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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03521934
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

  • To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with type 2 diabetes (T2D) and heart failure (HF) with left ventricular ejection fraction (LVEF) <50%, after admission for worsening heart failure (WHF).
  • To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with T2D and HF irrespective of LVEF after admission for WHF.

Secondary Objectives:

  • To demonstrate that, when compared to placebo in the toal patient population, sotagliflozin reduces the total number (i.e., including recurrent events) of the following clinical events:
  • Cardiovascular death, HHF or urgent HF visit.
  • To demonstrate that, when compared to placebo, sotagliflozin reduces:
  • The composite of positively adjudicated sustained ≥50% decrease in eGFR, chronic dialysis, renal transplant or positively adjudicated sustained eGFR <15 mL/min/1.73 m2 in the total patient population.
  • Cardiovascular death in patients with LVEF < 50%.
  • Cardiovascular death in the total patient population.
  • All-cause mortality in patients with LVEF < 50%.
  • All cause mortality in the total patient population.
  • To demonstrate the safety and tolerability of sotagliflozin in the total population in this study.

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 32 months.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 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
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

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. Cardiovascular (CV) death or hospitalization for heart failure (HHF) [ Time Frame: Baseline to approximately 32 months ]
    Time to first occurrence of either cardiovascular (CV) death or hospitalization for heart failure (HHF) in patients with left ventricular ejection fraction (LVEF) <50%

  2. Cardiovascular (CV) death or hospitalization for heart failure (HHF) [ Time Frame: Baseline to approximately 32 months ]
    Time to first occurrence of either CV death or HHF in the total patient population -


Secondary Outcome Measures :
  1. Total number of heart failure events [ Time Frame: Baseline to approximately 32 months ]
    Total number (i.e., including recurrent events) of the following clinical events in the total patient population: Cardiovascular death, Hospitalization for heart failure, Urgent HF visit

  2. Time to first composite renal event [ Time Frame: Baseline to approximately 32 months ]
    Time to first occurrence of the composite of positively adjudicated sustained ≥50% decrease in eGFR from Baseline (for ≥30 days), chronic dialysis, renal transplant, or positively adjudicated sustained eGFR <15 mL/min/1.73 m2 (for ≥30 days) in the total patient population.

  3. Cardiovascular (CV) death [ Time Frame: Baseline to approximately 32 months ]
    Time to CV death in patients with LVEF <50%

  4. Cardiovascular (CV) death [ Time Frame: Baseline to approximately 32 months ]
    Time to CV death in the total patient population

  5. All cause mortality [ Time Frame: Baseline to approximately 32 months ]
    Time to all-cause mortality in patients with LVEF <50%

  6. All cause mortality [ Time Frame: Baseline to approximately 32 months ]
    Time to all-cause mortality in the total patient population



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.


Layout table for eligibility information
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


Contacts
Layout table for location contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com

