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Trial record 1 of 1 for:    03521934
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Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03521934
Recruitment Status : Terminated (study terminated prematurely for financial reasons and Covid-19 pandemic)
First Posted : May 11, 2018
Last Update Posted : November 5, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

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 patients 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 KCCQ-12 score
  • Change in estimated glomerular filtration rate (eGFR)

Condition or disease Intervention/treatment Phase
Heart Failure Type 2 Diabetes Mellitus Drug: Sotagliflozin (SAR439954) Drug: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : June 5, 2020
Actual Study Completion Date : June 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Sotagliflozin
Sotagliflozin dose 1, once daily with possible uptitration in the first 8 months to dose 2
Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral


Placebo Comparator: Placebo
Placebo dose 1, once daily with possible uptitration in the first 8 months to dose 2
Drug: Placebo

Pharmaceutical form: tablet

Route of administration: oral





Primary Outcome Measures :
  1. Total occurrences of CV Death and Heart Failure Events [ Time Frame: Baseline through a maximum of 22.3 months ]
    The primary endpoint is the total occurrences (first and potentially subsequent) of CV death, Hospitalization for Heart Failure (HHF), and urgent HF visits after randomization.


Secondary Outcome Measures :
  1. Total occurrences of Heart Failure Events [ Time Frame: Baseline through a maximum of 22.3 months ]
    Total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization

  2. Time to CV Death [ Time Frame: Baseline through a maximum of 22.3 months ]
    Time to CV Death after randomization

  3. Total occurrences of 3-Point MACE plus HHF [ Time Frame: Baseline through a maximum of 22.3 months ]
    Total occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomization

  4. Total occurrences of CV Death, Heart Failure Events, and HF while hospitalized [ Time Frame: Baseline through a maximum of 22.3 months ]
    Total occurrences (first and potentially subsequent) after randomization of CV Death, HHF, urgent HF visits, and HF while hospitalized

  5. All-Cause Mortality [ Time Frame: Baseline through a maximum of 22.3 months ]
    Time from randomization to all-cause mortality

  6. Change in Kansas City Cardiomyopathy Questionnaire- 12 (KCCQ-12) Scores [ Time Frame: Baseline through a maximum of 22.3 months ]
    Change in KCCQ12 scores from baseline

  7. Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline through a maximum of 22.3 months ]
    Change in eGFR (mL/min/1.73m2/year) from baseline to the end of the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 pg/mL (≥450 pg/mL for patients with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600 pg/mL (≥1800 pg/mL for patients with atrial fibrillation).
  • Patients 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 patient'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 mL/min/1.73 m².
  • Pregnancy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521934


Locations
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United States, Alabama
Investigational Site Number 8400128
Alexander City, Alabama, United States, 35010
United States, Arizona
Investigational Site Number 8400109
Cottonwood, Arizona, United States, 86326
United States, Arkansas
Investigational Site Number 8400032
Little Rock, Arkansas, United States, 72205
Investigational Site Number 8400080
Little Rock, Arkansas, United States, 72205
United States, California
Investigational Site Number 8400075
Bakersfield, California, United States, 93309
Investigational Site Number 8400069
Fresno, California, United States, 93701
Investigational Site Number 8400008
Los Angeles, California, United States, 90024
Investigational Site Number 8400063
Los Angeles, California, United States, 90073
Investigational Site Number 8400127
National City, California, United States, 91950
Investigational Site Number 8400007
Redondo Beach, California, United States, 90277
Investigational Site Number 8400036
Stockton, California, United States, 95204
Investigational Site Number 8400033
Sylmar, California, United States, 91342
