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Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED)

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: NCT03315143
Recruitment Status : Active, not recruiting
First Posted : October 19, 2017
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Brief Summary:

Primary Objectives:

To demonstrate that, when compared to placebo in patients with type 2 diabetes (T2D), cardiovascular (CV) risk factors, and moderately impaired renal function, sotagliflozin:

  • Does not increase the risk of cardiovascular events including death from cardiovascular disease, non-fatal heart attack and non-fatal stroke;
  • Reduces the risk of death from CV disease or hospitalization for heart failure.

Secondary Objectives:

  • To demonstrate that, when compared to placebo in patients with T2D, CV risk factors, and moderately impaired renal function, sotagliflozin:
  • Reduces cardiovascular events including death from cardiovascular disease, non-fatal heart attack and non-fatal stroke;
  • Reduces risk of progression of kidney disease;
  • Reduces cardiovascular events including death from cardiovascular disease and emergency treatment for heart failure;
  • Reduces death from cardiovascular disease;
  • Reduces death from any cause.
  • To assess the safety and tolerability of sotagliflozin.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Chronic Kidney Diseases Drug: Sotagliflozin (SAR439954) Drug: Placebo Phase 3

Detailed Description:
Study duration per participant is approximately 27 to 51 months, assuming approximately 24 months of recruitment, and approximately 27 months of follow-up after the last patient is randomized.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sotagliflozin
Sotagliflozin dose 1 (1 tablet), once daily with possible uptitration in the first 6 months to dose 2 (2 tablets)
Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral


Placebo Comparator: Placebo
Placebo dose 1 (1 tablet), once daily with possible uptitration in the first 6 months to dose 2 (2 tablets)
Drug: Placebo

Pharmaceutical form: tablet

Route of administration: oral





Primary Outcome Measures :
  1. Time to first Major Adverse Cardiovascular Event (MACE) [ Time Frame: Baseline to approximately 51 months ]
    Time to the first occurrence of any of the following clinical events: Cardiovascular death, Non-fatal myocardial infarction (MI), Non-fatal stroke

  2. Time to cardiovascular death or hospitalization for heart failure [ Time Frame: Baseline to approximately 51 months ]
    Time to the first occurrence of any of the following clinical events: Cardiovascular death; Hospitalization for heart failure


Secondary Outcome Measures :
  1. Time to first composite renal event [ Time Frame: Baseline to approximately 51 months ]
    Time to the first occurrence of any of the following clinical events in patients with baseline eGFR ≥30 mL/min/1.73 m2: Sustained ≥50% decrease of eGFR from baseline (for ≥30 days); chronic dialysis, renal transplant or sustained eGFR <15 ml/min/1.73 m2 (for ≥30 days)

  2. Time to first composite renal event in subgroup of patients with macroalbuminuria [ Time Frame: Baseline to approximately 51 months ]
    Time to the first occurrence of any of the following clinical events in patients with baseline eGFR ≥30 mL/min/1.73 m2 and baseline UACR ≥300 mg/g: Sustained ≥50% decrease of eGFR from baseline (for ≥30 days); chronic dialysis, renal transplant or sustained eGFR <15 ml/min/1.73 m2 (for ≥30 days

  3. Total number of heart failure events [ Time Frame: Baseline to approximately 51 months ]
    Total number (ie, including recurrent events) of the following clinical events: Cardiovascular death, Hospitalization for heart failure; Urgent heart failure visit

  4. Cardiovascular (CV) death [ Time Frame: Baseline to approximately 51 months ]
    Time to CV death

  5. All cause mortality [ Time Frame: Baseline to approximately 51 months ]
    Time to all-cause mortality



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) ≥ 7%.
  • Estimated glomerular filtration rate (eGFR) ≥ 25 and ≤ 60 mL/min/1.73 m2.
  • Age 18 years or older with at least one major cardiovascular risk factor or age 55 years or older with at least two minor cardiovascular risk factors.
  • Signed written informed consent.

Exclusion criteria:

  • Antihyperglycemic treatment has not been stable within 12 weeks prior to screening.
  • Planned coronary procedure or surgery after randomization.
  • 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.