  Hide Study Locations
Locations
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United States, Alabama
Investigational Site Number 8400128 Recruiting
Alexander City, Alabama, United States, 35010
United States, Arizona
Investigational Site Number 8400109 Recruiting
Cottonwood, Arizona, United States, 86326
United States, Arkansas
Investigational Site Number 8400032 Recruiting
Little Rock, Arkansas, United States, 72205
Investigational Site Number 8400080 Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Investigational Site Number 8400075 Recruiting
Bakersfield, California, United States, 93309
Investigational Site Number 8400069 Recruiting
Fresno, California, United States, 93701
Investigational Site Number 8400008 Recruiting
Los Angeles, California, United States, 90024
Investigational Site Number 8400063 Recruiting
Los Angeles, California, United States, 90073
Investigational Site Number 8400007 Recruiting
Redondo Beach, California, United States, 90277
Investigational Site Number 8400036 Recruiting
Stockton, California, United States, 95204
Investigational Site Number 8400033 Recruiting
Sylmar, California, United States, 91342
Investigational Site Number 8400049 Recruiting
Torrance, California, United States, 90502
Investigational Site Number 8400028 Recruiting
Walnut Creek, California, United States, 94598
United States, Connecticut
Investigational Site Number 8400029 Recruiting
Bridgeport, Connecticut, United States, 06606
Investigational Site Number 8400086 Recruiting
Hartford, Connecticut, United States, 06102
Investigational Site Number 8400037 Recruiting
New Haven, Connecticut, United States, 06519
United States, Florida
Investigational Site Number 8400046 Recruiting
DeLand, Florida, United States, 32720
Investigational Site Number 8400009 Recruiting
Gainesville, Florida, United States, 32608
Investigational Site Number 8400079 Recruiting
Homestead, Florida, United States, 33033
Investigational Site Number 8400031 Recruiting
Jacksonville, Florida, United States, 32207
Investigational Site Number 8400022 Recruiting
Jacksonville, Florida, United States, 32216
Investigational Site Number 8400058 Recruiting
Miami Beach, Florida, United States, 33140
Investigational Site Number 8400105 Recruiting
Orlando, Florida, United States, 32806
Investigational Site Number 8400082 Recruiting
Pensacola, Florida, United States, 32504
Investigational Site Number 8400057 Recruiting
Port Charlotte, Florida, United States, 33952
Investigational Site Number 8400006 Recruiting
Sarasota, Florida, United States, 34239
Investigational Site Number 8400024 Recruiting
Tallahassee, Florida, United States, 32308
Investigational Site Number 8400035 Recruiting
Tampa, Florida, United States, 33609
Investigational Site Number 8400042 Recruiting
Tampa, Florida, United States, 33612
Investigational Site Number 8400004 Recruiting
Wellington, Florida, United States, 33449
United States, Georgia
Investigational Site Number 8400073 Recruiting
Atlanta, Georgia, United States, 30322-1020
Investigational Site Number 8400118 Recruiting
Tucker, Georgia, United States, 30084
United States, Illinois
Investigational Site Number 8400067 Recruiting
Arlington Heights, Illinois, United States, 60005
Investigational Site Number 8400043 Recruiting
Chicago, Illinois, United States, 60637
Investigational Site Number 8400072 Recruiting
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Investigational Site Number 8400055 Recruiting
Indianapolis, Indiana, United States, 46060
Investigational Site Number 8400020 Recruiting
Muncie, Indiana, United States, 47303-3400
Investigational Site Number 8400122 Recruiting
Richmond, Indiana, United States, 47374
United States, Iowa
Investigational Site Number 8400091 Recruiting
Waterloo, Iowa, United States, 50702
United States, Louisiana
Investigational Site Number 8400030 Recruiting
Covington, Louisiana, United States, 70433
United States, Maryland
Investigational Site Number 8400065 Recruiting
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Investigational Site Number 8400012 Recruiting
Boston, Massachusetts, United States, 02118
Investigational Site Number 8400001 Recruiting
Cambridge, Massachusetts, United States, 02135
United States, Michigan
Investigational Site Number 8400077 Recruiting
Detroit, Michigan, United States, 48202
Investigational Site Number 8400062 Recruiting
Kalamazoo, Michigan, United States, 49009
Investigational Site Number 8400017 Recruiting
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
Investigational Site Number 8400107 Recruiting
Duluth, Minnesota, United States, 55805
United States, Mississippi
Investigational Site Number 8400056 Recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Investigational Site Number 8400019 Recruiting
Columbia, Missouri, United States, 65201
Investigational Site Number 8400103 Recruiting
Lee's Summit, Missouri, United States, 64064
United States, Nebraska
Investigational Site Number 8400083 Recruiting
Omaha, Nebraska, United States, 68124
Investigational Site Number 8400071 Recruiting
Omaha, Nebraska, United States, 68198
United States, New Jersey
Investigational Site Number 8400015 Recruiting
Ridgewood, New Jersey, United States, 07450-2736
Investigational Site Number 8400050 Recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Investigational Site Number 8400097 Recruiting
