AzTrials
AzTrials

Heart FailurePhase 3NCT03521934

Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

A Phase 3 study testing Sotagliflozin in people with Heart Failure and Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 466 sites in 32 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Heart Failure, Type 2 Diabetes Mellitus
What is being tested?
Sotagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,222 participants
Where
466 sitesin 32 countries
Study dates
15 Jun 2018to 5 Jun 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

466 sites in 32 countries.

466 sites in 32 countries

United States94 sites

  • Investigational Site Number 8400131

    Albuquerque, New Mexico, 87131

  • Investigational Site Number 8400128

    Alexander City, Alabama, 35010

  • Investigational Site Number 8400065

    Annapolis, Maryland, 21401

  • Investigational Site Number 8400054

    Arlington, Oregon, 19001

  • Investigational Site Number 8400067

    Arlington Heights, Illinois, 60005

  • Investigational Site Number 8400073

    Atlanta, Georgia, 30322-1020

  • Investigational Site Number 8400075

    Bakersfield, California, 93309

  • Investigational Site Number 8400012

    Boston, Massachusetts, 02118

  • Investigational Site Number 8400029

    Bridgeport, Connecticut, 06606

  • Investigational Site Number 8400051

    Brooklyn, New York, 11203

  • Investigational Site Number 8400041

    Brownsville, Texas, 78521

  • Investigational Site Number 8400111

    Buffalo, New York, 14215

  • Investigational Site Number 8400001

    Cambridge, Massachusetts, 02135

  • Investigational Site Number 8400059

    Charleston, South Carolina, 29425

  • Investigational Site Number 8400043

    Chicago, Illinois, 60637

  • Investigational Site Number 8400087

    Cincinnati, Ohio, 45220

  • Investigational Site Number 8400047

    Cincinnati, Ohio, 45267

  • Investigational Site Number 8400126

    Clarksburg, West Virginia, 26301

  • Investigational Site Number 8400019

    Columbia, Missouri, 65201

  • Investigational Site Number 8400092

    Columbia, South Carolina, 29203

  • Investigational Site Number 8400109

    Cottonwood, Arizona, 86326

  • Investigational Site Number 8400030

    Covington, Louisiana, 70433

  • Investigational Site Number 8400074

    Dallas, Texas, 75226

  • Investigational Site Number 8400046

    DeLand, Florida, 32720

  • Investigational Site Number 8400077

    Detroit, Michigan, 48202

  • Investigational Site Number 8400134

    Doylestown, Pennsylvania, 18901

  • Investigational Site Number 8400107

    Duluth, Minnesota, 55805

  • Investigational Site Number 8400072

    Elk Grove Village, Illinois, 60007

  • Investigational Site Number 8400069

    Fresno, California, 93701

  • Investigational Site Number 8400009

    Gainesville, Florida, 32608

  • Investigational Site Number 8400132

    Grand Island, Nebraska, 68803

  • Investigational Site Number 8400045

    Greensboro, North Carolina, 27401

  • Investigational Site Number 8400104

    Greenville, South Carolina, 29605

  • Investigational Site Number 8400088

    Greenville, Tennessee, 30000

  • Investigational Site Number 8400079

    Homestead, Florida, 33033

  • Investigational Site Number 8400016

    Houston, Texas, 77030

  • Investigational Site Number 8400055

    Indianapolis, Indiana, 46060

  • Investigational Site Number 8400056

    Jackson, Mississippi, 39216

  • Investigational Site Number 8400031

    Jacksonville, Florida, 32207

  • Investigational Site Number 8400022

    Jacksonville, Florida, 32216

  • Investigational Site Number 8400062

    Kalamazoo, Michigan, 49009

  • Investigational Site Number 8400017

    Kalamazoo, Michigan, 49048

  • Investigational Site Number 8400098

    Lake Mary, Florida, 32746

  • Investigational Site Number 8400103

    Lee's Summit, Missouri, 64064

  • Investigational Site Number 8400130

    Lincoln, Nebraska, 68506

  • Investigational Site Number 8400032

    Little Rock, Arkansas, 72205

  • Investigational Site Number 8400080

    Little Rock, Arkansas, 72205

  • Investigational Site Number 8400008

    Los Angeles, California, 90024

  • Investigational Site Number 8400063

    Los Angeles, California, 90073

  • Investigational Site Number 8400093

    Manassas, Virginia, 20109

  • Investigational Site Number 8400048

    Manitowoc, Wisconsin, 54220

  • Investigational Site Number 8400095

    Maumee, Ohio, 43537

  • Investigational Site Number 8400123

    McKinney, Texas, 75071

  • Investigational Site Number 8400089

    Memphis, Tennessee, 38104

  • Investigational Site Number 8400058

    Miami Beach, Florida, 33140

  • Investigational Site Number 8400038

    Morgantown, West Virginia, 26506

  • Investigational Site Number 8400020

    Muncie, Indiana, 47303-3400

  • Investigational Site Number 8400053

    Nashville, Tennessee, 37212

  • Investigational Site Number 8400127

    National City, California, 91950

  • Investigational Site Number 8400044

    Natrona Heights, Pennsylvania, 15065

  • Investigational Site Number 8400101

    New Braunfels, Texas, 78130

  • Investigational Site Number 8400037

    New Haven, Connecticut, 06519

  • Investigational Site Number 8400083

    Omaha, Nebraska, 68124

  • Investigational Site Number 8400071

    Omaha, Nebraska, 68198

  • Investigational Site Number 8400105

    Orlando, Florida, 32806

  • Investigational Site Number 8400082

    Pensacola, Florida, 32504

  • Investigational Site Number 8400115

    Philadelphia, Pennsylvania, 19104

  • Investigational Site Number 8400057

    Port Charlotte, Florida, 33952

  • Investigational Site Number 8400114

    Providence, Rhode Island, 02903

  • Investigational Site Number 8400085

    Raleigh, North Carolina, 27610

  • Investigational Site Number 8400040

    Rapid City, South Dakota, 57701

  • Investigational Site Number 8400007

    Redondo Beach, California, 90277

  • Investigational Site Number 8400122

    Richmond, Indiana, 47374

  • Investigational Site Number 8400003

    Richmond, Virginia, 23249-0001

  • Investigational Site Number 8400015

    Ridgewood, New Jersey, 07450-2736

  • Investigational Site Number 8400006

    Sarasota, Florida, 34239

  • Investigational Site Number 8400039

    Sayre, Pennsylvania, 18840

  • Investigational Site Number 8400036

    Stockton, California, 95204

  • Investigational Site Number 8400033

    Sylmar, California, 91342

  • Investigational Site Number 8400035

    Tampa, Florida, 33609

  • Investigational Site Number 8400042

    Tampa, Florida, 33612

  • Investigational Site Number 8400097

    The Bronx, New York, 10457

  • Investigational Site Number 8400061

    The Bronx, New York, 10468-3904

  • Investigational Site Number 8400099

    Toledo, Ohio, 43699

  • Investigational Site Number 8400049

    Torrance, California, 90502

  • Investigational Site Number 8400118

    Tucker, Georgia, 30084

  • Investigational Site Number 8400066

    Victoria, Texas, 77901

  • Investigational Site Number 8400050

    Voorhees Township, New Jersey, 08043

  • Investigational Site Number 8400028

    Walnut Creek, California, 94598

  • Investigational Site Number 8400100

    Warwick, Rhode Island, 02886

  • Investigational Site Number 8400091

    Waterloo, Iowa, 50702

  • Investigational Site Number 8400004

    Wellington, Florida, 33449

  • Investigational Site Number 8400078

    Winston-Salem, North Carolina, 27157

  • Investigational Site Number 8400121

    Zanesville, Ohio, 43701

Other trials in United States

Germany29 sites

  • Investigational Site Number 2760020

    Bad Nauheim, 61231

  • Investigational Site Number 2760016

    Bad Oeynhausen, 32545

  • Investigational Site Number 2760013

    Berlin, 12203

  • Investigational Site Number 2760019

    Berlin, 13347

  • Investigational Site Number 2760001

    Berlin, 13353

  • Investigational Site Number 2760002

    Berlin, 13353

  • Investigational Site Number 2760025

    Bielefeld, 33604

  • Investigational Site Number 2760005

    Bonn, 53115

  • Investigational Site Number 2760021

    Bremen, 28277

  • Investigational Site Number 2760035

    Coburg, 96450

  • Investigational Site Number 2760027

    Cologne, 50733

  • Investigational Site Number 2760032

    Dortmund, 44137

  • Investigational Site Number 2760006

    Dortmund, 44379

  • Investigational Site Number 2760029

    Erfurt, 99097

  • Investigational Site Number 2760018

    Essen, 45138

  • Investigational Site Number 2760033

    Frankfurt am Main, 65929

  • Investigational Site Number 2760009

    Greifswald, 17475

  • Investigational Site Number 2760022

    Heidelberg, 69115

  • Investigational Site Number 2760031

    Heidelberg, 69120

  • Investigational Site Number 2760034

    Lahr, 77933

  • Investigational Site Number 2760030

    Langen, 63225

  • Investigational Site Number 2760014

    Leverkusen, 51375

  • Investigational Site Number 2760036

    Limburg, 65549

  • Investigational Site Number 2760012

    Ludwigshafen, 67063

  • Investigational Site Number 2760028

    Merseburg, 06217

  • Investigational Site Number 2760011

    Rotenburg an der Fulda, 36199

  • Investigational Site Number 2760015

    Rüsselsheim am Main, 65428

  • Investigational Site Number 2760007

    Witten, 58455

  • Investigational Site Number 2760026

    Würzburg, 97080

Other trials in Germany

Argentina28 sites

  • Investigational Site Number 0320031

    Caba, 1430

  • Investigational Site Number 0320009

    Caba, C1093AAS

  • Investigational Site Number 0320016

    Capital Federal, 1405

  • Investigational Site Number 0320002

    Ciudad de Buenos Aires, C1428DCO

  • Investigational Site Number 0320024

    Córdoba, 5000

  • Investigational Site Number 0320011

    Córdoba, X5000AAX

  • Investigational Site Number 0320003

    Córdoba, X5000JHQ

  • Investigational Site Number 0320010

    Córdoba, X5004BAL

  • Investigational Site Number 0320025

    Córdoba, X5006IKK

  • Investigational Site Number 0320022

    Corrientes, 3400

  • Investigational Site Number 0320001

    Corrientes, W3400AMZ

  • Investigational Site Number 0320029

    La Plata, B1900AXI

  • Investigational Site Number 0320007

    La Plata, B1906ESC

  • Investigational Site Number 0320006

    Merlo, B1722COV

  • Investigational Site Number 0320005

    Morón, B1708CGU

  • Investigational Site Number 0320012

    Olivos, 1638

  • Investigational Site Number 0320023

    Quilmes, 1878

  • Investigational Site Number 0320018

    Rosario, 2000

  • Investigational Site Number 0320013

    Rosario, S2000DSR

  • Investigational Site Number 0320008

    Salta, 4400

  • Investigational Site Number 0320020

    San Martin, B1685CSQ

  • Investigational Site Number 0320028

    San Miguel de Tucumán, T4000IFL

  • Investigational Site Number 0320030

    San Miguel de Tucumán, T4000JCU

  • Investigational Site Number 0320019

    San Miguel de Tucumán, T4000NIL

  • Investigational Site Number 0320017

    Santa Fe, S3000EOZ

  • Investigational Site Number 0320015

    Santa Fe, S3000FWO

  • Investigational Site Number 0320004

    Villa Belgrano, X5021FPQ

  • Investigational Site Number 0320014

    Villa María, X5900JKA

Other trials in Argentina

Italy21 sites

  • Investigational Site Number 3800006

    Arzignano (Vi), 36071

  • Investigational Site Number 3800011

    Brescia, 25123

  • Investigational Site Number 3800017

    Brescia, 25124

  • Investigational Site Number 3800005

    Cortona, 52044

  • Investigational Site Number 3800009

    Ferrara, 44124

  • Investigational Site Number 3800020

    Gallipoli, 73014

  • Investigational Site Number 3800003

    Legnago, 37045

  • Investigational Site Number 3800023

    Milan, 20122

  • Investigational Site Number 3800002

    Milan, 20138

  • Investigational Site Number 3800012

    Milan, 20138

  • Investigational Site Number 3800008

    Milan, 20162

  • Investigational Site Number 3800013

    Monza, 20052

  • Investigational Site Number 3800022

    Naples, 80131

  • Investigational Site Number 3800018

    Pavia, 27100

  • Investigational Site Number 3800004

    Perugia, 06132

  • Investigational Site Number 3800016

    Pozzilli, 86077

  • Investigational Site Number 3800014

    Rimini, 47900

  • Investigational Site Number 3800010

    Roma, 00153

  • Investigational Site Number 3800021

    Roma, 00189

  • Investigational Site Number 3800019

    Scorrano, 73020

  • Investigational Site Number 3800007

    Udine, 33100

Other trials in Italy

Spain21 sites

  • Investigational Site Number 7240006

    A Coruña, 15006

  • Investigational Site Number 7240016

    Alicante, 03010

  • Investigational Site Number 7240015

    Badalona, 08916

  • Investigational Site Number 7240020

    L'Hospitalet de Llobregat, 08907

  • Investigational Site Number 7240005

    Las Palmas de Gran Canaria, 35020

  • Investigational Site Number 7240021

    Madrid, 28031

  • Investigational Site Number 7240008

    Madrid, 28040

  • Investigational Site Number 7240004

    Málaga, 29010

  • Investigational Site Number 7240022

    Manises, 46940

  • Investigational Site Number 7240007

    Murcia, 30120

  • Investigational Site Number 7240014

    Olot, 17800

  • Investigational Site Number 7240009

    San Sebastián de los Reyes, 28702

  • Investigational Site Number 7240003

    Sanlúcar de Barrameda, 11540

  • Investigational Site Number 7240001

    Seville, 41014

  • Investigational Site Number 7240019

    Seville, 41071

  • Investigational Site Number 7240018

    Úbeda, 23400

  • Investigational Site Number 7240012

    Valencia, 46010

  • Investigational Site Number 7240011

    Valencia, 46014

  • Investigational Site Number 7240010

    Valencia, 46026

  • Investigational Site Number 7240002

    Villamartín, 11650

  • Investigational Site Number 7240013

    Zaragoza, 50009

Other trials in Spain

Russia20 sites

  • Investigational Site Number 6430026

    Ivanovo, 153012

  • Investigational Site Number 6430023

    Kazan', 420087

  • Investigational Site Number 6430002

    Kemerovo, 650002

  • Investigational Site Number 6430006

    Kemerovo, 650002

  • Investigational Site Number 6430005

    Moscow, 109240

  • Investigational Site Number 6430004

    Moscow, 111539

  • Investigational Site Number 6430022

    Moscow, 117292

  • Investigational Site Number 6430024

    Moscow, 119192

  • Investigational Site Number 6430001

    Moscow, 121552

  • Investigational Site Number 6430003

    Moscow, 121552

  • Investigational Site Number 6430010

    Moscow, 121552

  • Investigational Site Number 6430018

    Nizhny Novgorod, 603005

  • Investigational Site Number 6430013

    Rostov-on-Don, 344068

  • Investigational Site Number 6430025

    Saint Petersburg, 193312

  • Investigational Site Number 6430007

    Saint Petersburg, 195067

  • Investigational Site Number 6430012

    Saint Petersburg, 197341

  • Investigational Site Number 6430011

    Saint Petersburg, 198205

  • Investigational Site Number 6430009

    Saint Petersburg, 199106

  • Investigational Site Number 6430017

    Sochi, 354057

  • Investigational Site Number 6430016

    Tomsk, 634012

Other trials in Russia

Brazil19 sites

  • Investigational Site Number 0760009

    Belo Horizonte, 30110-908

  • Investigational Site Number 0760024

    Belo Horizonte, 30150-221

  • Investigational Site Number 0760002

    Blumenau, 89020-430

  • Investigational Site Number 0760011

    Brasília, 70390-903

  • Investigational Site Number 0760005

    Campinas, 13060-080

  • Investigational Site Number 0760006

    Campinas, 13092-111

  • Investigational Site Number 0760023

    Fortaleza, 60840-285

  • Investigational Site Number 0760018

    Goiânia, 74210050

  • Investigational Site Number 0760010

    Passo Fundo, 99010-180

  • Investigational Site Number 0760003

    Porto Alegre, 90020-090

  • Investigational Site Number 0760020

    Porto Alegre, 90035 003

  • Investigational Site Number 0760021

    Porto Alegre, 90610-000

  • Investigational Site Number 0760007

    Porto Alegre, 90620-001

  • Investigational Site Number 0760013

    Porto Alegre, 91350-250

  • Investigational Site Number 0760004

    Recife, 52051-380

  • Investigational Site Number 0760001

    São José do Rio Preto, 15090-000

  • Investigational Site Number 0760012

    São Paulo, 04012-909

  • Investigational Site Number 0760008

    São Paulo, 05403-000

  • Investigational Site Number 0760017

    Votuporanga, 15500-003

Other trials in Brazil

Hungary19 sites

  • Investigational Site Number 3480018

    Berettyóújfalu, 4100

  • Investigational Site Number 3480012

    Budapest, 1023

  • Investigational Site Number 3480016

    Budapest, 1085

  • Investigational Site Number 3480010

    Budapest, 1096

  • Investigational Site Number 3480019

    Budapest, 1115

  • Investigational Site Number 3480001

    Budapest, 1122

  • Investigational Site Number 3480015

    Budapest, 1125

  • Investigational Site Number 3480011

    Budapest, 1134

  • Investigational Site Number 3480014

    Budapest, 1145

  • Investigational Site Number 3480005

    Budapest, 1204

  • Investigational Site Number 3480007

    Debrecen, 4032

  • Investigational Site Number 3480002

    Dombóvár, 7200

  • Investigational Site Number 3480017

    Gyula, 5700

  • Investigational Site Number 3480008

    Hódmezövásárhely, 6800

  • Investigational Site Number 3480020

    Kistarcsa, 2143

  • Investigational Site Number 3480009

    Komárom, 2921

  • Investigational Site Number 3480013

    Pécs, 7624

  • Investigational Site Number 3480003

    Székesfehérvár, 8000

  • Investigational Site Number 3480006

    Zalaegerszeg, 8900

Other trials in Hungary

Poland19 sites

  • Investigational Site Number 6160007

    Bialystok, 15-276

  • Investigational Site Number 6160017

    Gdansk, 80-462

  • Investigational Site Number 6160002

    Grodzisk Mazowiecki, 05-825

  • Investigational Site Number 6160014

    Katowice, 40-635

  • Investigational Site Number 6160021

    Krakow, 30-693

  • Investigational Site Number 6160001

    Krakow, 31 -202

  • Investigational Site Number 6160003

    Krakow, 31-501

  • Investigational Site Number 6160012

    Krakow

  • Investigational Site Number 6160011

    Łęczna, 21-010

  • Investigational Site Number 6160016

    Lubin, 59-301

  • Investigational Site Number 6160005

    Miechów, 32-200

  • Investigational Site Number 6160022

    Poznan, 61-848

  • Investigational Site Number 6160006

    Torun, 87-100

  • Investigational Site Number 6160013

    Warsaw, 00-685

  • Investigational Site Number 6160004

    Warsaw, 03-242

  • Investigational Site Number 6160020

    Warsaw, 04-073

  • Investigational Site Number 6160024

    Warsaw, 04-349

  • Investigational Site Number 6160008

    Warsaw, 04-628

  • Investigational Site Number 6160015

    Zamość, 22-400

Other trials in Poland

Romania18 sites

  • Investigational Site Number 6420014

    Arad, 310037

  • Investigational Site Number 6420006

    Baia Mare, 430031

  • Investigational Site Number 6420015

    Brăila, 810325

  • Investigational Site Number 6420013

    Bucharest, 010825

  • Investigational Site Number 6420019

    Bucharest, 014461

  • Investigational Site Number 6420011

    Bucharest, 020125

  • Investigational Site Number 6420008

    Bucharest, 022322

  • Investigational Site Number 6420007

    Bucharest, 050659

  • Investigational Site Number 6420002

    Cluj-Napoca, 400001

  • Investigational Site Number 6420003

    Cluj-Napoca, 400347

  • Investigational Site Number 6420016

    Craiova, 200642

  • Investigational Site Number 6420005

    Oradea, 410169

  • Investigational Site Number 6420004

    Oradea, 410469

  • Investigational Site Number 6420018

    Satu Mare, 440156

  • Investigational Site Number 6420001

    Târgu Mureş, 540103

  • Investigational Site Number 6420012

    Tg-Mures, 540136

  • Investigational Site Number 6420009

    Timișoara, 300079

  • Investigational Site Number 6420010

    Timișoara, 300723

Other trials in Romania

Czechia14 sites

  • Investigational Site Number 2030001

    Brno, 62500

  • Investigational Site Number 2030003

    Brno, 63600

  • Investigational Site Number 2030004

    Brno, 65691

  • Investigational Site Number 2030014

    Kolín, 28002

  • Investigational Site Number 2030010

    Kroměříž, 76701

  • Investigational Site Number 2030005

    Liberec, 46063

  • Investigational Site Number 2030013

    Městec Králové, 28903

  • Investigational Site Number 2030018

    Prague, 10100

  • Investigational Site Number 2030002

    Prague, 12808

  • Investigational Site Number 2030017

    Prague, 15030

  • Investigational Site Number 2030007

    Praha 5 - Motol, 15006

  • Investigational Site Number 2030011

    Přerov, 75152

  • Investigational Site Number 2030015

    Pribram I, 26101

  • Investigational Site Number 2030006

    Slaný, 27401

Other trials in Czechia

Canada13 sites

  • Investigational Site Number 1240013

    Cambridge, N1R 6V6

  • Investigational Site Number 1240006

    Granby, J2G 1T7

  • Investigational Site Number 1240015

    Halifax, B3H 3A7

  • Investigational Site Number 1240002

    Montreal, H1T 1C8

  • Investigational Site Number 1240019

    Montreal, H3G 1A4

  • Investigational Site Number 1240018

    Montreal, H4A 3J1

  • Investigational Site Number 1240004

    Peterborough, K9J 0B2

  • Investigational Site Number 1240014

    Québec, G1V 4G5

  • Investigational Site Number 1240007

    Scarborough, M1B 4Z8

  • Investigational Site Number 1240005

    Sherbrooke, J1G 2E8

  • Investigational Site Number 1240011

    Toronto, M5B 1W8

  • Investigational Site Number 1240001

    Toronto, M5G 2C4

  • Investigational Site Number 1240009

    Trois-Rivières, G9A 5C5

Other trials in Canada

Israel12 sites

  • Investigational Site Number 3760013

    Ashkelon, 78278

  • Investigational Site Number 3760004

    Hadera, 38100

  • Investigational Site Number 3760005

    Haifa, 31096

  • Investigational Site Number 3760006

    Jerusalem, 91031

  • Investigational Site Number 3760003

    Jerusalem, 91120

  • Investigational Site Number 3760008

    Jerusalem

  • Investigational Site Number 3760010

    Nahariya, 22100

  • Investigational Site Number 3760002

    Petah Tikva, 49100

  • Investigational Site Number 3760011

    Rehovot, 76100

  • Investigational Site Number 3760009

    Safed, 13100

  • Investigational Site Number 3760001

    Tel Aviv, 64239

  • Investigational Site Number 3760012

    Tiberias, 15208

Other trials in Israel

Chile11 sites

  • Investigational Site Number 1520009

    Concepción

  • Investigational Site Number 1520011

    Santiago, 80004005

  • Investigational Site Number 1520006

    Santiago, 8053095

  • Investigational Site Number 1520003

    Santiago, 8380456

  • Investigational Site Number 1520004

    Santiago

  • Investigational Site Number 1520005

    Santiago

  • Investigational Site Number 1520012

    Santiago

  • Investigational Site Number 1520013

    Santiago

  • Investigational Site Number 1520002

    Temuco

  • Investigational Site Number 1520001

    Viña del Mar

  • Investigational Site Number 1520010

    Viña del Mar

Other trials in Chile

France11 sites

  • Investigational Site Number 2500009

    Chambray-lès-Tours, 37170

  • Investigational Site Number 2500008

    La Tronche, 38700

  • Investigational Site Number 2500004

    Le Chesnay, 78150

  • Investigational Site Number 2500002

    Le Coudray, 28360

  • Investigational Site Number 2500001

    Lille, 59037

  • Investigational Site Number 2500007

    Nantes, 44093

  • Investigational Site Number 2500012

    Nice, 06002

  • Investigational Site Number 2500006

    Paris, 75015

  • Investigational Site Number 2500003

    Paris, 75877

  • Investigational Site Number 2500005

    Toulouse, 31059

  • Investigational Site Number 2500013

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Greece10 sites

  • Investigational Site Number 3000012

    Athens, 11526

  • Investigational Site Number 3000004

    Athens, 11527

  • Investigational Site Number 3000002

    Chalcis, 34 100

  • Investigational Site Number 3000009

    Elefsina, 19600

  • Investigational Site Number 3000003

    Haidari, 12462

  • Investigational Site Number 3000005

    Heraklion, 71110

  • Investigational Site Number 3000007

    Ioannina, 455 00

  • Investigational Site Number 3000006

    Larissa, 41110

  • Investigational Site Number 3000001

    N. Ionia, 14233

  • Investigational Site Number 3000008

    Thessaloniki, 546 36

Other trials in Greece

Portugal10 sites

  • Investigational Site Number 6200012

    Braga, 4710-243

  • Investigational Site Number 6200001

    Coimbra, 3000-075

  • Investigational Site Number 6200011

    Guilhufe - Penafiel, 4564-007

  • Investigational Site Number 6200004

    Guimarães, 4810-061

  • Investigational Site Number 6200006

    Lisbon, 1449-005

  • Investigational Site Number 6200002

    Lisbon, 1500-650

  • Investigational Site Number 6200008

    Porto, 4099-001

  • Investigational Site Number 6200007

    Vila Franca de Xira, 2600-009

  • Investigational Site Number 6200003

    Vila Nova Gaia, 4434-502

  • Investigational Site Number 6200005

    Vila Real, 5000-508

Other trials in Portugal

South Korea10 sites

  • Investigational Site Number 4100008

    Bucheon-si, 14754

  • Investigational Site Number 4100010

    Busan, 49267

  • Investigational Site Number 4100004

    Daegu, 42472

  • Investigational Site Number 4100001

    Hwaseong-si, 18450

  • Investigational Site Number 4100003

    Incheon, 22332

  • Investigational Site Number 4100005

    Seongnam-si, 13620

  • Investigational Site Number 4100002

    Seoul, 03080

  • Investigational Site Number 4100007

    Seoul, 03722

  • Investigational Site Number 4100011

    Seoul, 05030

  • Investigational Site Number 4100009

    Seoul, 06351

Other trials in South Korea

Turkey (Türkiye)10 sites

  • Investigational Site Number 7920008

    Antalya, 07059

  • Investigational Site Number 7920006

    Çorum, 19200

  • Investigational Site Number 7920005

    Eskişehir, 26480

  • Investigational Site Number 7920002

    Haseki/ Istanbul, 34034

  • Investigational Site Number 7920011

    Istanbul, 34098

  • Investigational Site Number 7920012

    Izmir, 35340

  • Investigational Site Number 7920003

    Kocaeli, 41300

  • Investigational Site Number 7920004

    Mersin, 33169

  • Investigational Site Number 7920001

    Sivas, 58140

  • Investigational Site Number 7920010

    Trabzon, 61040

Other trials in Turkey (Türkiye)

United Kingdom10 sites

  • Investigational Site Number 8260005

    Bournemouth, BH7 7DW

  • Investigational Site Number 8260010

    Bristol, BS10 5NB

  • Investigational Site Number 8260008

    Chelmsford, CM1 7ET

  • Investigational Site Number 8260009

    Hull, HU16 5JQ

  • Investigational Site Number 8260002

    Newcastle, NE1 4LP

  • Investigational Site Number 8260001

    Oldham, OL1 2JH

  • Investigational Site Number 8260003

    Swansea, SA6 6NL

  • Investigational Site Number 8260006

    Swindon, SN3 6BB

  • Investigational Site Number 8260004

    Torquay, TQ2 7AA

  • Investigational Site Number 8260007

    York, YO31 8HE

Other trials in United Kingdom

Belgium8 sites

  • Investigational Site Number 0560002

    Aalst, 9300

  • Investigational Site Number 0560007

    Ghent, 9000

  • Investigational Site Number 0560004

    Kortrijk, 8500

  • Investigational Site Number 0560001

    Leuven, 3000

  • Investigational Site Number 0560003

    Liège, 4000

  • Investigational Site Number 0560005

    Mol, 2400

  • Investigational Site Number 0560006

    Mons, 7000

  • Investigational Site Number 0560008

    Roeselare, 8800

Other trials in Belgium

Netherlands8 sites

  • Investigational Site Number 5280004

    's-Hertogenbosch, 5223 GZ 's

  • Investigational Site Number 5280003

    Amsterdam, 1034 CS

  • Investigational Site Number 5280001

    Breda, 4819 EV

  • Investigational Site Number 5280007

    Delft, 2625 AD

  • Investigational Site Number 5280002

    Doetinchem, 7009 BL

  • Investigational Site Number 5280006

    Rotterdam, 3045 PM

  • Investigational Site Number 5280008

    Sneek, 8601

  • Investigational Site Number 5280005

    Veldhoven, 5504 DB

Other trials in Netherlands

Slovakia8 sites

  • Investigational Site Number 7030001

    Bratislava, 813 69

  • Investigational Site Number 7030004

    Bratislava, 833 48

  • Investigational Site Number 7030003

    Bratislava 3 - Kramare, 833 05

  • Investigational Site Number 7030010

    Brezno, 97742

  • Investigational Site Number 7030009

    Dolný Kubín, 02614

  • Investigational Site Number 7030002

    Košice, 040 01

  • Investigational Site Number 7030011

    Nitra, 950 01

  • Investigational Site Number 7030008

    Trnava, 91775

Other trials in Slovakia

Austria7 sites

  • Investigational Site Number 0400006

    Braunau am Inn, 5280

  • Investigational Site Number 0400002

    Feldkirch, 6800

  • Investigational Site Number 0400007

    Graz, 8036

  • Investigational Site Number 0400005

    Linz, 4010

  • Investigational Site Number 0400004

    Salzburg, 5020

  • Investigational Site Number 0400003

    Vienna, 1090

  • Investigational Site Number 0400001

    Vienna, 1160

Other trials in Austria

Lithuania6 sites

  • Investigational Site Number 4400002

    Kaunas, 50161

  • Investigational Site Number 4400005

    Kaunas, 50161

  • Investigational Site Number 4400004

    Klaipėda, LT-92288

  • Investigational Site Number 4400006

    Šiauliai, LT-76231

  • Investigational Site Number 4400001

    Vilnius, 08661

  • Investigational Site Number 4400003

    Vilnius, 08661

Other trials in Lithuania

New Zealand6 sites

  • Investigational Site Number 5540007

    Auckland, 1023

  • Investigational Site Number 5540006

    Christchurch, 8011

  • Investigational Site Number 5540002

    Hamilton, 3204

  • Investigational Site Number 5540004

    Lower Hutt

  • Investigational Site Number 5540005

    New Plymouth

  • Investigational Site Number 5540003

    Rotorua, 3010

Other trials in New Zealand

Sweden6 sites

  • Investigational Site Number 7520004

    Jönköping, 551 85

  • Investigational Site Number 7520002

    Malmö, 205 02

  • Investigational Site Number 7520006

    Skellefteå, 931 86

  • Investigational Site Number 7520007

    Stockholm, 118 83

  • Investigational Site Number 7520008

    Stockholm, 14186

  • Investigational Site Number 7520001

    Stockholm, 171 76

Other trials in Sweden

Denmark5 sites

  • Investigational Site Number 2080004

    Aalborg, 9100

  • Investigational Site Number 2080003

    Aarhus N, 8200

  • Investigational Site Number 2080002

    Glostrup Municipality, 2600

  • Investigational Site Number 2080001

    Herlev, 2730

  • Investigational Site Number 2080005

    København NV, 2400

Other trials in Denmark

Finland5 sites

  • Investigational Site Number 2460004

    Espoo, 02740

  • Investigational Site Number 2460001

    Helsinki, 00029 HUS

  • Investigational Site Number 2460002

    Jyväskylä, 40620

  • Investigational Site Number 2460003

    Oulu, 90220

  • Investigational Site Number 2460005

    Seinäjoki, 60220

Other trials in Finland

Latvia4 sites

  • Investigational Site Number 4280004

    Daugavpils, LV-5417

  • Investigational Site Number 4280002

    Liepāja, LV-3414

  • Investigational Site Number 4280001

    Riga, LV-1002

  • Investigational Site Number 4280003

    Riga, LV-1038

Other trials in Latvia

Australia2 sites

  • Investigational Site Number 0360007

    Murdoch, 6150

  • Investigational Site Number 0360001

    Wollongong, 2500

Other trials in Australia

Switzerland2 sites

  • Investigational Site Number 7560001

    Basel, 4031

  • Investigational Site Number 7560003

    Lugano, 6900

Other trials in Switzerland

About this study

Official title: 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)

Read more

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)
Read the detailed description

The estimated study duration for a given participants will be approximately 3 to 24 months.

Being tested
Sotagliflozin, Placebo
Medical subject headings
Heart Failure, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotagliflozinDrug

    Also called SAR439954

    Pharmaceutical form: tablet

    Route of administration: oral

  • PlaceboDrug

    Pharmaceutical form: tablet

    Route of administration: oral

Study groups in NCT03521934
Study groupRoleWhat they receive
SotagliflozinExperimentalSotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
Receives: Drug: Sotagliflozin
PlaceboPlacebo 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 21.9 months

Secondary outcomes (7)

  1. Total Number of Occurrences of HHF and Urgent HF Visits

    Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.

    Measured: Up to 21.9 months

  2. Total Number of Deaths From Cardiovascular Causes

    Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.

    Measured: Up to 21.9 months

  3. Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke

    Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomisation. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.

    Measured: Up to 21.9 months

  4. Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized

    Combined endpoint of the total number of occurrences (first and potentially subsequent) after 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.

    Measured: Up to 21.9 months

  5. Total Number of Deaths From Any Cause

    Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.

    Measured: Up to 21.9 months

  6. Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at 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.

    Measured: Baseline to Month 4

  7. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

    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.

    Measured: Baseline up to 21.9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2018
  2. Study start15 Jun 2018
  3. Primary completion5 Jun 2020
  4. Study completion5 Jun 2020

Why it stopped: Study terminated due to business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03521934
Sponsor's protocol ID
EFC15156
Other IDs
2017-003510-16, U1111-1190-7891, 2017
Status last verified
Sep 2022
First submitted
30 Apr 2018
Last updated
28 Oct 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.

Publications

  • Zhang Z, Kolm P, Dolman S, Alva M, Andrade K, Bhatt DL, Weintraub WS. Cost-Effectiveness of Sotagliflozin in Heart Failure Patients with Preserved and Reduced Ejection Fractions - Results from SOLOIST-WHF. Am J Cardiol. 2026 Sep 30:S0002-9149(26)00601-6. doi: 10.1016/j.amjcard.2026.09.025. Online ahead of print.

    PubMed 42815751

  • 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.

    PubMed 39260929

  • Weintraub 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.

    PubMed 38878007

  • Kim 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.

    PubMed 38771012

  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

    PubMed 38770818

  • 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.

    PubMed 34152828

  • 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.

    PubMed 33200892

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotagliflozin in people with Heart Failure and Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 466 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 466 sites in United States, Germany, Argentina, Italy, Spain and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF) (time frame: Up to 21.9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03521934, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.

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