Investigational Site Number 8400049
Torrance, California, United States, 90502
Investigational Site Number 8400028
Walnut Creek, California, United States, 94598
United States, Connecticut
Investigational Site Number 8400029
Bridgeport, Connecticut, United States, 06606
Investigational Site Number 8400037
New Haven, Connecticut, United States, 06519
United States, Florida
Investigational Site Number 8400046
DeLand, Florida, United States, 32720
Investigational Site Number 8400009
Gainesville, Florida, United States, 32608
Investigational Site Number 8400079
Homestead, Florida, United States, 33033
Investigational Site Number 8400031
Jacksonville, Florida, United States, 32207
Investigational Site Number 8400022
Jacksonville, Florida, United States, 32216
Investigational Site Number 8400098
Lake Mary, Florida, United States, 32746
Investigational Site Number 8400058
Miami Beach, Florida, United States, 33140
Investigational Site Number 8400105
Orlando, Florida, United States, 32806
Investigational Site Number 8400082
Pensacola, Florida, United States, 32504
Investigational Site Number 8400057
Port Charlotte, Florida, United States, 33952
Investigational Site Number 8400006
Sarasota, Florida, United States, 34239
Investigational Site Number 8400035
Tampa, Florida, United States, 33609
Investigational Site Number 8400042
Tampa, Florida, United States, 33612
Investigational Site Number 8400004
Wellington, Florida, United States, 33449
United States, Georgia
Investigational Site Number 8400073
Atlanta, Georgia, United States, 30322-1020
Investigational Site Number 8400118
Tucker, Georgia, United States, 30084
United States, Illinois
Investigational Site Number 8400067
Arlington Heights, Illinois, United States, 60005
Investigational Site Number 8400043
Chicago, Illinois, United States, 60637
Investigational Site Number 8400072
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Investigational Site Number 8400055
Indianapolis, Indiana, United States, 46060
Investigational Site Number 8400020
Muncie, Indiana, United States, 47303-3400
Investigational Site Number 8400122
Richmond, Indiana, United States, 47374
United States, Iowa
Investigational Site Number 8400091
Waterloo, Iowa, United States, 50702
United States, Louisiana
Investigational Site Number 8400030
Covington, Louisiana, United States, 70433
United States, Maryland
Investigational Site Number 8400065
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Investigational Site Number 8400012
Boston, Massachusetts, United States, 02118
Investigational Site Number 8400001
Cambridge, Massachusetts, United States, 02135
United States, Michigan
Investigational Site Number 8400077
Detroit, Michigan, United States, 48202
Investigational Site Number 8400062
Kalamazoo, Michigan, United States, 49009
Investigational Site Number 8400017
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
Investigational Site Number 8400107
Duluth, Minnesota, United States, 55805
United States, Mississippi
Investigational Site Number 8400056
Jackson, Mississippi, United States, 39216
United States, Missouri
Investigational Site Number 8400019
Columbia, Missouri, United States, 65201
Investigational Site Number 8400103
Lee's Summit, Missouri, United States, 64064
United States, Nebraska
Investigational Site Number 8400132
Grand Island, Nebraska, United States, 68803
Investigational Site Number 8400130
Lincoln, Nebraska, United States, 68506
Investigational Site Number 8400083
Omaha, Nebraska, United States, 68124
Investigational Site Number 8400071
Omaha, Nebraska, United States, 68198
United States, New Jersey
Investigational Site Number 8400015
Ridgewood, New Jersey, United States, 07450-2736
Investigational Site Number 8400050
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Investigational Site Number 8400131
Albuquerque, New Mexico, United States, 87131
United States, New York
Investigational Site Number 8400097
Bronx, New York, United States, 10457
Investigational Site Number 8400061
Bronx, New York, United States, 10468-3904
Investigational Site Number 8400051
Brooklyn, New York, United States, 11203
Investigational Site Number 8400111
Buffalo, New York, United States, 14215
United States, North Carolina
Investigational Site Number 8400045
Greensboro, North Carolina, United States, 27401
Investigational Site Number 8400085
Raleigh, North Carolina, United States, 27610
Investigational Site Number 8400078
