Clinical trial NCT03521934: Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Failure
Type 2 Diabetes Mellitus
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2018-05-11
Enrollment: 1222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
timeFrame: Up to 21.9 months
Secondary outcomes:
measure: Total Number of Occurrences of HHF and Urgent HF Visits
timeFrame: Up to 21.9 months
measure: Total Number of Deaths From Cardiovascular Causes
timeFrame: Up to 21.9 months
measure: Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
timeFrame: Up to 21.9 months
measure: Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
timeFrame: Up to 21.9 months
measure: Total Number of Deaths From Any Cause
timeFrame: Up to 21.9 months
measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4
timeFrame: Baseline to Month 4
measure: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline up to 21.9 months
Other outcomes:
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country: Germany
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city: Rotenburg An Der Fulda
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city: Witten
country: Germany
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city: Larissa
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city: N. Ionia
country: Greece
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country: Greece
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facility: Investigational Site Number 3480017
city: Hódmezövásárhely
country: Hungary
facility: Investigational Site Number 3480008
city: Kistarcsa
country: Hungary
facility: Investigational Site Number 3480020
city: Komárom
country: Hungary
facility: Investigational Site Number 3480009
city: Pécs
country: Hungary
facility: Investigational Site Number 3480013
city: Szekesfehervar
country: Hungary
facility: Investigational Site Number 3480003
city: Zalaegerszeg
country: Hungary
facility: Investigational Site Number 3480006
city: Ashkelon
country: Israel
facility: Investigational Site Number 3760013
city: Hadera
country: Israel
facility: Investigational Site Number 3760004
city: Haifa
country: Israel
facility: Investigational Site Number 3760005
city: Jerusalem
country: Israel
facility: Investigational Site Number 3760006
city: Jerusalem
country: Israel
facility: Investigational Site Number 3760003
city: Jerusalem
country: Israel
facility: Investigational Site Number 3760008
city: Nahariya
country: Israel
facility: Investigational Site Number 3760010
city: Petah-Tikva
country: Israel
facility: Investigational Site Number 3760002
city: Rehovot
country: Israel
facility: Investigational Site Number 3760011
city: Safed
country: Israel
facility: Investigational Site Number 3760009
city: Tel Aviv
country: Israel
facility: Investigational Site Number 3760001
city: Tiberias
country: Israel
facility: Investigational Site Number 3760012
city: Arzignano (Vi)
country: Italy
facility: Investigational Site Number 3800006
city: Brescia
country: Italy
facility: Investigational Site Number 3800011
city: Brescia
country: Italy
facility: Investigational Site Number 3800017
city: Cortona
country: Italy
facility: Investigational Site Number 3800005
city: Ferrara
country: Italy
facility: Investigational Site Number 3800009
city: Gallipoli
country: Italy
facility: Investigational Site Number 3800020
city: Legnago
country: Italy
facility: Investigational Site Number 3800003
city: Milano
country: Italy
facility: Investigational Site Number 3800023
city: Milano
country: Italy
facility: Investigational Site Number 3800002
city: Milano
country: Italy
facility: Investigational Site Number 3800012
city: Milano
country: Italy
facility: Investigational Site Number 3800008
city: Monza
country: Italy
facility: Investigational Site Number 3800013
city: Napoli
country: Italy
facility: Investigational Site Number 3800022
city: Pavia
country: Italy
facility: Investigational Site Number 3800018
city: Perugia
country: Italy
facility: Investigational Site Number 3800004
city: Pozzilli
country: Italy
facility: Investigational Site Number 3800016
city: Rimini
country: Italy
facility: Investigational Site Number 3800014
city: Roma
country: Italy
facility: Investigational Site Number 3800010
city: Roma
country: Italy
facility: Investigational Site Number 3800021
city: Scorrano
country: Italy
facility: Investigational Site Number 3800019
city: Udine
country: Italy
facility: Investigational Site Number 3800007
city: Bucheon-Si
country: Korea, Republic of
facility: Investigational Site Number 4100008
city: Busan
country: Korea, Republic of
facility: Investigational Site Number 4100010
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number 4100004
city: Hwaseong-Si
country: Korea, Republic of
facility: Investigational Site Number 4100001
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number 4100003
city: Seongnam-Si
country: Korea, Republic of
facility: Investigational Site Number 4100005
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100002
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100007
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100011
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100009
city: Daugavpils
country: Latvia
facility: Investigational Site Number 4280004
city: Liepaja
country: Latvia
facility: Investigational Site Number 4280002
city: Riga
country: Latvia
facility: Investigational Site Number 4280001
city: Riga
country: Latvia
facility: Investigational Site Number 4280003
city: Kaunas
country: Lithuania
facility: Investigational Site Number 4400002
city: Kaunas
country: Lithuania
