Study Stopped
Study terminated due to business decision
Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
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
3 other identifiers
interventional
1,222
31 countries
459
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 heart-failure
Started Jun 2018
Shorter than P25 for phase_3 heart-failure
459 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedStudy Start
First participant enrolled
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2020
CompletedResults Posted
Study results publicly available
October 28, 2022
CompletedOctober 28, 2022
September 1, 2022
2 years
April 30, 2018
September 30, 2022
September 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Up to 21.9 months
Secondary Outcomes (7)
Total Number of Occurrences of HHF and Urgent HF Visits
Up to 21.9 months
Total Number of Deaths From Cardiovascular Causes
Up to 21.9 months
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
Up to 21.9 months
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
Up to 21.9 months
Total Number of Deaths From Any Cause
Up to 21.9 months
- +2 more secondary outcomes
Study Arms (2)
Sotagliflozin
EXPERIMENTALSotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
Placebo
PLACEBO COMPARATORMatching 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.
Interventions
Pharmaceutical form: tablet Route of administration: oral
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lexicon Pharmaceuticalslead
- Sanoficollaborator
Study Sites (466)
Investigational Site Number 8400128
Alexander City, Alabama, 35010, United States
Investigational Site Number 8400109
Cottonwood, Arizona, 86326, United States
Investigational Site Number 8400032
Little Rock, Arkansas, 72205, United States
Investigational Site Number 8400080
Little Rock, Arkansas, 72205, United States
Investigational Site Number 8400075
Bakersfield, California, 93309, United States
Investigational Site Number 8400069
Fresno, California, 93701, United States
Investigational Site Number 8400008
Los Angeles, California, 90024, United States
Investigational Site Number 8400063
Los Angeles, California, 90073, United States
Investigational Site Number 8400127
National City, California, 91950, United States
Investigational Site Number 8400007
Redondo Beach, California, 90277, United States
Investigational Site Number 8400036
Stockton, California, 95204, United States
Investigational Site Number 8400033
Sylmar, California, 91342, United States
Investigational Site Number 8400049
Torrance, California, 90502, United States
Investigational Site Number 8400028
Walnut Creek, California, 94598, United States
Investigational Site Number 8400029
Bridgeport, Connecticut, 06606, United States
Investigational Site Number 8400037
New Haven, Connecticut, 06519, United States
Investigational Site Number 8400046
DeLand, Florida, 32720, United States
Investigational Site Number 8400009
Gainesville, Florida, 32608, United States
Investigational Site Number 8400079
Homestead, Florida, 33033, United States
Investigational Site Number 8400031
Jacksonville, Florida, 32207, United States
Investigational Site Number 8400022
Jacksonville, Florida, 32216, United States
Investigational Site Number 8400098
Lake Mary, Florida, 32746, United States
Investigational Site Number 8400058
Miami Beach, Florida, 33140, United States
Investigational Site Number 8400105
Orlando, Florida, 32806, United States
Investigational Site Number 8400082
Pensacola, Florida, 32504, United States
Investigational Site Number 8400057
Port Charlotte, Florida, 33952, United States
Investigational Site Number 8400006
Sarasota, Florida, 34239, United States
Investigational Site Number 8400035
Tampa, Florida, 33609, United States
Investigational Site Number 8400042
Tampa, Florida, 33612, United States
Investigational Site Number 8400004
Wellington, Florida, 33449, United States
Investigational Site Number 8400073
Atlanta, Georgia, 30322-1020, United States
Investigational Site Number 8400118
Tucker, Georgia, 30084, United States
Investigational Site Number 8400067
Arlington Heights, Illinois, 60005, United States
Investigational Site Number 8400043
Chicago, Illinois, 60637, United States
Investigational Site Number 8400072