Bronx, New York, United States, 10457
Investigational Site Number 8400061 Recruiting
Bronx, New York, United States, 10468-3904
Investigational Site Number 8400051 Recruiting
Brooklyn, New York, United States, 11203
United States, North Carolina
Investigational Site Number 8400045 Recruiting
Greensboro, North Carolina, United States, 27401
Investigational Site Number 8400085 Recruiting
Raleigh, North Carolina, United States, 27610
Investigational Site Number 8400078 Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Investigational Site Number 8400087 Recruiting
Cincinnati, Ohio, United States, 45220
Investigational Site Number 8400047 Recruiting
Cincinnati, Ohio, United States, 45267
Investigational Site Number 8400084 Recruiting
Cleveland, Ohio, United States, 44106
Investigational Site Number 8400095 Recruiting
Maumee, Ohio, United States, 43537
Investigational Site Number 8400099 Recruiting
Toledo, Ohio, United States, 43699
Investigational Site Number 8400121 Recruiting
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Investigational Site Number 8400014 Recruiting
Oklahoma City, Oklahoma, United States, 73084
United States, Oregon
Investigational Site Number 8400054 Recruiting
Arlington, Oregon, United States, 19001
United States, Pennsylvania
Investigational Site Number 8400134 Recruiting
Doylestown, Pennsylvania, United States, 18901
Investigational Site Number 8400044 Recruiting
Natrona Heights, Pennsylvania, United States, 15065
Investigational Site Number 8400115 Recruiting
Philadelphia, Pennsylvania, United States, 19104
Investigational Site Number 8400039 Recruiting
Sayre, Pennsylvania, United States, 18840
United States, Rhode Island
Investigational Site Number 8400100 Recruiting
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Investigational Site Number 8400059 Recruiting
Charleston, South Carolina, United States, 29425
Investigational Site Number 8400092 Recruiting
Columbia, South Carolina, United States, 29203
United States, South Dakota
Investigational Site Number 8400040 Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Investigational Site Number 8400088 Recruiting
Greenville, Tennessee, United States, 00000
Investigational Site Number 8400089 Recruiting
Memphis, Tennessee, United States, 38104
Investigational Site Number 8400053 Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Investigational Site Number 8400041 Recruiting
Brownsville, Texas, United States, 78521
Investigational Site Number 8400074 Recruiting
Dallas, Texas, United States, 75226
Investigational Site Number 8400016 Recruiting
Houston, Texas, United States, 77030
Investigational Site Number 8400123 Recruiting
McKinney, Texas, United States, 75071
Investigational Site Number 8400101 Recruiting
New Braunfels, Texas, United States, 78130
Investigational Site Number 8400066 Recruiting
Victoria, Texas, United States, 77901
United States, Virginia
Investigational Site Number 8400093 Recruiting
Manassas, Virginia, United States, 20109
Investigational Site Number 8400003 Recruiting
Richmond, Virginia, United States, 23249-0001
United States, West Virginia
Investigational Site Number 8400038 Recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Investigational Site Number 8400048 Recruiting
Manitowoc, Wisconsin, United States, 54220
Argentina
Investigational Site Number 0320031 Recruiting
Caba, Argentina, 1430
Investigational Site Number 0320009 Recruiting
Caba, Argentina, C1093AAS
Investigational Site Number 0320016 Completed
Capital Federal, Argentina, 1405
Investigational Site Number 0320002 Recruiting
Ciudad De Buenos Aires, Argentina, C1428DCO
Investigational Site Number 0320011 Recruiting
Cordoba, Argentina, X5000AAX
Investigational Site Number 0320010 Recruiting
Cordoba, Argentina, X5004BAL
Investigational Site Number 0320022 Recruiting
Corrientes, Argentina, 3400
Investigational Site Number 0320001 Recruiting
Corrientes, Argentina, W3400AMZ
Investigational Site Number 0320024 Recruiting
Córdoba, Argentina, 5000
Investigational Site Number 0320003 Recruiting
Córdoba, Argentina, X5000JHQ
Investigational Site Number 0320025 Recruiting
Córdoba, Argentina, X5006IKK
Investigational Site Number 0320029 Recruiting
La Plata, Argentina, B1900AXI
Investigational Site Number 0320007 Recruiting
La Plata, Argentina, B1906ESC
Investigational Site Number 0320006 Recruiting
Merlo, Argentina, B1722COV
Investigational Site Number 0320005 Recruiting
Moron, Argentina, B1708CGU
Investigational Site Number 0320012 Recruiting
Olivos, Argentina, 1638
Investigational Site Number 0320023 Recruiting
Quilmes, Argentina, 1878
Investigational Site Number 0320018 Recruiting
Rosario, Argentina, 2000
Investigational Site Number 0320013 Recruiting
Rosario, Argentina, S2000DSR
Investigational Site Number 0320008 Recruiting
Salta, Argentina, 4400
Investigational Site Number 0320020 Recruiting
San Martin, Argentina, B1685CSQ
Investigational Site Number 0320028 Recruiting
San Miguel De Tucuman, Argentina, T4000IFL
Investigational Site Number 0320019 Recruiting
San Miguel De Tucuman, Argentina, T4000NIL
Investigational Site Number 0320017 Recruiting
Santa Fe, Argentina, S3000EOZ
Investigational Site Number 0320015 Recruiting
Santa Fe, Argentina, S3000FWO
Investigational Site Number 0320030 Recruiting
Tucuman, Argentina, T4000JCU
