Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED)

September 30, 2022 updated by: Lexicon Pharmaceuticals

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10584

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina
    - Investigational Site Number 0320016
  - Buenos Aires, Argentina
    - Investigational Site Number 0320029
  - Caba, Argentina, 1120
    - Investigational Site Number 0320017
  - Caba, Argentina, C1093AAS
    - Investigational Site Number 0320002
  - Caba, Argentina, C1118AAE
    - Investigational Site Number 0320004
  - Caba, Argentina, C1119ACN
    - Investigational Site Number 0320018
  - Caba, Argentina, C1128AAF
    - Investigational Site Number 0320025
  - Caba, Argentina
    - Investigational Site Number 0320019
  - Capital Federal, Argentina, C1056ABJ
    - Investigational Site Number 0320027
  - Capital Federal, Argentina, C1179AAB
    - Investigational Site Number 0320015
  - Ciudad Autonoma De Bs.As, Argentina, C1428DCO
    - Investigational Site Number 0320014
  - Ciudad Autonoma De Buenos Aire, Argentina, C1204AAD
    - Investigational Site Number 0320023
  - Ciudadela, Argentina, B1702BML
    - Investigational Site Number 0320009
  - Cordoba, Argentina, X5000AAX
    - Investigational Site Number 0320001
  - Coronel Suarez, Argentina, B7540GHD
    - Investigational Site Number 0320008
  - Corrientes, Argentina, W3400AMZ
    - Investigational Site Number 0320011
  - La Plata, Argentina, B1900AXI
    - Investigational Site Number 0320028
  - La Plata, Argentina, B1906ESC
    - Investigational Site Number 0320006
  - Mar Del Plata, Argentina, B7600FZN
    - Investigational Site Number 0320024
  - Mar Del Plata, Argentina, B7600
    - Investigational Site Number 0320003
  - Merlo, Argentina, B1722COV
    - Investigational Site Number 0320020
  - Ramos Mejia, Argentina, B1704ETD
    - Investigational Site Number 0320007
  - Rosario, Argentina, S2000CVD
    - Investigational Site Number 0320030
  - Rosario, Argentina, S2000DEJ
    - Investigational Site Number 0320026
  - Salta, Argentina, 4400
    - Investigational Site Number 0320012
  - San Miguel De Tucuman, Argentina, T4000ICL
    - Investigational Site Number 0320021
  - Santa Fe, Argentina, S3000FWO
    - Investigational Site Number 0320013
  - Temperley, Argentina, 1842
    - Investigational Site Number 0320022
  - Villa Maria, Argentina, X5900JKA
    - Investigational Site Number 0320005
Australia
- - Adelaide, Australia, 5000
    - Investigational Site Number 0360014
  - Box Hill, Australia, 3128
    - Investigational Site Number 0360004
  - Elizabeth Vale, Australia, 5112
    - Investigational Site Number 0360015
  - Fitzroy, Australia, 3065
    - Investigational Site Number 0360005
  - Fremantle, Australia, 6160
    - Investigational Site Number 0360018
  - Fullarton, Australia, 5063
    - Investigational Site Number 0360007
  - Gosford, Australia, 2250
    - Investigational Site Number 0360002
  - Heidelberg, Australia, 3081
    - Investigational Site Number 0360016
  - Herston, Australia, 4029
    - Investigational Site Number 0360010
  - Liverpool, Australia, 2170
    - Investigational Site Number 0360009
  - Melbourne, Australia, 3004
    - Investigational Site Number 0360017
  - Merewether, Australia, 2291
    - Investigational Site Number 0360001
  - Oaklands Park, Australia, 5046
    - Investigational Site Number 0360012
  - Parkville, Australia, 3050
    - Investigational Site Number 0360011
  - Redcliffe, Australia, 4020
    - Investigational Site Number 0360008
  - Sherwood, Australia, 4075
    - Investigational Site Number 0360013
  - St Leonards, Australia, 2065
    - Investigational Site Number 0360019
  - Wollongong, Australia, 2500
    - Investigational Site Number 0360006
Belgium
- - Bonheiden, Belgium, 2820
    - Investigational Site Number 0560004
  - Gent, Belgium, 9000
    - Investigational Site Number 0560005
  - Kortrijk, Belgium, 8500
    - Investigational Site Number 0560003
  - La-Louvière, Belgium, 7100
    - Investigational Site Number 0560002
  - Leuven, Belgium, 3000
    - Investigational Site Number 0560001
Brazil
- - Blumenau, Brazil, 89020-430
    - Investigational Site Number 0760017
  - Brasilia, Brazil, 70200-730
    - Investigational Site Number 0760015
  - Brasilia, Brazil, 70390-903
    - Investigational Site Number 0760026
  - Campinas, Brazil, 13015-001
    - Investigational Site Number 0760008
  - Campinas, Brazil, 13060-080
    - Investigational Site Number 0760005
  - Canoas, Brazil, 92425-900
    - Investigational Site Number 0760018
  - Curitiba, Brazil, 80030-110
    - Investigational Site Number 0760019
  - Curitiba, Brazil, 80230-130
    - Investigational Site Number 0760011
  - Curitiba, Brazil, 80730-150
    - Investigational Site Number 0760007
  - Fortaleza, Brazil, 60115-282
    - Investigational Site Number 0760010
  - Fortaleza, Brazil, 60170-320
    - Investigational Site Number 0760002
  - Fortaleza, Brazil, 60430-350
    - Investigational Site Number 0760004
  - Passo Fundo, Brazil, 99010-180
    - Investigational Site Number 0760014
  - Porto Alegre, Brazil, 90020-090
    - Investigational Site Number 0760025
  - Porto Alegre, Brazil, 90430-001
    - Investigational Site Number 0760016
  - Recife, Brazil, 52051-380
    - Investigational Site Number 0760024
  - Rio De Janeiro, Brazil, 22271-100
    - Investigational Site Number 0760023
  - Sao Jose Do Rio Preto, Brazil, 15090-000
    - Investigational Site Number 0760001
  - Sao Jose Dos Campos, Brazil, 12243-280
    - Investigational Site Number 0760012
  - Sao Paulo, Brazil, 01228-200
    - Investigational Site Number 0760020
  - Sao Paulo, Brazil, 04038-002
    - Investigational Site Number 0760013
  - Sao Paulo, Brazil, 04266-010
    - Investigational Site Number 0760022
  - Sao Paulo, Brazil, 05403-000
    - Investigational Site Number 0760006
  - Sao Paulo, Brazil, 05403-000
    - Investigational Site Number 0760009
  - São Paulo, Brazil, 01.228-000
    - Investigational Site Number 0760003
  - Vitoria, Brazil, 29055 450
    - Investigational Site Number 0760021
Bulgaria
- - Blagoevgrad, Bulgaria, 2700
    - Investigational Site Number 1000015
  - Dobrich, Bulgaria, MULTIPROFILE HOSPITA
    - Investigational Site Number 1000008
  - Gabrovo, Bulgaria, 5300
    - Investigational Site Number 1000013
  - Plovdiv, Bulgaria, 4002
    - Investigational Site Number 1000003
  - Ruse, Bulgaria, 7002
    - Investigational Site Number 1000016
  - Silistra, Bulgaria, 7500
    - Investigational Site Number 1000014
  - Smolyan, Bulgaria, 4700
    - Investigational Site Number 1000007
  - Sofia, Bulgaria, 1750
    - Investigational Site Number 1000005
  - Sofia, Bulgaria, 1233
    - Investigational Site Number 1000011
  - Sofia, Bulgaria, 1431
    - Investigational Site Number 1000004
  - Sofia, Bulgaria, 1431
    - Investigational Site Number 1000006
  - Sofia, Bulgaria, 1632
    - Investigational Site Number 1000012
  - Sofia, Bulgaria, 1784
    - Investigational Site Number 1000017
  - Stara Zagora, Bulgaria, 6000
    - Investigational Site Number 1000001
  - Stara Zagora, Bulgaria, 6000
    - Investigational Site Number 1000018
Canada
- - Brampton, Canada, L6S0C6
    - Investigational Site Number 1240002
  - Burlington, Canada, L7M 4Y1
    - Investigational Site Number 1240013
  - Calgary, Canada, T2T 5C7
    - Investigational Site Number 1240021
  - Calgary, Canada, T2V 4J2