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): NCT03315143


Locations
Hide Hide 754 study locations
Layout table for location information
United States, Alabama
Investigational Site Number 8400017
Birmingham, Alabama, United States, 35205
Investigational Site Number 8400096
Sheffield, Alabama, United States, 35660
United States, Arizona
Investigational Site Number 8400004
Mesa, Arizona, United States, 85206
Investigational Site Number 8400059
Mesa, Arizona, United States, 85210
Investigational Site Number 8400021
Peoria, Arizona, United States, 85381
Investigational Site Number 8400014
Surprise, Arizona, United States, 85374
United States, Arkansas
Investigational Site Number 8400071
Little Rock, Arkansas, United States, 72211
United States, California
Investigational Site Number 8400039
Beverly Hills, California, United States, 90211
Investigational Site Number 8400042
Concord, California, United States, 94520
Investigational Site Number 8400089
Fresno, California, United States, 93720
Investigational Site Number 8400006
Huntington Park, California, United States, 90255
Investigational Site Number 8400036
Long Beach, California, United States, 90807
Investigational Site Number 8400073
Los Angeles, California, United States, 90017
Investigational Site Number 8400084
Los Angeles, California, United States, 90022-4302
Investigational Site Number 8400035
Los Gatos, California, United States, 95032
Investigational Site Number 8400043
Northridge, California, United States, 91325
Investigational Site Number 8400025
Sacramento, California, United States, 95821
Investigational Site Number 8400018
San Dimas, California, United States, 91713
Investigational Site Number 8400070
Temecula, California, United States, 92591
United States, Connecticut
Investigational Site Number 8400013
Waterbury, Connecticut, United States, 06708
United States, Florida
Investigational Site Number 8400095
Bradenton, Florida, United States, 34209
Investigational Site Number 8400090
Clearwater, Florida, United States, 33756
Investigational Site Number 8400121
Clearwater, Florida, United States, 33756
Investigational Site Number 8400049
Cooper City, Florida, United States, 33024
Investigational Site Number 8400092
Hialeah, Florida, United States, 33012
Investigational Site Number 8400026
Hollywood, Florida, United States, 33024
Investigational Site Number 8400134
Jacksonville, Florida, United States, 32204
Investigational Site Number 8400055
Jacksonville, Florida, United States, 32207-4966
Investigational Site Number 8400056
Jacksonville, Florida, United States, 32216
Investigational Site Number 8400031
Jacksonville, Florida, United States, 32277
Investigational Site Number 8400037
Maitland, Florida, United States, 32751
Investigational Site Number 8400078
Miami, Florida, United States, 33126
Investigational Site Number 8400117
Miami, Florida, United States, 33135
Investigational Site Number 8400119
Miami, Florida, United States, 33135
Investigational Site Number 8400118
Miami, Florida, United States, 33165
Investigational Site Number 8400105
Miami, Florida, United States, 33174
Investigational Site Number 8400120
Miami, Florida, United States, 33176
Investigational Site Number 8400088
North Miami Beach, Florida, United States, 33162
Investigational Site Number 8400106
Opa-locka, Florida, United States, 33054
Investigational Site Number 8400063
Ormond Beach, Florida, United States, 32174
Investigational Site Number 8400087
Palm Harbor, Florida, United States, 34684-3609
Investigational Site Number 8400058
Saint Petersburg, Florida, United States, 33713
Investigational Site Number 8400108
Spring Hill, Florida, United States, 34609
Investigational Site Number 8400051
Tampa, Florida, United States, 33624
United States, Georgia
Investigational Site Number 8400123
Atlanta, Georgia, United States, 30303
Investigational Site Number 8400076
Roswell, Georgia, United States, 30076
United States, Hawaii
Investigational Site Number 8400033
Honolulu, Hawaii, United States, 96814
United States, Illinois
Investigational Site Number 8400085
Arlington Heights, Illinois, United States, 60005
Investigational Site Number 8400104
Chicago, Illinois, United States, 60611
Investigational Site Number 8400027
Chicago, Illinois, United States, 60612
Investigational Site Number 8400124
Chicago, Illinois, United States, 60612
Investigational Site Number 8400001
Chicago, Illinois, United States, 60616
Investigational Site Number 8400052
Crystal Lake, Illinois, United States, 60012
Investigational Site Number 8400028
Springfield, Illinois, United States, 62711
United States, Indiana
Investigational Site Number 8400125
Michigan City, Indiana, United States, 46360
Investigational Site Number 8400098
Valparaiso, Indiana, United States, 46383
United States, Iowa
Investigational Site Number 8400003
Des Moines, Iowa, United States, 50314
United States, Kansas
Investigational Site Number 8400081
Topeka, Kansas, United States, 66606
United States, Kentucky
Investigational Site Number 8400041
Louisville, Kentucky, United States, 40213
United States, Maine
Investigational Site Number 8400080
Bangor, Maine, United States, 04401
United States, Michigan
Investigational Site Number 8400002
Flint, Michigan, United States, 48504
Investigational Site Number 8400069
Flint, Michigan, United States, 48532-3447
Investigational Site Number 8400016
Troy, Michigan, United States, 48098
United States, Minnesota
Investigational Site Number 8400023
Saint Cloud, Minnesota, United States, 56303
United States, Missouri
Investigational Site Number 8400066
Kansas City, Missouri, United States, 64111
Investigational Site Number 8400024
Saint Louis, Missouri, United States, 63136
Investigational Site Number 8400130
Washington, Missouri, United States, 63090
United States, Nebraska
Investigational Site Number 8400045
Omaha, Nebraska, United States, 68198-4100
United States, Nevada
Investigational Site Number 8400009