Investigational Site Number 0320004 Recruiting
Villa Belgrano, Argentina, X5021FPQ
Investigational Site Number 0320014 Recruiting
Villa Maria, Argentina, X5900JKA
Australia
Investigational Site Number 0360006 Recruiting
Birtinya, Australia, 4575
Investigational Site Number 0360002 Recruiting
Maroochydore, Australia, 4558
Investigational Site Number 0360007 Recruiting
Murdoch, Australia, 6150
Investigational Site Number 0360004 Recruiting
Redcliffe, Australia, 4020
Investigational Site Number 0360001 Recruiting
Wollongong, Australia, 2500
Austria
Investigational Site Number 0400006 Recruiting
Braunau Am Inn, Austria, 5280
Investigational Site Number 0400002 Recruiting
Feldkirch, Austria, 6800
Investigational Site Number 0400007 Recruiting
Graz, Austria, 8036
Investigational Site Number 0400005 Recruiting
Linz, Austria, 4010
Investigational Site Number 0400004 Recruiting
Salzburg, Austria, 5020
Investigational Site Number 0400003 Recruiting
Wien, Austria, 1090
Investigational Site Number 0400001 Recruiting
Wien, Austria, 1160
Belgium
Investigational Site Number 0560002 Recruiting
Aalst, Belgium, 9300
Investigational Site Number 0560007 Recruiting
Gent, Belgium, 9000
Investigational Site Number 0560004 Recruiting
Kortrijk, Belgium, 8500
Investigational Site Number 0560001 Recruiting
Leuven, Belgium, 3000
Investigational Site Number 0560003 Recruiting
Liège, Belgium, 4000
Investigational Site Number 0560005 Recruiting
Mol, Belgium, 2400
Investigational Site Number 0560006 Recruiting
Mons, Belgium, 7000
Investigational Site Number 0560008 Recruiting
Roeselare, Belgium, 8800
Brazil
Investigational Site Number 0760009 Recruiting
Belo Horizonte, Brazil, 30110-908
Investigational Site Number 0760024 Recruiting
Belo Horizonte, Brazil, 30150-221
Investigational Site Number 0760002 Recruiting
Blumenau, Brazil, 89020-430
Investigational Site Number 0760011 Recruiting
Brasilia, Brazil, 70390-903
Investigational Site Number 0760005 Recruiting
Campinas, Brazil, 13060-080
Investigational Site Number 0760006 Recruiting
Campinas, Brazil, 13092-111
Investigational Site Number 0760023 Recruiting
Fortaleza, Brazil, 60840-285
Investigational Site Number 0760018 Recruiting
Goiania, Brazil, 74210050
Investigational Site Number 0760010 Completed
Passo Fundo, Brazil, 99010-180
Investigational Site Number 0760003 Recruiting
Porto Alegre, Brazil, 90020-090
Investigational Site Number 0760020 Recruiting
Porto Alegre, Brazil, 90035 003
Investigational Site Number 0760021 Recruiting
Porto Alegre, Brazil, 90610-000
Investigational Site Number 0760007 Recruiting
Porto Alegre, Brazil, 90620-001
Investigational Site Number 0760013 Recruiting
Porto Alegre, Brazil, 91350-250
Investigational Site Number 0760004 Recruiting
Recife, Brazil, 52051-380
Investigational Site Number 0760001 Recruiting
Sao Jose Do Rio Preto, Brazil, 15090-000
Investigational Site Number 0760012 Recruiting
Sao Paulo, Brazil, 04012-909
Investigational Site Number 0760008 Recruiting
Sao Paulo, Brazil, 05403-000
Investigational Site Number 0760017 Recruiting
Votuporanga, Brazil, 15500-003
Canada
Investigational Site Number 1240013 Recruiting
Cambridge, Canada, N1R 6V6
Investigational Site Number 1240006 Recruiting
Granby, Canada, J2G 1T7
Investigational Site Number 1240015 Recruiting
Halifax, Canada, B3H 3A7
Investigational Site Number 1240003 Recruiting
Hamilton, Canada, L8L 2X2
Investigational Site Number 1240002 Recruiting
Montreal, Canada, H1T 1C8
Investigational Site Number 1240019 Recruiting
Montreal, Canada, H3G 1A4
Investigational Site Number 1240018 Recruiting
Montreal, Canada, H4A 3J1
Investigational Site Number 1240012 Recruiting
Ottawa, Canada, K1Y 4W7
Investigational Site Number 1240004 Recruiting
Peterborough, Canada, K9J 0B2
Investigational Site Number 1240014 Recruiting
Quebec, Canada, G1V 4G5
Investigational Site Number 1240007 Recruiting
Scarborough, Canada, M1B 4Z8
Investigational Site Number 1240005 Recruiting
Sherbrooke, Canada, J1G 2E8
Investigational Site Number 1240011 Recruiting
Toronto, Canada, M5B 1W8
Investigational Site Number 1240001 Recruiting
Toronto, Canada, M5G 2C4
Investigational Site Number 1240009 Recruiting
Trois-Rivières, Canada, G9A 5C5
Chile
Investigational Site Number 1520009 Completed
Concepción, Chile
Investigational Site Number 1520008 Recruiting
Santiago, Chile, 7650568
Investigational Site Number 1520011 Recruiting
Santiago, Chile, 80004005
Investigational Site Number 1520006 Recruiting
Santiago, Chile, 8053095
Investigational Site Number 1520003 Recruiting
Santiago, Chile, 8380456
Investigational Site Number 1520004 Recruiting
Santiago, Chile
Investigational Site Number 1520005 Recruiting
Santiago, Chile
Investigational Site Number 1520012 Recruiting
Santiago, Chile
Investigational Site Number 1520013 Recruiting
Santiago, Chile
Investigational Site Number 1520002 Recruiting
Temuco, Chile
Investigational Site Number 1520010 Recruiting
Vina Del Mar, Chile
Investigational Site Number 1520001 Recruiting
Viña Del Mar, Chile
Czechia
Investigational Site Number 2030001 Recruiting
Brno, Czechia, 62500
Investigational Site Number 2030003 Recruiting
Brno, Czechia, 63600
Investigational Site Number 2030004 Recruiting
Brno, Czechia, 65691
Investigational Site Number 2030014 Recruiting
Kolin 3, Czechia, 28002
Investigational Site Number 2030010 Recruiting
Kromeriz, Czechia, 76701