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Investigational Site Number 8400087
Cincinnati, Ohio, United States, 45220
Investigational Site Number 8400047
Cincinnati, Ohio, United States, 45267
Investigational Site Number 8400095
Maumee, Ohio, United States, 43537
Investigational Site Number 8400099
Toledo, Ohio, United States, 43699
Investigational Site Number 8400121
Zanesville, Ohio, United States, 43701
United States, Oregon
Investigational Site Number 8400054
Arlington, Oregon, United States, 19001
United States, Pennsylvania
Investigational Site Number 8400134
Doylestown, Pennsylvania, United States, 18901
Investigational Site Number 8400044
Natrona Heights, Pennsylvania, United States, 15065
Investigational Site Number 8400115
Philadelphia, Pennsylvania, United States, 19104
Investigational Site Number 8400039
Sayre, Pennsylvania, United States, 18840
United States, Rhode Island
Investigational Site Number 8400114
Providence, Rhode Island, United States, 02903
Investigational Site Number 8400100
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Investigational Site Number 8400059
Charleston, South Carolina, United States, 29425
Investigational Site Number 8400092
Columbia, South Carolina, United States, 29203
Investigational Site Number 8400104
Greenville, South Carolina, United States, 29605
United States, South Dakota
Investigational Site Number 8400040
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Investigational Site Number 8400088
Greenville, Tennessee, United States, 30000
Investigational Site Number 8400089
Memphis, Tennessee, United States, 38104
Investigational Site Number 8400053
Nashville, Tennessee, United States, 37212
United States, Texas
Investigational Site Number 8400041
Brownsville, Texas, United States, 78521
Investigational Site Number 8400074
Dallas, Texas, United States, 75226
Investigational Site Number 8400016
Houston, Texas, United States, 77030
Investigational Site Number 8400123
McKinney, Texas, United States, 75071
Investigational Site Number 8400101
New Braunfels, Texas, United States, 78130
Investigational Site Number 8400066
Victoria, Texas, United States, 77901
United States, Virginia
Investigational Site Number 8400093
Manassas, Virginia, United States, 20109
Investigational Site Number 8400003
Richmond, Virginia, United States, 23249-0001
United States, West Virginia
Investigational Site Number 8400126
Clarksburg, West Virginia, United States, 26301
Investigational Site Number 8400038
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Investigational Site Number 8400048
Manitowoc, Wisconsin, United States, 54220
Argentina
Investigational Site Number 0320031
Caba, Argentina, 1430
Investigational Site Number 0320009
Caba, Argentina, C1093AAS
Investigational Site Number 0320016
Capital Federal, Argentina, 1405
Investigational Site Number 0320002
Ciudad De Buenos Aires, Argentina, C1428DCO
Investigational Site Number 0320011
Cordoba, Argentina, X5000AAX
Investigational Site Number 0320010
Cordoba, Argentina, X5004BAL
Investigational Site Number 0320022
Corrientes, Argentina, 3400
Investigational Site Number 0320001
Corrientes, Argentina, W3400AMZ
Investigational Site Number 0320024
Córdoba, Argentina, 5000
Investigational Site Number 0320003
Córdoba, Argentina, X5000JHQ
Investigational Site Number 0320025
Córdoba, Argentina, X5006IKK
Investigational Site Number 0320029
La Plata, Argentina, B1900AXI
Investigational Site Number 0320007
La Plata, Argentina, B1906ESC
Investigational Site Number 0320006
Merlo, Argentina, B1722COV
Investigational Site Number 0320005
Moron, Argentina, B1708CGU
Investigational Site Number 0320012
Olivos, Argentina, 1638
Investigational Site Number 0320023
Quilmes, Argentina, 1878
Investigational Site Number 0320018
Rosario, Argentina, 2000
Investigational Site Number 0320013
Rosario, Argentina, S2000DSR
Investigational Site Number 0320008
Salta, Argentina, 4400
Investigational Site Number 0320020
San Martin, Argentina, B1685CSQ
Investigational Site Number 0320028
San Miguel De Tucuman, Argentina, T4000IFL
Investigational Site Number 0320019
San Miguel De Tucuman, Argentina, T4000NIL
Investigational Site Number 0320017
Santa Fe, Argentina, S3000EOZ
Investigational Site Number 0320015
Santa Fe, Argentina, S3000FWO
Investigational Site Number 0320030
Tucuman, Argentina, T4000JCU
Investigational Site Number 0320004