Las Vegas, Nevada, United States, 89148
United States, New York
Investigational Site Number 8400101
Albany, New York, United States, 12206
Investigational Site Number 8400061
Laurelton, New York, United States, 11413
Investigational Site Number 8400046
New York, New York, United States, 10029-6501
Investigational Site Number 8400112
Rosedale, New York, United States, 11422
Investigational Site Number 8400062
Smithtown, New York, United States, 11787
United States, North Carolina
Investigational Site Number 8400079
Greenville, North Carolina, United States, 27834-5704
Investigational Site Number 8400020
Morehead City, North Carolina, United States, 28557
Investigational Site Number 8400048
Morehead City, North Carolina, United States, 28557
Investigational Site Number 8400010
Morganton, North Carolina, United States, 28655
United States, North Dakota
Investigational Site Number 8400072
Fargo, North Dakota, United States, 58103
United States, Ohio
Investigational Site Number 8400038
Cincinnati, Ohio, United States, 45219
Investigational Site Number 8400007
Cincinnati, Ohio, United States, 45241
Investigational Site Number 8400015
Columbus, Ohio, United States, 43210
Investigational Site Number 8400113
Lorain, Ohio, United States, 44053
Investigational Site Number 8400011
Mentor, Ohio, United States, 44060
United States, Oregon
Investigational Site Number 8400109
Bend, Oregon, United States, 97702
United States, Pennsylvania
Investigational Site Number 8400047
Beaver, Pennsylvania, United States, 15009
Investigational Site Number 8400019
Greensburg, Pennsylvania, United States, 15601
Investigational Site Number 8400097
Indiana, Pennsylvania, United States, 15701-3578
Investigational Site Number 8400032
Levittown, Pennsylvania, United States, 19056-2404
Investigational Site Number 8400053
Philadelphia, Pennsylvania, United States, 19107
Investigational Site Number 8400012
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Investigational Site Number 8400064
Anderson, South Carolina, United States, 29621
Investigational Site Number 8400030
Greer, South Carolina, United States, 29651
Investigational Site Number 8400029
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Investigational Site Number 8400040
Memphis, Tennessee, United States, 38163
United States, Texas
Investigational Site Number 8400114
Arlington, Texas, United States, 76015
Investigational Site Number 8400067
Corpus Christi, Texas, United States, 78814
Investigational Site Number 8400082
Dallas, Texas, United States, 75231
Investigational Site Number 8400022
El Paso, Texas, United States, 79935
Investigational Site Number 8400099
Houston, Texas, United States, 77043
Investigational Site Number 8400103
Houston, Texas, United States, 77070
Investigational Site Number 8400086
Katy, Texas, United States, 77450
Investigational Site Number 8400100
Mesquite, Texas, United States, 75150
Investigational Site Number 8400094
Plano, Texas, United States, 75093
Investigational Site Number 8400116
San Antonio, Texas, United States, 78224
Investigational Site Number 8400091
Waco, Texas, United States, 76710
United States, Utah
Investigational Site Number 8400065
Bountiful, Utah, United States, 84010-7717
Investigational Site Number 8400131
Ogden, Utah, United States, 84405
United States, Vermont
Investigational Site Number 8400093
Bennington, Vermont, United States, 05201
Investigational Site Number 8400060
South Burlington, Vermont, United States, 05403
United States, Virginia
Investigational Site Number 8400133
Danville, Virginia, United States, 24541-2834
Investigational Site Number 8400054
Fairfax, Virginia, United States, 22039
Investigational Site Number 8400132
Falls Church, Virginia, United States, 22044
Investigational Site Number 8400034
Manassas, Virginia, United States, 20110
Investigational Site Number 8400050
Norfolk, Virginia, United States, 23510
Investigational Site Number 8400044
Richmond, Virginia, United States, 23235
Investigational Site Number 8400111
Richmond, Virginia, United States, 23249
United States, Washington
Investigational Site Number 8400083
Federal Way, Washington, United States, 98003
Investigational Site Number 8400068
Spokane, Washington, United States, 99207
Argentina
Investigational Site Number 0320016
Buenos Aires, Argentina
Investigational Site Number 0320029
Buenos Aires, Argentina
Investigational Site Number 0320017
Caba, Argentina, 1120
Investigational Site Number 0320002
Caba, Argentina, C1093AAS
Investigational Site Number 0320004
Caba, Argentina, C1118AAE
Investigational Site Number 0320018
Caba, Argentina, C1119ACN
Investigational Site Number 0320025
Caba, Argentina, C1128AAF
Investigational Site Number 0320019
Caba, Argentina
Investigational Site Number 0320027
Capital Federal, Argentina, C1056ABJ
Investigational Site Number 0320015
Capital Federal, Argentina, C1179AAB
Investigational Site Number 0320014
Ciudad Autonoma De Bs.As, Argentina, C1428DCO
Investigational Site Number 0320023
Ciudad Autonoma De Buenos Aire, Argentina, C1204AAD
Investigational Site Number 0320009
Ciudadela, Argentina, B1702BML
Investigational Site Number 0320001
Cordoba, Argentina, X5000AAX
Investigational Site Number 0320008
Coronel Suarez, Argentina, B7540GHD
Investigational Site Number 0320011
Corrientes, Argentina, W3400AMZ
Investigational Site Number 0320028
La Plata, Argentina, B1900AXI
Investigational Site Number 0320006
La Plata, Argentina, B1906ESC
Investigational Site Number 0320024
Mar Del Plata, Argentina, B7600FZN
Investigational Site Number 0320003
Mar Del Plata, Argentina, B7600
Investigational Site Number 0320020
Merlo, Argentina, B1722COV
Investigational Site Number 0320007
Ramos Mejia, Argentina, B1704ETD
Investigational Site Number 0320030
Rosario, Argentina, S2000CVD
Investigational Site Number 0320026
Rosario, Argentina, S2000DEJ
Investigational Site Number 0320012
Salta, Argentina, 4400
Investigational Site Number 0320021
San Miguel De Tucuman, Argentina, T4000ICL