Elk Grove Village, Illinois, 60007, United States
Investigational Site Number 8400055
Indianapolis, Indiana, 46060, United States
Investigational Site Number 8400020
Muncie, Indiana, 47303-3400, United States
Investigational Site Number 8400122
Richmond, Indiana, 47374, United States
Investigational Site Number 8400091
Waterloo, Iowa, 50702, United States
Investigational Site Number 8400030
Covington, Louisiana, 70433, United States
Investigational Site Number 8400065
Annapolis, Maryland, 21401, United States
Investigational Site Number 8400012
Boston, Massachusetts, 02118, United States
Investigational Site Number 8400001
Cambridge, Massachusetts, 02135, United States
Investigational Site Number 8400077
Detroit, Michigan, 48202, United States
Investigational Site Number 8400062
Kalamazoo, Michigan, 49009, United States
Investigational Site Number 8400017
Kalamazoo, Michigan, 49048, United States
Investigational Site Number 8400107
Duluth, Minnesota, 55805, United States
Investigational Site Number 8400056
Jackson, Mississippi, 39216, United States
Investigational Site Number 8400019
Columbia, Missouri, 65201, United States
Investigational Site Number 8400103
Lee's Summit, Missouri, 64064, United States
Investigational Site Number 8400132
Grand Island, Nebraska, 68803, United States
Investigational Site Number 8400130
Lincoln, Nebraska, 68506, United States
Investigational Site Number 8400083
Omaha, Nebraska, 68124, United States
Investigational Site Number 8400071
Omaha, Nebraska, 68198, United States
Investigational Site Number 8400015
Ridgewood, New Jersey, 07450-2736, United States
Investigational Site Number 8400050
Voorhees Township, New Jersey, 08043, United States
Investigational Site Number 8400131
Albuquerque, New Mexico, 87131, United States
Investigational Site Number 8400051
Brooklyn, New York, 11203, United States
Investigational Site Number 8400111
Buffalo, New York, 14215, United States
Investigational Site Number 8400097
The Bronx, New York, 10457, United States
Investigational Site Number 8400061
The Bronx, New York, 10468-3904, United States
Investigational Site Number 8400045
Greensboro, North Carolina, 27401, United States
Investigational Site Number 8400085
Raleigh, North Carolina, 27610, United States
Investigational Site Number 8400078
Winston-Salem, North Carolina, 27157, United States
Investigational Site Number 8400087
Cincinnati, Ohio, 45220, United States
Investigational Site Number 8400047
Cincinnati, Ohio, 45267, United States
Investigational Site Number 8400095
Maumee, Ohio, 43537, United States
Investigational Site Number 8400099
Toledo, Ohio, 43699, United States
Investigational Site Number 8400121
Zanesville, Ohio, 43701, United States
Investigational Site Number 8400054
Arlington, Oregon, 19001, United States
Investigational Site Number 8400134
Doylestown, Pennsylvania, 18901, United States
Investigational Site Number 8400044
Natrona Heights, Pennsylvania, 15065, United States
Investigational Site Number 8400115
Philadelphia, Pennsylvania, 19104, United States
Investigational Site Number 8400039
Sayre, Pennsylvania, 18840, United States
Investigational Site Number 8400114
Providence, Rhode Island, 02903, United States
Investigational Site Number 8400100
Warwick, Rhode Island, 02886, United States
Investigational Site Number 8400059
Charleston, South Carolina, 29425, United States
Investigational Site Number 8400092
Columbia, South Carolina, 29203, United States
Investigational Site Number 8400104
Greenville, South Carolina, 29605, United States
Investigational Site Number 8400040
Rapid City, South Dakota, 57701, United States
Investigational Site Number 8400088
Greenville, Tennessee, 30000, United States
Investigational Site Number 8400089
Memphis, Tennessee, 38104, United States
Investigational Site Number 8400053
Nashville, Tennessee, 37212, United States
Investigational Site Number 8400041
Brownsville, Texas, 78521, United States
Investigational Site Number 8400074
Dallas, Texas, 75226, United States
Investigational Site Number 8400016
Houston, Texas, 77030, United States
Investigational Site Number 8400123
McKinney, Texas, 75071, United States
Investigational Site Number 8400101
New Braunfels, Texas, 78130, United States