Investigational Site Number 2030005 Recruiting
Liberec, Czechia, 46063
Investigational Site Number 2030013 Recruiting
Mestec Kralove, Czechia, 28903
Investigational Site Number 2030002 Recruiting
Praha 2, Czechia, 12808
Investigational Site Number 2030007 Recruiting
Praha 5 - Motol, Czechia, 15006
Investigational Site Number 2030017 Recruiting
Praha 5, Czechia, 15030
Investigational Site Number 2030011 Recruiting
Prerov, Czechia, 75152
Investigational Site Number 2030015 Recruiting
Pribram I, Czechia, 26101
Investigational Site Number 2030006 Recruiting
Slany, Czechia, 27401
Denmark
Investigational Site Number 2080003 Recruiting
Aarhus N, Denmark, 8200
Investigational Site Number 2080002 Recruiting
Glostrup, Denmark, 2600
Investigational Site Number 2080001 Recruiting
Herlev, Denmark, 2730
Investigational Site Number 2080005 Recruiting
København Nv, Denmark, 2400
Investigational Site Number 2080004 Recruiting
Ålborg, Denmark, 9100
Finland
Investigational Site Number 2460004 Recruiting
Espoo, Finland, 02740
Investigational Site Number 2460001 Recruiting
Helsinki, Finland, 00029 HUS
Investigational Site Number 2460002 Recruiting
Jyväskylä, Finland, 40620
Investigational Site Number 2460003 Recruiting
Oulu, Finland, 90220
Investigational Site Number 2460005 Recruiting
Seinäjoki, Finland, 60220
France
Investigational Site Number 2500009 Recruiting
Chambray Les Tours, France, 37170
Investigational Site Number 2500008 Recruiting
La Tronche, France, 38700
Investigational Site Number 2500004 Recruiting
Le Chesnay, France, 78150
Investigational Site Number 2500002 Recruiting
Le Coudray, France, 28360
Investigational Site Number 2500001 Recruiting
Lille Cedex, France, 59037
Investigational Site Number 2500007 Recruiting
Nantes Cedex 1, France, 44093
Investigational Site Number 2500012 Recruiting
Nice Cedex 1, France, 06002
Investigational Site Number 2500003 Recruiting
Paris Cedex 18, France, 75877
Investigational Site Number 2500006 Recruiting
Paris, France, 75015
Investigational Site Number 2500005 Recruiting
Toulouse Cedex 9, France, 31059
Investigational Site Number 2500013 Recruiting
Vandoeuvre-Les-Nancy Cedex, France, 54511
Germany
Investigational Site Number 2760020 Recruiting
Bad Nauheim, Germany, 61231
Investigational Site Number 2760016 Recruiting
Bad Oeynhausen, Germany, 32545
Investigational Site Number 2760013 Recruiting
Berlin, Germany, 12203
Investigational Site Number 2760019 Recruiting
Berlin, Germany, 13347
Investigational Site Number 2760001 Recruiting
Berlin, Germany, 13353
Investigational Site Number 2760002 Recruiting
Berlin, Germany, 13353
Investigational Site Number 2760025 Recruiting
Bielefeld, Germany, 33604
Investigational Site Number 2760005 Recruiting
Bonn, Germany, 53115
Investigational Site Number 2760021 Recruiting
Bremen, Germany, 28277
Investigational Site Number 2760035 Recruiting
Coburg, Germany, 96450
Investigational Site Number 2760032 Recruiting
Dortmund, Germany, 44137
Investigational Site Number 2760006 Recruiting
Dortmund, Germany, 44379
Investigational Site Number 2760029 Recruiting
Erfurt, Germany, 99097
Investigational Site Number 2760018 Recruiting
Essen, Germany, 45138
Investigational Site Number 2760033 Recruiting
Frankfurt Am Main, Germany, 65929
Investigational Site Number 2760009 Recruiting
Greifswald, Germany, 17475
Investigational Site Number 2760022 Recruiting
Heidelberg, Germany, 69115
Investigational Site Number 2760031 Recruiting
Heidelberg, Germany, 69120
Investigational Site Number 2760027 Recruiting
Köln, Germany, 50733
Investigational Site Number 2760034 Recruiting
Lahr, Germany, 77933
Investigational Site Number 2760030 Recruiting
Langen, Germany, 63225
Investigational Site Number 2760014 Recruiting
Leverkusen, Germany, 51375
Investigational Site Number 2760036 Recruiting
Limburg, Germany, 65549
Investigational Site Number 2760012 Recruiting
Ludwigshafen, Germany, 67063
Investigational Site Number 2760028 Recruiting
Merseburg, Germany, 06217
Investigational Site Number 2760011 Recruiting
Rotenburg An Der Fulda, Germany, 36199
Investigational Site Number 2760015 Recruiting
Rüsselsheim, Germany, 65428
Investigational Site Number 2760007 Recruiting
Witten, Germany, 58455
Investigational Site Number 2760026 Recruiting
Würzburg, Germany, 97080
Greece
Investigational Site Number 3000012 Recruiting
Athens, Greece, 11526
Investigational Site Number 3000004 Recruiting
Athens, Greece, 11527
Investigational Site Number 3000002 Recruiting
Chalkida, Greece, 34 100
Investigational Site Number 3000003 Recruiting
Chaïdári, Greece, 12462
Investigational Site Number 3000009 Recruiting
Elefsina, Greece, 19600
Investigational Site Number 3000005 Recruiting
Heraklion, Greece, 71110
Investigational Site Number 3000007 Recruiting
Ioannina, Greece, 455 00
Investigational Site Number 3000006 Recruiting
Larissa, Greece, 41110
Investigational Site Number 3000001 Recruiting
N. Ionia, Greece, 14233
Investigational Site Number 3000008 Recruiting
Thessaloniki, Greece, 546 36
Hungary
Investigational Site Number 3480018 Recruiting
Berettyóújfalu, Hungary, 4100
Investigational Site Number 3480012 Recruiting
Budapest, Hungary, 1023
Investigational Site Number 3480016 Recruiting
Budapest, Hungary, 1085
Investigational Site Number 3480010 Recruiting
Budapest, Hungary, 1096
Investigational Site Number 3480019 Recruiting