Villa Belgrano, Argentina, X5021FPQ
Investigational Site Number 0320014
Villa Maria, Argentina, X5900JKA
Australia
Investigational Site Number 0360007
Murdoch, Australia, 6150
Investigational Site Number 0360001
Wollongong, Australia, 2500
Austria
Investigational Site Number 0400006
Braunau, Austria, 5280
Investigational Site Number 0400002
Feldkirch, Austria, 6800
Investigational Site Number 0400007
Graz, Austria, 8036
Investigational Site Number 0400005
Linz, Austria, 4010
Investigational Site Number 0400004
Salzburg, Austria, 5020
Investigational Site Number 0400003
Wien, Austria, 1090
Investigational Site Number 0400001
Wien, Austria, 1160
Belgium
Investigational Site Number 0560002
Aalst, Belgium, 9300
Investigational Site Number 0560007
Gent, Belgium, 9000
Investigational Site Number 0560004
Kortrijk, Belgium, 8500
Investigational Site Number 0560001
Leuven, Belgium, 3000
Investigational Site Number 0560003
Liège, Belgium, 4000
Investigational Site Number 0560005
Mol, Belgium, 2400
Investigational Site Number 0560006
Mons, Belgium, 7000
Investigational Site Number 0560008
Roeselare, Belgium, 8800
Brazil
Investigational Site Number 0760009
Belo Horizonte, Brazil, 30110-908
Investigational Site Number 0760024
Belo Horizonte, Brazil, 30150-221
Investigational Site Number 0760002
Blumenau, Brazil, 89020-430
Investigational Site Number 0760011
Brasilia, Brazil, 70390-903
Investigational Site Number 0760005
Campinas, Brazil, 13060-080
Investigational Site Number 0760006
Campinas, Brazil, 13092-111
Investigational Site Number 0760023
Fortaleza, Brazil, 60840-285
Investigational Site Number 0760018
Goiania, Brazil, 74210050
Investigational Site Number 0760010
Passo Fundo, Brazil, 99010-180
Investigational Site Number 0760003
Porto Alegre, Brazil, 90020-090
Investigational Site Number 0760020
Porto Alegre, Brazil, 90035 003
Investigational Site Number 0760021
Porto Alegre, Brazil, 90610-000
Investigational Site Number 0760007
Porto Alegre, Brazil, 90620-001
Investigational Site Number 0760013
Porto Alegre, Brazil, 91350-250
Investigational Site Number 0760004
Recife, Brazil, 52051-380
Investigational Site Number 0760001
Sao Jose Do Rio Preto, Brazil, 15090-000
Investigational Site Number 0760012
Sao Paulo, Brazil, 04012-909
Investigational Site Number 0760008
Sao Paulo, Brazil, 05403-000
Investigational Site Number 0760017
Votuporanga, Brazil, 15500-003
Canada
Investigational Site Number 1240013
Cambridge, Canada, N1R 6V6
Investigational Site Number 1240006
Granby, Canada, J2G 1T7
Investigational Site Number 1240015
Halifax, Canada, B3H 3A7
Investigational Site Number 1240002
Montreal, Canada, H1T 1C8
Investigational Site Number 1240019
Montreal, Canada, H3G 1A4
Investigational Site Number 1240018
Montreal, Canada, H4A 3J1
Investigational Site Number 1240004
Peterborough, Canada, K9J 0B2
Investigational Site Number 1240014
Quebec, Canada, G1V 4G5
Investigational Site Number 1240007
Scarborough, Canada, M1B 4Z8
Investigational Site Number 1240005
Sherbrooke, Canada, J1G 2E8
Investigational Site Number 1240011
Toronto, Canada, M5B 1W8
Investigational Site Number 1240001
Toronto, Canada, M5G 2C4
Investigational Site Number 1240009
Trois-Rivières, Canada, G9A 5C5
Chile
Investigational Site Number 1520009
Concepción, Chile
Investigational Site Number 1520011
Santiago, Chile, 80004005
Investigational Site Number 1520006
Santiago, Chile, 8053095
Investigational Site Number 1520003
Santiago, Chile, 8380456
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 1520010
Vina Del Mar, Chile
Investigational Site Number 1520001
Viña Del Mar, Chile
Czechia
Investigational Site Number 2030001
Brno, Czechia, 62500
Investigational Site Number 2030003
Brno, Czechia, 63600
Investigational Site Number 2030004
Brno, Czechia, 65691
Investigational Site Number 2030014
Kolin 3, Czechia, 28002
Investigational Site Number 2030010
Kromeriz, Czechia, 76701
Investigational Site Number 2030005
Liberec, Czechia, 46063
Investigational Site Number 2030013
Mestec Kralove, Czechia, 28903
Investigational Site Number 2030018
Praha 10, Czechia, 10100
Investigational Site Number 2030002
Praha 2, Czechia, 12808
Investigational Site Number 2030007
Praha 5 - Motol, Czechia, 15006
Investigational Site Number 2030017
Praha 5, Czechia, 15030
Investigational Site Number 2030011
Prerov, Czechia, 75152
Investigational Site Number 2030015
Pribram I, Czechia, 26101
Investigational Site Number 2030006