Investigational Site Number 0320013
Santa Fe, Argentina, S3000FWO
Investigational Site Number 0320022
Temperley, Argentina, 1842
Investigational Site Number 0320005
Villa Maria, Argentina, X5900JKA
Australia
Investigational Site Number 0360014
Adelaide, Australia, 5000
Investigational Site Number 0360004
Box Hill, Australia, 3128
Investigational Site Number 0360015
Elizabeth Vale, Australia, 5112
Investigational Site Number 0360005
Fitzroy, Australia, 3065
Investigational Site Number 0360018
Fremantle, Australia, 6160
Investigational Site Number 0360007
Fullarton, Australia, 5063
Investigational Site Number 0360002
Gosford, Australia, 2250
Investigational Site Number 0360016
Heidelberg, Australia, 3081
Investigational Site Number 0360010
Herston, Australia, 4029
Investigational Site Number 0360009
Liverpool, Australia, 2170
Investigational Site Number 0360017
Melbourne, Australia, 3004
Investigational Site Number 0360001
Merewether, Australia, 2291
Investigational Site Number 0360012
Oaklands Park, Australia, 5046
Investigational Site Number 0360011
Parkville, Australia, 3050
Investigational Site Number 0360008
Redcliffe, Australia, 4020
Investigational Site Number 0360013
Sherwood, Australia, 4075
Investigational Site Number 0360019
St Leonards, Australia, 2065
Investigational Site Number 0360006
Wollongong, Australia, 2500
Belgium
Investigational Site Number 0560004
Bonheiden, Belgium, 2820
Investigational Site Number 0560005
Gent, Belgium, 9000
Investigational Site Number 0560003
Kortrijk, Belgium, 8500
Investigational Site Number 0560002
La-Louvière, Belgium, 7100
Investigational Site Number 0560001
Leuven, Belgium, 3000
Brazil
Investigational Site Number 0760017
Blumenau, Brazil, 89020-430
Investigational Site Number 0760015
Brasilia, Brazil, 70200-730
Investigational Site Number 0760026
Brasilia, Brazil, 70390-903
Investigational Site Number 0760008
Campinas, Brazil, 13015-001
Investigational Site Number 0760005
Campinas, Brazil, 13060-080
Investigational Site Number 0760018
Canoas, Brazil, 92425-900
Investigational Site Number 0760019
Curitiba, Brazil, 80030-110
Investigational Site Number 0760011
Curitiba, Brazil, 80230-130
Investigational Site Number 0760007
Curitiba, Brazil, 80730-150
Investigational Site Number 0760010
Fortaleza, Brazil, 60115-282
Investigational Site Number 0760002
Fortaleza, Brazil, 60170-320
Investigational Site Number 0760004
Fortaleza, Brazil, 60430-350
Investigational Site Number 0760014
Passo Fundo, Brazil, 99010-180
Investigational Site Number 0760025
Porto Alegre, Brazil, 90020-090
Investigational Site Number 0760016
Porto Alegre, Brazil, 90430-001
Investigational Site Number 0760024
Recife, Brazil, 52051-380
Investigational Site Number 0760023
Rio De Janeiro, Brazil, 22271-100
Investigational Site Number 0760001
Sao Jose Do Rio Preto, Brazil, 15090-000
Investigational Site Number 0760012
Sao Jose Dos Campos, Brazil, 12243-280
Investigational Site Number 0760020
Sao Paulo, Brazil, 01228-200
Investigational Site Number 0760013
Sao Paulo, Brazil, 04038-002
Investigational Site Number 0760022
Sao Paulo, Brazil, 04266-010
Investigational Site Number 0760006
Sao Paulo, Brazil, 05403-000
Investigational Site Number 0760009
Sao Paulo, Brazil, 05403-000
Investigational Site Number 0760003
São Paulo, Brazil, 01.228-000
Investigational Site Number 0760021
Vitoria, Brazil, 29055 450
Bulgaria
Investigational Site Number 1000015
Blagoevgrad, Bulgaria, 2700
Investigational Site Number 1000008
Dobrich, Bulgaria, MULTIPROFILE HOSPITA
Investigational Site Number 1000013
Gabrovo, Bulgaria, 5300
Investigational Site Number 1000003
Plovdiv, Bulgaria, 4002
Investigational Site Number 1000016
Ruse, Bulgaria, 7002
Investigational Site Number 1000014
Silistra, Bulgaria, 7500
Investigational Site Number 1000007
Smolyan, Bulgaria, 4700
Investigational Site Number 1000011
Sofia, Bulgaria, 1233
Investigational Site Number 1000004
Sofia, Bulgaria, 1431
Investigational Site Number 1000006
Sofia, Bulgaria, 1431
Investigational Site Number 1000012
Sofia, Bulgaria, 1632
Investigational Site Number 1000005
Sofia, Bulgaria, 1750
Investigational Site Number 1000017
Sofia, Bulgaria, 1784
Investigational Site Number 1000001
Stara Zagora, Bulgaria, 6000
Investigational Site Number 1000018
Stara Zagora, Bulgaria, 6000
Canada
Investigational Site Number 1240002
Brampton, Canada, L6S0C6
Investigational Site Number 1240013
Burlington, Canada, L7M 4Y1
Investigational Site Number 1240021
Calgary, Canada, T2T 5C7
Investigational Site Number 1240005
Calgary, Canada, T2V 4J2
Investigational Site Number 1240029
Concord, Canada, L4K 4M2
Investigational Site Number 1240004
Edmonton, Canada, T5A 4L8
Investigational Site Number 1240010
Edmonton, Canada, T6H 2L4
Investigational Site Number 1240027
Halifax, Canada, B3H 2Y9
Investigational Site Number 1240023
Hamilton, Canada, L8N 3Z5
Investigational Site Number 1240011
London, Canada, N6A 4V2
Investigational Site Number 1240019
Montreal, Canada, H1T 1C8
Investigational Site Number 1240017
Montreal, Canada, H4A 2C6
Investigational Site Number 1240018
Montreal, Canada, H4N 2W2
Investigational Site Number 1240007
Newmarket, Canada, L3Y 5G8
Investigational Site Number 1240026
Oshawa, Canada, L1G 2B9
Investigational Site Number 1240016
Oshawa, Canada, L1J 2K1
Investigational Site Number 1240006
Ottawa, Canada, K1H7W9
Investigational Site Number 1240022
Quebec, Canada, G1G 3Z4
Investigational Site Number 1240025
Quebec, Canada, G1V 4G5
Investigational Site Number 1240014
Quebec, Canada, G1V 4W2
Investigational Site Number 1240003
Quebec, Canada, G1W-4R4
Investigational Site Number 1240034
Saint-Charles-Borromee, Canada, J6E 6J2
Investigational Site Number 1240032
St-Marc-Des-Carrieres, Canada, G0A 4B0
Investigational Site Number 1240033
St. John'S, Canada, A1B 3V6
Investigational Site Number 1240008
Sudbury, Canada, P3E 4H5
Investigational Site Number 1240031
Surrey, Canada, V3V 0C6
Investigational Site Number 1240028