    - Investigational Site Number 1240005
  - Concord, Canada, L4K 4M2
    - Investigational Site Number 1240029
  - Edmonton, Canada, T5A 4L8
    - Investigational Site Number 1240004
  - Edmonton, Canada, T6H 2L4
    - Investigational Site Number 1240010
  - Halifax, Canada, B3H 2Y9
    - Investigational Site Number 1240027
  - Hamilton, Canada, L8N 3Z5
    - Investigational Site Number 1240023
  - London, Canada, N6A 4V2
    - Investigational Site Number 1240011
  - Montreal, Canada, H1T 1C8
    - Investigational Site Number 1240019
  - Montreal, Canada, H4A 2C6
    - Investigational Site Number 1240017
  - Montreal, Canada, H4N 2W2
    - Investigational Site Number 1240018
  - Newmarket, Canada, L3Y 5G8
    - Investigational Site Number 1240007
  - Oshawa, Canada, L1G 2B9
    - Investigational Site Number 1240026
  - Oshawa, Canada, L1J 2K1
    - Investigational Site Number 1240016
  - Ottawa, Canada, K1H7W9
    - Investigational Site Number 1240006
  - Quebec, Canada, G1G 3Z4
    - Investigational Site Number 1240022
  - Quebec, Canada, G1V 4G5
    - Investigational Site Number 1240025
  - Quebec, Canada, G1V 4W2
    - Investigational Site Number 1240014
  - Quebec, Canada, G1W-4R4
    - Investigational Site Number 1240003
  - Saint-Charles-Borromee, Canada, J6E 6J2
    - Investigational Site Number 1240034
  - St-Marc-Des-Carrieres, Canada, G0A 4B0
    - Investigational Site Number 1240032
  - St. John'S, Canada, A1B 3V6
    - Investigational Site Number 1240033
  - Sudbury, Canada, P3E 4H5
    - Investigational Site Number 1240008
  - Surrey, Canada, V3V 0C6
    - Investigational Site Number 1240031
  - Toronto, Canada, M6G 1M2
    - Investigational Site Number 1240028
  - Trois-Rivieres, Canada, G8Z 3R9
    - Investigational Site Number 1240015
  - Vancouver, Canada, V5Y 3W2
    - Investigational Site Number 1240001
  - Victoria, Canada, V8R 1B2
    - Investigational Site Number 1240030
Chile
- - Concepción, Chile, 4070566
    - Investigational Site Number 1520015
  - Osorno, Chile, 5311092
    - Investigational Site Number 1520003
  - Punta Arenas, Chile, 6210490
    - Investigational Site Number 1520012
  - Santiago, Chile, 7500571
    - Investigational Site Number 1520013
  - Santiago, Chile, 7500588
    - Investigational Site Number 1520018
  - Santiago, Chile, 7500710
    - Investigational Site Number 1520001
  - Santiago, Chile, 7500710
    - Investigational Site Number 1520004
  - Santiago, Chile, 7500739
    - Investigational Site Number 1520006
  - Santiago, Chile, 7591047
    - Investigational Site Number 1520014
  - Santiago, Chile, 7650568
    - Investigational Site Number 1520016
  - Santiago, Chile, 7770086
    - Investigational Site Number 1520017
  - Santiago, Chile, 7770086
    - Investigational Site Number 1520020
  - Santiago, Chile, 8053095
    - Investigational Site Number 1520009
  - Santiago, Chile, 8207257
    - Investigational Site Number 1520011
  - Santiago, Chile, 833-0024
    - Investigational Site Number 1520026
  - Santiago, Chile, 8330336
    - Investigational Site Number 1520010
  - Santiago, Chile, 8380456
    - Investigational Site Number 1520007
  - Santiago, Chile, 8900132
    - Investigational Site Number 1520021
  - Santiago, Chile, 8910131
    - Investigational Site Number 1520022
  - Santiago, Chile
    - Investigational Site Number 1520002
  - Talca, Chile
    - Investigational Site Number 1520024
  - Temuco, Chile, 4781156
    - Investigational Site Number 1520019
  - Temuco, Chile, 4781173
    - Investigational Site Number 1520025
  - Temuco, Chile, 4813299
    - Investigational Site Number 1520005
  - Viña Del Mar, Chile
    - Investigational Site Number 1520008
China
- - Beijing, China, 100034
    - Investigational Site Number 1560019
  - Beijing, China, 100037
    - Investigational Site Number 1560001
  - Beijing, China, 100044
    - Investigational Site Number 1560002
  - Beijing, China, 100730
    - Investigational Site Number 1560003
  - Beijing, China, 100730
    - Investigational Site Number 1560032
  - Changchun, China, 130021
    - Investigational Site Number 1560012
  - Changchun, China, 130021
    - Investigational Site Number 1560023
  - Changchun, China, 130033
    - Investigational Site Number 1560034
  - Changsha, China, 410013
    - Investigational Site Number 1560022
  - Chengdu, China, 610041
    - Investigational Site Number 1560021
  - Dalian, China, 116011
    - Investigational Site Number 1560018
  - Dalian, China, 116033
    - Investigational Site Number 1560010
  - Guangzhou, China, 510080
    - Investigational Site Number 1560007
  - Haikou, China, 570102
    - Investigational Site Number 1560016
  - Hengyang, China, 421001
    - Investigational Site Number 1560033
  - Hohhot, China, 010020
    - Investigational Site Number 1560038
  - Huai'An, China, 223300
    - Investigational Site Number 1560005
  - Jinan, China, 250013
    - Investigational Site Number 1560009
  - Jining, China
    - Investigational Site Number 1560037
  - Nanchang, China, 330006
    - Investigational Site Number 1560031
  - Nanjing, China, 210008
    - Investigational Site Number 1560004
  - Shanghai, China, 200120
    - Investigational Site Number 1560006
  - Shenyang, China, 110016
    - Investigational Site Number 1560036
  - Siping, China, 136000
    - Investigational Site Number 1560020
  - Suzhou, China, 215004
    - Investigational Site Number 1560025
  - Suzhou, China, 215006
    - Investigational Site Number 1560014
  - Taizhou, China, 317000
    - Investigational Site Number 1560026
  - Tianjin, China, 300121
    - Investigational Site Number 1560028
  - Tianjin, China, 300211
    - Investigational Site Number 1560029
  - Wuhan, China, 430033
    - Investigational Site Number 1560024
  - Xi'An, China, 710061
    - Investigational Site Number 1560027
  - Xinxiang, China, 453000
    - Investigational Site Number 1560035
  - Zhenjiang, China, 212001
    - Investigational Site Number 1560008
Czechia
- - Brno, Czechia, 62500
    - Investigational Site Number 2030012
  - Brno, Czechia, 63900
    - Investigational Site Number 2030002
  - Broumov, Czechia, 550 01
    - Investigational Site Number 2030021
  - Humpolec, Czechia, 396 01
    - Investigational Site Number 2030017
  - Liberec, Czechia, 46063
    - Investigational Site Number 2030014
  - Marianske Lazne, Czechia, 353 01
    - Investigational Site Number 2030007
  - Mestec Kralove, Czechia, 28903
    - Investigational Site Number 2030015
  - Plzen, Czechia, 301 00
    - Investigational Site Number 2030009
  - Praha 1, Czechia, 11694
    - Investigational Site Number 2030019
  - Praha 10, Czechia, 10800
    - Investigational Site Number 2030016
  - Praha 2, Czechia, 12808
    - Investigational Site Number 2030006
  - Praha 4, Czechia, 14021
    - Investigational Site Number 2030005
  - Praha 6, Czechia, 16900
    - Investigational Site Number 2030011
  - Praha 8, Czechia, 18100
    - Investigational Site Number 2030018
  - Revnice, Czechia, 25230
    - Investigational Site Number 2030010
  - Slany, Czechia, 27401
    - Investigational Site Number 2030020
  - Trutnov, Czechia, 54101
    - Investigational Site Number 2030001
  - Vsetin, Czechia, 75501
    - Investigational Site Number 2030008
Denmark
- - Aarhus N, Denmark, 8200
    - Investigational Site Number 2080003
  - Aarhus N, Denmark, 8200
    - Investigational Site Number 2080005
  - Gentofte, Denmark, 2900
    - Investigational Site Number 2080009
  - Herlev, Denmark, 2730
    - Investigational Site Number 2080004
  - Hvidovre, Denmark, 2650
    - Investigational Site Number 2080008
  - København Nv, Denmark, 2400
    - Investigational Site Number 2080002
  - Slagelse, Denmark, 4200
    - Investigational Site Number 2080007
  - Svendborg, Denmark, 5700
    - Investigational Site Number 2080006
Estonia
- - Tallinn, Estonia, 13419
    - Investigational Site Number 2330001
  - Tallinn, Estonia, 10138
    - Investigational Site Number 2330003
  - Tartu, Estonia, 51014
    - Investigational Site Number 2330002
France
- - Corbeil-Essonnes, France, 91106
    - Investigational Site Number 2500003
  - La Rochelle Cedex, France, 17019
    - Investigational Site Number 2500002
  - Paris, France, 75010
    - Investigational Site Number 2500005
  - Paris, France, 75018
    - Investigational Site Number 2500006
  - Paris Cedex 18, France, 75877
    - Investigational Site Number 2500001
  - Toulouse Cedex 9, France, 31059
    - Investigational Site Number 2500004
  - Venissieux, France, 69200
    - Investigational Site Number 2500007
Georgia
- - Batumi, Georgia, 6010
    - Investigational Site Number 2680004
  - Kutaisi, Georgia
    - Investigational Site Number 2680001
  - Tbilisi, Georgia, 0159
    - Investigational Site Number 2680007
  - Tbilisi, Georgia, 102
    - Investigational Site Number 2680005
  - Tbilisi, Georgia, 159
    - Investigational Site Number 2680003
  - Tbilisi, Georgia, 159
    - Investigational Site Number 2680006
  - Tbilisi, Georgia
    - Investigational Site Number 2680002
Germany
- - Berlin, Germany, 12351
    - Investigational Site Number 2760008
  - Essen, Germany, 45136
    - Investigational Site Number 2760005
  - Freiburg, Germany, 79106
    - Investigational Site Number 2760001
  - Hamburg, Germany, 22041
    - Investigational Site Number 2760007
  - Kassel, Germany, 34121
    - Investigational Site Number 2760002
  - Leipzig, Germany, 04103
    - Investigational Site Number 2760006
  - Münster, Germany, 48149
    - Investigational Site Number 2760003
  - Oldenburg In Holstein, Germany, 23758
    - Investigational Site Number 2760009
Greece
- - Athens, Greece, 11527
    - Investigational Site Number 3000001
  - Ioannina, Greece, 45500
    - Investigational Site Number 3000002
  - Larissa, Greece, 41110
    - Investigational Site Number 3000004
  - Pireas, Greece, 18454
    - Investigational Site Number 3000003
  - Thessaloniki, Greece, 54629
    - Investigational Site Number 3000005
Guatemala
- - Guatemala, Guatemala, 01001
    - Investigational Site Number 3200007
  - Guatemala, Guatemala, 01010
    - Investigational Site Number 3200013
  - Guatemala, Guatemala, 01014
    - Investigational Site Number 3200001
  - Guatemala, Guatemala, 1010
    - Investigational Site Number 3200002
  - Guatemala, Guatemala, 1010
    - Investigational Site Number 3200009
  - Guatemala, Guatemala
    - Investigational Site Number 3200010
  - Quetzaltenango, Guatemala, 09001
    - Investigational Site Number 3200006
  - Quetzaltenango, Guatemala, 09001
    - Investigational Site Number 3200014
  - Quetzaltenango, Guatemala, 9011
    - Investigational Site Number 3200004
Hungary
- - Budapest, Hungary, 1122
    - Investigational Site Number 3480001
  - Budapest, Hungary, 1027
    - Investigational Site Number 3480017
  - Budapest, Hungary, 1042
    - Investigational Site Number 3480004
  - Budapest, Hungary, 1096
    - Investigational Site Number 3480011
  - Budapest, Hungary, 1125
    - Investigational Site Number 3480010
  - Budapest, Hungary, 1134
    - Investigational Site Number 3480012
  - Budapest, Hungary, 1145
    - Investigational Site Number 3480016
  - Budapest, Hungary, 1204
    - Investigational Site Number 3480018
  - Békéscsaba, Hungary, 5600
    - Investigational Site Number 3480006
  - Debrecen, Hungary, 4032
    - Investigational Site Number 3480002
  - Debrecen, Hungary, 4032
    - Investigational Site Number 3480008
  - Kaposvár, Hungary, 7400
    - Investigational Site Number 3480013
  - Nyíregyháza, Hungary, 4400
    - Investigational Site Number 3480014
  - Nyíregyháza, Hungary, 4400
    - Investigational Site Number 3480015
  - Szekesfehervar, Hungary, 8000
    - Investigational Site Number 3480003
  - Zalaegerszeg, Hungary, 8900
    - Investigational Site Number 3480007
India
- - Ahmedabad, India, 380060
    - Investigational Site Number 3560025
  - Aurangabad, India, 431003
    - Investigational Site Number 3560040
  - Bangalore, India, 560 034
    - Investigational Site Number 3560010
  - Bangalore, India, 560 054.
    - Investigational Site Number 3560026
  - Belgaum, India, 590010
    - Investigational Site Number 3560005
  - Bengaluru, India, 560017
    - Investigational Site Number 3560008
  - Chandigarh, India, 160062
    - Investigational Site Number 3560022
  - Gurgaon, India, 122001
    - Investigational site Number 3560003
  - Gurgaon, India, 122001
    - Investigational Site Number 3560004
  - Hyderabad, India, 500001
    - Investigational Site Number 3560018
  - Hyderabad, India, 500012
    - Investigational Site Number 3560001
  - Hyderabad, India, 500063
    - Investigational Site Number 3560007
  - Jaipur, India, 302017
    - Investigational Site Number 3560002
  - Kochi, India
    - Investigational Site Number 3560024
  - Kolkata, India, 700027
    - Investigational Site Number 3560016
  - Kozhikode, India, 673008
    - Investigational Site Number 3560030
  - Ludhiana, India, 141008
    - Investigational Site Number 3560006
  - Mangalore, India, 575002
    - Investigational Site Number 3560027
  - Mangalore, India, 575018
    - Investigational Site Number 3560028
  - Mumbai, India
    - Investigational Site Number 3560017
  - Mysore, India, 570015
    - Investigational Site Number 3560037
  - Nagpur, India, 440009
    - Investigational site Number 3560013
  - Nagpur, India, 440010
    - Investigational Site Number 3560014
  - Nashik, India, 42003
    - Investigational Site Number 3560021
  - New Delhi, India, 110 029
    - Investigational Site Number 3560041
  - New Delhi, India, 110002
    - Investigational Site Number 3560034
  - Pune, India, 411001
    - Investigational Site Number 3560019
  - Pune, India, 411004
    - Investigational Site Number 3560035
  - Pune, India, 411004
    - Investigational Site Number 3560042
  - Pune, India, 411010
    - Investigational Site Number 3560038
  - Pune, India, 411019
    - Investigational Site Number 3560012
  - Varanasi, India, 221 005
    - Investigational Site Number 3560043
  - Vellore, India, 632004
    - Investigational Site Number 3560020
  - Wardha, India, 442004
    - Investigational Site Number 3560015
Israel
- - Beer Sheva, Israel, 84101
    - Investigational Site Number 3760008
  - Haifa, Israel, 31048
    - Investigational Site Number 3760005
  - Haifa, Israel, 31096
    - Investigational Site Number 3760007
  - Jerusalem, Israel, 91031
    - Investigational Site Number 3760001
  - Jerusalem, Israel, 91120
    - Investigational Site Number 3760002
  - Nahariya, Israel, 22100
    - Investigational Site Number 3760004
  - Tel Aviv, Israel, 64239
    - Investigational site number 3760003
  - Tel Hashomer, Israel, 52621
    - Investigational Site Number 3760006
Italy
- - Catanzaro, Italy, 88100
    - Investigational Site Number 3800006
  - Catanzaro, Italy, 88100
    - Investigational Site Number 3800010
  - Chieri, Italy, 10023
    - Investigational Site Number 3800009
  - Livorno, Italy, 57123
    - Investigational Site Number 3800007
  - Milano, Italy, 20132
    - Investigational Site Number 3800002
  - Milano, Italy, 20145
    - Investigational Site Number 3800008
  - Orbassano, Italy, 10043
    - Investigational Site Number 3800005
  - Ravenna, Italy, 48100
    - Investigational Site Number 3800011
  - Roma, Italy, 00133
    - Investigational Site Number 3800004
  - Verona, Italy, 37126
    - Investigational Site Number 3800001
Korea, Republic of
- - Bucheon-Si, Korea, Republic of, 14647
    - Investigational Site Number 4100011
  - Busan, Korea, Republic of, 49201
    - Investigational Site Number 4100005
  - Gwangju, Korea, Republic of, 61469
    - Investigational Site Number 4100007
  - Incheon, Korea, Republic of, 22332
    - Investigational Site Number 4100001
  - Seongnam-Si, Korea, Republic of, 13620
    - Investigational Site Number 4100002
  - Seoul, Korea, Republic of, 03080
    - Investigational Site Number 4100003
  - Seoul, Korea, Republic of, 03722
    - Investigational Site Number 4100006
  - Seoul, Korea, Republic of, 05505
    - Investigational Site Number 4100008
  - Seoul, Korea, Republic of, 06351
    - Investigational Site Number 4100004
  - Uijeongbu-Si, Korea, Republic of, 11765
    - Investigational Site Number 4100010
Latvia
- - Daugavpils, Latvia, LV-5417
    - Investigational Site Number 4280004
  - Liepāja, Latvia, LV3414
    - Investigational Site Number 4280002
  - Ogre, Latvia, LV-5001
    - Investigational Site Number 4280007
  - Riga, Latvia, LV-1011
    - Investigational Site Number 4280001
  - Riga, Latvia, LV-1002
    - Investigational Site Number 4280006
  - Riga, Latvia, LV-1038
    - Investigational Site Number 4280005
  - Sigulda, Latvia, LV-2150
    - Investigational Site Number 4280003
Lithuania
- - Kaunas, Lithuania, 49449
    - Investigational Site Number 4400006
  - Kaunas, Lithuania, 51270
    - Investigational Site Number 4400003
  - Kaunas, Lithuania, LT-50161
    - Investigational Site Number 4400009
  - Kedainiai, Lithuania, LT-57164
    - Investigational Site Number 4400008
  - Klaipeda, Lithuania, 92111
    - Investigational Site Number 4400004
  - Klaipeda, Lithuania, LT-92304
    - Investigational Site Number 4400002
  - Ukmerge, Lithuania, 20184
    - Investigational Site Number 4400007
  - Utena, Lithuania, LT-28151
    - Investigational Site Number 4400005
  - Vilnius, Lithuania, 08661
    - Investigational Site Number 4400001
Mexico
- - Actopan, Mexico, 42500
    - Investigational Site Number 4840009
  - Aguascalientes, Mexico, 20230
    - Investigational Site Number 4840013
  - Aguascalientes, Mexico, 20230
    - Investigational Site Number 4840019
  - Cdmx, Mexico, 06760
    - Investigational Site Number 4840018
  - Celaya, Mexico, 38000
    - Investigational Site Number 4840005
  - Cuernavaca, Mexico, 62250
    - Investigational Site Number 4840002
  - Distrito Federal, Mexico, 07760
    - Investigational Site Number 4840025
  - Durango, Mexico, 34000
    - Investigational Site Number 4840007
  - Durango, Mexico, 34080
    - Investigational Site Number 4840023
  - Guadalajara, Mexico, 44150
    - Investigational Site Number 4840033
  - Guadalajara, Mexico, 44160
    - Investigational Site Number 4840024
  - Guadalajara, Mexico, 44210
    - Investigational Site Number 4840003
  - Guadalajara, Mexico, 44210
    - Investigational Site Number 4840011
  - Guadalajara, Mexico, 44280
    - Investigational Site Number 4840027
  - Guadalajara, Mexico, 44600
    - Investigational Site Number 4840004
  - Guadalajara, Mexico, 44650
    - Investigational Site Number 4840010
  - Guadalajara, Mexico
    - Investigational Site Number 4840030
  - Merida, Mexico, 97070
    - Investigational Site Number 4840034
  - Monterrey, Mexico, 64460
    - Investigational Site Number 4840001
  - Monterrey, Mexico, 64020
    - Investigational Site Number 4840021
  - Monterrey, Mexico, 64060
    - Investigational Site Number 4840020
  - Mérida, Mexico, 72129
    - Investigational Site Number 4840028
  - Queretaro, Mexico, 76000
    - Investigational Site Number 4840014
  - Toluca, Mexico, 50130
    - Investigational Site Number 4840015
  - Veracruz, Mexico, 91910
    - Investigational Site Number 4840008
  - Xalapa, Mexico, 91193
    - Investigational Site Number 4840016
  - Zapopan, Mexico, 45116
    - Investigational Site Number 4840026
Netherlands
- - Almelo, Netherlands, 7609 PP
    - Investigational Site Number 5280004
  - Groningen, Netherlands, 9728 NT
    - Investigational Site Number 5280001
  - Hoogeveen, Netherlands, 7909 AA
    - Investigational Site Number 5280003
  - Meppel, Netherlands, 7943 KA
    - Investigational Site Number 5280005
  - Rotterdam, Netherlands, 3045 PM
    - Investigational Site Number 5280002
New Zealand
- - Auckland, New Zealand, 1023
    - Investigational Site Number 5540014
  - Birkenhead, New Zealand, 0626
    - Investigational Site Number 5540006
  - Birkenhead, New Zealand, 0626
    - Investigational Site Number 5540009
  - Christchurch, New Zealand, 8011
    - Investigational Site Number 5540002
  - Christchurch, New Zealand
    - Investigational Site Number 5540003
  - Christchurch, New Zealand
    - Investigational Site Number 5540012
  - Dunedin, New Zealand, 9016
    - Investigational Site Number 5540007
  - Hamilton, New Zealand, 3240
    - Investigational Site Number 5540016
  - New Plymouth, New Zealand
    - Investigational Site Number 5540013
  - Palmerston North, New Zealand, 4414
    - Investigational Site Number 5540015
  - Rotorua, New Zealand, 3010
    - Investigational Site Number 5540005
  - Takapuna, New Zealand, 1309
    - Investigational Site Number 5540010
  - Tauranga, New Zealand, 3001
    - Investigational Site Number 5540008
  - Tauranga, New Zealand, 3001
    - Investigational Site Number 5540011
  - Wellington, New Zealand, 6021
    - Investigational Site Number 5540004
North Macedonia
- - Skopje, North Macedonia, 1000
    - Investigational Site Number 8070003
  - Struga, North Macedonia, 6330
    - Investigational Site Number 8070005
  - Tetovo, North Macedonia, 1200
    - Investigational Site Number 8070001
  - Tetovo, North Macedonia, 1200
    - Investigational Site Number 8070004
Norway
- - Hamar, Norway, 2317
    - Investigational Site Number 5780005
  - Hønefoss, Norway, 3515
    - Investigational Site Number 5780001
  - Oslo, Norway, 0514
    - Investigational Site Number 5780003
  - Oslo, Norway, 373
    - Investigational Site Number 5780002
  - Skedsmokorset, Norway, 2020
    - Investigational Site Number 5780004
Peru
- - Arequipa, Peru
    - Investigational Site Number 6040004
  - Callao, Peru, CALLAO 02
    - Investigational Site Number 6040006
  - Callao, Peru
    - Investigational Site Number 6040009
  - Chancay, Peru
    - Investigational Site Number 6040024
  - Chiclayo, Peru
    - Investigational Site Number 6040005
  - Cuzco, Peru
    - Investigational Site Number 6040010
  - Lima, Peru, 09
    - Investigational Site Number 6040001
  - Lima, Peru, 15135
    - Investigational Site Number 6040025
  - Lima, Peru, LIMA 01
    - Investigational Site Number 6040016
  - Lima, Peru, LIMA 14
    - Investigational Site Number 6040020
  - Lima, Peru, Lima 17
    - Investigational Site Number 6040013
  - Lima, Peru, LIMA 27
    - Investigational Site Number 6040023
  - Lima, Peru, Lima 29
    - Investigational Site Number 6040007
  - Lima, Peru, LIMA 31
    - Investigational Site Number 6040019
  - Lima, Peru, LIMA 32
    - Investigational Site Number 6040022
  - Lima, Peru, Lima 41
    - Investigational Site Number 6040012
  - Lima, Peru
    - Investigational Site Number 6040017
  - Lima Lima, Peru, Lima 01
    - Investigational Site Number 6040014
  - Piura, Peru, 20000
    - Investigational Site Number 6040011
  - Trujillo, Peru
    - Investigational Site Number 6040002
Poland
- - Bialystok, Poland, 15-276
    - Investigational Site Number 6160027
  - Bialystok, Poland, 15-435
    - Investigational Site Number 6160011
  - Bydgoszcz, Poland, 85-079
    - Investigational Site Number 6160029
  - Bydgoszcz, Poland, 85-231
    - Investigational Site Number 6160030
  - Bydgoszcz, Poland, 85-822
    - Investigational Site Number 6160006
  - Bytom, Poland, 41-902
    - Investigational Site Number 6160018
  - Czeladz, Poland, 41-250
    - Investigational Site Number 6160002
  - Gdynia, Poland, 81-394
    - Investigational Site Number 6160003
  - Gdynia, Poland, 81-472
    - Investigational Site Number 6160005
  - Grodzisk Mazowiecki, Poland, 05-825
    - Investigational Site Number 6160008
  - Grodzisk Mazowiecki, Poland, 05-825
    - Investigational Site Number 6160031
  - Katowice, Poland, 40-611
    - Investigational Site Number 6160023
  - Katowice, Poland, 40-748
    - Investigational Site Number 6160026
  - Kielce, Poland, 25-525
    - Investigational Site Number 6160022
  - Krakow, Poland, 31-135
    - Investigational Site Number 6160019
  - Krakow, Poland, 31-261
    - Investigational Site Number 6160024
  - Krakow, Poland, 31-548
    - Investigational Site Number 6160010
  - Lodz, Poland, 90-242
    - Investigational Site Number 6160016
  - Lodz, Poland, 91-347
    - Investigational Site Number 6160013
  - Lodz, Poland
    - Investigational Site Number 6160015
  - Lublin, Poland, 20-044
    - Investigational Site Number 6160007
  - Poznan, Poland, 60-589
    - Investigational Site Number 6160033
  - Pulawy, Poland, 24-100
    - Investigational Site Number 6160021
  - Staszow, Poland, 28-200
    - Investigational Site Number 6160028
  - Torun, Poland, 87-100
    - Investigational Site Number 6160020
  - Warszawa, Poland, 02-097
    - Investigational Site Number 6160001
  - Warszawa, Poland, 00-631
    - Investigational Site Number 6160014
  - Warszawa, Poland, 02-005
    - Investigational Site Number 6160025
  - Warszawa, Poland, 02-507
    - Investigational Site Number 6160004
  - Wroclaw, Poland, 52-416
    - Investigational Site Number 6160012
  - Zabrze, Poland, 41-800
    - Investigational Site Number 6160017
  - Zamosc, Poland, 22-400
    - Investigational Site Number 6160032
Portugal
- - Almada, Portugal, 2801-951
    - Investigational Site Number 6200004
  - Caldas Da Rainha, Portugal, 2500-176
    - Investigational Site Number 6200005
  - Carnaxide, Portugal, 2790-134
    - Investigational Site Number 6200009
  - Coimbra, Portugal, 3000-075
    - Investigational Site Number 6200002
  - Leiria, Portugal, 2410-197
    - Investigational Site Number 6200008
  - Lisboa, Portugal, 1250
    - Investigational Site Number 6200001
  - Loures, Portugal, 2674-514
    - Investigational Site Number 6200007
  - Porto, Portugal, 4099-001
    - Investigational Site Number 6200003
Puerto Rico
- - San Juan, Puerto Rico, 00917
    - Investigational Site Number 8400122
Romania
- - Bacau, Romania, 600154
    - Investigational Site Number 6420008
  - Baia Mare, Maramures, Romania, 430222
    - Investigational Site Number 6420005
  - Brasov, Romania, 500097
    - Investigational Site Number 6420009
  - Bucuresti, Romania, 010507
    - Investigational Site Number 6420013
  - Bucuresti, Romania, 010627
    - Investigational Site Number 6420014
  - Bucuresti, Romania, 020475
    - Investigational Site Number 6420012
  - Bucuresti, Romania, 022441
    - Investigational Site Number 6420011
  - Craiova, Romania, 200349
    - Investigational Site Number 6420002
  - Oradea, Romania, 410469
    - Investigational Site Number 6420004
  - Oradea, Romania, 410159
    - Investigational Site Number 6420003
  - Ploiesti, Romania, 100561
    - Investigational Site Number 6420010
  - Targoviste, Dambovita, Romania, 130095
    - Investigational Site Number 6420001
  - Targu Mures, Mures, Romania, 540142
    - Investigational Site Number 6420006
  - Targu Mures, Mures, Romania, 540142
    - Investigational Site Number 6420007
Russian Federation
- - Kaliningrad, Russian Federation, 236035
    - Investigational Site Number 6430028
  - Kazan, Russian Federation, 420101
    - Investigational Site Number 6430018
  - Kemerovo, Russian Federation, 650002
    - Investigational Site Number 6430001
  - Kemerovo, Russian Federation, 650070
    - Investigational Site Number 6430035
  - Krasnodar, Russian Federation, 350042
    - Investigational Site Number 6430025
  - Krasnodar, Russian Federation, 350063
    - Investigational Site Number 6430040
  - Krasnodar, Russian Federation, 350086
    - Investigational Site Number 6430010
  - Moscow, Russian Federation, 121374
    - Investigational Site Number 6430002
  - Moscow, Russian Federation, 101990
    - Investigational Site Number 6430015
  - Moscow, Russian Federation, 101990
    - Investigational Site Number 6430016
  - Moscow, Russian Federation, 105554
    - Investigational Site Number 6430046
  - Moscow, Russian Federation, 117292
    - Investigational Site Number 6430003
  - Moscow, Russian Federation, 119192
    - Investigational Site Number 6430036
  - Moscow, Russian Federation, 119991
    - Investigational Site Number 6430005
  - Moscow, Russian Federation, 119991
    - Investigational Site Number 6430039
  - Moscow, Russian Federation, 121309
    - Investigational Site Number 6430021
  - Moscow, Russian Federation, 125284
    - Investigational Site Number 6430020
  - Moscow, Russian Federation, 127644
    - Investigational Site Number 6430024
  - Nizhniy Novgorod, Russian Federation, 603005
    - Investigational Site Number 6430033
  - Novosibirsk, Russian Federation, 630005
    - Investigational Site Number 6430037
  - Novosibirsk, Russian Federation, 630089
    - Investigational Site Number 6430034
  - Perm, Russian Federation, 614077
    - Investigational Site Number 6430007
  - Rostov-Na-Donu, Russian Federation, 344068
    - Investigational Site Number 6430019
  - Saint-Petersburg, Russian Federation, 192242
    - Investigational Site Number 6430012
  - Saint-Petersburg, Russian Federation, 197110
    - Investigational Site Number 6430044
  - Saint-Petersburg, Russian Federation, 197110
    - Investigational Site Number 6430045
  - Saint-Petersburg, Russian Federation, 198205
    - Investigational Site Number 6430043
  - Saratov, Russian Federation, 410028
    - Investigational Site Number 6430009
  - Saratov, Russian Federation, 410028
    - Investigational Site Number 6430013
  - Saratov, Russian Federation, 410039
    - Investigational Site Number 6430042
  - Sochi, Russian Federation, 354057
    - Investigational Site Number 6430026
  - Sochi, Russian Federation, 354057
    - Investigational Site Number 6430027
  - St-Petersburg, Russian Federation, 193312
    - Investigational Site Number 6430041
  - St-Petersburg, Russian Federation, 194044
    - Investigational Site Number 6430006
  - St-Petersburg, Russian Federation, 194044
    - Investigational Site Number 6430008
  - St-Petersburg, Russian Federation, 194044
    - Investigational Site Number 6430030
  - St-Petersburg, Russian Federation, 197341
    - Investigational Site Number 6430014
  - St-Petersburg, Russian Federation, 197341
    - Investigational Site Number 6430017
  - St-Petersburg, Russian Federation, 199106
    - Investigational Site Number 6430004
  - Tomsk, Russian Federation, 634012
    - Investigational Site Number 6430011
  - Tomsk, Russian Federation, 634050
    - Investigational Site Number 6430038
  - Tyumen, Russian Federation, 625000
    - Investigational Site Number 6430032
  - Vladimir, Russian Federation, 600020
    - Investigational Site Number 6430023
  - Vladimir, Russian Federation, 600023
    - Investigational Site Number 6430022
  - Yaroslavl, Russian Federation, 150002
    - Investigational Site Number 6430031
Serbia
- - Belgrade, Serbia, 11000
    - Investigational Site Number 6880002
  - Belgrade, Serbia, 11000
    - Investigational Site Number 6880003
  - Belgrade, Serbia, 11000
    - Investigational Site Number 6880004
  - Kragujevac, Serbia, 34000
    - Investigational Site Number 6880005
  - Nis, Serbia, 18000
    - Investigational Site Number 6880001
  - Nis, Serbia, 18000
    - Investigational Site Number 6880006
  - Nis, Serbia, 18000
    - Investigational Site Number 6880007
Slovakia
- - Bardejov, Slovakia, 085 01
    - Investigational Site Number 7030006
  - Bratislava, Slovakia, 813 69
    - Investigational Site Number 7030012
  - Kosice, Slovakia, 040 01
    - Investigational Site Number 7030011
  - Lubochna, Slovakia, 034 91
    - Investigational Site Number 7030001
  - Lucenec, Slovakia, 984 39
    - Investigational Site Number 7030008
  - Lucenec, Slovakia, 98401
    - Investigational Site Number 7030009
  - Lucenec, Slovakia, 98401
    - Investigational Site Number 7030010
  - Moldava Nad Bodvou, Slovakia, 04525
    - Investigational Site Number 7030004
  - Presov, Slovakia, 080 01
    - Investigational Site Number 7030013
  - Roznava, Slovakia, 04801
    - Investigational Site Number 7030003
  - Sabinov, Slovakia, 083 01
    - Investigational Site Number 7030002
  - Svidnik, Slovakia, 089 01
    - Investigational Site Number 7030007
South Africa
- - Brits, South Africa, 0250
    - Investigational Site Number 7100005
  - Cape Town, South Africa, 7530
    - Investigational Site Number 7100009
  - Cape Town, South Africa, 7570
    - Investigational Site Number 7100006
  - Parow, South Africa, 7500
    - Investigational Site Number 7100001
  - Pinelands, South Africa, 7405
    - Investigational Site Number 7100012
  - Pretoria, South Africa, 0002
    - Investigational Site Number 7100011
  - Pretoria, South Africa, 0083
    - Investigational Site Number 7100014
  - Pretoria, South Africa, 0157
    - Investigational Site Number 7100008
  - Rivonia, South Africa, 2128
    - Investigational Site Number 7100010
  - Soweto, South Africa, 1818
    - Investigational Site Number 7100007
  - Umkomaas, South Africa, 4170
    - Investigational Site Number 7100002
  - Vosloorus, South Africa, 1475
    - Investigational Site Number 7100013
  - Western Cape, South Africa, 7130
    - Investigational Site Number 7100003
Spain
- - Almería, Spain, 04120
    - Investigational Site Number 7240003
  - Barcelona, Spain, 08035
    - Investigational Site Number 7240014
  - Barcelona, Spain, 08041
    - Investigational Site Number 7240011
  - Córdoba, Spain, 14004
    - Investigational Site Number 7240009
  - El Puerto De Santa Maria, Spain, 11500
    - Investigational Site Number 7240024
  - Granada, Spain, 18016
    - Investigational Site Number 7240016
  - La Coruña, Spain, 15006
    - Investigational Site Number 7240015
  - Madrid, Spain, 28023
    - Investigational Site Number 7240001
  - Madrid, Spain, 28034
    - Investigational Site Number 7240019
  - Madrid, Spain, 28040
    - Investigational Site Number 7240006
  - Madrid, Spain, 28046
    - Investigational Site Number 7240010
  - Madrid, Spain, 28046
    - Investigational Site Number 7240020
  - Sabadell, Spain, 08208
    - Investigational Site Number 7240025
  - Sanlúcar De Barrameda, Spain, 11540
    - Investigational Site Number 7240023
  - Santa Cruz De Tenerife, Spain, 38320
    - Investigational Site Number 7240013
  - Santiago De Compostela, Spain, 15706
    - Investigational Site Number 7240007
  - Sevilla, Spain, 41014
    - Investigational Site Number 7240026
  - Sevilla, Spain, 41071
    - Investigational Site Number 7240012
  - Valencia, Spain, 46010
    - Investigational Site Number 7240004
  - Vigo, Spain, 36312
    - Investigational Site Number 7240002
  - Villamartín, Spain, 11650
    - Investigational Site Number 7240022
  - Zaragoza, Spain, 50009
    - Investigational Site Number 7240008
Sweden
- - Falun, Sweden, 791 82
    - Investigational Site Number 7520007
  - Lund, Sweden, 221 85
    - Investigational Site Number 7520005
  - Mölndal, Sweden, 43180
    - Investigational Site Number 7520004
  - Rättvik, Sweden, 79530
    - Investigational Site Number 7520003
  - Stockholm, Sweden, 112 21
    - Investigational Site Number 7520008
  - Stockholm, Sweden, 118 83
    - Investigational Site Number 7520002
  - Stockholm, Sweden, 14186
    - Investigational Site Number 7520006
  - Uppsala, Sweden, 751 85
    - Investigational Site Number 7520001
Switzerland
- - Olten, Switzerland, 4600
    - Investigational Site Number 7560001
  - Zollikerberg, Switzerland, 8125
    - Investigational Site Number 7560002
Taiwan
- - Hsinchu, Taiwan, 30071
    - Investigational Site Number 1580005
  - Kaohsiung, Taiwan, 807
    - Investigational Site Number 1580008
  - Linkou, Taiwan
    - Investigational Site Number 1580004
  - Taichung, Taiwan, 40447
    - Investigational Site Number 1580006
  - Tainan, Taiwan, 704
    - Investigational Site Number 1580002
  - Tainan, Taiwan, 710
    - Investigational Site Number 1580007
  - Taipei, Taiwan, 100
    - Investigational Site Number 1580003
  - Taipei, Taiwan, 112
    - Investigational Site Number 1580001
Turkey
- - Antalya, Turkey, 07070
    - Investigational Site Number 7920018
  - Aydın, Turkey, 09100
    - Investigational Site Number 7920010
  - Corum, Turkey, 19200
    - Investigational Site Number 7920004
  - Gaziantep, Turkey, 27310
    - Investigational Site Number 7920016
  - Istanbul, Turkey
    - Investigational Site Number 7920001
  - Istanbul, Turkey, 34034
    - Investigational Site Number 7920011
  - Istanbul, Turkey, 34390
    - Investigational Site Number 7920009
  - Istanbul, Turkey
    - Investigational Site Number 7920007
  - Istanbul, Turkey
    - Investigational Site Number 7920017
  - Izmir, Turkey, 35340
    - Investigational site number 7920003
  - Kayseri, Turkey, 38039
    - Investigational Site Number 7920013
  - Kocaeli, Turkey, 41380
    - Investigational Site Number 7920014
  - Kutahya, Turkey
    - Investigational site number 7920005
  - Malatya, Turkey
    - Investigational Site Number 7920015
  - Mersin, Turkey, 33169
    - Investigational site number 7920008
  - Sivas, Turkey, 58140
    - Investigational Site Number 7920002
Ukraine
- - Dnipro, Ukraine, 49005
    - Investigational Site Number 8040020
  - Dnipro, Ukraine, 49600
    - Investigational Site Number 8040006
  - Ivano-Frankivsk, Ukraine, 76000
    - Investigational Site Number 8040009
  - Ivano-Frankivsk, Ukraine, 76018
    - Investigational Site Number 8040012
  - Kharkiv, Ukraine, 61039
    - Investigational Site Number 8040021
  - Kharkiv, Ukraine, 61058
    - Investigational Site Number 8040011
  - Kharkiv, Ukraine, 61166
    - Investigational Site Number 8040008
  - Kiev, Ukraine, 02091
    - Investigational Site Number 8040002
  - Kiev, Ukraine, 02660
    - Investigational Site Number 8040024
  - Kyiv, Ukraine, 03049
    - Investigational Site Number 8040003
  - Kyiv, Ukraine, 03115
    - Investigational Site Number 8040015
  - Kyiv, Ukraine, 04050
    - Investigational Site Number 8040019
  - Kyiv, Ukraine, 04114
    - Investigational Site Number 8040010
  - Kyiv, Ukraine
    - Investigational Site Number 8040026
  - Lutsk, Ukraine, 43005
    - Investigational Site Number 8040023
  - Lutsk, Ukraine, 43024
    - Investigational Site Number 8040025
  - Lviv, Ukraine, 79011
    - Investigational Site Number 8040022
  - Ternopil, Ukraine, 46000
    - Investigational Site Number 8040001
  - Vinnitsya, Ukraine, 21018
    - Investigational Site Number 8040016
  - Vinnitsya, Ukraine, 21100
    - Investigational Site Number 8040007
  - Vinnytsya, Ukraine, 21001
    - Investigational Site Number 8040004
  - Zhytomyr, Ukraine
    - Investigational Site Number 8040018
United Kingdom
- - Belfast, United Kingdom, BT12 6BA
    - Investigational Site Number 8260003
  - Chippenham, United Kingdom, SN14 6GT
    - Investigational Site Number 8260007
  - Davyhulme, Manchester, United Kingdom, M41 5SL
    - Investigational Site Number 8260009
  - Glasgow, United Kingdom, G21 3UW
    - Investigational Site Number 8260010
  - Hayle, United Kingdom, TR27 5DT
    - Investigational Site Number 8260004
  - Inverness, United Kingdom, IV2 3UJ
    - Investigational Site Number 8260011
  - Ipswich, United Kingdom, IP4 5PD
    - Investigational Site Number 8260002
  - Maidstone, United Kingdom, ME16 9QQ
    - Investigational Site Number 8260006
  - Swansea, United Kingdom, SA2 8PP
    - Investigational Site Number 8260001
United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - Investigational Site Number 8400017
  - Sheffield, Alabama, United States, 35660
    - Investigational Site Number 8400096
- Arizona
  - Mesa, Arizona, United States, 85206
    - Investigational Site Number 8400004
  - Mesa, Arizona, United States, 85210
    - Investigational Site Number 8400059
  - Peoria, Arizona, United States, 85381
    - Investigational Site Number 8400021
  - Surprise, Arizona, United States, 85374
    - Investigational Site Number 8400014
- Arkansas
  - Little Rock, Arkansas, United States, 72211
    - Investigational Site Number 8400071
- California
  - Beverly Hills, California, United States, 90211
    - Investigational Site Number 8400039
  - Concord, California, United States, 94520
    - Investigational Site Number 8400042
  - Fresno, California, United States, 93720
    - Investigational Site Number 8400089
  - Huntington Park, California, United States, 90255
    - Investigational Site Number 8400006
  - Long Beach, California, United States, 90807
    - Investigational Site Number 8400036
  - Los Angeles, California, United States, 90017
    - Investigational Site Number 8400073
  - Los Angeles, California, United States, 90022-4302
    - Investigational Site Number 8400084
  - Los Gatos, California, United States, 95032
    - Investigational Site Number 8400035
  - Northridge, California, United States, 91325
    - Investigational Site Number 8400043
  - Sacramento, California, United States, 95821
    - Investigational Site Number 8400025
  - San Dimas, California, United States, 91713
    - Investigational Site Number 8400018
  - Temecula, California, United States, 92591
    - Investigational Site Number 8400070
- Connecticut
  - Waterbury, Connecticut, United States, 06708
    - Investigational Site Number 8400013
- Florida
  - Bradenton, Florida, United States, 34209
    - Investigational Site Number 8400095
  - Clearwater, Florida, United States, 33756
    - Investigational Site Number 8400090
  - Clearwater, Florida, United States, 33756
    - Investigational Site Number 8400121
  - Cooper City, Florida, United States, 33024
    - Investigational Site Number 8400049
  - Hialeah, Florida, United States, 33012
    - Investigational Site Number 8400092
  - Hollywood, Florida, United States, 33024
    - Investigational Site Number 8400026
  - Jacksonville, Florida, United States, 32204
    - Investigational Site Number 8400134
  - Jacksonville, Florida, United States, 32207-4966
    - Investigational Site Number 8400055
  - Jacksonville, Florida, United States, 32216
    - Investigational Site Number 8400056
  - Jacksonville, Florida, United States, 32277
    - Investigational Site Number 8400031
  - Maitland, Florida, United States, 32751
    - Investigational Site Number 8400037
  - Miami, Florida, United States, 33126
    - Investigational Site Number 8400078
  - Miami, Florida, United States, 33135
    - Investigational Site Number 8400117
  - Miami, Florida, United States, 33135
    - Investigational Site Number 8400119
  - Miami, Florida, United States, 33165
    - Investigational Site Number 8400118
  - Miami, Florida, United States, 33174
    - Investigational Site Number 8400105
  - Miami, Florida, United States, 33176
    - Investigational Site Number 8400120
  - North Miami Beach, Florida, United States, 33162
    - Investigational Site Number 8400088
  - Opa-locka, Florida, United States, 33054
    - Investigational Site Number 8400106
  - Ormond Beach, Florida, United States, 32174
    - Investigational Site Number 8400063
  - Palm Harbor, Florida, United States, 34684-3609
    - Investigational Site Number 8400087
  - Saint Petersburg, Florida, United States, 33713
    - Investigational Site Number 8400058
  - Spring Hill, Florida, United States, 34609
    - Investigational Site Number 8400108
  - Tampa, Florida, United States, 33624
    - Investigational Site Number 8400051
- Georgia
  - Atlanta, Georgia, United States, 30303
    - Investigational Site Number 8400123
  - Roswell, Georgia, United States, 30076
    - Investigational Site Number 8400076
- Hawaii
  - Honolulu, Hawaii, United States, 96814
    - Investigational Site Number 8400033
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Investigational Site Number 8400085
  - Chicago, Illinois, United States, 60611
    - Investigational Site Number 8400104
  - Chicago, Illinois, United States, 60612
    - Investigational Site Number 8400027
  - Chicago, Illinois, United States, 60612
    - Investigational Site Number 8400124
  - Chicago, Illinois, United States, 60616
    - Investigational Site Number 8400001
  - Crystal Lake, Illinois, United States, 60012
    - Investigational Site Number 8400052
  - Springfield, Illinois, United States, 62711
    - Investigational Site Number 8400028
- Indiana
  - Michigan City, Indiana, United States, 46360
    - Investigational Site Number 8400125
  - Valparaiso, Indiana, United States, 46383
    - Investigational Site Number 8400098
- Iowa
  - Des Moines, Iowa, United States, 50314
    - Investigational Site Number 8400003
- Kansas
  - Topeka, Kansas, United States, 66606
    - Investigational Site Number 8400081
- Kentucky
  - Louisville, Kentucky, United States, 40213
    - Investigational Site Number 8400041
- Maine
  - Bangor, Maine, United States, 04401
    - Investigational Site Number 8400080
- Michigan
  - Flint, Michigan, United States, 48504
    - Investigational Site Number 8400002
  - Flint, Michigan, United States, 48532-3447
    - Investigational Site Number 8400069
  - Troy, Michigan, United States, 48098
    - Investigational Site Number 8400016
- Minnesota
  - Saint Cloud, Minnesota, United States, 56303
    - Investigational Site Number 8400023
- Missouri
  - Kansas City, Missouri, United States, 64111
    - Investigational Site Number 8400066
  - Saint Louis, Missouri, United States, 63136
    - Investigational Site Number 8400024
  - Washington, Missouri, United States, 63090
    - Investigational Site Number 8400130
- Nebraska
  - Omaha, Nebraska, United States, 68198-4100
    - Investigational Site Number 8400045
- Nevada
  - Las Vegas, Nevada, United States, 89148
    - Investigational Site Number 8400009
- New York
  - Albany, New York, United States, 12206
    - Investigational Site Number 8400101
  - Laurelton, New York, United States, 11413
    - Investigational Site Number 8400061
  - New York, New York, United States, 10029-6501
    - Investigational Site Number 8400046
  - Rosedale, New York, United States, 11422
    - Investigational Site Number 8400112
  - Smithtown, New York, United States, 11787
    - Investigational Site Number 8400062
- North Carolina
  - Greenville, North Carolina, United States, 27834-5704
    - Investigational Site Number 8400079
  - Morehead City, North Carolina, United States, 28557
    - Investigational Site Number 8400020
  - Morehead City, North Carolina, United States, 28557
    - Investigational Site Number 8400048
  - Morganton, North Carolina, United States, 28655
    - Investigational Site Number 8400010
- North Dakota
  - Fargo, North Dakota, United States, 58103
    - Investigational Site Number 8400072
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Investigational Site Number 8400038
  - Cincinnati, Ohio, United States, 45241
    - Investigational Site Number 8400007
  - Columbus, Ohio, United States, 43210
    - Investigational Site Number 8400015
  - Lorain, Ohio, United States, 44053
    - Investigational Site Number 8400113
  - Mentor, Ohio, United States, 44060
    - Investigational Site Number 8400011
- Oregon
  - Bend, Oregon, United States, 97702
    - Investigational Site Number 8400109
- Pennsylvania
  - Beaver, Pennsylvania, United States, 15009
    - Investigational Site Number 8400047
  - Greensburg, Pennsylvania, United States, 15601
    - Investigational Site Number 8400019
  - Indiana, Pennsylvania, United States, 15701-3578
    - Investigational Site Number 8400097
  - Levittown, Pennsylvania, United States, 19056-2404
    - Investigational Site Number 8400032
  - Philadelphia, Pennsylvania, United States, 19107
    - Investigational Site Number 8400053
  - Pittsburgh, Pennsylvania, United States, 15212
    - Investigational Site Number 8400012
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Investigational Site Number 8400064
  - Greer, South Carolina, United States, 29651
    - Investigational Site Number 8400030
  - Myrtle Beach, South Carolina, United States, 29572
    - Investigational Site Number 8400029
- Tennessee
  - Memphis, Tennessee, United States, 38163
    - Investigational Site Number 8400040
- Texas
  - Arlington, Texas, United States, 76015
    - Investigational Site Number 8400114
  - Corpus Christi, Texas, United States, 78814
    - Investigational Site Number 8400067
  - Dallas, Texas, United States, 75231
    - Investigational Site Number 8400082
  - El Paso, Texas, United States, 79935
    - Investigational Site Number 8400022
  - Houston, Texas, United States, 77043
    - Investigational Site Number 8400099
  - Houston, Texas, United States, 77070
    - Investigational Site Number 8400103
  - Katy, Texas, United States, 77450
    - Investigational Site Number 8400086
  - Mesquite, Texas, United States, 75150
    - Investigational Site Number 8400100
  - Plano, Texas, United States, 75093
    - Investigational Site Number 8400094
  - San Antonio, Texas, United States, 78224
    - Investigational Site Number 8400116
  - Waco, Texas, United States, 76710
    - Investigational Site Number 8400091
- Utah
  - Bountiful, Utah, United States, 84010-7717
    - Investigational Site Number 8400065
  - Ogden, Utah, United States, 84405
    - Investigational Site Number 8400131
- Vermont
  - Bennington, Vermont, United States, 05201
    - Investigational Site Number 8400093
  - South Burlington, Vermont, United States, 05403
    - Investigational Site Number 8400060
- Virginia
  - Danville, Virginia, United States, 24541-2834
    - Investigational Site Number 8400133
  - Fairfax, Virginia, United States, 22039
    - Investigational Site Number 8400054
  - Falls Church, Virginia, United States, 22044
    - Investigational Site Number 8400132
  - Manassas, Virginia, United States, 20110
    - Investigational Site Number 8400034
  - Norfolk, Virginia, United States, 23510
    - Investigational Site Number 8400050
  - Richmond, Virginia, United States, 23235
    - Investigational Site Number 8400044
  - Richmond, Virginia, United States, 23249
    - Investigational Site Number 8400111
- Washington
  - Federal Way, Washington, United States, 98003
    - Investigational Site Number 8400083
  - Spokane, Washington, United States, 99207
    - Investigational Site Number 8400068

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria :

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.

Exclusion criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sotagliflozin Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.	Drug: Sotagliflozin Sotagliflozin was administered as a tablet(s), orally once daily. Other Names: SAR439954
PLACEBO_COMPARATOR: Placebo 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.	Drug: Placebo Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Occurrences of HHF and Urgent HF Visits Time Frame: Up to 30 months	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.	Up to 30 months
Number of Deaths From Cardiovascular Causes Time Frame: Up to 30 months	Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.	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	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.	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	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.	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	Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.	Up to 30 months
Number of Deaths From Any Cause Time Frame: Up to 30 months	Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.	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	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.	Up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lexicon Pharmaceuticals

Collaborators

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 19, 2017

Primary Completion (ACTUAL)

July 8, 2020

Study Completion (ACTUAL)

July 8, 2020

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (ACTUAL)

October 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

EFC14875
2017-002644-32
U1111-1187-8703 (OTHER: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (ACTUAL)

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ACTUAL)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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Clinical Trials on Sotagliflozin

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