 8400078
Miami, Florida, 33126
Investigational Site Number 8400117
Miami, Florida, 33135
Investigational Site Number 8400119
Miami, Florida, 33135
Investigational Site Number 8400118
Miami, Florida, 33165
Investigational Site Number 8400105
Miami, Florida, 33174
Investigational Site Number 8400120
Miami, Florida, 33176
Investigational Site Number 8400125
Michigan City, Indiana, 46360
Investigational Site Number 8400020
Morehead City, North Carolina, 28557
Investigational Site Number 8400048
Morehead City, North Carolina, 28557
Investigational Site Number 8400010
Morganton, North Carolina, 28655
Investigational Site Number 8400029
Myrtle Beach, South Carolina, 29572
Investigational Site Number 8400046
New York, New York, 10029-6501
Investigational Site Number 8400050
Norfolk, Virginia, 23510
Investigational Site Number 8400088
North Miami Beach, Florida, 33162
Investigational Site Number 8400043
Northridge, California, 91325
Investigational Site Number 8400131
Ogden, Utah, 84405
Investigational Site Number 8400045
Omaha, Nebraska, 68198-4100
Investigational Site Number 8400106
Opa-locka, Florida, 33054
Investigational Site Number 8400063
Ormond Beach, Florida, 32174
Investigational Site Number 8400087
Palm Harbor, Florida, 34684-3609
Investigational Site Number 8400021
Peoria, Arizona, 85381
Investigational Site Number 8400053
Philadelphia, Pennsylvania, 19107
Investigational Site Number 8400012
Pittsburgh, Pennsylvania, 15212
Investigational Site Number 8400094
Plano, Texas, 75093
Investigational Site Number 8400044
Richmond, Virginia, 23235
Investigational Site Number 8400111
Richmond, Virginia, 23249
Investigational Site Number 8400112
Rosedale, New York, 11422
Investigational Site Number 8400076
Roswell, Georgia, 30076
Investigational Site Number 8400025
Sacramento, California, 95821
Investigational Site Number 8400023
Saint Cloud, Minnesota, 56303
Investigational Site Number 8400116
San Antonio, Texas, 78224
Investigational Site Number 8400018
San Dimas, California, 91713
Investigational Site Number 8400096
Sheffield, Alabama, 35660
Investigational Site Number 8400062
Smithtown, New York, 11787
Investigational Site Number 8400060
South Burlington, Vermont, 05403
Investigational Site Number 8400068
Spokane, Washington, 99207
Investigational Site Number 8400108
Spring Hill, Florida, 34609
Investigational Site Number 8400028
Springfield, Illinois, 62711
Investigational Site Number 8400024
St Louis, Missouri, 63136
Investigational Site Number 8400058
St. Petersburg, Florida, 33713
Investigational Site Number 8400014
Surprise, Arizona, 85374
Investigational Site Number 8400051
Tampa, Florida, 33624
Investigational Site Number 8400070
Temecula, California, 92591
Investigational Site Number 8400081
Topeka, Kansas, 66606
Investigational Site Number 8400016
Troy, Michigan, 48098
Investigational Site Number 8400098
Valparaiso, Indiana, 46383
Investigational Site Number 8400091
Waco, Texas, 76710
Investigational Site Number 8400130
Washington, Missouri, 63090
Investigational Site Number 8400013
Waterbury, Connecticut, 06708
Russia45 sites
Investigational Site Number 6430028
Kaliningrad, 236035
Investigational Site Number 6430018
Kazan', 420101
Investigational Site Number 6430001
Kemerovo, 650002
Investigational Site Number 6430035
Kemerovo, 650070
Investigational Site Number 6430025
Krasnodar, 350042
Investigational Site Number 6430040
Krasnodar, 350063
Investigational Site Number 6430010
Krasnodar, 350086
Investigational Site Number 6430015
Moscow, 101990
Investigational Site Number 6430016
Moscow, 101990
Investigational Site Number 6430046
Moscow, 105554
Investigational Site Number 6430003
Moscow, 117292
Investigational Site Number 6430036
Moscow, 119192
Investigational Site Number 6430005
Moscow, 119991
Investigational Site Number 6430039
Moscow, 119991
Investigational Site Number 6430021
Moscow, 121309
Investigational Site Number 6430002
Moscow, 121374
Investigational Site Number 6430020
Moscow, 125284
Investigational Site Number 6430024
Moscow, 127644
Investigational Site Number 6430033
Nizhny Novgorod, 603005
Investigational Site Number 6430037
Novosibirsk, 630005
Investigational Site Number 6430034
Novosibirsk, 630089
Investigational Site Number 6430007
Perm, 614077
Investigational Site Number 6430019
Rostov-on-Don, 344068
Investigational Site Number 6430012
Saint Petersburg, 192242
Investigational Site Number 6430041
Saint Petersburg, 193312
Investigational Site Number 6430006
Saint Petersburg, 194044
Investigational Site Number 6430008
Saint Petersburg, 194044
Investigational Site Number 6430030
Saint Petersburg, 194044
Investigational Site Number 6430044
Saint Petersburg, 197110
Investigational Site Number 6430045
Saint Petersburg, 197110
Investigational Site Number 6430014
Saint Petersburg, 197341
Investigational Site Number 6430017
Saint Petersburg, 197341
Investigational Site Number 6430043
Saint Petersburg, 198205
Investigational Site Number 6430004
Saint Petersburg, 199106
Investigational Site Number 6430009
Saratov, 410028
Investigational Site Number 6430013
Saratov, 410028
Investigational Site Number 6430042
Saratov, 410039
Investigational Site Number 6430026
Sochi, 354057
Investigational Site Number 6430027
Sochi, 354057
Investigational Site Number 6430011
Tomsk, 634012
Investigational Site Number 6430038
Tomsk, 634050
Investigational Site Number 6430032
Tyumen, 625000
Investigational Site Number 6430023
Vladimir, 600020
Investigational Site Number 6430022
Vladimir, 600023
Investigational Site Number 6430031
Yaroslavl, 150002
India34 sites
Investigational Site Number 3560025
Ahmedabad, 380060
Investigational Site Number 3560010
Bangalore, 560 034
Investigational Site Number 3560026
Bangalore, 560 054.