Slany, Czechia, 27401
Denmark
Investigational Site Number 2080003
Aarhus N, Denmark, 8200
Investigational Site Number 2080002
Glostrup, Denmark, 2600
Investigational Site Number 2080001
Herlev, Denmark, 2730
Investigational Site Number 2080005
København Nv, Denmark, 2400
Investigational Site Number 2080004
Ålborg, Denmark, 9100
Finland
Investigational Site Number 2460004
Espoo, Finland, 02740
Investigational Site Number 2460001
Helsinki, Finland, 00029 HUS
Investigational Site Number 2460002
Jyväskylä, Finland, 40620
Investigational Site Number 2460003
Oulu, Finland, 90220
Investigational Site Number 2460005
Seinäjoki, Finland, 60220
France
Investigational Site Number 2500009
Chambray Les Tours, France, 37170
Investigational Site Number 2500008
La Tronche, France, 38700
Investigational Site Number 2500004
Le Chesnay, France, 78150
Investigational Site Number 2500002
Le Coudray, France, 28360
Investigational Site Number 2500001
Lille, France, 59037
Investigational Site Number 2500007
Nantes Cedex 1, France, 44093
Investigational Site Number 2500012
Nice Cedex 1, France, 06002
Investigational Site Number 2500003
Paris Cedex 18, France, 75877
Investigational Site Number 2500006
Paris, France, 75015
Investigational Site Number 2500005
Toulouse Cedex 9, France, 31059
Investigational Site Number 2500013
Vandoeuvre-Les-Nancy Cedex, France, 54511
Germany
Investigational Site Number 2760020
Bad Nauheim, Germany, 61231
Investigational Site Number 2760016
Bad Oeynhausen, Germany, 32545
Investigational Site Number 2760013
Berlin, Germany, 12203
Investigational Site Number 2760019
Berlin, Germany, 13347
Investigational Site Number 2760001
Berlin, Germany, 13353
Investigational Site Number 2760002
Berlin, Germany, 13353
Investigational Site Number 2760025
Bielefeld, Germany, 33604
Investigational Site Number 2760005
Bonn, Germany, 53115
Investigational Site Number 2760021
Bremen, Germany, 28277
Investigational Site Number 2760035
Coburg, Germany, 96450
Investigational Site Number 2760032
Dortmund, Germany, 44137
Investigational Site Number 2760006
Dortmund, Germany, 44379
Investigational Site Number 2760029
Erfurt, Germany, 99097
Investigational Site Number 2760018
Essen, Germany, 45138
Investigational Site Number 2760033
Frankfurt Am Main, Germany, 65929
Investigational Site Number 2760009
Greifswald, Germany, 17475
Investigational Site Number 2760022
Heidelberg, Germany, 69115
Investigational Site Number 2760031
Heidelberg, Germany, 69120
Investigational Site Number 2760027
Köln, Germany, 50733
Investigational Site Number 2760034
Lahr, Germany, 77933
Investigational Site Number 2760030
Langen, Germany, 63225
Investigational Site Number 2760014
Leverkusen, Germany, 51375
Investigational Site Number 2760036
Limburg, Germany, 65549
Investigational Site Number 2760012
Ludwigshafen, Germany, 67063
Investigational Site Number 2760028
Merseburg, Germany, 06217
Investigational Site Number 2760011
Rotenburg An Der Fulda, Germany, 36199
Investigational Site Number 2760015
Rüsselsheim, Germany, 65428
Investigational Site Number 2760007
Witten, Germany, 58455
Investigational Site Number 2760026
Würzburg, Germany, 97080
Greece
Investigational Site Number 3000012
Athens, Greece, 11526
Investigational Site Number 3000004
Athens, Greece, 11527
Investigational Site Number 3000002
Chalkida, Greece, 34 100
Investigational Site Number 3000009
Elefsina, Greece, 19600
Investigational Site Number 3000003
Haidari, Greece, 12462
Investigational Site Number 3000005
Heraklion, Greece, 71110
Investigational Site Number 3000007
Ioannina, Greece, 455 00
Investigational Site Number 3000006
Larissa, Greece, 41110
Investigational Site Number 3000001
N. Ionia, Greece, 14233
Investigational Site Number 3000008
Thessaloniki, Greece, 546 36
Hungary
Investigational Site Number 3480018
Berettyóújfalu, Hungary, 4100
Investigational Site Number 3480012
Budapest, Hungary, 1023
Investigational Site Number 3480016
Budapest, Hungary, 1085
Investigational Site Number 3480010
Budapest, Hungary, 1096
Investigational Site Number 3480019
Budapest, Hungary, 1115
Investigational Site Number 3480001
Budapest, Hungary, 1122
Investigational Site Number 3480015
Budapest, Hungary, 1125
Investigational Site Number 3480011
Budapest, Hungary, 1134
Investigational Site Number 3480014
Budapest, Hungary, 1145
Investigational Site Number 3480005
Budapest, Hungary, 1204
Investigational Site Number 3480007