Toronto, Canada, M6G 1M2
Investigational Site Number 1240015
Trois-Rivieres, Canada, G8Z 3R9
Investigational Site Number 1240001
Vancouver, Canada, V5Y 3W2
Investigational Site Number 1240030
Victoria, Canada, V8R 1B2
Chile
Investigational Site Number 1520015
Concepción, Chile, 4070566
Investigational Site Number 1520003
Osorno, Chile, 5311092
Investigational Site Number 1520012
Punta Arenas, Chile, 6210490
Investigational Site Number 1520013
Santiago, Chile, 7500571
Investigational Site Number 1520018
Santiago, Chile, 7500588
Investigational Site Number 1520001
Santiago, Chile, 7500710
Investigational Site Number 1520004
Santiago, Chile, 7500710
Investigational Site Number 1520006
Santiago, Chile, 7500739
Investigational Site Number 1520014
Santiago, Chile, 7591047
Investigational Site Number 1520016
Santiago, Chile, 7650568
Investigational Site Number 1520017
Santiago, Chile, 7770086
Investigational Site Number 1520020
Santiago, Chile, 7770086
Investigational Site Number 1520009
Santiago, Chile, 8053095
Investigational Site Number 1520011
Santiago, Chile, 8207257
Investigational Site Number 1520026
Santiago, Chile, 833-0024
Investigational Site Number 1520010
Santiago, Chile, 8330336
Investigational Site Number 1520007
Santiago, Chile, 8380456
Investigational Site Number 1520021
Santiago, Chile, 8900132
Investigational Site Number 1520022
Santiago, Chile, 8910131
Investigational Site Number 1520002
Santiago, Chile
Investigational Site Number 1520024
Talca, Chile
Investigational Site Number 1520019
Temuco, Chile, 4781156
Investigational Site Number 1520025
Temuco, Chile, 4781173
Investigational Site Number 1520005
Temuco, Chile, 4813299
Investigational Site Number 1520008
Viña Del Mar, Chile
China
Investigational Site Number 1560019
Beijing, China, 100034
Investigational Site Number 1560001
Beijing, China, 100037
Investigational Site Number 1560002
Beijing, China, 100044
Investigational Site Number 1560003
Beijing, China, 100730
Investigational Site Number 1560032
Beijing, China, 100730
Investigational Site Number 1560012
Changchun, China, 130021
Investigational Site Number 1560023
Changchun, China, 130021
Investigational Site Number 1560034
Changchun, China, 130033
Investigational Site Number 1560022
Changsha, China, 410013
Investigational Site Number 1560021
Chengdu, China, 610041
Investigational Site Number 1560018
Dalian, China, 116011
Investigational Site Number 1560010
Dalian, China, 116033
Investigational Site Number 1560007
Guangzhou, China, 510080
Investigational Site Number 1560016
Haikou, China, 570102
Investigational Site Number 1560033
Hengyang, China, 421001
Investigational Site Number 1560038
Hohhot, China, 010020
Investigational Site Number 1560005
Huai'An, China, 223300
Investigational Site Number 1560009
Jinan, China, 250013
Investigational Site Number 1560037
Jining, China
Investigational Site Number 1560031
Nanchang, China, 330006
Investigational Site Number 1560004
Nanjing, China, 210008
Investigational Site Number 1560006
Shanghai, China, 200120
Investigational Site Number 1560036
Shenyang, China, 110016
Investigational Site Number 1560020
Siping, China, 136000
Investigational Site Number 1560025
Suzhou, China, 215004
Investigational Site Number 1560014
Suzhou, China, 215006
Investigational Site Number 1560026
Taizhou, China, 317000
Investigational Site Number 1560028
Tianjin, China, 300121
Investigational Site Number 1560029
Tianjin, China, 300211
Investigational Site Number 1560024
Wuhan, China, 430033
Investigational Site Number 1560027
Xi'An, China, 710061
Investigational Site Number 1560035
Xinxiang, China, 453000
Investigational Site Number 1560008
Zhenjiang, China, 212001
Czechia
Investigational Site Number 2030012
Brno, Czechia, 62500
Investigational Site Number 2030002
Brno, Czechia, 63900
Investigational Site Number 2030021
Broumov, Czechia, 550 01
Investigational Site Number 2030017
Humpolec, Czechia, 396 01
Investigational Site Number 2030014
Liberec, Czechia, 46063
Investigational Site Number 2030007
Marianske Lazne, Czechia, 353 01
Investigational Site Number 2030015
Mestec Kralove, Czechia, 28903
Investigational Site Number 2030009
Plzen, Czechia, 301 00
Investigational Site Number 2030016
Praha 10, Czechia, 10800
Investigational Site Number 2030019
Praha 1, Czechia, 11694
Investigational Site Number 2030006
Praha 2, Czechia, 12808
Investigational Site Number 2030005
Praha 4, Czechia, 14021
Investigational Site Number 2030011
Praha 6, Czechia, 16900
Investigational Site Number 2030018
Praha 8, Czechia, 18100
Investigational Site Number 2030010
Revnice, Czechia, 25230
Investigational Site Number 2030020
Slany, Czechia, 27401
Investigational Site Number 2030001
Trutnov, Czechia, 54101
Investigational Site Number 2030008
Vsetin, Czechia, 75501
Denmark
Investigational Site Number 2080003
Aarhus N, Denmark, 8200
Investigational Site Number 2080005
Aarhus N, Denmark, 8200
Investigational Site Number 2080009
Gentofte, Denmark, 2900
Investigational Site Number 2080004
Herlev, Denmark, 2730
Investigational Site Number 2080008
Hvidovre, Denmark, 2650
Investigational Site Number 2080002
København Nv, Denmark, 2400
Investigational Site Number 2080007
Slagelse, Denmark, 4200
Investigational Site Number 2080006
Svendborg, Denmark, 5700
Estonia
Investigational Site Number 2330003
Tallinn, Estonia, 10138
Investigational Site Number 2330001
Tallinn, Estonia, 13419
Investigational Site Number 2330002
Tartu, Estonia, 51014
France
Investigational Site Number 2500003
Corbeil-Essonnes, France, 91106
Investigational Site Number 2500002
La Rochelle Cedex, France, 17019
Investigational Site Number 2500001
Paris Cedex 18, France, 75877
Investigational Site Number 2500005
Paris, France, 75010
Investigational Site Number 2500006
Paris, France, 75018
Investigational Site Number 2500004
Toulouse Cedex 9, France, 31059
Investigational Site Number 2500007
Venissieux, France, 69200
Georgia
Investigational Site Number 2680004
Batumi, Georgia, 6010
Investigational Site Number 2680001
Kutaisi, Georgia
Investigational Site Number 2680007
Tbilisi, Georgia, 0159
Investigational Site Number 2680005
Tbilisi, Georgia, 102
Investigational Site Number 2680003
Tbilisi, Georgia, 159
Investigational Site Number 2680006
Tbilisi, Georgia, 159
Investigational Site Number 2680002
Tbilisi, Georgia
Germany
Investigational Site Number 2760008
Berlin, Germany, 12351
Investigational Site Number 2760005
Essen, Germany, 45136
Investigational Site Number 2760001
Freiburg, Germany, 79106
Investigational Site Number 2760007
Hamburg, Germany, 22041
Investigational Site Number 2760002
Kassel, Germany, 34121
Investigational Site Number 2760006
Leipzig, Germany, 04103
Investigational Site Number 2760003
Münster, Germany, 48149
Investigational Site Number 2760009
Oldenburg In Holstein, Germany, 23758
Greece
Investigational Site Number 3000001
Athens, Greece, 11527
Investigational Site Number 3000002
Ioannina, Greece, 45500
Investigational Site Number 3000004
Larissa, Greece, 41110
Investigational Site Number 3000003
Pireas, Greece, 18454
Investigational Site Number 3000005
Thessaloniki, Greece, 54629
Guatemala
Investigational Site Number 3200007
Guatemala, Guatemala, 01001
Investigational Site Number 3200013
Guatemala, Guatemala, 01010
Investigational Site Number 3200001
Guatemala, Guatemala, 01014
Investigational Site Number 3200002
Guatemala, Guatemala, 1010
Investigational Site Number 3200009
Guatemala, Guatemala, 1010
Investigational Site Number 3200010
Guatemala, Guatemala
Investigational Site Number 3200006
Quetzaltenango, Guatemala, 09001
Investigational Site Number 3200014
Quetzaltenango, Guatemala, 09001
Investigational Site Number 3200004
Quetzaltenango, Guatemala, 9011
Hungary
Investigational Site Number 3480017
Budapest, Hungary, 1027
Investigational Site Number 3480004
Budapest, Hungary, 1042
Investigational Site Number 3480011
Budapest, Hungary, 1096
Investigational Site Number 3480001
Budapest, Hungary, 1122
Investigational Site Number 3480010
Budapest, Hungary, 1125
Investigational Site Number 3480012
Budapest, Hungary, 1134
Investigational Site Number 3480016
Budapest, Hungary, 1145
Investigational Site Number 3480018
Budapest, Hungary, 1204
Investigational Site Number 3480006
Békéscsaba, Hungary, 5600
Investigational Site Number 3480002
Debrecen, Hungary, 4032
Investigational Site Number 3480008
Debrecen, Hungary, 4032
Investigational Site Number 3480013
Kaposvár, Hungary, 7400
Investigational Site Number 3480014
Nyíregyháza, Hungary, 4400
Investigational Site Number 3480015
Nyíregyháza, Hungary, 4400
Investigational Site Number 3480003
Szekesfehervar, Hungary, 8000
Investigational Site Number 3480007
Zalaegerszeg, Hungary, 8900
India
Investigational Site Number 3560025
Ahmedabad, India, 380060
Investigational Site Number 3560040
Aurangabad, India, 431003
Investigational Site Number 3560010
Bangalore, India, 560 034
Investigational Site Number 3560026
Bangalore, India, 560 054.
Investigational Site Number 3560005
Belgaum, India, 590010
Investigational Site Number 3560008
Bengaluru, India, 560017
Investigational Site Number 3560022
Chandigarh, India, 160062
Investigational Site Number 3560003
Gurgaon, India, 122001
Investigational Site Number 3560004
Gurgaon, India, 122001
Investigational Site Number 3560018
Hyderabad, India, 500001
Investigational Site Number 3560001
Hyderabad, India, 500012
Investigational Site Number 3560007
Hyderabad, India, 500063
Investigational Site Number 3560002
Jaipur, India, 302017
Investigational Site Number 3560024
Kochi, India
Investigational Site Number 3560016
Kolkata, India, 700027
Investigational Site Number 3560030
Kozhikode, India, 673008
Investigational Site Number 3560006
Ludhiana, India, 141008
Investigational Site Number 3560027
Mangalore, India, 575002
Investigational Site Number 3560028
Mangalore, India, 575018
Investigational Site Number 3560017
Mumbai, India
Investigational Site Number 3560037
Mysore, India, 570015
Investigational Site Number 3560013
Nagpur, India, 440009
Investigational Site Number 3560014
Nagpur, India, 440010
Investigational Site Number 3560021
Nashik, India, 42003
Investigational Site Number 3560041
New Delhi, India, 110 029
Investigational Site Number 3560034
New Delhi, India, 110002
Investigational Site Number 3560019
Pune, India, 411001
Investigational Site Number 3560035
Pune, India, 411004
Investigational Site Number 3560042
Pune, India, 411004
Investigational Site Number 3560038
Pune, India, 411010
Investigational Site Number 3560012
Pune, India, 411019
Investigational Site Number 3560043
Varanasi, India, 221 005
Investigational Site Number 3560020
Vellore, India, 632004
Investigational Site Number 3560015
Wardha, India, 442004
Israel
Investigational Site Number 3760008
Beer Sheva, Israel, 84101
Investigational Site Number 3760005
Haifa, Israel, 31048
Investigational Site Number 3760007
Haifa, Israel, 31096
Investigational Site Number 3760001
Jerusalem, Israel, 91031
Investigational Site Number 3760002
Jerusalem, Israel, 91120
Investigational Site Number 3760004
Nahariya, Israel, 22100
Investigational Site Number 3760003
Tel Aviv, Israel, 64239
Investigational Site Number 3760006
Tel Hashomer, Israel, 52621
Italy
Investigational Site Number 3800006
Catanzaro, Italy, 88100
Investigational Site Number 3800010
Catanzaro, Italy, 88100
Investigational Site Number 3800009
Chieri, Italy, 10023
Investigational Site Number 3800007
Livorno, Italy, 57123
Investigational Site Number 3800002
Milano, Italy, 20132
Investigational Site Number 3800008
Milano, Italy, 20145
Investigational Site Number 3800005
Orbassano, Italy, 10043
Investigational Site Number 3800011
Ravenna, Italy, 48100
Investigational Site Number 3800004
Roma, Italy, 00133
Investigational Site Number 3800001
Verona, Italy, 37126
Korea, Republic of
Investigational Site Number 4100011
Bucheon-Si, Korea, Republic of, 14647
Investigational Site Number 4100005
Busan, Korea, Republic of, 49201
Investigational Site Number 4100007
Gwangju, Korea, Republic of, 61469
Investigational Site Number 4100001
Incheon, Korea, Republic of, 22332
Investigational Site Number 4100002
Seongnam-Si, Korea, Republic of, 13620
Investigational Site Number 4100003
Seoul, Korea, Republic of, 03080
Investigational Site Number 4100006
Seoul, Korea, Republic of, 03722
Investigational Site Number 4100008
Seoul, Korea, Republic of, 05505
Investigational Site Number 4100004
Seoul, Korea, Republic of, 06351
Investigational Site Number 4100010
Uijeongbu-Si, Korea, Republic of, 11765
Latvia
Investigational Site Number 4280004
Daugavpils, Latvia, LV-5417
Investigational Site Number 4280002
Liepāja, Latvia, LV3414
Investigational Site Number 4280007
Ogre, Latvia, LV-5001
Investigational Site Number 4280006
Riga, Latvia, LV-1002
Investigational Site Number 4280001
Riga, Latvia, LV-1011
Investigational Site Number 4280005
Riga, Latvia, LV-1038
Investigational Site Number 4280003
Sigulda, Latvia, LV-2150
Lithuania
Investigational Site Number 4400006
Kaunas, Lithuania, 49449
Investigational Site Number 4400003
Kaunas, Lithuania, 51270
Investigational Site Number 4400009
Kaunas, Lithuania, LT-50161
Investigational Site Number 4400008
Kedainiai, Lithuania, LT-57164
Investigational Site Number 4400004
Klaipeda, Lithuania, 92111
Investigational Site Number 4400002
Klaipeda, Lithuania, LT-92304
Investigational Site Number 4400007
Ukmerge, Lithuania, 20184
Investigational Site Number 4400005
Utena, Lithuania, LT-28151
Investigational Site Number 4400001
Vilnius, Lithuania, 08661
Mexico
Investigational Site Number 4840009
Actopan, Mexico, 42500
Investigational Site Number 4840013
Aguascalientes, Mexico, 20230
Investigational Site Number 4840019
Aguascalientes, Mexico, 20230
Investigational Site Number 4840018
Cdmx, Mexico, 06760
Investigational Site Number 4840005
Celaya, Mexico, 38000
Investigational Site Number 4840002
Cuernavaca, Mexico, 62250
Investigational Site Number 4840025
Distrito Federal, Mexico, 07760
Investigational Site Number 4840007
Durango, Mexico, 34000
Investigational Site Number 4840023
Durango, Mexico, 34080
Investigational Site Number 4840033
Guadalajara, Mexico, 44150
Investigational Site Number 4840024
Guadalajara, Mexico, 44160
Investigational Site Number 4840003
Guadalajara, Mexico, 44210
Investigational Site Number 4840011
Guadalajara, Mexico, 44210
Investigational Site Number 4840027
Guadalajara, Mexico, 44280
Investigational Site Number 4840004
Guadalajara, Mexico, 44600
Investigational Site Number 4840010
Guadalajara, Mexico, 44650
Investigational Site Number 4840030
Guadalajara, Mexico
Investigational Site Number 4840034
Merida, Mexico, 97070
Investigational Site Number 4840021
Monterrey, Mexico, 64020
Investigational Site Number 4840020
Monterrey, Mexico, 64060
Investigational Site Number 4840001
Monterrey, Mexico, 64460
Investigational Site Number 4840028
Mérida, Mexico, 72129
Investigational Site Number 4840014
Queretaro, Mexico, 76000
Investigational Site Number 4840015
Toluca, Mexico, 50130
Investigational Site Number 4840008
Veracruz, Mexico, 91910
Investigational Site Number 4840016
Xalapa, Mexico, 91193
Investigational Site Number 4840026
Zapopan, Mexico, 45116
Netherlands
Investigational Site Number 5280004
Almelo, Netherlands, 7609 PP
Investigational Site Number 5280001
Groningen, Netherlands, 9728 NT
Investigational Site Number 5280003
Hoogeveen, Netherlands, 7909 AA
Investigational Site Number 5280005
Meppel, Netherlands, 7943 KA
Investigational Site Number 5280002
Rotterdam, Netherlands, 3045 PM
New Zealand
Investigational Site Number 5540014
Auckland, New Zealand, 1023
Investigational Site Number 5540006
Birkenhead, New Zealand, 0626
Investigational Site Number 5540009
Birkenhead, New Zealand, 0626
Investigational Site Number 5540002
Christchurch, New Zealand, 8011
Investigational Site Number 5540003
Christchurch, New Zealand
Investigational Site Number 5540012
Christchurch, New Zealand
Investigational Site Number 5540007
Dunedin, New Zealand, 9016
Investigational Site Number 5540016
Hamilton, New Zealand, 3240
Investigational Site Number 5540013
New Plymouth, New Zealand
Investigational Site Number 5540015
Palmerston North, New Zealand, 4414
Investigational Site Number 5540005
Rotorua, New Zealand, 3010
Investigational Site Number 5540010
Takapuna, New Zealand, 1309
Investigational Site Number 5540008
Tauranga, New Zealand, 3001
Investigational Site Number 5540011
Tauranga, New Zealand, 3001
Investigational Site Number 5540004
Wellington, New Zealand, 6021
North Macedonia
Investigational Site Number 8070003
Skopje, North Macedonia, 1000
Investigational Site Number 8070005
Struga, North Macedonia, 6330
Investigational Site Number 8070001
Tetovo, North Macedonia, 1200
Investigational Site Number 8070004
Tetovo, North Macedonia, 1200
Norway
Investigational Site Number 5780005
Hamar, Norway, 2317
Investigational Site Number 5780001
Hønefoss, Norway, 3515
Investigational Site Number 5780003
Oslo, Norway, 0514
Investigational Site Number 5780002
Oslo, Norway, 373
Investigational Site Number 5780004
Skedsmokorset, Norway, 2020
Peru
Investigational Site Number 6040004
Arequipa, Peru
Investigational Site Number 6040006
Callao, Peru, CALLAO 02
Investigational Site Number 6040009
Callao, Peru
Investigational Site Number 6040024
Chancay, Peru
Investigational Site Number 6040005
Chiclayo, Peru
Investigational Site Number 6040010
Cuzco, Peru
Investigational Site Number 6040014
Lima Lima, Peru, Lima 01
Investigational Site Number 6040001
Lima, Peru, 09
Investigational Site Number 6040025
Lima, Peru, 15135
Investigational Site Number 6040016
Lima, Peru, LIMA 01
Investigational Site Number 6040020
Lima, Peru, LIMA 14
Investigational Site Number 6040013
Lima, Peru, Lima 17
Investigational Site Number 6040023
Lima, Peru, LIMA 27
Investigational Site Number 6040007
Lima, Peru, Lima 29
Investigational Site Number 6040019
Lima, Peru, LIMA 31