facility: Investigational Site Number 4400005
city: Klaipeda
country: Lithuania
facility: Investigational Site Number 4400004
city: Siauliai
country: Lithuania
facility: Investigational Site Number 4400006
city: Vilnius
country: Lithuania
facility: Investigational Site Number 4400001
city: Vilnius
country: Lithuania
facility: Investigational Site Number 4400003
city: Amsterdam
country: Netherlands
facility: Investigational Site Number 5280003
city: Breda
country: Netherlands
facility: Investigational Site Number 5280001
city: Delft
country: Netherlands
facility: Investigational Site Number 5280007
city: Doetinchem
country: Netherlands
facility: Investigational Site Number 5280002
city: Hertogenbosch
country: Netherlands
facility: Investigational Site Number 5280004
city: Rotterdam
country: Netherlands
facility: Investigational Site Number 5280006
city: Sneek
country: Netherlands
facility: Investigational Site Number 5280008
city: Veldhoven
country: Netherlands
facility: Investigational Site Number 5280005
city: Auckland
country: New Zealand
facility: Investigational Site Number 5540007
city: Christchurch
country: New Zealand
facility: Investigational Site Number 5540006
city: Hamilton
country: New Zealand
facility: Investigational Site Number 5540002
city: Lower Hutt
country: New Zealand
facility: Investigational Site Number 5540004
city: New Plymouth
country: New Zealand
facility: Investigational Site Number 5540005
city: Rotorua
country: New Zealand
facility: Investigational Site Number 5540003
city: Bialystok
country: Poland
facility: Investigational Site Number 6160007
city: Gdansk
country: Poland
facility: Investigational Site Number 6160017
city: Grodzisk Mazowiecki
country: Poland
facility: Investigational Site Number 6160002
city: Katowice
country: Poland
facility: Investigational Site Number 6160014
city: Krakow
country: Poland
facility: Investigational Site Number 6160021
city: Krakow
country: Poland
facility: Investigational Site Number 6160001
city: Krakow
country: Poland
facility: Investigational Site Number 6160003
city: Krakow
country: Poland
facility: Investigational Site Number 6160012
city: Leczna
country: Poland
facility: Investigational Site Number 6160011
city: Lubin
country: Poland
facility: Investigational Site Number 6160016
city: Miechow
country: Poland
facility: Investigational Site Number 6160005
city: Poznan
country: Poland
facility: Investigational Site Number 6160022
city: Torun
country: Poland
facility: Investigational Site Number 6160006
city: Warszawa
country: Poland
facility: Investigational Site Number 6160013
city: Warszawa
country: Poland
facility: Investigational Site Number 6160004
city: Warszawa
country: Poland
facility: Investigational Site Number 6160020
city: Warszawa
country: Poland
facility: Investigational Site Number 6160024
city: Warszawa
country: Poland
facility: Investigational Site Number 6160008
city: Zamosc
country: Poland
facility: Investigational Site Number 6160015
city: Braga
country: Portugal
facility: Investigational Site Number 6200012
city: Coimbra
country: Portugal
facility: Investigational Site Number 6200001
city: Guilhufe - Penafiel
country: Portugal
facility: Investigational Site Number 6200011
city: Guimarães
country: Portugal
facility: Investigational Site Number 6200004
city: Lisboa
country: Portugal
facility: Investigational Site Number 6200006
city: Lisboa
country: Portugal
facility: Investigational Site Number 6200002
city: Porto
country: Portugal
facility: Investigational Site Number 6200008
city: Vila Franca De Xira
country: Portugal
facility: Investigational Site Number 6200007
city: Vila Nova Gaia
country: Portugal
facility: Investigational Site Number 6200003
city: Vila Real
country: Portugal
facility: Investigational Site Number 6200005
city: Arad
country: Romania
facility: Investigational Site Number 6420014
city: Baia Mare
country: Romania
facility: Investigational Site Number 6420006
city: Braila
country: Romania
facility: Investigational Site Number 6420015
city: Bucharest
country: Romania
facility: Investigational Site Number 6420013
city: Bucuresti
country: Romania
facility: Investigational Site Number 6420019
city: Bucuresti
country: Romania
facility: Investigational Site Number 6420011
city: Bucuresti
country: Romania
facility: Investigational Site Number 6420008
city: Bucuresti
country: Romania
facility: Investigational Site Number 6420007
city: Cluj Napoca
country: Romania
facility: Investigational Site Number 6420002
city: Cluj Napoca
country: Romania
facility: Investigational Site Number 6420003
city: Craiova
country: Romania
facility: Investigational Site Number 6420016
city: Oradea
country: Romania
facility: Investigational Site Number 6420005
city: Oradea
country: Romania
facility: Investigational Site Number 6420004
city: Satu Mare
country: Romania
facility: Investigational Site Number 6420018
city: Targu Mures
country: Romania
facility: Investigational Site Number 6420001
city: Tg-Mures
country: Romania
facility: Investigational Site Number 6420012
city: Timisoara
country: Romania
facility: Investigational Site Number 6420009
city: Timisoara
country: Romania
facility: Investigational Site Number 6420010
city: Ivanovo
country: Russian Federation
facility: Investigational Site Number 6430026
city: Kazan
country: Russian Federation
facility: Investigational Site Number 6430023
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 6430002
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 6430006
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430005
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430004