Debrecen, Hungary, 4032
Investigational Site Number 3480002
Dombóvár, Hungary, 7200
Investigational Site Number 3480017
Gyula, Hungary, 5700
Investigational Site Number 3480008
Hódmezövásárhely, Hungary, 6800
Investigational Site Number 3480020
Kistarcsa, Hungary, 2143
Investigational Site Number 3480009
Komárom, Hungary, 2921
Investigational Site Number 3480013
Pécs, Hungary, 7624
Investigational Site Number 3480003
Szekesfehervar, Hungary, 8000
Investigational Site Number 3480006
Zalaegerszeg, Hungary, 8900
Israel
Investigational Site Number 3760013
Ashkelon, Israel, 78278
Investigational Site Number 3760004
Hadera, Israel, 38100
Investigational Site Number 3760005
Haifa, Israel, 31096
Investigational Site Number 3760006
Jerusalem, Israel, 91031
Investigational Site Number 3760003
Jerusalem, Israel, 91120
Investigational Site Number 3760008
Jerusalem, Israel
Investigational Site Number 3760010
Nahariya, Israel, 22100
Investigational Site Number 3760002
Petah-Tikva, Israel, 49100
Investigational Site Number 3760011
Rehovot, Israel, 76100
Investigational Site Number 3760009
Safed, Israel, 13100
Investigational Site Number 3760001
Tel Aviv, Israel, 64239
Investigational Site Number 3760012
Tiberias, Israel, 15208
Italy
Investigational Site Number 3800006
Arzignano (Vi), Italy, 36071
Investigational Site Number 3800011
Brescia, Italy, 25123
Investigational Site Number 3800017
Brescia, Italy, 25124
Investigational Site Number 3800005
Cortona, Italy, 52044
Investigational Site Number 3800009
Ferrara, Italy, 44124
Investigational Site Number 3800020
Gallipoli, Italy, 73014
Investigational Site Number 3800003
Legnago, Italy, 37045
Investigational Site Number 3800023
Milano, Italy, 20122
Investigational Site Number 3800002
Milano, Italy, 20138
Investigational Site Number 3800012
Milano, Italy, 20138
Investigational Site Number 3800008
Milano, Italy, 20162
Investigational Site Number 3800013
Monza, Italy, 20052
Investigational Site Number 3800022
Napoli, Italy, 80131
Investigational Site Number 3800018
Pavia, Italy, 27100
Investigational Site Number 3800004
Perugia, Italy, 06132
Investigational Site Number 3800016
Pozzilli, Italy, 86077
Investigational Site Number 3800014
Rimini, Italy, 47900
Investigational Site Number 3800010
Roma, Italy, 00153
Investigational Site Number 3800021
Roma, Italy, 00189
Investigational Site Number 3800019
Scorrano, Italy, 73020
Investigational Site Number 3800007
Udine, Italy, 33100
Korea, Republic of
Investigational Site Number 4100008
Bucheon-Si, Korea, Republic of, 14754
Investigational Site Number 4100010
Busan, Korea, Republic of, 49267
Investigational Site Number 4100004
Daegu, Korea, Republic of, 42472
Investigational Site Number 4100001
Hwaseong-Si, Korea, Republic of, 18450
Investigational Site Number 4100003
Incheon, Korea, Republic of, 22332
Investigational Site Number 4100005
Seongnam-Si, Korea, Republic of, 13620
Investigational Site Number 4100002
Seoul, Korea, Republic of, 03080
Investigational Site Number 4100007
Seoul, Korea, Republic of, 03722
Investigational Site Number 4100011
Seoul, Korea, Republic of, 05030
Investigational Site Number 4100009
Seoul, Korea, Republic of, 06351
Latvia
Investigational Site Number 4280004
Daugavpils, Latvia, LV-5417
Investigational Site Number 4280002
Liepaja, Latvia, LV-3414
Investigational Site Number 4280001
Riga, Latvia, LV-1002
Investigational Site Number 4280003
Riga, Latvia, LV-1038
Lithuania
Investigational Site Number 4400002
Kaunas, Lithuania, 50161
Investigational Site Number 4400005
Kaunas, Lithuania, 50161
Investigational Site Number 4400004
Klaipeda, Lithuania, LT-92288
Investigational Site Number 4400006
Siauliai, Lithuania, LT-76231
Investigational Site Number 4400001
Vilnius, Lithuania, 08661
Investigational Site Number 4400003
Vilnius, Lithuania, 08661
Netherlands
Investigational Site Number 5280003
Amsterdam, Netherlands, 1034 CS
Investigational Site Number 5280001
Breda, Netherlands, 4819 EV
Investigational Site Number 5280007
Delft, Netherlands, 2625 AD
Investigational Site Number 5280002
Doetinchem, Netherlands, 7009 BL
Investigational Site Number 5280004
Hertogenbosch, Netherlands, 5223 GZ 's
Investigational Site Number 5280006
Rotterdam, Netherlands, 3045 PM
Investigational Site Number 5280008
Sneek, Netherlands, 8601
Investigational Site Number 5280005
Veldhoven, Netherlands, 5504 DB
New Zealand