Budapest, Hungary, 1115
Investigational Site Number 3480001 Recruiting
Budapest, Hungary, 1122
Investigational Site Number 3480015 Recruiting
Budapest, Hungary, 1125
Investigational Site Number 3480011 Recruiting
Budapest, Hungary, 1134
Investigational Site Number 3480014 Recruiting
Budapest, Hungary, 1145
Investigational Site Number 3480005 Recruiting
Budapest, Hungary, 1204
Investigational Site Number 3480004 Recruiting
Cegléd, Hungary, 2700
Investigational Site Number 3480007 Recruiting
Debrecen, Hungary, 4032
Investigational Site Number 3480002 Recruiting
Dombóvár, Hungary, 7200
Investigational Site Number 3480017 Recruiting
Gyula, Hungary, 5700
Investigational Site Number 3480008 Recruiting
Hódmezövásárhely, Hungary, 6800
Investigational Site Number 3480020 Recruiting
Kistarcsa, Hungary, 2143
Investigational Site Number 3480009 Recruiting
Komárom, Hungary, 2921
Investigational Site Number 3480013 Recruiting
Pécs, Hungary, 7624
Investigational Site Number 3480003 Recruiting
Szekesfehervar, Hungary, 8000
Investigational Site Number 3480006 Recruiting
Zalaegerszeg, Hungary, 8900
Israel
Investigational Site Number 3760013 Recruiting
Ashkelon, Israel, 78278
Investigational Site Number 3760004 Recruiting
Hadera, Israel, 38100
Investigational Site Number 3760005 Recruiting
Haifa, Israel, 31096
Investigational Site Number 3760006 Recruiting
Jerusalem, Israel, 91031
Investigational Site Number 3760003 Recruiting
Jerusalem, Israel, 91120
Investigational Site Number 3760008 Recruiting
Jerusalem, Israel
Investigational Site Number 3760010 Recruiting
Nahariya, Israel, 22100
Investigational Site Number 3760002 Recruiting
Petah-Tikva, Israel, 49100
Investigational Site Number 3760011 Recruiting
Rehovot, Israel, 76100
Investigational Site Number 3760009 Recruiting
Safed, Israel, 13100
Investigational Site Number 3760001 Completed
Tel Aviv, Israel, 64239
Investigational Site Number 3760012 Recruiting
Tiberias, Israel, 15208
Italy
Investigational Site Number 3800006 Recruiting
Arzignano (Vi), Italy, 36071
Investigational Site Number 3800011 Recruiting
Brescia, Italy, 25123
Investigational Site Number 3800017 Recruiting
Brescia, Italy, 25124
Investigational Site Number 3800005 Recruiting
Cortona, Italy, 52044
Investigational Site Number 3800009 Recruiting
Ferrara, Italy, 44124
Investigational Site Number 3800020 Recruiting
Gallipoli, Italy, 73014
Investigational Site Number 3800003 Recruiting
Legnago, Italy, 37045
Investigational Site Number 3800023 Recruiting
Milano, Italy, 20122
Investigational Site Number 3800002 Recruiting
Milano, Italy, 20138
Investigational Site Number 3800012 Recruiting
Milano, Italy, 20138
Investigational Site Number 3800008 Recruiting
Milano, Italy, 20162
Investigational Site Number 3800001 Recruiting
Monza, Italy, 20052
Investigational Site Number 3800013 Recruiting
Monza, Italy, 20052
Investigational Site Number 3800022 Recruiting
Napoli, Italy, 80131
Investigational Site Number 3800018 Recruiting
Pavia, Italy, 27100
Investigational Site Number 3800004 Recruiting
Perugia, Italy, 06132
Investigational Site Number 3800016 Recruiting
Pozzilli, Italy, 86077
Investigational Site Number 3800014 Recruiting
Rimini, Italy, 47900
Investigational Site Number 3800010 Recruiting
Roma, Italy, 00153
Investigational Site Number 3800021 Recruiting
Roma, Italy, 00189
Investigational Site Number 3800019 Recruiting
Scorrano, Italy, 73020
Investigational Site Number 3800007 Recruiting
Udine, Italy, 33100
Korea, Republic of
Investigational Site Number 4100008 Recruiting
Bucheon-Si, Korea, Republic of, 14754
Investigational Site Number 4100010 Recruiting
Busan, Korea, Republic of, 49267
Investigational Site Number 4100004 Recruiting
Daegu, Korea, Republic of, 42472
Investigational Site Number 4100001 Recruiting
Hwaseong-Si, Korea, Republic of, 18450
Investigational Site Number 4100003 Recruiting
Incheon, Korea, Republic of, 22332
Investigational Site Number 4100005 Recruiting
Seongnam-Si, Korea, Republic of, 13620
Investigational Site Number 4100002 Recruiting
Seoul, Korea, Republic of, 03080
Investigational Site Number 4100007 Recruiting
Seoul, Korea, Republic of, 03722
Investigational Site Number 4100011 Recruiting
Seoul, Korea, Republic of, 05030
Investigational Site Number 4100009 Recruiting
Seoul, Korea, Republic of, 06351
Latvia
Investigational Site Number 4280004 Recruiting
Daugavpils, Latvia, LV-5417
Investigational Site Number 4280002 Recruiting
Liepaja, Latvia, LV-3414
Investigational Site Number 4280001 Recruiting
Riga, Latvia, LV-1002
Investigational Site Number 4280003 Recruiting
Riga, Latvia, LV-1038
Lithuania
Investigational Site Number 4400002 Recruiting
Kaunas, Lithuania, LT-50161
Investigational Site Number 4400005 Recruiting
Kaunas, Lithuania, LT-50161
Investigational Site Number 4400004 Recruiting
Klaipeda, Lithuania, LT-92288
Investigational Site Number 4400006 Recruiting
Siauliai, Lithuania, LT-76231
Investigational Site Number 4400001 Recruiting
Vilnius, Lithuania, 08661
Investigational Site Number 4400003 Recruiting
Vilnius, Lithuania, 08661
Netherlands
Investigational Site Number 5280003 Recruiting
Amsterdam, Netherlands, 1034 CS
Investigational Site Number 5280001 Recruiting
Breda, Netherlands, 4819 EV
Investigational Site Number 5280007 Recruiting
Delft, Netherlands, 2625 AD
Investigational Site Number 5280002 Recruiting
Doetinchem, Netherlands, 7009 BL
Investigational Site Number 5280004 Recruiting
Hertogenbosch, Netherlands, 5223 GZ 's
Investigational Site Number 5280006 Recruiting
Rotterdam, Netherlands, 3045 PM
Investigational Site Number 5280008 Recruiting
Sneek, Netherlands, 8601
Investigational Site Number 5280005 Recruiting
Veldhoven, Netherlands, 5504 DB
New Zealand
Investigational Site Number 5540007 Recruiting
Auckland, New Zealand, 1023
Investigational Site Number 5540006 Recruiting
Christchurch, New Zealand, 8011
Investigational Site Number 5540002 Recruiting
Hamilton, New Zealand, 3204
Investigational Site Number 5540004 Recruiting
Lower Hutt, New Zealand
Investigational Site Number 5540005 Recruiting
New Plymouth, New Zealand
Investigational Site Number 5540003 Recruiting
Rotorua, New Zealand, 3010
Poland
Investigational Site Number 6160007 Recruiting
Bialystok, Poland, 15-276
Investigational Site Number 6160017 Recruiting
Gdansk, Poland, 80-462
Investigational Site Number 6160002 Recruiting
Grodzisk Mazowiecki, Poland, 05-825
Investigational Site Number 6160014 Recruiting
Katowice, Poland, 40-635
Investigational Site Number 6160021 Recruiting
Krakow, Poland, 30-693
Investigational Site Number 6160001 Recruiting
Krakow, Poland, 31 -202
Investigational Site Number 6160003 Recruiting
Krakow, Poland, 31-501
Investigational Site Number 6160012 Recruiting
Krakow, Poland
Investigational Site Number 6160011 Recruiting
Leczna, Poland, 21-010
Investigational Site Number 6160005 Recruiting
Miechow, Poland, 32-200
Investigational Site Number 6160022 Recruiting
Poznan, Poland, 61-848
Investigational Site Number 6160006 Recruiting
Torun, Poland, 87-100
Investigational Site Number 6160013 Recruiting
Warszawa, Poland, 00-685
Investigational Site Number 6160004 Recruiting
Warszawa, Poland, 03-242
Investigational Site Number 6160020 Recruiting
Warszawa, Poland, 04-073
Investigational Site Number 6160008 Recruiting
Warszawa, Poland, 04-628
Investigational Site Number 6160015 Recruiting
Zamosc, Poland, 22-400
Portugal
Investigational Site Number 6200012 Recruiting
Braga, Portugal, 4710-243
Investigational Site Number 6200001 Recruiting
Coimbra, Portugal, 3000-075
Investigational Site Number 6200011 Recruiting
Guilhufe, Portugal, 4564-007
Investigational Site Number 6200004 Recruiting
Guimarães, Portugal, 4810-061
Investigational Site Number 6200006 Recruiting
Lisboa, Portugal, 1449-005
Investigational Site Number 6200002 Recruiting
Lisboa, Portugal, 1500-650
Investigational Site Number 6200008 Recruiting
Porto, Portugal, 4099-001
Investigational Site Number 6200007 Recruiting
Vila Franca De Xira, Portugal, 2600-009
Investigational Site Number 6200003 Recruiting
Vila Nova De Gaia, Portugal, 4434-502
Investigational Site Number 6200005 Recruiting
Vila Real, Portugal, 5000-508
Romania
Investigational Site Number 6420014 Recruiting
Arad, Romania, 310037
Investigational Site Number 6420006 Recruiting
Baia Mare, Romania, 430031
Investigational Site Number 6420015 Recruiting
Braila, Romania, 810325
Investigational Site Number 6420013 Recruiting
Bucharest, Romania, 010825
Investigational Site Number 6420019 Recruiting
Bucuresti, Romania, 014461
Investigational Site Number 6420011 Recruiting
Bucuresti, Romania, 020125
Investigational Site Number 6420008 Recruiting
Bucuresti, Romania, 022322
Investigational Site Number 6420007 Recruiting
Bucuresti, Romania, 050653
Investigational Site Number 6420002 Recruiting
Cluj Napoca, Romania, 400001
Investigational Site Number 6420003 Recruiting
Cluj Napoca, Romania, 400347
Investigational Site Number 6420016 Recruiting
Craiova, Romania, 200642
Investigational Site Number 6420005 Recruiting
Oradea, Romania, 410169
Investigational Site Number 6420004 Recruiting
Oradea, Romania, 410469
Investigational Site Number 6420018 Recruiting
Satu Mare, Romania, 440156
Investigational Site Number 6420001 Recruiting
Targu Mures, Romania, 540103
Investigational Site Number 6420012 Recruiting
Tg-Mures, Romania, 540136
Investigational Site Number 6420009 Recruiting
Timisoara, Romania, 300079
Investigational Site Number 6420010 Recruiting
Timisoara, Romania, 300723
Russian Federation
Investigational Site Number 6430026 Recruiting
Ivanovo, Russian Federation, 153012
Investigational Site Number 6430023 Recruiting
Kazan, Russian Federation, 420087
Investigational Site Number 6430002 Recruiting
Kemerovo, Russian Federation, 650002
Investigational Site Number 6430006 Recruiting
Kemerovo, Russian Federation, 650002
Investigational Site Number 6430005 Recruiting
Moscow, Russian Federation, 109240
Investigational Site Number 6430004 Recruiting
Moscow, Russian Federation, 111539
Investigational Site Number 6430022 Recruiting
Moscow, Russian Federation, 117292
Investigational Site Number 6430024 Recruiting
Moscow, Russian Federation, 119192
Investigational Site Number 6430001 Recruiting
Moscow, Russian Federation, 121552
Investigational Site Number 6430003 Recruiting
Moscow, Russian Federation, 121552
Investigational Site Number 6430010 Recruiting
Moscow, Russian Federation, 121552
Investigational Site Number 6430018 Recruiting
Nizhniy Novgorod, Russian Federation, 603005
Investigational Site Number 6430013 Recruiting
Rostov-Na-Donu, Russian Federation, 344068
Investigational Site Number 6430011 Recruiting
Saint-Petersburg, Russian Federation, 198205
Investigational Site Number 6430017 Recruiting
Sochi, Russian Federation, 354057
Investigational Site Number 6430025 Recruiting
St-Petersburg, Russian Federation, 193312
Investigational Site Number 6430007 Recruiting
St-Petersburg, Russian Federation, 195067
Investigational Site Number 6430012 Recruiting
St-Petersburg, Russian Federation, 197341
Investigational Site Number 6430009 Recruiting
St-Petersburg, Russian Federation, 199106
Investigational Site Number 6430016 Recruiting
Tomsk, Russian Federation, 634012
Slovakia
Investigational Site Number 7030004 Recruiting
Bratislava 37, Slovakia, 833 48
Investigational Site Number 7030001 Recruiting
Bratislava, Slovakia, 813 69
Investigational Site Number 7030003 Recruiting
Bratislava, Slovakia, 833 05
Investigational Site Number 7030010 Recruiting
Brezno, Slovakia, 97742
Investigational Site Number 7030009 Recruiting
Dolny Kubin, Slovakia, 02614
Investigational Site Number 7030002 Recruiting
Kosice, Slovakia, 040 01
Investigational Site Number 7030011 Recruiting
Nitra, Slovakia, 950 01
Investigational Site Number 7030008 Recruiting
Trnava, Slovakia, 91775
Spain
Investigational Site Number 7240016 Recruiting
Alicante, Spain, 03010
Investigational Site Number 7240015 Completed
Badalona, Spain, 08916
Investigational Site Number 7240020 Recruiting
Hospitalet De Llobregat, Spain, 08907
Investigational Site Number 7240006 Recruiting
La Coruña, Spain, 15006
Investigational Site Number 7240005 Recruiting
Las Palmas De Gran Canaria, Spain, 35020
Investigational Site Number 7240021 Recruiting
Madrid, Spain, 28031
Investigational Site Number 7240008 Recruiting
Madrid, Spain, 28040
Investigational Site Number 7240022 Recruiting
Manises, Spain, 46940
Investigational Site Number 7240007 Recruiting
Murcia, Spain, 30120
Investigational Site Number 7240004 Recruiting
Málaga, Spain, 29010
Investigational Site Number 7240014 Recruiting
Olot, Spain, 17800
Investigational Site Number 7240009 Recruiting
San Sebastián De Los Reyes, Spain, 28702
Investigational Site Number 7240003 Recruiting
Sanlúcar De Barrameda, Spain, 11540
Investigational Site Number 7240001 Recruiting
Sevilla, Spain, 41014
Investigational Site Number 7240019 Recruiting
Sevilla, Spain, 41071
Investigational Site Number 7240012 Recruiting
Valencia, Spain, 46010
Investigational Site Number 7240011 Recruiting
Valencia, Spain, 46014
Investigational Site Number 7240010 Recruiting
Valencia, Spain, 46026
Investigational Site Number 7240002 Recruiting
Villamartín, Spain, 11650
Investigational Site Number 7240013 Recruiting
Zaragoza, Spain, 50009
Investigational Site Number 7240018 Recruiting
Úbeda, Spain, 23400
Sweden
Investigational Site Number 7520004 Recruiting
Jönköping, Sweden, 551 85
Investigational Site Number 7520002 Recruiting
Malmö, Sweden, 205 02
Investigational Site Number 7520006 Recruiting
Skellefteå, Sweden, 931 86
Investigational Site Number 7520007 Recruiting
Stockholm, Sweden, 118 83
Investigational Site Number 7520008 Recruiting
Stockholm, Sweden, 14186
Investigational Site Number 7520001 Recruiting
Stockholm, Sweden, 171 76
Switzerland
Investigational Site Number 7560001 Recruiting
Basel, Switzerland, 4031
Investigational Site Number 7560003 Recruiting
Lugano, Switzerland, 6900
Turkey
Investigational Site Number 7920008 Recruiting
Antalya, Turkey, 07059
Investigational Site Number 7920006 Recruiting
Corum, Turkey, 19200
Investigational Site Number 7920005 Recruiting
Eskisehir, Turkey, 26480
Investigational Site Number 7920002 Recruiting
Haseki/ Istanbul, Turkey, 34034
Investigational Site Number 7920011 Recruiting
Istanbul, Turkey, 34098
Investigational Site Number 7920012 Recruiting
Izmir, Turkey, 35340
Investigational Site Number 7920003 Recruiting
Kocaeli, Turkey, 41300
Investigational Site Number 7920004 Recruiting
Mersin, Turkey, 33169
Investigational Site Number 7920001 Recruiting
Sivas, Turkey, 58140
Investigational Site Number 7920010 Recruiting
Trabzon, Turkey, 61040
United Kingdom
Investigational Site Number 8260005 Recruiting
Bournemouth, United Kingdom, BH7 7DW
Investigational Site Number 8260010 Recruiting
Bristol, United Kingdom, BS10 5NB
Investigational Site Number 8260008 Recruiting
Chelmsford, United Kingdom, CM1 7ET
Investigational Site Number 8260009 Recruiting
Hull, United Kingdom, HU16 5JQ
Investigational Site Number 8260002 Recruiting
Newcastle, United Kingdom, NE1 4LP
Investigational Site Number 8260001 Recruiting
Oldham, United Kingdom, OL1 2JH
Investigational Site Number 8260003 Recruiting
Swansea, United Kingdom, SA6 6NL
Investigational Site Number 8260006 Recruiting
Swindon, United Kingdom, SN3 6BB
Investigational Site Number 8260004 Recruiting
Torquay, United Kingdom, TQ2 7AA
Investigational Site Number 8260007 Recruiting
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03521934     History of Changes
Other Study ID Numbers: EFC15156
2017-003510-16 ( EudraCT Number )
U1111-1190-7891 ( Other Identifier: UTN )
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
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. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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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:
Layout table for MeSH terms
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