Investigational Site Number 3560005
Belagavi, 590010
Investigational Site Number 3560008
Bengaluru, 560017
Investigational Site Number 3560022
Chandigarh, 160062
Investigational Site Number 3560040
Chhatrapati Sambhajinagar, 431003
Investigational Site Number 3560003
Gūrgaon, 122001
Investigational Site Number 3560004
Gūrgaon, 122001
Investigational Site Number 3560018
Hyderabad, 500001
Investigational Site Number 3560001
Hyderabad, 500012
Investigational Site Number 3560007
Hyderabad, 500063
Investigational Site Number 3560002
Jaipur, 302017
Investigational Site Number 3560024
Kochi
Investigational Site Number 3560016
Kolkata, 700027
Investigational Site Number 3560030
Kozhikode, 673008
Investigational Site Number 3560006
Ludhiana, 141008
Investigational Site Number 3560027
Mangalore, 575002
Investigational Site Number 3560028
Mangalore, 575018
Investigational Site Number 3560017
Mumbai
Investigational Site Number 3560037
Mysore, 570015
Investigational Site Number 3560013
Nagpur, 440009
Investigational Site Number 3560014
Nagpur, 440010
Investigational Site Number 3560021
Nashik, 42003
Investigational Site Number 3560041
New Delhi, 110 029
Investigational Site Number 3560034
New Delhi, 110002
Investigational Site Number 3560019
Pune, 411001
Investigational Site Number 3560035
Pune, 411004
Investigational Site Number 3560042
Pune, 411004
Investigational Site Number 3560038
Pune, 411010
Investigational Site Number 3560012
Pune, 411019
Investigational Site Number 3560043
Varanasi, 221 005
Investigational Site Number 3560020
Vellore, 632004
Investigational Site Number 3560015
Wardha, 442004
China33 sites
Investigational Site Number 1560019
Beijing, 100034
Investigational Site Number 1560001
Beijing, 100037
Investigational Site Number 1560002
Beijing, 100044
Investigational Site Number 1560003
Beijing, 100730
Investigational Site Number 1560032
Beijing, 100730
Investigational Site Number 1560012
Changchun, 130021
Investigational Site Number 1560023
Changchun, 130021
Investigational Site Number 1560034
Changchun, 130033
Investigational Site Number 1560022
Changsha, 410013
Investigational Site Number 1560021
Chengdu, 610041
Investigational Site Number 1560018
Dalian, 116011
Investigational Site Number 1560010
Dalian, 116033
Investigational Site Number 1560007
Guangzhou, 510080
Investigational Site Number 1560016
Haikou, 570102
Investigational Site Number 1560033
Hengyang, 421001
Investigational Site Number 1560038
Hohhot, 010020
Investigational Site Number 1560005
Huai'an, 223300
Investigational Site Number 1560009
Jinan, 250013
Investigational Site Number 1560037
Jining
Investigational Site Number 1560031
Nanchang, 330006
Investigational Site Number 1560004
Nanjing, 210008
Investigational Site Number 1560006
Shanghai, 200120
Investigational Site Number 1560036
Shenyang, 110016
Investigational Site Number 1560020
Siping, 136000
Investigational Site Number 1560025
Suzhou, 215004
Investigational Site Number 1560014
Suzhou, 215006
Investigational Site Number 1560026
Taizhou, 317000
Investigational Site Number 1560028
Tianjin, 300121
Investigational Site Number 1560029
Tianjin, 300211
Investigational Site Number 1560024
Wuhan, 430033
Investigational Site Number 1560027
Xi'an, 710061
Investigational Site Number 1560035
Xinxiang, 453000
Investigational Site Number 1560008
Zhenjiang, 212001
Poland32 sites
Investigational Site Number 6160027
Bialystok, 15-276
Investigational Site Number 6160011
Bialystok, 15-435
Investigational Site Number 6160029
Bydgoszcz, 85-079
Investigational Site Number 6160030
Bydgoszcz, 85-231
Investigational Site Number 6160006
Bydgoszcz, 85-822
Investigational Site Number 6160018
Bytom, 41-902
Investigational Site Number 6160002
Czeladź, 41-250
Investigational Site Number 6160003
Gdynia, 81-394
Investigational Site Number 6160005
Gdynia, 81-472
Investigational Site Number 6160008
Grodzisk Mazowiecki, 05-825
Investigational Site Number 6160031
Grodzisk Mazowiecki, 05-825
Investigational Site Number 6160023
Katowice, 40-611
Investigational Site Number 6160026
Katowice, 40-748
Investigational Site Number 6160022
Kielce, 25-525
Investigational Site Number 6160019
Krakow, 31-135
Investigational Site Number 6160024
Krakow, 31-261
Investigational Site Number 6160010
Krakow, 31-548
Investigational Site Number 6160016
Lodz, 90-242
Investigational Site Number 6160013
Lodz, 91-347
Investigational Site Number 6160015
Lodz
Investigational Site Number 6160007
Lublin, 20-044
Investigational Site Number 6160033
Poznan, 60-589
Investigational Site Number 6160021
Puławy, 24-100
Investigational Site Number 6160028
Staszów, 28-200
Investigational Site Number 6160020
Torun, 87-100
Investigational Site Number 6160014
Warsaw, 00-631
Investigational Site Number 6160025
Warsaw, 02-005
Investigational Site Number 6160001
Warsaw, 02-097
Investigational Site Number 6160004
Warsaw, 02-507
Investigational Site Number 6160012
Wroclaw, 52-416
Investigational Site Number 6160017
Zabrze, 41-800
Investigational Site Number 6160032
Zamość, 22-400
Canada30 sites
Investigational Site Number 1240002
Brampton, L6S0C6
Investigational Site Number 1240013
Burlington, L7M 4Y1
Investigational Site Number 1240021
Calgary, T2T 5C7
Investigational Site Number 1240005
Calgary, T2V 4J2
Investigational Site Number 1240029
Concord, L4K 4M2
Investigational Site Number 1240004
Edmonton, T5A 4L8
Investigational Site Number 1240010
Edmonton, T6H 2L4
Investigational Site Number 1240008
Greater Sudbury, P3E 4H5
Investigational Site Number 1240027
Halifax, B3H 2Y9
Investigational Site Number 1240023
Hamilton, L8N 3Z5
Investigational Site Number 1240011
London, N6A 4V2
Investigational Site Number 1240019
Montreal, H1T 1C8