Investigational Site Number 5540007
Auckland, New Zealand, 1023
Investigational Site Number 5540006
Christchurch, New Zealand, 8011
Investigational Site Number 5540002
Hamilton, New Zealand, 3204
Investigational Site Number 5540004
Lower Hutt, New Zealand
Investigational Site Number 5540005
New Plymouth, New Zealand
Investigational Site Number 5540003
Rotorua, New Zealand, 3010
Poland
Investigational Site Number 6160007
Bialystok, Poland, 15-276
Investigational Site Number 6160017
Gdansk, Poland, 80-462
Investigational Site Number 6160002
Grodzisk Mazowiecki, Poland, 05-825
Investigational Site Number 6160014
Katowice, Poland, 40-635
Investigational Site Number 6160021
Krakow, Poland, 30-693
Investigational Site Number 6160001
Krakow, Poland, 31 -202
Investigational Site Number 6160003
Krakow, Poland, 31-501
Investigational Site Number 6160012
Krakow, Poland
Investigational Site Number 6160011
Leczna, Poland, 21-010
Investigational Site Number 6160016
Lubin, Poland, 59-301
Investigational Site Number 6160005
Miechow, Poland, 32-200
Investigational Site Number 6160022
Poznan, Poland, 61-848
Investigational Site Number 6160006
Torun, Poland, 87-100
Investigational Site Number 6160013
Warszawa, Poland, 00-685
Investigational Site Number 6160004
Warszawa, Poland, 03-242
Investigational Site Number 6160020
Warszawa, Poland, 04-073
Investigational Site Number 6160024
Warszawa, Poland, 04-349
Investigational Site Number 6160008
Warszawa, Poland, 04-628
Investigational Site Number 6160015
Zamosc, Poland, 22-400
Portugal
Investigational Site Number 6200012
Braga, Portugal, 4710-243
Investigational Site Number 6200001
Coimbra, Portugal, 3000-075
Investigational Site Number 6200011
Guilhufe - Penafiel, Portugal, 4564-007
Investigational Site Number 6200004
Guimarães, Portugal, 4810-061
Investigational Site Number 6200006
Lisboa, Portugal, 1449-005
Investigational Site Number 6200002
Lisboa, Portugal, 1500-650
Investigational Site Number 6200008
Porto, Portugal, 4099-001
Investigational Site Number 6200007
Vila Franca De Xira, Portugal, 2600-009
Investigational Site Number 6200003
Vila Nova Gaia, Portugal, 4434-502
Investigational Site Number 6200005
Vila Real, Portugal, 5000-508
Romania
Investigational Site Number 6420014
Arad, Romania, 310037
Investigational Site Number 6420006
Baia Mare, Romania, 430031
Investigational Site Number 6420015
Braila, Romania, 810325
Investigational Site Number 6420013
Bucharest, Romania, 010825
Investigational Site Number 6420019
Bucuresti, Romania, 014461
Investigational Site Number 6420011
Bucuresti, Romania, 020125
Investigational Site Number 6420008
Bucuresti, Romania, 022322
Investigational Site Number 6420007
Bucuresti, Romania, 050659
Investigational Site Number 6420002
Cluj Napoca, Romania, 400001
Investigational Site Number 6420003
Cluj Napoca, Romania, 400347
Investigational Site Number 6420016
Craiova, Romania, 200642
Investigational Site Number 6420005
Oradea, Romania, 410169
Investigational Site Number 6420004
Oradea, Romania, 410469
Investigational Site Number 6420018
Satu Mare, Romania, 440156
Investigational Site Number 6420001
Targu Mures, Romania, 540103
Investigational Site Number 6420012
Tg-Mures, Romania, 540136
Investigational Site Number 6420009
Timisoara, Romania, 300079
Investigational Site Number 6420010
Timisoara, Romania, 300723
Russian Federation
Investigational Site Number 6430026
Ivanovo, Russian Federation, 153012
Investigational Site Number 6430023
Kazan, Russian Federation, 420087
Investigational Site Number 6430002
Kemerovo, Russian Federation, 650002
Investigational Site Number 6430006
Kemerovo, Russian Federation, 650002
Investigational Site Number 6430005
Moscow, Russian Federation, 109240
Investigational Site Number 6430004
Moscow, Russian Federation, 111539
Investigational Site Number 6430022
Moscow, Russian Federation, 117292
Investigational Site Number 6430024
Moscow, Russian Federation, 119192
Investigational Site Number 6430001
Moscow, Russian Federation, 121552
Investigational Site Number 6430003
Moscow, Russian Federation, 121552
Investigational Site Number 6430010
Moscow, Russian Federation, 121552
Investigational Site Number 6430018
Nizhniy Novgorod, Russian Federation, 603005
Investigational Site Number 6430013
Rostov-Na-Donu, Russian Federation, 344068
Investigational Site Number 6430011
Saint-Petersburg, Russian Federation, 198205
Investigational Site Number 6430017