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430022
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430024
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430001
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430003
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430010
city: Nizhniy Novgorod
country: Russian Federation
facility: Investigational Site Number 6430018
city: Rostov-Na-Donu
country: Russian Federation
facility: Investigational Site Number 6430013
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430011
city: Sochi
country: Russian Federation
facility: Investigational Site Number 6430017
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430025
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430007
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430012
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430009
city: Tomsk
country: Russian Federation
facility: Investigational Site Number 6430016
city: Bratislava 3 - Kramare
country: Slovakia
facility: Investigational Site Number 7030003
city: Bratislava 37
country: Slovakia
facility: Investigational Site Number 7030004
city: Bratislava
country: Slovakia
facility: Investigational Site Number 7030001
city: Brezno
country: Slovakia
facility: Investigational Site Number 7030010
city: Dolny Kubin
country: Slovakia
facility: Investigational Site Number 7030009
city: Kosice
country: Slovakia
facility: Investigational Site Number 7030002
city: Nitra
country: Slovakia
facility: Investigational Site Number 7030011
city: Trnava
country: Slovakia
facility: Investigational Site Number 7030008
city: Alicante
country: Spain
facility: Investigational Site Number 7240016
city: Badalona
country: Spain
facility: Investigational Site Number 7240015
city: Hospitalet De Llobregat
country: Spain
facility: Investigational Site Number 7240020
city: La Coruña
country: Spain
facility: Investigational Site Number 7240006
city: Las Palmas De Gran Canaria
country: Spain
facility: Investigational Site Number 7240005
city: Madrid
country: Spain
facility: Investigational Site Number 7240021
city: Madrid
country: Spain
facility: Investigational Site Number 7240008
city: Manises
country: Spain
facility: Investigational Site Number 7240022
city: Murcia
country: Spain
facility: Investigational Site Number 7240007
city: Málaga
country: Spain
facility: Investigational Site Number 7240004
city: Olot
country: Spain
facility: Investigational Site Number 7240014
city: San Sebastián De Los Reyes
country: Spain
facility: Investigational Site Number 7240009
city: Sanlúcar De Barrameda
country: Spain
facility: Investigational Site Number 7240003
city: Sevilla
country: Spain
facility: Investigational Site Number 7240001
city: Sevilla
country: Spain
facility: Investigational Site Number 7240019
city: Valencia
country: Spain
facility: Investigational Site Number 7240012
city: Valencia
country: Spain
facility: Investigational Site Number 7240011
city: Valencia
country: Spain
facility: Investigational Site Number 7240010
city: Villamartín
country: Spain
facility: Investigational Site Number 7240002
city: Zaragoza
country: Spain
facility: Investigational Site Number 7240013
city: Úbeda
country: Spain
facility: Investigational Site Number 7240018
city: Jönköping
country: Sweden
facility: Investigational Site Number 7520004
city: Malmö
country: Sweden
facility: Investigational Site Number 7520002
city: Skellefteå
country: Sweden
facility: Investigational Site Number 7520006
city: Stockholm
country: Sweden
facility: Investigational Site Number 7520007
city: Stockholm
country: Sweden
facility: Investigational Site Number 7520008
city: Stockholm
country: Sweden
facility: Investigational Site Number 7520001
city: Basel
country: Switzerland
facility: Investigational Site Number 7560001
city: Lugano
country: Switzerland
facility: Investigational Site Number 7560003
city: Antalya
country: Turkey
facility: Investigational Site Number 7920008
city: Corum
country: Turkey
facility: Investigational Site Number 7920006
city: Eskisehir
country: Turkey
facility: Investigational Site Number 7920005
city: Haseki/ Istanbul
country: Turkey
facility: Investigational Site Number 7920002
city: Istanbul
country: Turkey
facility: Investigational Site Number 7920011
city: Izmir
country: Turkey
facility: Investigational Site Number 7920012
city: Kocaeli
country: Turkey
facility: Investigational Site Number 7920003
city: Mersin
country: Turkey
facility: Investigational Site Number 7920004
city: Sivas
country: Turkey
facility: Investigational Site Number 7920001
city: Trabzon
country: Turkey
facility: Investigational Site Number 7920010
city: Bournemouth
country: United Kingdom
facility: Investigational Site Number 8260005
city: Bristol
country: United Kingdom
facility: Investigational Site Number 8260010
city: Chelmsford
country: United Kingdom
facility: Investigational Site Number 8260008
city: Hull
country: United Kingdom
facility: Investigational Site Number 8260009
city: Newcastle
country: United Kingdom
facility: Investigational Site Number 8260002
city: Oldham
country: United Kingdom
facility: Investigational Site Number 8260001
city: Swansea
country: United Kingdom
facility: Investigational Site Number 8260003
city: Swindon
country: United Kingdom
facility: Investigational Site Number 8260006
city: Torquay
country: United Kingdom
facility: Investigational Site Number 8260004
city: York
country: United Kingdom
facility: Investigational Site Number 8260007
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Suman Wason, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.