Investigational Site Number 1240017
Montreal, H4A 2C6
Investigational Site Number 1240018
Montreal, H4N 2W2
Investigational Site Number 1240007
Newmarket, L3Y 5G8
Investigational Site Number 1240026
Oshawa, L1G 2B9
Investigational Site Number 1240016
Oshawa, L1J 2K1
Investigational Site Number 1240006
Ottawa, K1H7W9
Investigational Site Number 1240022
Québec, G1G 3Z4
Investigational Site Number 1240025
Québec, G1V 4G5
Investigational Site Number 1240014
Québec, G1V 4W2
Investigational Site Number 1240003
Québec, G1W-4R4
Investigational Site Number 1240034
Saint-Charles-Borromée, J6E 6J2
Investigational Site Number 1240032
Saint-Marc-des-Carrieres, G0A 4B0
Investigational Site Number 1240033
St. John's, A1B 3V6
Investigational Site Number 1240031
Surrey, V3V 0C6
Investigational Site Number 1240028
Toronto, M6G 1M2
Investigational Site Number 1240015
Trois-Rivières, G8Z 3R9
Investigational Site Number 1240001
Vancouver, V5Y 3W2
Investigational Site Number 1240030
Victoria, V8R 1B2
Argentina29 sites
Investigational Site Number 0320016
Buenos Aires
Investigational Site Number 0320029
Buenos Aires
Investigational Site Number 0320017
Caba, 1120
Investigational Site Number 0320002
Caba, C1093AAS
Investigational Site Number 0320004
Caba, C1118AAE
Investigational Site Number 0320018
Caba, C1119ACN
Investigational Site Number 0320025
Caba, C1128AAF
Investigational Site Number 0320019
Caba
Investigational Site Number 0320027
Capital Federal, C1056ABJ
Investigational Site Number 0320015
Capital Federal, C1179AAB
Investigational Site Number 0320014
Ciudad Autonoma de Bs.As, C1428DCO
Investigational Site Number 0320023
Ciudad Autonoma de Buenos Aire, C1204AAD
Investigational Site Number 0320009
Ciudadela, B1702BML
Investigational Site Number 0320001
Córdoba, X5000AAX
Investigational Site Number 0320008
Coronel Suárez, B7540GHD
Investigational Site Number 0320011
Corrientes, W3400AMZ
Investigational Site Number 0320028
La Plata, B1900AXI
Investigational Site Number 0320006
La Plata, B1906ESC
Investigational Site Number 0320024
Mar del Plata, B7600FZN
Investigational Site Number 0320003
Mar del Plata, B7600
Investigational Site Number 0320020
Merlo, B1722COV
Investigational Site Number 0320007
Ramos Mejía, B1704ETD
Investigational Site Number 0320030
Rosario, S2000CVD
Investigational Site Number 0320026
Rosario, S2000DEJ
Investigational Site Number 0320012
Salta, 4400
Investigational Site Number 0320021
San Miguel de Tucumán, T4000ICL
Investigational Site Number 0320013
Santa Fe, S3000FWO
Investigational Site Number 0320022
Temperley, 1842
Investigational Site Number 0320005
Villa María, X5900JKA
Mexico27 sites
Investigational Site Number 4840009
Actopan, 42500
Investigational Site Number 4840013
Aguascalientes, 20230
Investigational Site Number 4840019
Aguascalientes, 20230
Investigational Site Number 4840005
Celaya, 38000
Investigational Site Number 4840002
Cuernavaca, 62250
Investigational Site Number 4840025
Distrito Federal, 07760
Investigational Site Number 4840007
Durango, 34000
Investigational Site Number 4840023
Durango, 34080
Investigational Site Number 4840033
Guadalajara, 44150
Investigational Site Number 4840024
Guadalajara, 44160
Investigational Site Number 4840003
Guadalajara, 44210
Investigational Site Number 4840011
Guadalajara, 44210
Investigational Site Number 4840027
Guadalajara, 44280
Investigational Site Number 4840004
Guadalajara, 44600
Investigational Site Number 4840010
Guadalajara, 44650
Investigational Site Number 4840030
Guadalajara
Investigational Site Number 4840028
Mérida, 72129
Investigational Site Number 4840034
Mérida, 97070
Investigational Site Number 4840018
Mexico City, 06760
Investigational Site Number 4840021
Monterrey, 64020
Investigational Site Number 4840020
Monterrey, 64060
Investigational Site Number 4840001
Monterrey, 64460
Investigational Site Number 4840014
Querétaro, 76000
Investigational Site Number 4840015
Toluca, 50130
Investigational Site Number 4840008
Veracruz, 91910
Investigational Site Number 4840016
Xalapa, 91193
Investigational Site Number 4840026
Zapopan, 45116
Brazil26 sites
Investigational Site Number 0760017
Blumenau, 89020-430
Investigational Site Number 0760015
Brasília, 70200-730
Investigational Site Number 0760026
Brasília, 70390-903
Investigational Site Number 0760008
Campinas, 13015-001
Investigational Site Number 0760005
Campinas, 13060-080
Investigational Site Number 0760018
Canoas, 92425-900
Investigational Site Number 0760019
Curitiba, 80030-110
Investigational Site Number 0760011
Curitiba, 80230-130
Investigational Site Number 0760007
Curitiba, 80730-150
Investigational Site Number 0760010
Fortaleza, 60115-282
Investigational Site Number 0760002
Fortaleza, 60170-320
Investigational Site Number 0760004
Fortaleza, 60430-350
Investigational Site Number 0760014
Passo Fundo, 99010-180
Investigational Site Number 0760025
Porto Alegre, 90020-090
Investigational Site Number 0760016
Porto Alegre, 90430-001
Investigational Site Number 0760024
Recife, 52051-380
Investigational Site Number 0760023
Rio de Janeiro, 22271-100
Investigational Site Number 0760001
São José do Rio Preto, 15090-000
Investigational Site Number 0760012
São José dos Campos, 12243-280
Investigational Site Number 0760003
São Paulo, 01.228-000
Investigational Site Number 0760020
São Paulo, 01228-200
Investigational Site Number 0760013
São Paulo, 04038-002
Investigational Site Number 0760022
São Paulo, 04266-010
Investigational Site Number 0760006
São Paulo, 05403-000
Investigational Site Number 0760009
São Paulo, 05403-000
Investigational Site Number 0760021
Vitória, 29055 450
Chile25 sites
Investigational Site Number 1520015
Concepción, 4070566
Investigational Site Number 1520003
Osorno, 5311092
Investigational Site Number 1520012
Punta Arenas, 6210490
Investigational Site Number 1520013
Santiago, 7500571
Investigational Site Number 1520018
Santiago, 7500588
Investigational Site Number 1520001
Santiago, 7500710
Investigational Site Number 1520004
Santiago, 7500710
Investigational Site Number 1520006
Santiago, 7500739
Investigational Site Number 1520014
Santiago, 7591047
Investigational Site Number 1520016
Santiago, 7650568
Investigational Site Number 1520017
Santiago, 7770086
Investigational Site Number 1520020
Santiago, 7770086
Investigational Site Number 1520009
Santiago, 8053095
Investigational Site Number 1520011
Santiago, 8207257
Investigational Site Number 1520026
Santiago, 833-0024
Investigational Site Number 1520010
Santiago, 8330336
Investigational Site Number 1520007
Santiago, 8380456
Investigational Site Number 1520021
Santiago, 8900132
Investigational Site Number 1520022
Santiago, 8910131
Investigational Site Number 1520002
Santiago
Investigational Site Number 1520024
Talca
Investigational Site Number 1520019
Temuco, 4781156
Investigational Site Number 1520025
Temuco, 4781173
Investigational Site Number 1520005
Temuco, 4813299
Investigational Site Number 1520008
Viña del Mar
Spain22 sites
Investigational Site Number 7240015
A Coruña, 15006
Investigational Site Number 7240003
Almería, 04120
Investigational Site Number 7240014
Barcelona, 08035
Investigational Site Number 7240011
Barcelona, 08041
Investigational Site Number 7240009
Córdoba, 14004
Investigational Site Number 7240024
El Puerto de Santa María, 11500
Investigational Site Number 7240016
Granada, 18016
Investigational Site Number 7240001
Madrid, 28023
Investigational Site Number 7240019
Madrid, 28034
Investigational Site Number 7240006
Madrid, 28040
Investigational Site Number 7240010
Madrid, 28046
Investigational Site Number 7240020
Madrid, 28046
Investigational Site Number 7240025
Sabadell, 08208
Investigational Site Number 7240023
Sanlúcar de Barrameda, 11540
Investigational Site Number 7240013
Santa Cruz de Tenerife, 38320
Investigational Site Number 7240007
Santiago de Compostela, 15706
Investigational Site Number 7240026
Seville, 41014
Investigational Site Number 7240012
Seville, 41071
Investigational Site Number 7240004
Valencia, 46010
Investigational Site Number 7240002
Vigo, 36312
Investigational Site Number 7240022
Villamartín, 11650
Investigational Site Number 7240008
Zaragoza, 50009
Ukraine22 sites
Investigational Site Number 8040020
Dnipro, 49005
Investigational Site Number 8040006
Dnipro, 49600
Investigational Site Number 8040009
Ivano-Frankivsk, 76000
Investigational Site Number 8040012
Ivano-Frankivsk, 76018
Investigational Site Number 8040021
Kharkiv, 61039
Investigational Site Number 8040011
Kharkiv, 61058
Investigational Site Number 8040008
Kharkiv, 61166
Investigational Site Number 8040002
Kiev, 02091
Investigational Site Number 8040024
Kiev, 02660
Investigational Site Number 8040003
Kyiv, 03049
Investigational Site Number 8040015
Kyiv, 03115
Investigational Site Number 8040019
Kyiv, 04050
Investigational Site Number 8040010
Kyiv, 04114
Investigational Site Number 8040026
Kyiv
Investigational Site Number 8040023
Lutsk, 43005
Investigational Site Number 8040025
Lutsk, 43024
Investigational Site Number 8040022
Lviv, 79011
Investigational Site Number 8040001
Ternopil, 46000
Investigational Site Number 8040016
Vinnitsya, 21018
Investigational Site Number 8040007
Vinnitsya, 21100
Investigational Site Number 8040004
Vinnytsia, 21001
Investigational Site Number 8040018
Zhytomyr
Peru20 sites
Investigational Site Number 6040004
Arequipa
Investigational Site Number 6040006
Callao, CALLAO 02
Investigational Site Number 6040009
Callao
Investigational Site Number 6040024
Chancay
Investigational Site Number 6040005
Chiclayo
Investigational Site Number 6040010
Cuzco
Investigational Site Number 6040001
Lima, 09
Investigational Site Number 6040025
Lima, 15135
Investigational Site Number 6040016
Lima, LIMA 01
Investigational Site Number 6040020
Lima, LIMA 14
Investigational Site Number 6040013
Lima, Lima 17
Investigational Site Number 6040023
Lima, LIMA 27
Investigational Site Number 6040007
Lima, Lima 29
Investigational Site Number 6040019
Lima, LIMA 31
Investigational Site Number 6040022
Lima, LIMA 32
Investigational Site Number 6040012
Lima, Lima 41
Investigational Site Number 6040017
Lima
Investigational Site Number 6040014
Lima Lima, Lima 01
Investigational Site Number 6040011
Piura, 20000
Investigational Site Number 6040002
Trujillo
Australia18 sites
Investigational Site Number 0360014
Adelaide, 5000
Investigational Site Number 0360004
Box Hill, 3128
Investigational Site Number 0360015
Elizabeth Vale, 5112
Investigational Site Number 0360005
Fitzroy, 3065
Investigational Site Number 0360018
Fremantle, 6160
Investigational Site Number 0360007
Fullarton, 5063
Investigational Site Number 0360002
Gosford, 2250
Investigational Site Number 0360016
Heidelberg, 3081
Investigational Site Number 0360010
Herston, 4029
Investigational Site Number 0360009
Liverpool, 2170
Investigational Site Number 0360017
Melbourne, 3004
Investigational Site Number 0360001
Merewether, 2291
Investigational Site Number 0360012
Oaklands Park, 5046
Investigational Site Number 0360011
Parkville, 3050
Investigational Site Number 0360008
Redcliffe, 4020
Investigational Site Number 0360013
Sherwood, 4075
Investigational Site Number 0360019
St Leonards, 2065
Investigational Site Number 0360006
Wollongong, 2500
Czechia18 sites
Investigational Site Number 2030012
Brno, 62500
Investigational Site Number 2030002
Brno, 63900
Investigational Site Number 2030021
Broumov, 550 01
Investigational Site Number 2030017
Humpolec, 396 01
Investigational Site Number 2030014
Liberec, 46063
Investigational Site Number 2030007
Mariánské Lázně, 353 01
Investigational Site Number 2030015
Městec Králové, 28903
Investigational Site Number 2030009
Pilsen, 301 00
Investigational Site Number 2030016
Prague, 10800
Investigational Site Number 2030019
Prague, 11694
Investigational Site Number 2030006
Prague, 12808
Investigational Site Number 2030005
Prague, 14021
Investigational Site Number 2030011
Prague, 16900
Investigational Site Number 2030018
Prague, 18100
Investigational Site Number 2030010
Řevnice, 25230
Investigational Site Number 2030020
Slaný, 27401
Investigational Site Number 2030001
Trutnov, 54101
Investigational Site Number 2030008
Vsetín, 75501
Hungary16 sites
Investigational Site Number 3480006
Békéscsaba, 5600
Investigational Site Number 3480017
Budapest, 1027
Investigational Site Number 3480004
Budapest, 1042
Investigational Site Number 3480011
Budapest, 1096
Investigational Site Number 3480001
Budapest, 1122
Investigational Site Number 3480010
Budapest, 1125
Investigational Site Number 3480012
Budapest, 1134
Investigational Site Number 3480016
Budapest, 1145
Investigational Site Number 3480018
Budapest, 1204
Investigational Site Number 3480002
Debrecen, 4032
Investigational Site Number 3480008
Debrecen, 4032
Investigational Site Number 3480013
Kaposvár, 7400
Investigational Site Number 3480014
Nyíregyháza, 4400
Investigational Site Number 3480015
Nyíregyháza, 4400
Investigational Site Number 3480003
Székesfehérvár, 8000
Investigational Site Number 3480007
Zalaegerszeg, 8900
Turkey (Türkiye)16 sites
Investigational Site Number 7920018
Antalya, 07070
Investigational Site Number 7920010
Aydin, 09100
Investigational Site Number 7920004
Çorum, 19200
Investigational Site Number 7920016
Gaziantep, 27310
Investigational Site Number 7920011
Istanbul, 34034
Investigational Site Number 7920009
Istanbul, 34390
Investigational Site Number 7920001
Istanbul
Investigational Site Number 7920007
Istanbul
Investigational Site Number 7920017
Istanbul
Investigational Site Number 7920003
Izmir, 35340
Investigational Site Number 7920013
Kayseri, 38039
Investigational Site Number 7920014
Kocaeli, 41380
Investigational Site Number 7920005
Kütahya
Investigational Site Number 7920015
Malatya
Investigational Site Number 7920008
Mersin, 33169
Investigational Site Number 7920002
Sivas, 58140
Bulgaria15 sites
Investigational Site Number 1000015
Blagoevgrad, 2700
Investigational Site Number 1000008
Dobrich, MULTIPROFILE HOSPITA
Investigational Site Number 1000013
Gabrovo, 5300
Investigational Site Number 1000003
Plovdiv, 4002
Investigational Site Number 1000016
Rousse, 7002
Investigational Site Number 1000014
Silistra, 7500
Investigational Site Number 1000007
Smolyan, 4700
Investigational Site Number 1000011
Sofia, 1233
Investigational Site Number 1000004
Sofia, 1431
Investigational Site Number 1000006
Sofia, 1431
Investigational Site Number 1000012
Sofia, 1632
Investigational Site Number 1000005
Sofia, 1750
Investigational Site Number 1000017
Sofia, 1784
Investigational Site Number 1000001
Stara Zagora, 6000
Investigational Site Number 1000018
Stara Zagora, 6000
New Zealand15 sites
Investigational Site Number 5540014
Auckland, 1023
Investigational Site Number 5540006
Birkenhead, 0626
Investigational Site Number 5540009
Birkenhead, 0626
Investigational Site Number 5540002
Christchurch, 8011
Investigational Site Number 5540003
Christchurch
Investigational Site Number 5540012
Christchurch
Investigational Site Number 5540007
Dunedin, 9016
Investigational Site Number 5540016
Hamilton, 3240
Investigational Site Number 5540013
New Plymouth
Investigational Site Number 5540015
Palmerston North, 4414
Investigational Site Number 5540005
Rotorua, 3010
Investigational Site Number 5540010
Takapuna, 1309
Investigational Site Number 5540008
Tauranga, 3001
Investigational Site Number 5540011
Tauranga, 3001
Investigational Site Number 5540004
Wellington, 6021
Romania14 sites
Investigational Site Number 6420008
Bacau, 600154
Investigational Site Number 6420005
Baia Mare, Maramures, 430222
Investigational Site Number 6420009
Brasov, 500097
Investigational Site Number 6420013
Bucharest, 010507
Investigational Site Number 6420014
Bucharest, 010627
Investigational Site Number 6420012
Bucharest, 020475
Investigational Site Number 6420011
Bucharest, 022441
Investigational Site Number 6420002
Craiova, 200349
Investigational Site Number 6420003
Oradea, 410159
Investigational Site Number 6420004
Oradea, 410469
Investigational Site Number 6420010
Ploieşti, 100561
Investigational Site Number 6420001
Targoviste, Dambovita, 130095
Investigational Site Number 6420006
Targu Mures, Mures, 540142
Investigational Site Number 6420007
Targu Mures, Mures, 540142
South Africa13 sites
Investigational Site Number 7100005
Brits, 0250
Investigational Site Number 7100009
Cape Town, 7530
Investigational Site Number 7100006
Cape Town, 7570
Investigational Site Number 7100002
eMkhomazi, 4170
Investigational Site Number 7100001
Parow, 7500
Investigational Site Number 7100012
Pinelands, 7405
Investigational Site Number 7100011
Pretoria, 0002
Investigational Site Number 7100014
Pretoria, 0083
Investigational Site Number 7100008
Pretoria, 0157
Investigational Site Number 7100010
Rivonia, 2128
Investigational Site Number 7100007
Soweto, 1818
Investigational Site Number 7100013
Vosloorus, 1475
Investigational Site Number 7100003
Western Cape, 7130
Slovakia12 sites
Investigational Site Number 7030006
Bardejov, 085 01
Investigational Site Number 7030012
Bratislava, 813 69
Investigational Site Number 7030011
Košice, 040 01
Investigational Site Number 7030001
Ľubochňa, 034 91
Investigational Site Number 7030008
Lučenec, 984 39
Investigational Site Number 7030009
Lučenec, 98401
Investigational Site Number 7030010
Lučenec, 98401
Investigational Site Number 7030004
Moldava nad Bodvou, 04525
Investigational Site Number 7030013
Prešov, 080 01
Investigational Site Number 7030003
Rožňava, 04801
Investigational Site Number 7030002
Sabinov, 083 01
Investigational Site Number 7030007
Svidník, 089 01
Italy10 sites
Investigational Site Number 3800006
Catanzaro, 88100
Investigational Site Number 3800010
Catanzaro, 88100
Investigational Site Number 3800009
Chieri, 10023
Investigational Site Number 3800007
Livorno, 57123
Investigational Site Number 3800002
Milan, 20132
Investigational Site Number 3800008
Milan, 20145
Investigational Site Number 3800005
Orbassano, 10043
Investigational Site Number 3800011
Ravenna, 48100
Investigational Site Number 3800004
Roma, 00133
Investigational Site Number 3800001
Verona, 37126
South Korea10 sites
Investigational Site Number 4100011
Bucheon-si, 14647
Investigational Site Number 4100005
Busan, 49201
Investigational Site Number 4100007
Gwangju, 61469
Investigational Site Number 4100001
Incheon, 22332
Investigational Site Number 4100002
Seongnam-si, 13620
Investigational Site Number 4100003
Seoul, 03080
Investigational Site Number 4100006
Seoul, 03722
Investigational Site Number 4100008
Seoul, 05505
Investigational Site Number 4100004
Seoul, 06351
Investigational Site Number 4100010
Uijeongbu-si, 11765
Guatemala9 sites
Investigational Site Number 3200007
Guatemala City, 01001
Investigational Site Number 3200013
Guatemala City, 01010
Investigational Site Number 3200001
Guatemala City, 01014
Investigational Site Number 3200002
Guatemala City, 1010
Investigational Site Number 3200009
Guatemala City, 1010
Investigational Site Number 3200010
Guatemala City
Investigational Site Number 3200006
Quetzaltenango, 09001
Investigational Site Number 3200014
Quetzaltenango, 09001
Investigational Site Number 3200004
Quetzaltenango, 9011
Lithuania9 sites
Investigational Site Number 4400006
Kaunas, 49449
Investigational Site Number 4400003
Kaunas, 51270
Investigational Site Number 4400009
Kaunas, LT-50161
Investigational Site Number 4400008
Kėdainiai, LT-57164
Investigational Site Number 4400004
Klaipėda, 92111
Investigational Site Number 4400002
Klaipėda, LT-92304
Investigational Site Number 4400007
Ukmerge, 20184
Investigational Site Number 4400005
Utena, LT-28151
Investigational Site Number 4400001
Vilnius, 08661
United Kingdom9 sites
Investigational Site Number 8260003
Belfast, BT12 6BA
Investigational Site Number 8260007
Chippenham, SN14 6GT
Investigational Site Number 8260009
Davyhulme, Manchester, M41 5SL
Investigational Site Number 8260010
Glasgow, G21 3UW
Investigational Site Number 8260004
Hayle, TR27 5DT
Investigational Site Number 8260011
Inverness, IV2 3UJ
Investigational Site Number 8260002
Ipswich, IP4 5PD
Investigational Site Number 8260006
Maidstone, ME16 9QQ
Investigational Site Number 8260001
Swansea, SA2 8PP
Denmark8 sites
Investigational Site Number 2080003
Aarhus N, 8200
Investigational Site Number 2080005
Aarhus N, 8200
Investigational Site Number 2080009
Gentofte Municipality, 2900
Investigational Site Number 2080004
Herlev, 2730
Investigational Site Number 2080008
Hvidovre, 2650
Investigational Site Number 2080002
København NV, 2400
Investigational Site Number 2080007
Slagelse, 4200
Investigational Site Number 2080006
Svendborg, 5700
Germany8 sites
Investigational Site Number 2760008
Berlin, 12351
Investigational Site Number 2760005
Essen, 45136
Investigational Site Number 2760001
Freiburg im Breisgau, 79106
Investigational Site Number 2760007
Hamburg, 22041
Investigational Site Number 2760002
Kassel, 34121
Investigational Site Number 2760006
Leipzig, 04103
Investigational Site Number 2760003
Münster, 48149
Investigational Site Number 2760009
Oldenburg in Holstein, 23758
Israel8 sites
Investigational Site Number 3760008
Beersheba, 84101
Investigational Site Number 3760005
Haifa, 31048
Investigational Site Number 3760007
Haifa, 31096
Investigational Site Number 3760001
Jerusalem, 91031
Investigational Site Number 3760002
Jerusalem, 91120
Investigational Site Number 3760004
Nahariya, 22100
Investigational Site Number 3760003
Tel Aviv, 64239
Investigational Site Number 3760006
Tel HaShomer, 52621
Portugal8 sites
Investigational Site Number 6200004
Almada, 2801-951
Investigational Site Number 6200005
Caldas da Rainha, 2500-176
Investigational Site Number 6200009
Carnaxide, 2790-134
Investigational Site Number 6200002
Coimbra, 3000-075
Investigational Site Number 6200008
Leiria, 2410-197
Investigational Site Number 6200001
Lisbon, 1250
Investigational Site Number 6200007
Loures, 2674-514
Investigational Site Number 6200003
Porto, 4099-001
Sweden8 sites
Investigational Site Number 7520007
Falun, 791 82
Investigational Site Number 7520005
Lund, 221 85
Investigational Site Number 7520004
Mölndal, 43180
Investigational Site Number 7520003
Rättvik, 79530
Investigational Site Number 7520008
Stockholm, 112 21
Investigational Site Number 7520002
Stockholm, 118 83
Investigational Site Number 7520006
Stockholm, 14186
Investigational Site Number 7520001
Uppsala, 751 85
Taiwan8 sites
Investigational Site Number 1580005
Hsinchu, 30071
Investigational Site Number 1580008
Kaohsiung City, 807
Investigational Site Number 1580004
Linkou District
Investigational Site Number 1580006
Taichung, 40447
Investigational Site Number 1580002
Tainan, 704
Investigational Site Number 1580007
Tainan, 710
Investigational Site Number 1580003
Taipei, 100
Investigational Site Number 1580001
Taipei, 112
France7 sites
Investigational Site Number 2500003
Corbeil-Essonnes, 91106
Investigational Site Number 2500002
La Rochelle, 17019
Investigational Site Number 2500005
Paris, 75010
Investigational Site Number 2500006
Paris, 75018
Investigational Site Number 2500001
Paris, 75877
Investigational Site Number 2500004
Toulouse, 31059
Investigational Site Number 2500007
Vénissieux, 69200
Georgia7 sites
Investigational Site Number 2680004
Batumi, 6010
Investigational Site Number 2680001
Kutaisi
Investigational Site Number 2680007
Tbilisi, 0159
Investigational Site Number 2680005
Tbilisi, 102
Investigational Site Number 2680003
Tbilisi, 159
Investigational Site Number 2680006
Tbilisi, 159
Investigational Site Number 2680002
Tbilisi
Latvia7 sites
Investigational Site Number 4280004
Daugavpils, LV-5417
Investigational Site Number 4280002
Liepāja, LV3414
Investigational Site Number 4280007
Ogre, LV-5001
Investigational Site Number 4280006
Riga, LV-1002
Investigational Site Number 4280001
Riga, LV-1011
Investigational Site Number 4280005
Riga, LV-1038
Investigational Site Number 4280003
Sigulda, LV-2150
Serbia7 sites
Investigational Site Number 6880002
Belgrade, 11000
Investigational Site Number 6880003
Belgrade, 11000
Investigational Site Number 6880004
Belgrade, 11000
Investigational Site Number 6880005
Kragujevac, 34000
Investigational Site Number 6880001
Niš, 18000
Investigational Site Number 6880006
Niš, 18000
Investigational Site Number 6880007
Niš, 18000
Belgium5 sites
Investigational Site Number 0560004
Bonheiden, 2820
Investigational Site Number 0560005
Ghent, 9000
Investigational Site Number 0560003
Kortrijk, 8500
Investigational Site Number 0560002
La Louvière, 7100
Investigational Site Number 0560001
Leuven, 3000
Greece5 sites
Investigational Site Number 3000001
Athens, 11527
Investigational Site Number 3000002
Ioannina, 45500
Investigational Site Number 3000004
Larissa, 41110
Investigational Site Number 3000003
Piraeus, 18454
Investigational Site Number 3000005
Thessaloniki, 54629
Netherlands5 sites
Investigational Site Number 5280004
Almelo, 7609 PP
Investigational Site Number 5280001
Groningen, 9728 NT
Investigational Site Number 5280003
Hoogeveen, 7909 AA
Investigational Site Number 5280005
Meppel, 7943 KA
Investigational Site Number 5280002
Rotterdam, 3045 PM
Norway5 sites
Investigational Site Number 5780005
Hamar, 2317
Investigational Site Number 5780001
Hønefoss, 3515
Investigational Site Number 5780003
Oslo, 0514
Investigational Site Number 5780002
Oslo, 373
Investigational Site Number 5780004
Skedsmokorset, 2020
North Macedonia4 sites
Investigational Site Number 8070003
Skopje, 1000
Investigational Site Number 8070005
Struga, 6330
Investigational Site Number 8070001
Tetovo, 1200
Investigational Site Number 8070004
Tetovo, 1200
Estonia3 sites
Investigational Site Number 2330003
Tallinn, 10138
Investigational Site Number 2330001
Tallinn, 13419
Investigational Site Number 2330002
Tartu, 51014
Switzerland2 sites
Investigational Site Number 7560001
Olten, 4600
Investigational Site Number 7560002
Zollikerberg, 8125
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function
The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.
- Being tested
- Sotagliflozin, Placebo
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotagliflozinDrug
Also called SAR439954
Sotagliflozin was administered as a tablet(s), orally once daily.
PlaceboDrug
Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Sotagliflozin | Experimental | Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months. Receives: Drug: Sotagliflozin |
| Placebo | Placebo comparator | Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Measured: Up to 30 months
Secondary outcomes (7)
Total Number of Occurrences of HHF and Urgent HF Visits
Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Measured: Up to 30 months
Number of Deaths From Cardiovascular Causes
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Measured: Up to 30 months
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Measured: Up to 30 months
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomization of HHF, urgent HF visits, CV Death, and HF while hospitalized. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Measured: Up to 30 months
Number of Occurrences After Randomization of the Composite of Sustained ≥50% Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline (for ≥30 Days), Chronic Dialysis, Renal Transplant, or Sustained eGFR <15 mL/Min/1.73 m^2 (for ≥30 Days)
Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Measured: Up to 30 months
Number of Deaths From Any Cause
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Measured: Up to 30 months
Total Number of Occurrences of CV Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start19 Dec 2017
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Why it stopped: study terminated due to business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10,584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Suman Wason, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315143
- Sponsor's protocol ID
- EFC14875
- Other IDs
- 2017-002644-32, U1111-1187-8703, 2017
- Acronym
- SCORED
- Status last verified
- Sep 2022
- First submitted
- 16 Oct 2017
- Last updated
- 28 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Publications
Aggarwal R, Bhatt DL, Szarek M, Cannon CP, Leiter LA, Inzucchi SE, Lopes RD, McGuire DK, Lewis JB, Riddle MC, Davies MJ, Banks P, Carroll AK, Scirica BM, Ray KK, Kosiborod MN, Cherney DZI, Udell JA, Verma S, Mason RP, Pitt B, Steg PG. Effect of sotagliflozin on major adverse cardiovascular events: a prespecified secondary analysis of the SCORED randomised trial. Lancet Diabetes Endocrinol. 2025 Apr;13(4):321-332. doi: 10.1016/S2213-8587(24)00362-0. Epub 2025 Feb 14.
PubMed 39961315Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818Sridhar VS, Bhatt DL, Odutayo A, Szarek M, Davies MJ, Banks P, Pitt B, Steg PG, Cherney DZI. Sotagliflozin and Kidney Outcomes, Kidney Function, and Albuminuria in Type 2 Diabetes and CKD: A Secondary Analysis of the SCORED Trial. Clin J Am Soc Nephrol. 2024 May 1;19(5):557-564. doi: 10.2215/CJN.0000000000000414. Epub 2024 Jan 26.
PubMed 38277468Bhatt DL, Szarek M, Pitt B, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Inzucchi SE, Kosiborod MN, Cherney DZI, Dwyer JP, Scirica BM, Bailey CJ, Diaz R, Ray KK, Udell JA, Lopes RD, Lapuerta P, Steg PG; SCORED Investigators. Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease. N Engl J Med. 2021 Jan 14;384(2):129-139. doi: 10.1056/NEJMoa2030186. Epub 2020 Nov 16.
PubMed 33200891Cefalo CMA, Cinti F, Moffa S, Impronta F, Sorice GP, Mezza T, Pontecorvi A, Giaccari A. Sotagliflozin, the first dual SGLT inhibitor: current outlook and perspectives. Cardiovasc Diabetol. 2019 Feb 28;18(1):20. doi: 10.1186/s12933-019-0828-y.
PubMed 30819210
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function
- ClinicalTrials.gov ID
- NCT03315143
- Acronym / sponsor ID
- SCORED / EFC14875
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study terminated due to business decision
- Enrolment
- 10,584 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Posted 28 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sotagliflozin | Experimental | Drug: SotagliflozinSotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) ≥7%.
- Estimated glomerular filtration rate (eGFR) ≥25 and ≤60 milliliter/minute (mL/min)/1.73 square meter (m^2).
- Age 18 years or older with at least one major cardiovascular risk factor or age 55 years or older with at least two minor cardiovascular risk factors.
- Signed written informed consent.
Key exclusion criteria (5 listed)
- Antihyperglycemic treatment has not been stable within 12 weeks prior to screening.
- Planned coronary procedure or surgery after randomization.
- Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization.
- Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotagliflozinAlso: SAR439954Sotagliflozin was administered as a tablet(s), orally once daily. | Drug | Sotagliflozin |
| PlaceboPlacebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily. | Drug | Placebo |
Primary outcome
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
Time frame: Up to 30 months
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
7 secondary outcomes
Total Number of Occurrences of HHF and Urgent HF Visits
Time frame: Up to 30 months
Number of Deaths From Cardiovascular Causes
Time frame: Up to 30 months
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
Time frame: Up to 30 months
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
Time frame: Up to 30 months
Number of Occurrences After Randomization of the Composite of Sustained ≥50% Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline (for ≥30 Days), Chronic Dialysis, Renal Transplant, or Sustained eGFR <15 mL/Min/1.73 m^2 (for ≥30 Days)
Time frame: Up to 30 months
Number of Deaths From Any Cause
Time frame: Up to 30 months
Total Number of Occurrences of CV Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Time frame: Up to 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39961315Aggarwal R, Bhatt DL, Szarek M, Cannon CP, Leiter LA, Inzucchi SE, Lopes RD, McGuire DK, Lewis JB, Riddle MC, Davies MJ, Banks P, Carroll AK, Scirica BM, Ray KK, Kosiborod MN, Cherney DZI, Udell JA, Verma S, Mason RP, Pitt B, Steg PG. Effect of sotagliflozin on major adverse cardiovascular events: a prespecified secondary analysis of the SCORED randomised trial. Lancet Diabetes Endocrinol. 2025 Apr;13(4):321-332. doi: 10.1016/S2213-8587(24)00362-0. Epub 2025 Feb 14.
- Derived from this study: PubMed 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
- Derived from this study: PubMed 38277468Sridhar VS, Bhatt DL, Odutayo A, Szarek M, Davies MJ, Banks P, Pitt B, Steg PG, Cherney DZI. Sotagliflozin and Kidney Outcomes, Kidney Function, and Albuminuria in Type 2 Diabetes and CKD: A Secondary Analysis of the SCORED Trial. Clin J Am Soc Nephrol. 2024 May 1;19(5):557-564. doi: 10.2215/CJN.0000000000000414. Epub 2024 Jan 26.
- Derived from this study: PubMed 33200891Bhatt DL, Szarek M, Pitt B, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Inzucchi SE, Kosiborod MN, Cherney DZI, Dwyer JP, Scirica BM, Bailey CJ, Diaz R, Ray KK, Udell JA, Lopes RD, Lapuerta P, Steg PG; SCORED Investigators. Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease. N Engl J Med. 2021 Jan 14;384(2):129-139. doi: 10.1056/NEJMoa2030186. Epub 2020 Nov 16.
- Derived from this study: PubMed 30819210Cefalo CMA, Cinti F, Moffa S, Impronta F, Sorice GP, Mezza T, Pontecorvi A, Giaccari A. Sotagliflozin, the first dual SGLT inhibitor: current outlook and perspectives. Cardiovasc Diabetol. 2019 Feb 28;18(1):20. doi: 10.1186/s12933-019-0828-y.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Wason, MD study director
Lexicon Pharmaceuticals, Inc.
754 sites in 45 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sotagliflozin in people with Heart Failure and Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 754 sites in 45 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 754 sites in United States, Russia, India, China, Poland and 40 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF) (time frame: Up to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03315143, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.