Sochi, Russian Federation, 354057
Investigational Site Number 6430025
St-Petersburg, Russian Federation, 193312
Investigational Site Number 6430007
St-Petersburg, Russian Federation, 195067
Investigational Site Number 6430012
St-Petersburg, Russian Federation, 197341
Investigational Site Number 6430009
St-Petersburg, Russian Federation, 199106
Investigational Site Number 6430016
Tomsk, Russian Federation, 634012
Slovakia
Investigational Site Number 7030003
Bratislava 3 - Kramare, Slovakia, 833 05
Investigational Site Number 7030004
Bratislava 37, Slovakia, 833 48
Investigational Site Number 7030001
Bratislava, Slovakia, 813 69
Investigational Site Number 7030010
Brezno, Slovakia, 97742
Investigational Site Number 7030009
Dolny Kubin, Slovakia, 02614
Investigational Site Number 7030002
Kosice, Slovakia, 040 01
Investigational Site Number 7030011
Nitra, Slovakia, 950 01
Investigational Site Number 7030008
Trnava, Slovakia, 91775
Spain
Investigational Site Number 7240016
Alicante, Spain, 03010
Investigational Site Number 7240015
Badalona, Spain, 08916
Investigational Site Number 7240020
Hospitalet De Llobregat, Spain, 08907
Investigational Site Number 7240006
La Coruña, Spain, 15006
Investigational Site Number 7240005
Las Palmas De Gran Canaria, Spain, 35020
Investigational Site Number 7240021
Madrid, Spain, 28031
Investigational Site Number 7240008
Madrid, Spain, 28040
Investigational Site Number 7240022
Manises, Spain, 46940
Investigational Site Number 7240007
Murcia, Spain, 30120
Investigational Site Number 7240004
Málaga, Spain, 29010
Investigational Site Number 7240014
Olot, Spain, 17800
Investigational Site Number 7240009
San Sebastián De Los Reyes, Spain, 28702
Investigational Site Number 7240003
Sanlúcar De Barrameda, Spain, 11540
Investigational Site Number 7240001
Sevilla, Spain, 41014
Investigational Site Number 7240019
Sevilla, Spain, 41071
Investigational Site Number 7240012
Valencia, Spain, 46010
Investigational Site Number 7240011
Valencia, Spain, 46014
Investigational Site Number 7240010
Valencia, Spain, 46026
Investigational Site Number 7240002
Villamartín, Spain, 11650
Investigational Site Number 7240013
Zaragoza, Spain, 50009
Investigational Site Number 7240018
Úbeda, Spain, 23400
Sweden
Investigational Site Number 7520004
Jönköping, Sweden, 551 85
Investigational Site Number 7520002
Malmö, Sweden, 205 02
Investigational Site Number 7520006
Skellefteå, Sweden, 931 86
Investigational Site Number 7520007
Stockholm, Sweden, 118 83
Investigational Site Number 7520008
Stockholm, Sweden, 14186
Investigational Site Number 7520001
Stockholm, Sweden, 171 76
Switzerland
Investigational Site Number 7560001
Basel, Switzerland, 4031
Investigational Site Number 7560003
Lugano, Switzerland, 6900
Turkey
Investigational Site Number 7920008
Antalya, Turkey, 07059
Investigational Site Number 7920006
Corum, Turkey, 19200
Investigational Site Number 7920005
Eskisehir, Turkey, 26480
Investigational Site Number 7920002
Haseki/ Istanbul, Turkey, 34034
Investigational Site Number 7920011
Istanbul, Turkey, 34098
Investigational Site Number 7920012
Izmir, Turkey, 35340
Investigational Site Number 7920003
Kocaeli, Turkey, 41300
Investigational Site Number 7920004
Mersin, Turkey, 33169
Investigational Site Number 7920001
Sivas, Turkey, 58140
Investigational Site Number 7920010
Trabzon, Turkey, 61040
United Kingdom
Investigational Site Number 8260005
Bournemouth, United Kingdom, BH7 7DW
Investigational Site Number 8260010
Bristol, United Kingdom, BS10 5NB
Investigational Site Number 8260008
Chelmsford, United Kingdom, CM1 7ET
Investigational Site Number 8260009
Hull, United Kingdom, HU16 5JQ
Investigational Site Number 8260002
Newcastle, United Kingdom, NE1 4LP
Investigational Site Number 8260001
Oldham, United Kingdom, OL1 2JH
Investigational Site Number 8260003
Swansea, United Kingdom, SA6 6NL
Investigational Site Number 8260006
Swindon, United Kingdom, SN3 6BB
Investigational Site Number 8260004
Torquay, United Kingdom, TQ2 7AA
Investigational Site Number 8260007
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Lexicon Pharmaceuticals
Sanofi
Investigators
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Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03521934    
Other Study ID Numbers: EFC15156
2017-003510-16 ( EudraCT Number )
U1111-1190-7891 ( Other Identifier: UTN )
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs