Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
September 30, 2022 updated by: Lexicon Pharmaceuticals
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients With Type 2 Diabetes POST Worsening Heart Failure
Primary Objective:
To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF)
Secondary Objectives:
To compare the effects of sotagliflozin to placebo on:
- The total occurrences of HHF and urgent visit for HF
- The occurrence of CV death
- The occurrence of all-cause mortality
- The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke
- Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score
- Change in estimated glomerular filtration rate (eGFR)
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The estimated study duration for a given participants will be approximately 3 to 24 months.
Study Type
Interventional
Enrollment (Actual)
1222
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
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Caba, Argentina, 1430
- Investigational Site Number 0320031
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Caba, Argentina, C1093AAS
- Investigational Site Number 0320009
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Capital Federal, Argentina, 1405
- Investigational Site Number 0320016
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Ciudad De Buenos Aires, Argentina, C1428DCO
- Investigational Site Number 0320002
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Cordoba, Argentina, X5000AAX
- Investigational Site Number 0320011
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Cordoba, Argentina, X5004BAL
- Investigational Site Number 0320010
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Corrientes, Argentina, 3400
- Investigational Site Number 0320022
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Corrientes, Argentina, W3400AMZ
- Investigational Site Number 0320001
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Córdoba, Argentina, 5000
- Investigational Site Number 0320024
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Córdoba, Argentina, X5000JHQ
- Investigational Site Number 0320003
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Córdoba, Argentina, X5006IKK
- Investigational Site Number 0320025
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La Plata, Argentina, B1900AXI
- Investigational Site Number 0320029
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La Plata, Argentina, B1906ESC
- Investigational Site Number 0320007
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Merlo, Argentina, B1722COV
- Investigational Site Number 0320006
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Moron, Argentina, B1708CGU
- Investigational Site Number 0320005
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Olivos, Argentina, 1638
- Investigational Site Number 0320012
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Quilmes, Argentina, 1878
- Investigational Site Number 0320023
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Rosario, Argentina, 2000
- Investigational Site Number 0320018
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Rosario, Argentina, S2000DSR
- Investigational Site Number 0320013
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Salta, Argentina, 4400
- Investigational Site Number 0320008
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San Martin, Argentina, B1685CSQ
- Investigational Site Number 0320020
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San Miguel De Tucuman, Argentina, T4000IFL
- Investigational Site Number 0320028
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San Miguel De Tucuman, Argentina, T4000NIL
- Investigational Site Number 0320019
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Santa Fe, Argentina, S3000EOZ
- Investigational Site Number 0320017
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Santa Fe, Argentina, S3000FWO
- Investigational Site Number 0320015
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Tucuman, Argentina, T4000JCU
- Investigational Site Number 0320030
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Villa Belgrano, Argentina, X5021FPQ
- Investigational Site Number 0320004
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Villa Maria, Argentina, X5900JKA
- Investigational Site Number 0320014
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Murdoch, Australia, 6150
- Investigational Site Number 0360007
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Wollongong, Australia, 2500
- Investigational Site Number 0360001
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Braunau, Austria, 5280
- Investigational Site Number 0400006
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Feldkirch, Austria, 6800
- Investigational site number 0400002
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Graz, Austria, 8036
- Investigational Site Number 0400007
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Linz, Austria, 4010
- Investigational Site Number 0400005
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Salzburg, Austria, 5020
- Investigational Site Number 0400004
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Wien, Austria, 1090
- Investigational site number 0400003
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Wien, Austria, 1160
- Investigational Site Number 0400001
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Aalst, Belgium, 9300
- Investigational Site Number 0560002
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Gent, Belgium, 9000
- Investigational Site Number 0560007
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Kortrijk, Belgium, 8500
- Investigational Site Number 0560004
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Leuven, Belgium, 3000
- Investigational Site Number 0560001
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Liège, Belgium, 4000
- Investigational Site Number 0560003
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Mol, Belgium, 2400
- Investigational Site Number 0560005
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Mons, Belgium, 7000
- Investigational Site Number 0560006
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Roeselare, Belgium, 8800
- Investigational Site Number 0560008
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Belo Horizonte, Brazil, 30110-908
- Investigational Site Number 0760009
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Belo Horizonte, Brazil, 30150-221
- Investigational Site Number 0760024
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Blumenau, Brazil, 89020-430
- Investigational Site Number 0760002
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Brasilia, Brazil, 70390-903
- Investigational Site Number 0760011
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Campinas, Brazil, 13060-080
- Investigational Site Number 0760005
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Campinas, Brazil, 13092-111
- Investigational Site Number 0760006
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Fortaleza, Brazil, 60840-285
- Investigational Site Number 0760023
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Goiania, Brazil, 74210050
- Investigational Site Number 0760018
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Passo Fundo, Brazil, 99010-180
- Investigational Site Number 0760010
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Porto Alegre, Brazil, 90020-090
- Investigational Site Number 0760003
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Porto Alegre, Brazil, 90035 003
- Investigational Site Number 0760020
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Porto Alegre, Brazil, 90610-000
- Investigational Site Number 0760021
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Porto Alegre, Brazil, 90620-001
- Investigational Site Number 0760007
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Porto Alegre, Brazil, 91350-250
- Investigational Site Number 0760013
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Recife, Brazil, 52051-380
- Investigational Site Number 0760004
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Sao Jose Do Rio Preto, Brazil, 15090-000
- Investigational Site Number 0760001
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Sao Paulo, Brazil, 04012-909
- Investigational Site Number 0760012
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Sao Paulo, Brazil, 05403-000
- Investigational Site Number 0760008
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Votuporanga, Brazil, 15500-003
- Investigational Site Number 0760017
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Cambridge, Canada, N1R 6V6
- Investigational Site Number 1240013
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Granby, Canada, J2G 1T7
- Investigational Site Number 1240006
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Halifax, Canada, B3H 3A7
- Investigational Site Number 1240015
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Montreal, Canada, H1T 1C8
- Investigational Site Number 1240002
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Montreal, Canada, H3G 1A4
- Investigational Site Number 1240019
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Montreal, Canada, H4A 3J1
- Investigational Site Number 1240018
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Peterborough, Canada, K9J 0B2
- Investigational Site Number 1240004
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Quebec, Canada, G1V 4G5
- Investigational Site Number 1240014
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Scarborough, Canada, M1B 4Z8
- Investigational Site Number 1240007
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Sherbrooke, Canada, J1G 2E8
- Investigational Site Number 1240005
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Toronto, Canada, M5B 1W8
- Investigational Site Number 1240011
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Toronto, Canada, M5G 2C4
- Investigational Site Number 1240001
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Trois-Rivières, Canada, G9A 5C5
- Investigational Site Number 1240009
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Concepción, Chile
- Investigational Site Number 1520009
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Santiago, Chile, 8380456
- Investigational Site Number 1520003
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Santiago, Chile
- Investigational Site Number 1520005
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Santiago, Chile, 80004005
- Investigational Site Number 1520011
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Santiago, Chile, 8053095
- Investigational Site Number 1520006
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Santiago, Chile
- Investigational Site Number 1520004
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Santiago, Chile
- Investigational Site Number 1520012
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Santiago, Chile
- Investigational Site Number 1520013
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Temuco, Chile
- Investigational Site Number 1520002
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Vina Del Mar, Chile
- Investigational Site Number 1520010
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Viña Del Mar, Chile
- Investigational Site Number 1520001
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Brno, Czechia, 62500
- Investigational Site Number 2030001
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Brno, Czechia, 63600
- Investigational Site Number 2030003
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Brno, Czechia, 65691
- Investigational Site Number 2030004
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Kolin 3, Czechia, 28002
- Investigational Site Number 2030014
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Kromeriz, Czechia, 76701
- Investigational Site Number 2030010
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Liberec, Czechia, 46063
- Investigational Site Number 2030005
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Mestec Kralove, Czechia, 28903
- Investigational Site Number 2030013
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Praha 10, Czechia, 10100
- Investigational Site Number 2030018
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Praha 2, Czechia, 12808
- Investigational Site Number 2030002
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Praha 5, Czechia, 15030
- Investigational Site Number 2030017
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Praha 5 - Motol, Czechia, 15006
- Investigational Site Number 2030007
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Prerov, Czechia, 75152
- Investigational Site Number 2030011
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Pribram I, Czechia, 26101
- Investigational Site Number 2030015
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Slany, Czechia, 27401
- Investigational Site Number 2030006
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Aarhus N, Denmark, 8200
- Investigational Site Number 2080003
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Glostrup, Denmark, 2600
- Investigational Site Number 2080002
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Herlev, Denmark, 2730
- Investigational Site Number 2080001
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København Nv, Denmark, 2400
- Investigational Site Number 2080005
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Ålborg, Denmark, 9100
- Investigational Site Number 2080004
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Espoo, Finland, 02740
- Investigational Site Number 2460004
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Helsinki, Finland, 00029 HUS
- Investigational Site Number 2460001
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Jyväskylä, Finland, 40620
- Investigational Site Number 2460002
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Oulu, Finland, 90220
- Investigational Site Number 2460003
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Seinäjoki, Finland, 60220
- Investigational Site Number 2460005
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Chambray Les Tours, France, 37170
- Investigational Site Number 2500009
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La Tronche, France, 38700
- Investigational Site Number 2500008
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Le Chesnay, France, 78150
- Investigational Site Number 2500004
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Le Coudray, France, 28360
- Investigational Site Number 2500002
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Lille, France, 59037
- Investigational Site Number 2500001
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Nantes Cedex 1, France, 44093
- Investigational Site Number 2500007
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Nice Cedex 1, France, 06002
- Investigational Site Number 2500012
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Paris, France, 75015
- Investigational Site Number 2500006
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Paris Cedex 18, France, 75877
- Investigational Site Number 2500003
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Toulouse Cedex 9, France, 31059
- Investigational Site Number 2500005
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Vandoeuvre-Les-Nancy Cedex, France, 54511
- Investigational Site Number 2500013
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Bad Nauheim, Germany, 61231
- Investigational Site Number 2760020
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Bad Oeynhausen, Germany, 32545
- Investigational Site Number 2760016
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Berlin, Germany, 13353
- Investigational Site Number 2760001
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Berlin, Germany, 12203
- Investigational Site Number 2760013
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Berlin, Germany, 13347
- Investigational Site Number 2760019
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Berlin, Germany, 13353
- Investigational Site Number 2760002
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Bielefeld, Germany, 33604
- Investigational Site Number 2760025
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Bonn, Germany, 53115
- Investigational Site Number 2760005
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Bremen, Germany, 28277
- Investigational Site Number 2760021
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Coburg, Germany, 96450
- Investigational Site Number 2760035
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Dortmund, Germany, 44137
- Investigational Site Number 2760032
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Dortmund, Germany, 44379
- Investigational Site Number 2760006
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Erfurt, Germany, 99097
- Investigational Site Number 2760029
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Essen, Germany, 45138
- Investigational Site Number 2760018
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Frankfurt Am Main, Germany, 65929
- Investigational Site Number 2760033
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Greifswald, Germany, 17475
- Investigational Site Number 2760009
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Heidelberg, Germany, 69115
- Investigational Site Number 2760022
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Heidelberg, Germany, 69120
- Investigational Site Number 2760031
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Köln, Germany, 50733
- Investigational Site Number 2760027
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Lahr, Germany, 77933
- Investigational Site Number 2760034
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Langen, Germany, 63225
- Investigational Site Number 2760030
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Leverkusen, Germany, 51375
- Investigational Site Number 2760014
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Limburg, Germany, 65549
- Investigational Site Number 2760036
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Ludwigshafen, Germany, 67063
- Investigational Site Number 2760012
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Merseburg, Germany, 06217
- Investigational Site Number 2760028
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Rotenburg An Der Fulda, Germany, 36199
- Investigational Site Number 2760011
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Rüsselsheim, Germany, 65428
- Investigational Site Number 2760015
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Witten, Germany, 58455
- Investigational Site Number 2760007
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Würzburg, Germany, 97080
- Investigational Site Number 2760026
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Athens, Greece, 11526
- Investigational Site Number 3000012
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Athens, Greece, 11527
- Investigational Site Number 3000004
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Chalkida, Greece, 34 100
- Investigational Site Number 3000002
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Elefsina, Greece, 19600
- Investigational Site Number 3000009
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Haidari, Greece, 12462
- Investigational Site Number 3000003
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Heraklion, Greece, 71110
- Investigational Site Number 3000005
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Ioannina, Greece, 455 00
- Investigational Site Number 3000007
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Larissa, Greece, 41110
- Investigational Site Number 3000006
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N. Ionia, Greece, 14233
- Investigational Site Number 3000001
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Thessaloniki, Greece, 546 36
- Investigational Site Number 3000008
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Berettyóújfalu, Hungary, 4100
- Investigational Site Number 3480018
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Budapest, Hungary, 1122
- Investigational Site Number 3480001
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Budapest, Hungary, 1023
- Investigational Site Number 3480012
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Budapest, Hungary, 1085
- Investigational Site Number 3480016
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Budapest, Hungary, 1096
- Investigational Site Number 3480010
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Budapest, Hungary, 1115
- Investigational Site Number 3480019
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Budapest, Hungary, 1125
- Investigational Site Number 3480015
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Budapest, Hungary, 1134
- Investigational Site Number 3480011
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Budapest, Hungary, 1145
- Investigational Site Number 3480014
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Budapest, Hungary, 1204
- Investigational Site Number 3480005
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Debrecen, Hungary, 4032
- Investigational Site Number 3480007
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Dombóvár, Hungary, 7200
- Investigational Site Number 3480002
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Gyula, Hungary, 5700
- Investigational Site Number 3480017
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Hódmezövásárhely, Hungary, 6800
- Investigational Site Number 3480008
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Kistarcsa, Hungary, 2143
- Investigational Site Number 3480020
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Komárom, Hungary, 2921
- Investigational Site Number 3480009
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Pécs, Hungary, 7624
- Investigational Site Number 3480013
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Szekesfehervar, Hungary, 8000
- Investigational Site Number 3480003
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Zalaegerszeg, Hungary, 8900
- Investigational Site Number 3480006
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Ashkelon, Israel, 78278
- Investigational Site Number 3760013
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Hadera, Israel, 38100
- Investigational Site Number 3760004
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Haifa, Israel, 31096
- Investigational Site Number 3760005
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Jerusalem, Israel, 91031
- Investigational Site Number 3760006
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Jerusalem, Israel, 91120
- Investigational site number 3760003
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Jerusalem, Israel
- Investigational Site Number 3760008
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Nahariya, Israel, 22100
- Investigational Site Number 3760010
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Petah-Tikva, Israel, 49100
- Investigational Site Number 3760002
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Rehovot, Israel, 76100
- Investigational Site Number 3760011
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Safed, Israel, 13100
- Investigational Site Number 3760009
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Tel Aviv, Israel, 64239
- Investigational Site Number 3760001
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Tiberias, Israel, 15208
- Investigational Site Number 3760012
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Arzignano (Vi), Italy, 36071
- Investigational Site Number 3800006
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Brescia, Italy, 25123
- Investigational Site Number 3800011
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Brescia, Italy, 25124
- Investigational Site Number 3800017
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Cortona, Italy, 52044
- Investigational Site Number 3800005
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Ferrara, Italy, 44124
- Investigational Site Number 3800009
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Gallipoli, Italy, 73014
- Investigational Site Number 3800020
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Legnago, Italy, 37045
- Investigational Site Number 3800003
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Milano, Italy, 20122
- Investigational Site Number 3800023
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Milano, Italy, 20138
- Investigational Site Number 3800002
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Milano, Italy, 20138
- Investigational Site Number 3800012
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Milano, Italy, 20162
- Investigational Site Number 3800008
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Monza, Italy, 20052
- Investigational Site Number 3800013
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Napoli, Italy, 80131
- Investigational Site Number 3800022
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Pavia, Italy, 27100
- Investigational Site Number 3800018
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Perugia, Italy, 06132
- Investigational Site Number 3800004
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Pozzilli, Italy, 86077
- Investigational Site Number 3800016
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Rimini, Italy, 47900
- Investigational Site Number 3800014
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Roma, Italy, 00153
- Investigational Site Number 3800010
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Roma, Italy, 00189
- Investigational Site Number 3800021
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Scorrano, Italy, 73020
- Investigational Site Number 3800019
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Udine, Italy, 33100
- Investigational Site Number 3800007
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Bucheon-Si, Korea, Republic of, 14754
- Investigational Site Number 4100008
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Busan, Korea, Republic of, 49267
- Investigational Site Number 4100010
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Daegu, Korea, Republic of, 42472
- Investigational Site Number 4100004
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Hwaseong-Si, Korea, Republic of, 18450
- Investigational Site Number 4100001
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Incheon, Korea, Republic of, 22332
- Investigational Site Number 4100003
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Seongnam-Si, Korea, Republic of, 13620
- Investigational Site Number 4100005
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Seoul, Korea, Republic of, 03080
- Investigational Site Number 4100002
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Seoul, Korea, Republic of, 03722
- Investigational Site Number 4100007
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Seoul, Korea, Republic of, 05030
- Investigational Site Number 4100011
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Seoul, Korea, Republic of, 06351
- Investigational Site Number 4100009
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Daugavpils, Latvia, LV-5417
- Investigational Site Number 4280004
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Liepaja, Latvia, LV-3414
- Investigational Site Number 4280002
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Riga, Latvia, LV-1002
- Investigational Site Number 4280001
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Riga, Latvia, LV-1038
- Investigational Site Number 4280003
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Kaunas, Lithuania, 50161
- Investigational Site Number 4400002
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Kaunas, Lithuania, 50161
- Investigational Site Number 4400005
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Klaipeda, Lithuania, LT-92288
- Investigational Site Number 4400004
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Siauliai, Lithuania, LT-76231
- Investigational Site Number 4400006
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Vilnius, Lithuania, 08661
- Investigational Site Number 4400001
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Vilnius, Lithuania, 08661
- Investigational Site Number 4400003
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Amsterdam, Netherlands, 1034 CS
- Investigational Site Number 5280003
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Breda, Netherlands, 4819 EV
- Investigational Site Number 5280001
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Delft, Netherlands, 2625 AD
- Investigational Site Number 5280007
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Doetinchem, Netherlands, 7009 BL
- Investigational Site Number 5280002
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Hertogenbosch, Netherlands, 5223 GZ 's
- Investigational Site Number 5280004
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Rotterdam, Netherlands, 3045 PM
- Investigational Site Number 5280006
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Sneek, Netherlands, 8601
- Investigational Site Number 5280008
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Veldhoven, Netherlands, 5504 DB
- Investigational Site Number 5280005
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Auckland, New Zealand, 1023
- Investigational Site Number 5540007
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Christchurch, New Zealand, 8011
- Investigational Site Number 5540006
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Hamilton, New Zealand, 3204
- Investigational Site Number 5540002
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Lower Hutt, New Zealand
- Investigational Site Number 5540004
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New Plymouth, New Zealand
- Investigational Site Number 5540005
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Rotorua, New Zealand, 3010
- Investigational Site Number 5540003
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Bialystok, Poland, 15-276
- Investigational Site Number 6160007
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Gdansk, Poland, 80-462
- Investigational Site Number 6160017
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Grodzisk Mazowiecki, Poland, 05-825
- Investigational Site Number 6160002
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Katowice, Poland, 40-635
- Investigational Site Number 6160014
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Krakow, Poland, 31-501
- Investigational Site Number 6160003
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Krakow, Poland, 30-693
- Investigational Site Number 6160021
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Krakow, Poland, 31 -202
- Investigational Site Number 6160001
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Krakow, Poland
- Investigational Site Number 6160012
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Leczna, Poland, 21-010
- Investigational Site Number 6160011
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Lubin, Poland, 59-301
- Investigational Site Number 6160016
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Miechow, Poland, 32-200
- Investigational Site Number 6160005
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Poznan, Poland, 61-848
- Investigational Site Number 6160022
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Torun, Poland, 87-100
- Investigational Site Number 6160006
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Warszawa, Poland, 00-685
- Investigational Site Number 6160013
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Warszawa, Poland, 03-242
- Investigational Site Number 6160004
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Warszawa, Poland, 04-073
- Investigational Site Number 6160020
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Warszawa, Poland, 04-349
- Investigational Site Number 6160024
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Warszawa, Poland, 04-628
- Investigational Site Number 6160008
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Zamosc, Poland, 22-400
- Investigational Site Number 6160015
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Braga, Portugal, 4710-243
- Investigational Site Number 6200012
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Coimbra, Portugal, 3000-075
- Investigational Site Number 6200001
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Guilhufe - Penafiel, Portugal, 4564-007
- Investigational Site Number 6200011
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Guimarães, Portugal, 4810-061
- Investigational Site Number 6200004
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Lisboa, Portugal, 1449-005
- Investigational Site Number 6200006
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Lisboa, Portugal, 1500-650
- Investigational Site Number 6200002
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Porto, Portugal, 4099-001
- Investigational Site Number 6200008
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Vila Franca De Xira, Portugal, 2600-009
- Investigational Site Number 6200007
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Vila Nova Gaia, Portugal, 4434-502
- Investigational Site Number 6200003
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Vila Real, Portugal, 5000-508
- Investigational Site Number 6200005
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Arad, Romania, 310037
- Investigational Site Number 6420014
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Baia Mare, Romania, 430031
- Investigational Site Number 6420006
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Braila, Romania, 810325
- Investigational Site Number 6420015
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Bucharest, Romania, 010825
- Investigational Site Number 6420013
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Bucuresti, Romania, 014461
- Investigational Site Number 6420019
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Bucuresti, Romania, 020125
- Investigational Site Number 6420011
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Bucuresti, Romania, 022322
- Investigational Site Number 6420008
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Bucuresti, Romania, 050659
- Investigational Site Number 6420007
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Cluj Napoca, Romania, 400001
- Investigational Site Number 6420002
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Cluj Napoca, Romania, 400347
- Investigational Site Number 6420003
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Craiova, Romania, 200642
- Investigational Site Number 6420016
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Oradea, Romania, 410469
- Investigational Site Number 6420004
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Oradea, Romania, 410169
- Investigational Site Number 6420005
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Satu Mare, Romania, 440156
- Investigational Site Number 6420018
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Targu Mures, Romania, 540103
- Investigational Site Number 6420001
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Tg-Mures, Romania, 540136
- Investigational Site Number 6420012
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Timisoara, Romania, 300079
- Investigational Site Number 6420009
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Timisoara, Romania, 300723
- Investigational Site Number 6420010
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Ivanovo, Russian Federation, 153012
- Investigational Site Number 6430026
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Kazan, Russian Federation, 420087
- Investigational Site Number 6430023
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Kemerovo, Russian Federation, 650002
- Investigational Site Number 6430002
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Kemerovo, Russian Federation, 650002
- Investigational Site Number 6430006
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Moscow, Russian Federation, 111539
- Investigational Site Number 6430004
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Moscow, Russian Federation, 109240
- Investigational Site Number 6430005
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Moscow, Russian Federation, 117292
- Investigational Site Number 6430022
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Moscow, Russian Federation, 119192
- Investigational Site Number 6430024
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Moscow, Russian Federation, 121552
- Investigational Site Number 6430001
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Moscow, Russian Federation, 121552
- Investigational Site Number 6430003
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Moscow, Russian Federation, 121552
- Investigational Site Number 6430010
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Nizhniy Novgorod, Russian Federation, 603005
- Investigational Site Number 6430018
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Rostov-Na-Donu, Russian Federation, 344068
- Investigational Site Number 6430013
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Saint-Petersburg, Russian Federation, 198205
- Investigational Site Number 6430011
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Sochi, Russian Federation, 354057
- Investigational Site Number 6430017
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St-Petersburg, Russian Federation, 193312
- Investigational Site Number 6430025
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St-Petersburg, Russian Federation, 195067
- Investigational Site Number 6430007
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St-Petersburg, Russian Federation, 197341
- Investigational Site Number 6430012
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St-Petersburg, Russian Federation, 199106
- Investigational Site Number 6430009
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Tomsk, Russian Federation, 634012
- Investigational Site Number 6430016
-
-
-
-
-
Bratislava, Slovakia, 813 69
- Investigational Site Number 7030001
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Bratislava 3 - Kramare, Slovakia, 833 05
- Investigational Site Number 7030003
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Bratislava 37, Slovakia, 833 48
- Investigational Site Number 7030004
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Brezno, Slovakia, 97742
- Investigational Site Number 7030010
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Dolny Kubin, Slovakia, 02614
- Investigational Site Number 7030009
-
Kosice, Slovakia, 040 01
- Investigational Site Number 7030002
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Nitra, Slovakia, 950 01
- Investigational Site Number 7030011
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Trnava, Slovakia, 91775
- Investigational Site Number 7030008
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-
-
-
-
Alicante, Spain, 03010
- Investigational Site Number 7240016
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Badalona, Spain, 08916
- Investigational Site Number 7240015
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Hospitalet De Llobregat, Spain, 08907
- Investigational Site Number 7240020
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La Coruña, Spain, 15006
- Investigational Site Number 7240006
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Las Palmas De Gran Canaria, Spain, 35020
- Investigational Site Number 7240005
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Madrid, Spain, 28031
- Investigational Site Number 7240021
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Madrid, Spain, 28040
- Investigational Site Number 7240008
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Manises, Spain, 46940
- Investigational Site Number 7240022
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Murcia, Spain, 30120
- Investigational Site Number 7240007
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Málaga, Spain, 29010
- Investigational Site Number 7240004
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Olot, Spain, 17800
- Investigational Site Number 7240014
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San Sebastián De Los Reyes, Spain, 28702
- Investigational Site Number 7240009
-
Sanlúcar De Barrameda, Spain, 11540
- Investigational Site Number 7240003
-
Sevilla, Spain, 41014
- Investigational Site Number 7240001
-
Sevilla, Spain, 41071
- Investigational Site Number 7240019
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Valencia, Spain, 46010
- Investigational Site Number 7240012
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Valencia, Spain, 46014
- Investigational Site Number 7240011
-
Valencia, Spain, 46026
- Investigational Site Number 7240010
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Villamartín, Spain, 11650
- Investigational Site Number 7240002
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Zaragoza, Spain, 50009
- Investigational Site Number 7240013
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Úbeda, Spain, 23400
- Investigational Site Number 7240018
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-
-
-
-
Jönköping, Sweden, 551 85
- Investigational Site Number 7520004
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Malmö, Sweden, 205 02
- Investigational Site Number 7520002
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Skellefteå, Sweden, 931 86
- Investigational Site Number 7520006
-
Stockholm, Sweden, 171 76
- Investigational Site Number 7520001
-
Stockholm, Sweden, 118 83
- Investigational Site Number 7520007
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Stockholm, Sweden, 14186
- Investigational Site Number 7520008
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-
-
-
-
Basel, Switzerland, 4031
- Investigational Site Number 7560001
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Lugano, Switzerland, 6900
- Investigational Site Number 7560003
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-
-
-
-
Antalya, Turkey, 07059
- Investigational site number 7920008
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Corum, Turkey, 19200
- Investigational Site Number 7920006
-
Eskisehir, Turkey, 26480
- Investigational site number 7920005
-
Haseki/ Istanbul, Turkey, 34034
- Investigational Site Number 7920002
-
Istanbul, Turkey, 34098
- Investigational Site Number 7920011
-
Izmir, Turkey, 35340
- Investigational Site Number 7920012
-
Kocaeli, Turkey, 41300
- Investigational site number 7920003
-
Mersin, Turkey, 33169
- Investigational Site Number 7920004
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Sivas, Turkey, 58140
- Investigational Site Number 7920001
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Trabzon, Turkey, 61040
- Investigational Site Number 7920010
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-
-
-
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Bournemouth, United Kingdom, BH7 7DW
- Investigational Site Number 8260005
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Bristol, United Kingdom, BS10 5NB
- Investigational Site Number 8260010
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Chelmsford, United Kingdom, CM1 7ET
- Investigational Site Number 8260008
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Hull, United Kingdom, HU16 5JQ
- Investigational Site Number 8260009
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Newcastle, United Kingdom, NE1 4LP
- Investigational Site Number 8260002
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Oldham, United Kingdom, OL1 2JH
- Investigational Site Number 8260001
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Swansea, United Kingdom, SA6 6NL
- Investigational Site Number 8260003
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Swindon, United Kingdom, SN3 6BB
- Investigational Site Number 8260006
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Torquay, United Kingdom, TQ2 7AA
- Investigational Site Number 8260004
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York, United Kingdom, YO31 8HE
- Investigational Site Number 8260007
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-
-
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Alabama
-
Alexander City, Alabama, United States, 35010
- Investigational Site Number 8400128
-
-
Arizona
-
Cottonwood, Arizona, United States, 86326
- Investigational Site Number 8400109
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Investigational Site Number 8400032
-
Little Rock, Arkansas, United States, 72205
- Investigational Site Number 8400080
-
-
California
-
Bakersfield, California, United States, 93309
- Investigational Site Number 8400075
-
Fresno, California, United States, 93701
- Investigational Site Number 8400069
-
Los Angeles, California, United States, 90024
- Investigational Site Number 8400008
-
Los Angeles, California, United States, 90073
- Investigational Site Number 8400063
-
National City, California, United States, 91950
- Investigational Site Number 8400127
-
Redondo Beach, California, United States, 90277
- Investigational Site Number 8400007
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Stockton, California, United States, 95204
- Investigational Site Number 8400036
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Sylmar, California, United States, 91342
- Investigational Site Number 8400033
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Torrance, California, United States, 90502
- Investigational Site Number 8400049
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Walnut Creek, California, United States, 94598
- Investigational Site Number 8400028
-
-
Connecticut
-
Bridgeport, Connecticut, United States, 06606
- Investigational Site Number 8400029
-
New Haven, Connecticut, United States, 06519
- Investigational Site Number 8400037
-
-
Florida
-
DeLand, Florida, United States, 32720
- Investigational Site Number 8400046
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Gainesville, Florida, United States, 32608
- Investigational Site Number 8400009
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Homestead, Florida, United States, 33033
- Investigational Site Number 8400079
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Jacksonville, Florida, United States, 32207
- Investigational Site Number 8400031
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Jacksonville, Florida, United States, 32216
- Investigational Site Number 8400022
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Lake Mary, Florida, United States, 32746
- Investigational Site Number 8400098
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Miami Beach, Florida, United States, 33140
- Investigational Site Number 8400058
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Orlando, Florida, United States, 32806
- Investigational Site Number 8400105
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Pensacola, Florida, United States, 32504
- Investigational Site Number 8400082
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Port Charlotte, Florida, United States, 33952
- Investigational Site Number 8400057
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Sarasota, Florida, United States, 34239
- Investigational Site Number 8400006
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Tampa, Florida, United States, 33609
- Investigational Site Number 8400035
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Tampa, Florida, United States, 33612
- Investigational Site Number 8400042
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Wellington, Florida, United States, 33449
- Investigational Site Number 8400004
-
-
Georgia
-
Atlanta, Georgia, United States, 30322-1020
- Investigational Site Number 8400073
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Tucker, Georgia, United States, 30084
- Investigational Site Number 8400118
-
-
Illinois
-
Arlington Heights, Illinois, United States, 60005
- Investigational Site Number 8400067
-
Chicago, Illinois, United States, 60637
- Investigational Site Number 8400043
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Elk Grove Village, Illinois, United States, 60007
- Investigational Site Number 8400072
-
-
Indiana
-
Indianapolis, Indiana, United States, 46060
- Investigational Site Number 8400055
-
Muncie, Indiana, United States, 47303-3400
- Investigational Site Number 8400020
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Richmond, Indiana, United States, 47374
- Investigational Site Number 8400122
-
-
Iowa
-
Waterloo, Iowa, United States, 50702
- Investigational Site Number 8400091
-
-
Louisiana
-
Covington, Louisiana, United States, 70433
- Investigational Site Number 8400030
-
-
Maryland
-
Annapolis, Maryland, United States, 21401
- Investigational Site Number 8400065
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Investigational Site Number 8400012
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Cambridge, Massachusetts, United States, 02135
- Investigational Site Number 8400001
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Investigational Site Number 8400077
-
Kalamazoo, Michigan, United States, 49009
- Investigational Site Number 8400062
-
Kalamazoo, Michigan, United States, 49048
- Investigational Site Number 8400017
-
-
Minnesota
-
Duluth, Minnesota, United States, 55805
- Investigational Site Number 8400107
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- Investigational Site Number 8400056
-
-
Missouri
-
Columbia, Missouri, United States, 65201
- Investigational Site Number 8400019
-
Lee's Summit, Missouri, United States, 64064
- Investigational Site Number 8400103
-
-
Nebraska
-
Grand Island, Nebraska, United States, 68803
- Investigational Site Number 8400132
-
Lincoln, Nebraska, United States, 68506
- Investigational Site Number 8400130
-
Omaha, Nebraska, United States, 68124
- Investigational Site Number 8400083
-
Omaha, Nebraska, United States, 68198
- Investigational Site Number 8400071
-
-
New Jersey
-
Ridgewood, New Jersey, United States, 07450-2736
- Investigational Site Number 8400015
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Voorhees, New Jersey, United States, 08043
- Investigational Site Number 8400050
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- Investigational Site Number 8400131
-
-
New York
-
Bronx, New York, United States, 10457
- Investigational Site Number 8400097
-
Bronx, New York, United States, 10468-3904
- Investigational Site Number 8400061
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Brooklyn, New York, United States, 11203
- Investigational Site Number 8400051
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Buffalo, New York, United States, 14215
- Investigational Site Number 8400111
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-
North Carolina
-
Greensboro, North Carolina, United States, 27401
- Investigational Site Number 8400045
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Raleigh, North Carolina, United States, 27610
- Investigational Site Number 8400085
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Winston-Salem, North Carolina, United States, 27157
- Investigational Site Number 8400078
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-
Ohio
-
Cincinnati, Ohio, United States, 45220
- Investigational Site Number 8400087
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Cincinnati, Ohio, United States, 45267
- Investigational Site Number 8400047
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Maumee, Ohio, United States, 43537
- Investigational Site Number 8400095
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Toledo, Ohio, United States, 43699
- Investigational Site Number 8400099
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Zanesville, Ohio, United States, 43701
- Investigational Site Number 8400121
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-
Oregon
-
Arlington, Oregon, United States, 19001
- Investigational Site Number 8400054
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Pennsylvania
-
Doylestown, Pennsylvania, United States, 18901
- Investigational Site Number 8400134
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Natrona Heights, Pennsylvania, United States, 15065
- Investigational Site Number 8400044
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Philadelphia, Pennsylvania, United States, 19104
- Investigational Site Number 8400115
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Sayre, Pennsylvania, United States, 18840
- Investigational Site Number 8400039
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Investigational Site Number 8400114
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Warwick, Rhode Island, United States, 02886
- Investigational Site Number 8400100
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South Carolina
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Charleston, South Carolina, United States, 29425
- Investigational Site Number 8400059
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Columbia, South Carolina, United States, 29203
- Investigational Site Number 8400092
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Greenville, South Carolina, United States, 29605
- Investigational Site Number 8400104
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Investigational Site Number 8400040
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Tennessee
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Greenville, Tennessee, United States, 30000
- Investigational Site Number 8400088
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Memphis, Tennessee, United States, 38104
- Investigational Site Number 8400089
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Nashville, Tennessee, United States, 37212
- Investigational Site Number 8400053
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Texas
-
Brownsville, Texas, United States, 78521
- Investigational Site Number 8400041
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Dallas, Texas, United States, 75226
- Investigational Site Number 8400074
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Houston, Texas, United States, 77030
- Investigational Site Number 8400016
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McKinney, Texas, United States, 75071
- Investigational Site Number 8400123
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New Braunfels, Texas, United States, 78130
- Investigational Site Number 8400101
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Victoria, Texas, United States, 77901
- Investigational Site Number 8400066
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Virginia
-
Manassas, Virginia, United States, 20109
- Investigational Site Number 8400093
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Richmond, Virginia, United States, 23249-0001
- Investigational Site Number 8400003
-
-
West Virginia
-
Clarksburg, West Virginia, United States, 26301
- Investigational Site Number 8400126
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Morgantown, West Virginia, United States, 26506
- Investigational Site Number 8400038
-
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Wisconsin
-
Manitowoc, Wisconsin, United States, 54220
- Investigational Site Number 8400048
-
-
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 to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Type 2 Diabetes Mellitus.
- Admitted to the hospital, or urgent heart failure visit for worsening heart failure.
- Prior diagnosis of heart failure (> 3 months).
- Prior chronic treatment for heart failure with a loop diuretic (eg furosemide, torsemide, bumetanide) for > 30 days.
- Randomized when hemodynamically stable, prior to hospital discharge or within 3 days of discharge.
- Brain natriuretic peptide (BNP) ≥150 picograms per milliliter (pg/mL) (≥450 pg/mL for participants with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600 pg/mL (≥1800 pg/mL for participants with atrial fibrillation).
- Participants with Left Ventricular Ejection Fraction <40% should be on beta-blockers and renin-angiotensin-aldosterone system (RAAS) inhibitors as per local guidelines unless contraindicated.
- Signed written informed consent.
Exclusion criteria:
- Age < 18 years or > 85 years.
- Worsening heart failure attributed to other causes such as pulmonary embolism, stroke, heart attack.
- Cardiac surgery or coronary procedure within 1 month or planned during study.
- 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.
- Acute coronary syndromes within 3 months prior to Randomization.
- Hemodynamically significant uncorrected primary valvular disease.
- Significant pulmonary disease contributing substantially to the participant's dyspnea.
- End stage Heart Failure.
- History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar coma within 3 months prior to screening.
- History of stroke within 3 months prior to randomization.
- History of dialysis within 1 year prior to randomization.
- History of solid organ transplant or on a transplant list (if heart transplant, defined as status 1 transplant).
- Severe kidney disease as defined by glomerular filtration rate (eGFR) <30 milliliter per minute per 1.72 meter square (mL/min/1.73 m^2).
- Pregnancy.
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Sotagliflozin
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Pharmaceutical form: tablet Route of administration: oral
Other Names:
|
|
PLACEBO_COMPARATOR: Placebo
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
Pharmaceutical form: tablet Route of administration: oral |
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 21.9 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 21.9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Number of Occurrences of HHF and Urgent HF Visits
Time Frame: Up to 21.9 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 21.9 months
|
|
Total Number of Deaths From Cardiovascular Causes
Time Frame: Up to 21.9 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 21.9 months
|
|
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
Time Frame: Up to 21.9 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 randomisation.
Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
|
Up to 21.9 months
|
|
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
Time Frame: Up to 21.9 months
|
Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomisation of HHF, urgent HF visits, CV Death and HF while hospitalised.
Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
|
Up to 21.9 months
|
|
Total Number of Deaths From Any Cause
Time Frame: Up to 21.9 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 21.9 months
|
|
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4
Time Frame: Baseline to Month 4
|
KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks.
The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status.
A positive change from baseline indicates improvement.
An analysis of covariance (ANCOVA) model was used for analysis.
|
Baseline to Month 4
|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline up to 21.9 months
|
eGFR is a test for renal function.
A blood sample was collected and was sent to a central laboratory.
eGFR was calculated by the Modification of Diet in Renal Disease (MDRD) equation reported as milliliters/minute/1.73 meter squared (mL/min/1.73
m^2).
A mixed model for repeated measures (MMRM) was used for analysis.
|
Baseline up to 21.9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
- Szarek M, Bhatt DL, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Banks P, Tesfaye E, Ezekowitz JA, Verma S, Pitt B; SOLOIST-WHF committees and investigators. Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure : A Randomized Trial. Ann Intern Med. 2021 Aug;174(8):1065-1072. doi: 10.7326/M21-0651. Epub 2021 Jun 22.
- Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.
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)
June 15, 2018
Primary Completion (ACTUAL)
June 5, 2020
Study Completion (ACTUAL)
June 5, 2020
Study Registration Dates
First Submitted
April 30, 2018
First Submitted That Met QC Criteria
April 30, 2018
First Posted (ACTUAL)
May 11, 2018
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
- Heart Diseases
- Cardiovascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Heart Failure
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Sodium-Glucose Transporter 2 Inhibitors
- (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Other Study ID Numbers
- EFC15156
- 2017-003510-16 (EUDRACT_NUMBER)
- U1111-1190-7891 (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
No
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.