Investigational Site Number 8400066
Victoria, Texas, 77901, United States
Investigational Site Number 8400093
Manassas, Virginia, 20109, United States
Investigational Site Number 8400003
Richmond, Virginia, 23249-0001, United States
Investigational Site Number 8400126
Clarksburg, West Virginia, 26301, United States
Investigational Site Number 8400038
Morgantown, West Virginia, 26506, United States
Investigational Site Number 8400048
Manitowoc, Wisconsin, 54220, United States
Investigational Site Number 0320031
Caba, 1430, Argentina
Investigational Site Number 0320009
Caba, C1093AAS, Argentina
Investigational Site Number 0320016
Capital Federal, 1405, Argentina
Investigational Site Number 0320002
Ciudad de Buenos Aires, C1428DCO, Argentina
Investigational Site Number 0320022
Corrientes, 3400, Argentina
Investigational Site Number 0320001
Corrientes, W3400AMZ, Argentina
Investigational Site Number 0320024
Córdoba, 5000, Argentina
Investigational Site Number 0320011
Córdoba, X5000AAX, Argentina
Investigational Site Number 0320003
Córdoba, X5000JHQ, Argentina
Investigational Site Number 0320010
Córdoba, X5004BAL, Argentina
Investigational Site Number 0320025
Córdoba, X5006IKK, Argentina
Investigational Site Number 0320029
La Plata, B1900AXI, Argentina
Investigational Site Number 0320007
La Plata, B1906ESC, Argentina
Investigational Site Number 0320006
Merlo, B1722COV, Argentina
Investigational Site Number 0320005
Morón, B1708CGU, Argentina
Investigational Site Number 0320012
Olivos, 1638, Argentina
Investigational Site Number 0320023
Quilmes, 1878, Argentina
Investigational Site Number 0320018
Rosario, 2000, Argentina
Investigational Site Number 0320013
Rosario, S2000DSR, Argentina
Investigational Site Number 0320008
Salta, 4400, Argentina
Investigational Site Number 0320020
San Martín, B1685CSQ, Argentina
Investigational Site Number 0320028
San Miguel de Tucumán, T4000IFL, Argentina
Investigational Site Number 0320030
San Miguel de Tucumán, T4000JCU, Argentina
Investigational Site Number 0320019
San Miguel de Tucumán, T4000NIL, Argentina
Investigational Site Number 0320017
Santa Fe, S3000EOZ, Argentina
Investigational Site Number 0320015
Santa Fe, S3000FWO, Argentina
Investigational Site Number 0320004
Villa Belgrano, X5021FPQ, Argentina
Investigational Site Number 0320014
Villa María, X5900JKA, Argentina
Investigational Site Number 0360007
Murdoch, 6150, Australia
Investigational Site Number 0360001
Wollongong, 2500, Australia
Investigational Site Number 0400006
Braunau am Inn, 5280, Austria
Investigational Site Number 0400002
Feldkirch, 6800, Austria
Investigational Site Number 0400007
Graz, 8036, Austria
Investigational Site Number 0400005
Linz, 4010, Austria
Investigational Site Number 0400004
Salzburg, 5020, Austria
Investigational Site Number 0400003
Vienna, 1090, Austria
Investigational Site Number 0400001
Vienna, 1160, Austria
Investigational Site Number 0560002
Aalst, 9300, Belgium
Investigational Site Number 0560007
Ghent, 9000, Belgium
Investigational Site Number 0560004
Kortrijk, 8500, Belgium
Investigational Site Number 0560001
Leuven, 3000, Belgium
Investigational Site Number 0560003
Liège, 4000, Belgium
Investigational Site Number 0560005
Mol, 2400, Belgium
Investigational Site Number 0560006
Mons, 7000, Belgium
Investigational Site Number 0560008
Roeselare, 8800, Belgium
Investigational Site Number 0760009
Belo Horizonte, 30110-908, Brazil
Investigational Site Number 0760024
Belo Horizonte, 30150-221, Brazil
Investigational Site Number 0760002
Blumenau, 89020-430, Brazil
Investigational Site Number 0760011
Brasília, 70390-903, Brazil
Investigational Site Number 0760005
Campinas, 13060-080, Brazil
Investigational Site Number 0760006
Campinas, 13092-111, Brazil
Investigational Site Number 0760023
Fortaleza, 60840-285, Brazil
Investigational Site Number 0760018
Goiânia, 74210050, Brazil
Investigational Site Number 0760010
Passo Fundo, 99010-180, Brazil
Investigational Site Number 0760003
Porto Alegre, 90020-090, Brazil
Investigational Site Number 0760020
Porto Alegre, 90035 003, Brazil
Investigational Site Number 0760021
Porto Alegre, 90610-000, Brazil
Investigational Site Number 0760007
Porto Alegre, 90620-001, Brazil
Investigational Site Number 0760013
Porto Alegre, 91350-250, Brazil
Investigational Site Number 0760004
Recife, 52051-380, Brazil
Investigational Site Number 0760001
São José do Rio Preto, 15090-000, Brazil
Investigational Site Number 0760012
São Paulo, 04012-909, Brazil
Investigational Site Number 0760008
São Paulo, 05403-000, Brazil
Investigational Site Number 0760017
Votuporanga, 15500-003, Brazil
Investigational Site Number 1240013
Cambridge, N1R 6V6, Canada
Investigational Site Number 1240006
Granby, J2G 1T7, Canada
Investigational Site Number 1240015
Halifax, B3H 3A7, Canada
Investigational Site Number 1240002
Montreal, H1T 1C8, Canada
Investigational Site Number 1240019
Montreal, H3G 1A4, Canada
Investigational Site Number 1240018
Montreal, H4A 3J1, Canada
Investigational Site Number 1240004
Peterborough, K9J 0B2, Canada
Investigational Site Number 1240014
Québec, G1V 4G5, Canada
Investigational Site Number 1240007
Scarborough, M1B 4Z8, Canada
Investigational Site Number 1240005
Sherbrooke, J1G 2E8, Canada
Investigational Site Number 1240011
Toronto, M5B 1W8, Canada
Investigational Site Number 1240001
Toronto, M5G 2C4, Canada
Investigational Site Number 1240009
Trois-Rivières, G9A 5C5, Canada
Investigational Site Number 1520009
Concepción, Chile
Investigational Site Number 1520011
Santiago, 80004005, Chile
Investigational Site Number 1520006
Santiago, 8053095, Chile
Investigational Site Number 1520003
Santiago, 8380456, Chile
Investigational Site Number 1520004
Santiago, Chile
Investigational Site Number 1520005
Santiago, Chile
Investigational Site Number 1520012
Santiago, Chile
Investigational Site Number 1520013
Santiago, Chile
Investigational Site Number 1520002
Temuco, Chile
Investigational Site Number 1520001
Viña del Mar, Chile
Investigational Site Number 1520010
Viña del Mar, Chile
Investigational Site Number 2030001
Brno, 62500, Czechia
Investigational Site Number 2030003
Brno, 63600, Czechia
Investigational Site Number 2030004
Brno, 65691, Czechia
Investigational Site Number 2030014
Kolín, 28002, Czechia
Investigational Site Number 2030010
Kroměříž, 76701, Czechia
Investigational Site Number 2030005
Liberec, 46063, Czechia
Investigational Site Number 2030013
Městec Králové, 28903, Czechia
Investigational Site Number 2030018
Prague, 10100, Czechia
Investigational Site Number 2030002
Prague, 12808, Czechia
Investigational Site Number 2030017
Prague, 15030, Czechia
Investigational Site Number 2030007
Praha 5 - Motol, 15006, Czechia
Investigational Site Number 2030015
Pribram I, 26101, Czechia
Investigational Site Number 2030011
Přerov, 75152, Czechia
Investigational Site Number 2030006
Slaný, 27401, Czechia
Investigational Site Number 2080004
Aalborg, 9100, Denmark
Investigational Site Number 2080003
Aarhus N, 8200, Denmark
Investigational Site Number 2080002
Glostrup Municipality, 2600, Denmark
Investigational Site Number 2080001
Herlev, 2730, Denmark
Investigational Site Number 2080005
København NV, 2400, Denmark
Investigational Site Number 2460004
Espoo, 02740, Finland
Investigational Site Number 2460001
Helsinki, 00029 HUS, Finland
Investigational Site Number 2460002
Jyväskylä, 40620, Finland
Investigational Site Number 2460003
Oulu, 90220, Finland
Investigational Site Number 2460005
Seinäjoki, 60220, Finland
Investigational Site Number 2500009
Chambray-lès-Tours, 37170, France
Investigational Site Number 2500008
La Tronche, 38700, France
Investigational Site Number 2500004
Le Chesnay, 78150, France
Investigational Site Number 2500002
Le Coudray, 28360, France
Investigational Site Number 2500001
Lille, 59037, France
Investigational Site Number 2500007
Nantes, 44093, France
Investigational Site Number 2500012
Nice, 06002, France
Investigational Site Number 2500006
Paris, 75015, France
Investigational Site Number 2500003
Paris, 75877, France
Investigational Site Number 2500005
Toulouse, 31059, France
Investigational Site Number 2500013
Vandœuvre-lès-Nancy, 54511, France
Investigational Site Number 2760020
Bad Nauheim, 61231, Germany
Investigational Site Number 2760016
Bad Oeynhausen, 32545, Germany
Investigational Site Number 2760013
Berlin, 12203, Germany
Investigational Site Number 2760019
Berlin, 13347, Germany
Investigational Site Number 2760001
Berlin, 13353, Germany
Investigational Site Number 2760002
Berlin, 13353, Germany
Investigational Site Number 2760025
Bielefeld, 33604, Germany
Investigational Site Number 2760005
Bonn, 53115, Germany
Investigational Site Number 2760021
Bremen, 28277, Germany
Investigational Site Number 2760035
Coburg, 96450, Germany
Investigational Site Number 2760027
Cologne, 50733, Germany
Investigational Site Number 2760032
Dortmund, 44137, Germany
Investigational Site Number 2760006
Dortmund, 44379, Germany
Investigational Site Number 2760029
Erfurt, 99097, Germany
Investigational Site Number 2760018
Essen, 45138, Germany
Investigational Site Number 2760033
Frankfurt am Main, 65929, Germany
Investigational Site Number 2760009
Greifswald, 17475, Germany
Investigational Site Number 2760022
Heidelberg, 69115, Germany
Investigational Site Number 2760031
Heidelberg, 69120, Germany
Investigational Site Number 2760034
Lahr, 77933, Germany
Investigational Site Number 2760030
Langen, 63225, Germany
Investigational Site Number 2760014
Leverkusen, 51375, Germany
Investigational Site Number 2760036
Limburg, 65549, Germany
Investigational Site Number 2760012
Ludwigshafen, 67063, Germany
Investigational Site Number 2760028
Merseburg, 06217, Germany
Investigational Site Number 2760011
Rotenburg an der Fulda, 36199, Germany
Investigational Site Number 2760015
Rüsselsheim am Main, 65428, Germany
Investigational Site Number 2760007
Witten, 58455, Germany
Investigational Site Number 2760026
Würzburg, 97080, Germany
Investigational Site Number 3000012
Athens, 11526, Greece
Investigational Site Number 3000004
Athens, 11527, Greece
Investigational Site Number 3000002
Chalcis, 34 100, Greece
Investigational Site Number 3000009
Elefsina, 19600, Greece
Investigational Site Number 3000003
Haidari, 12462, Greece
Investigational Site Number 3000005
Heraklion, 71110, Greece
Investigational Site Number 3000007
Ioannina, 455 00, Greece
Investigational Site Number 3000006
Larissa, 41110, Greece
Investigational Site Number 3000001
N. Ionia, 14233, Greece
Investigational Site Number 3000008
Thessaloniki, 546 36, Greece
Investigational Site Number 3480018
Berettyóújfalu, 4100, Hungary
Investigational Site Number 3480012
Budapest, 1023, Hungary
Investigational Site Number 3480016
Budapest, 1085, Hungary
Investigational Site Number 3480010
Budapest, 1096, Hungary
Investigational Site Number 3480019
Budapest, 1115, Hungary
Investigational Site Number 3480001
Budapest, 1122, Hungary
Investigational Site Number 3480015
Budapest, 1125, Hungary
Investigational Site Number 3480011
Budapest, 1134, Hungary
Investigational Site Number 3480014
Budapest, 1145, Hungary
Investigational Site Number 3480005
Budapest, 1204, Hungary
Investigational Site Number 3480007
Debrecen, 4032, Hungary
Investigational Site Number 3480002
Dombóvár, 7200, Hungary
Investigational Site Number 3480017
Gyula, 5700, Hungary
Investigational Site Number 3480008
Hódmezövásárhely, 6800, Hungary
Investigational Site Number 3480020
Kistarcsa, 2143, Hungary
Investigational Site Number 3480009
Komárom, 2921, Hungary
Investigational Site Number 3480013
Pécs, 7624, Hungary
Investigational Site Number 3480003
Székesfehérvár, 8000, Hungary
Investigational Site Number 3480006
Zalaegerszeg, 8900, Hungary
Investigational Site Number 3760013
Ashkelon, 78278, Israel
Investigational Site Number 3760004
Hadera, 38100, Israel
Investigational Site Number 3760005
Haifa, 31096, Israel
Investigational Site Number 3760006
Jerusalem, 91031, Israel
Investigational Site Number 3760003
Jerusalem, 91120, Israel
Investigational Site Number 3760008
Jerusalem, Israel
Investigational Site Number 3760010
Nahariya, 22100, Israel
Investigational Site Number 3760002
Petah Tikva, 49100, Israel
Investigational Site Number 3760011
Rehovot, 76100, Israel
Investigational Site Number 3760009
Safed, 13100, Israel
Investigational Site Number 3760001
Tel Aviv, 64239, Israel
Investigational Site Number 3760012
Tiberias, 15208, Israel
Investigational Site Number 3800006
Arzignano (Vi), 36071, Italy
Investigational Site Number 3800011
Brescia, 25123, Italy
Investigational Site Number 3800017
Brescia, 25124, Italy
Investigational Site Number 3800005
Cortona, 52044, Italy
Investigational Site Number 3800009
Ferrara, 44124, Italy
Investigational Site Number 3800020
Gallipoli, 73014, Italy
Investigational Site Number 3800003
Legnago, 37045, Italy
Investigational Site Number 3800023
Milan, 20122, Italy
Investigational Site Number 3800002
Milan, 20138, Italy
Investigational Site Number 3800012
Milan, 20138, Italy
Investigational Site Number 3800008
Milan, 20162, Italy
Investigational Site Number 3800013
Monza, 20052, Italy
Investigational Site Number 3800022
Napoli, 80131, Italy
Investigational Site Number 3800018
Pavia, 27100, Italy
Investigational Site Number 3800004
Perugia, 06132, Italy
Investigational Site Number 3800016
Pozzilli, 86077, Italy
Investigational Site Number 3800014
Rimini, 47900, Italy
Investigational Site Number 3800010
Roma, 00153, Italy
Investigational Site Number 3800021
Roma, 00189, Italy
Investigational Site Number 3800019
Scorrano, 73020, Italy
Investigational Site Number 3800007
Udine, 33100, Italy
Investigational Site Number 4280004
Daugavpils, LV-5417, Latvia
Investigational Site Number 4280002
Liepāja, LV-3414, Latvia
Investigational Site Number 4280001
Riga, LV-1002, Latvia
Investigational Site Number 4280003
Riga, LV-1038, Latvia
Investigational Site Number 4400002
Kaunas, 50161, Lithuania
Investigational Site Number 4400005
Kaunas, 50161, Lithuania
Investigational Site Number 4400004
Klaipėda, LT-92288, Lithuania
Investigational Site Number 4400006
Šiauliai, LT-76231, Lithuania
Investigational Site Number 4400001
Vilnius, 08661, Lithuania
Investigational Site Number 4400003
Vilnius, 08661, Lithuania
Investigational Site Number 5280004
's-Hertogenbosch, 5223 GZ 's, Netherlands
Investigational Site Number 5280003
Amsterdam, 1034 CS, Netherlands
Investigational Site Number 5280001
Breda, 4819 EV, Netherlands
Investigational Site Number 5280007
Delft, 2625 AD, Netherlands
Investigational Site Number 5280002
Doetinchem, 7009 BL, Netherlands
Investigational Site Number 5280006
Rotterdam, 3045 PM, Netherlands
Investigational Site Number 5280008
Sneek, 8601, Netherlands
Investigational Site Number 5280005
Veldhoven, 5504 DB, Netherlands
Investigational Site Number 5540007
Auckland, 1023, New Zealand
Investigational Site Number 5540006
Christchurch, 8011, New Zealand
Investigational Site Number 5540002
Hamilton, 3204, New Zealand
Investigational Site Number 5540004
Lower Hutt, New Zealand
Investigational Site Number 5540005
New Plymouth, New Zealand
Investigational Site Number 5540003
Rotorua, 3010, New Zealand
Investigational Site Number 6160007
Bialystok, 15-276, Poland
Investigational Site Number 6160017
Gdansk, 80-462, Poland
Investigational Site Number 6160002
Grodzisk Mazowiecki, 05-825, Poland
Investigational Site Number 6160014
Katowice, 40-635, Poland
Investigational Site Number 6160021
Krakow, 30-693, Poland
Investigational Site Number 6160001
Krakow, 31 -202, Poland
Investigational Site Number 6160003
Krakow, 31-501, Poland
Investigational Site Number 6160012
Krakow, Poland
Investigational Site Number 6160016
Lubin, 59-301, Poland
Investigational Site Number 6160005
Miechów, 32-200, Poland
Investigational Site Number 6160022
Poznan, 61-848, Poland
Investigational Site Number 6160006
Torun, 87-100, Poland
Investigational Site Number 6160013
Warsaw, 00-685, Poland
Investigational Site Number 6160004
Warsaw, 03-242, Poland
Investigational Site Number 6160020
Warsaw, 04-073, Poland
Investigational Site Number 6160024
Warsaw, 04-349, Poland
Investigational Site Number 6160008
Warsaw, 04-628, Poland
Investigational Site Number 6160015
Zamość, 22-400, Poland
Investigational Site Number 6160011
Łęczna, 21-010, Poland
Investigational Site Number 6200012
Braga, 4710-243, Portugal
Investigational Site Number 6200001
Coimbra, 3000-075, Portugal
Investigational Site Number 6200011
Guilhufe - Penafiel, 4564-007, Portugal
Investigational Site Number 6200004
Guimarães, 4810-061, Portugal
Investigational Site Number 6200006
Lisbon, 1449-005, Portugal
Investigational Site Number 6200002
Lisbon, 1500-650, Portugal
Investigational Site Number 6200008
Porto, 4099-001, Portugal
Investigational Site Number 6200007
Vila Franca de Xira, 2600-009, Portugal
Investigational Site Number 6200003
Vila Nova Gaia, 4434-502, Portugal
Investigational Site Number 6200005
Vila Real, 5000-508, Portugal
Investigational Site Number 6420014
Arad, 310037, Romania
Investigational Site Number 6420006
Baia Mare, 430031, Romania
Investigational Site Number 6420015
Brăila, 810325, Romania
Investigational Site Number 6420013
Bucharest, 010825, Romania
Investigational Site Number 6420019
Bucharest, 014461, Romania
Investigational Site Number 6420011
Bucharest, 020125, Romania
Investigational Site Number 6420008
Bucharest, 022322, Romania
Investigational Site Number 6420007
Bucharest, 050659, Romania
Investigational Site Number 6420002
Cluj-Napoca, 400001, Romania
Investigational Site Number 6420003
Cluj-Napoca, 400347, Romania
Investigational Site Number 6420016
Craiova, 200642, Romania
Investigational Site Number 6420005
Oradea, 410169, Romania
Investigational Site Number 6420004
Oradea, 410469, Romania
Investigational Site Number 6420018
Satu Mare, 440156, Romania
Investigational Site Number 6420001
Târgu Mureş, 540103, Romania
Investigational Site Number 6420012
Tg-Mures, 540136, Romania
Investigational Site Number 6420009
Timișoara, 300079, Romania
Investigational Site Number 6420010
Timișoara, 300723, Romania
Investigational Site Number 6430026
Ivanovo, 153012, Russia
Investigational Site Number 6430023
Kazan', 420087, Russia
Investigational Site Number 6430002
Kemerovo, 650002, Russia
Investigational Site Number 6430006
Kemerovo, 650002, Russia
Investigational Site Number 6430005
Moscow, 109240, Russia
Investigational Site Number 6430004
Moscow, 111539, Russia
Investigational Site Number 6430022
Moscow, 117292, Russia
Investigational Site Number 6430024
Moscow, 119192, Russia
Investigational Site Number 6430001
Moscow, 121552, Russia
Investigational Site Number 6430003
Moscow, 121552, Russia
Investigational Site Number 6430010
Moscow, 121552, Russia
Investigational Site Number 6430018
Nizhny Novgorod, 603005, Russia
Investigational Site Number 6430013
Rostov-on-Don, 344068, Russia
Investigational Site Number 6430025
Saint Petersburg, 193312, Russia
Investigational Site Number 6430007
Saint Petersburg, 195067, Russia
Investigational Site Number 6430012
Saint Petersburg, 197341, Russia
Investigational Site Number 6430011
Saint Petersburg, 198205, Russia
Investigational Site Number 6430009
Saint Petersburg, 199106, Russia
Investigational Site Number 6430017
Sochi, 354057, Russia
Investigational Site Number 6430016
Tomsk, 634012, Russia
Investigational Site Number 7030001
Bratislava, 813 69, Slovakia
Investigational Site Number 7030004
Bratislava, 833 48, Slovakia
Investigational Site Number 7030003
Bratislava 3 - Kramare, 833 05, Slovakia
Investigational Site Number 7030010
Brezno, 97742, Slovakia
Investigational Site Number 7030009
Dolný Kubín, 02614, Slovakia
Investigational Site Number 7030002
Košice, 040 01, Slovakia
Investigational Site Number 7030011
Nitra, 950 01, Slovakia
Investigational Site Number 7030008
Trnava, 91775, Slovakia
Investigational Site Number 4100008
Bucheon-si, 14754, South Korea
Investigational Site Number 4100010
Busan, 49267, South Korea
Investigational Site Number 4100004
Daegu, 42472, South Korea
Investigational Site Number 4100001
Hwaseong-si, 18450, South Korea
Investigational Site Number 4100003
Incheon, 22332, South Korea
Investigational Site Number 4100005
Seongnam-si, 13620, South Korea
Investigational Site Number 4100002
Seoul, 03080, South Korea
Investigational Site Number 4100007
Seoul, 03722, South Korea
Investigational Site Number 4100011
Seoul, 05030, South Korea
Investigational Site Number 4100009
Seoul, 06351, South Korea
Investigational Site Number 7240006
A Coruña, 15006, Spain
Investigational Site Number 7240016
Alicante, 03010, Spain
Investigational Site Number 7240015
Badalona, 08916, Spain
Investigational Site Number 7240020
L'Hospitalet de Llobregat, 08907, Spain
Investigational Site Number 7240005
Las Palmas de Gran Canaria, 35020, Spain
Investigational Site Number 7240021
Madrid, 28031, Spain
Investigational Site Number 7240008
Madrid, 28040, Spain
Investigational Site Number 7240022
Manises, 46940, Spain
Investigational Site Number 7240004
Málaga, 29010, Spain
Investigational Site Number 7240007
Murcia, 30120, Spain
Investigational Site Number 7240014
Olot, 17800, Spain
Investigational Site Number 7240009
San Sebastián de los Reyes, 28702, Spain
Investigational Site Number 7240003
Sanlúcar de Barrameda, 11540, Spain
Investigational Site Number 7240001
Seville, 41014, Spain
Investigational Site Number 7240019
Seville, 41071, Spain
Investigational Site Number 7240018
Úbeda, 23400, Spain
Investigational Site Number 7240012
Valencia, 46010, Spain
Investigational Site Number 7240011
Valencia, 46014, Spain
Investigational Site Number 7240010
Valencia, 46026, Spain
Investigational Site Number 7240002
Villamartín, 11650, Spain
Investigational Site Number 7240013
Zaragoza, 50009, Spain
Investigational Site Number 7520004
Jönköping, 551 85, Sweden
Investigational Site Number 7520002
Malmo, 205 02, Sweden
Investigational Site Number 7520006
Skellefteå, 931 86, Sweden
Investigational Site Number 7520007
Stockholm, 118 83, Sweden
Investigational Site Number 7520008
Stockholm, 14186, Sweden
Investigational Site Number 7520001
Stockholm, 171 76, Sweden
Investigational Site Number 7560001
Basel, 4031, Switzerland
Investigational Site Number 7560003
Lugano, 6900, Switzerland
Investigational Site Number 7920008
Antalya, 07059, Turkey (Türkiye)
Investigational Site Number 7920006
Çorum, 19200, Turkey (Türkiye)
Investigational Site Number 7920005
Eskişehir, 26480, Turkey (Türkiye)
Investigational Site Number 7920002
Haseki/ Istanbul, 34034, Turkey (Türkiye)
Investigational Site Number 7920011
Istanbul, 34098, Turkey (Türkiye)
Investigational Site Number 7920012
Izmir, 35340, Turkey (Türkiye)
Investigational Site Number 7920003
Kocaeli, 41300, Turkey (Türkiye)
Investigational Site Number 7920004
Mersin, 33169, Turkey (Türkiye)
Investigational Site Number 7920001
Sivas, 58140, Turkey (Türkiye)
Investigational Site Number 7920010
Trabzon, 61040, Turkey (Türkiye)
Investigational Site Number 8260005
Bournemouth, BH7 7DW, United Kingdom
Investigational Site Number 8260010
Bristol, BS10 5NB, United Kingdom
Investigational Site Number 8260008
Chelmsford, CM1 7ET, United Kingdom
Investigational Site Number 8260009
Hull, HU16 5JQ, United Kingdom
Investigational Site Number 8260002
Newcastle, NE1 4LP, United Kingdom
Investigational Site Number 8260001
Oldham, OL1 2JH, United Kingdom
Investigational Site Number 8260003
Swansea, SA6 6NL, United Kingdom
Investigational Site Number 8260006
Swindon, SN3 6BB, United Kingdom
Investigational Site Number 8260004
Torquay, TQ2 7AA, United Kingdom
Investigational Site Number 8260007
York, YO31 8HE, United Kingdom
Related Publications (6)
Bhatt AS, Bhatt DL, Steg PG, Szarek M, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Testani JM, Wilcox CS, Davies M, Pitt B, Kosiborod MN. Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF. J Am Coll Cardiol. 2024 Sep 17;84(12):1078-1088. doi: 10.1016/j.jacc.2024.06.036.
PMID: 39260929DERIVEDWeintraub WS, Kolm P, Dolman S, Alva M, Bhatt DL, Zhang Z. Cost-Effectiveness of Sotagliflozin in SOLOIST-WHF. JACC Heart Fail. 2024 Sep;12(9):1600-1610. doi: 10.1016/j.jchf.2024.04.018. Epub 2024 Jun 12.
PMID: 38878007DERIVEDKim J, Wang S, Sikirica S, Shafrin J. Cost-effectiveness of sotagliflozin for the treatment of patients with diabetes and recent worsening heart failure. J Comp Eff Res. 2024 Jun;13(6):e230190. doi: 10.57264/cer-2023-0190. Epub 2024 May 21.
PMID: 38771012DERIVEDNatale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PMID: 38770818DERIVEDSzarek 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.
PMID: 34152828DERIVEDBhatt 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.
PMID: 33200892DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations of the trial such as small numbers of participants analyzed or technical problems leading to unreliable data. The study was terminated prematurely due to business decision.
Results Point of Contact
- Title
- Medical Affairs
- Organization
- Lexicon Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Suman Wason, MD
Lexicon Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2018
First Posted
May 11, 2018
Study Start
June 15, 2018
Primary Completion
June 5, 2020
Study Completion
June 5, 2020
Last Updated
October 28, 2022
Results First Posted
October 28, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
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.