Investigational Site Number 6040022
Lima, Peru, LIMA 32
Investigational Site Number 6040012
Lima, Peru, Lima 41
Investigational Site Number 6040017
Lima, Peru
Investigational Site Number 6040011
Piura, Peru, 20000
Investigational Site Number 6040002
Trujillo, Peru
Poland
Investigational Site Number 6160027
Bialystok, Poland, 15-276
Investigational Site Number 6160011
Bialystok, Poland, 15-435
Investigational Site Number 6160029
Bydgoszcz, Poland, 85-079
Investigational Site Number 6160030
Bydgoszcz, Poland, 85-231
Investigational Site Number 6160006
Bydgoszcz, Poland, 85-822
Investigational Site Number 6160018
Bytom, Poland, 41-902
Investigational Site Number 6160002
Czeladz, Poland, 41-250
Investigational Site Number 6160003
Gdynia, Poland, 81-394
Investigational Site Number 6160005
Gdynia, Poland, 81-472
Investigational Site Number 6160008
Grodzisk Mazowiecki, Poland, 05-825
Investigational Site Number 6160031
Grodzisk Mazowiecki, Poland, 05-825
Investigational Site Number 6160023
Katowice, Poland, 40-611
Investigational Site Number 6160026
Katowice, Poland, 40-748
Investigational Site Number 6160022
Kielce, Poland, 25-525
Investigational Site Number 6160019
Krakow, Poland, 31-135
Investigational Site Number 6160024
Krakow, Poland, 31-261
Investigational Site Number 6160010
Krakow, Poland, 31-548
Investigational Site Number 6160016
Lodz, Poland, 90-242
Investigational Site Number 6160013
Lodz, Poland, 91-347
Investigational Site Number 6160015
Lodz, Poland
Investigational Site Number 6160007
Lublin, Poland, 20-044
Investigational Site Number 6160033
Poznan, Poland, 60-589
Investigational Site Number 6160021
Pulawy, Poland, 24-100
Investigational Site Number 6160028
Staszow, Poland, 28-200
Investigational Site Number 6160020
Torun, Poland, 87-100
Investigational Site Number 6160014
Warszawa, Poland, 00-631
Investigational Site Number 6160025
Warszawa, Poland, 02-005
Investigational Site Number 6160001
Warszawa, Poland, 02-097
Investigational Site Number 6160004
Warszawa, Poland, 02-507
Investigational Site Number 6160012
Wroclaw, Poland, 52-416
Investigational Site Number 6160017
Zabrze, Poland, 41-800
Investigational Site Number 6160032
Zamosc, Poland, 22-400
Portugal
Investigational Site Number 6200004
Almada, Portugal, 2801-951
Investigational Site Number 6200005
Caldas Da Rainha, Portugal, 2500-176
Investigational Site Number 6200009
Carnaxide, Portugal, 2790-134
Investigational Site Number 6200002
Coimbra, Portugal, 3000-075
Investigational Site Number 6200008
Leiria, Portugal, 2410-197
Investigational Site Number 6200001
Lisboa, Portugal, 1250
Investigational Site Number 6200007
Loures, Portugal, 2674-514
Investigational Site Number 6200003
Porto, Portugal, 4099-001
Puerto Rico
Investigational Site Number 8400122
San Juan, Puerto Rico, 00917
Romania
Investigational Site Number 6420008
Bacau, Romania, 600154
Investigational Site Number 6420005
Baia Mare, Maramures, Romania, 430222
Investigational Site Number 6420009
Brasov, Romania, 500097
Investigational Site Number 6420013
Bucuresti, Romania, 010507
Investigational Site Number 6420014
Bucuresti, Romania, 010627
Investigational Site Number 6420012
Bucuresti, Romania, 020475
Investigational Site Number 6420011
Bucuresti, Romania, 022441
Investigational Site Number 6420002
Craiova, Romania, 200349
Investigational Site Number 6420003
Oradea, Romania, 410159
Investigational Site Number 6420004
Oradea, Romania, 410469
Investigational Site Number 6420010
Ploiesti, Romania, 100561
Investigational Site Number 6420001
Targoviste, Dambovita, Romania, 130095
Investigational Site Number 6420006
Targu Mures, Mures, Romania, 540142
Investigational Site Number 6420007
Targu Mures, Mures, Romania, 540142
Russian Federation
Investigational Site Number 6430028
Kaliningrad, Russian Federation, 236035
Investigational Site Number 6430018
Kazan, Russian Federation, 420101
Investigational Site Number 6430001
Kemerovo, Russian Federation, 650002
Investigational Site Number 6430035
Kemerovo, Russian Federation, 650070
Investigational Site Number 6430025
Krasnodar, Russian Federation, 350042
Investigational Site Number 6430040
Krasnodar, Russian Federation, 350063
Investigational Site Number 6430010
Krasnodar, Russian Federation, 350086
Investigational Site Number 6430015
Moscow, Russian Federation, 101990
Investigational Site Number 6430016
Moscow, Russian Federation, 101990
Investigational Site Number 6430046
Moscow, Russian Federation, 105554
Investigational Site Number 6430003
Moscow, Russian Federation, 117292
Investigational Site Number 6430036
Moscow, Russian Federation, 119192
Investigational Site Number 6430005
Moscow, Russian Federation, 119991
Investigational Site Number 6430039
Moscow, Russian Federation, 119991
Investigational Site Number 6430021
Moscow, Russian Federation, 121309
Investigational Site Number 6430002
Moscow, Russian Federation, 121374
Investigational Site Number 6430020
Moscow, Russian Federation, 125284
Investigational Site Number 6430024
Moscow, Russian Federation, 127644
Investigational Site Number 6430033
Nizhniy Novgorod, Russian Federation, 603005
Investigational Site Number 6430037
Novosibirsk, Russian Federation, 630005
Investigational Site Number 6430034
Novosibirsk, Russian Federation, 630089
Investigational Site Number 6430007
Perm, Russian Federation, 614077
Investigational Site Number 6430019
Rostov-Na-Donu, Russian Federation, 344068
Investigational Site Number 6430012
Saint-Petersburg, Russian Federation, 192242
Investigational Site Number 6430044
Saint-Petersburg, Russian Federation, 197110
Investigational Site Number 6430045
Saint-Petersburg, Russian Federation, 197110
Investigational Site Number 6430043
Saint-Petersburg, Russian Federation, 198205
Investigational Site Number 6430009
Saratov, Russian Federation, 410028
Investigational Site Number 6430013
Saratov, Russian Federation, 410028
Investigational Site Number 6430042
Saratov, Russian Federation, 410039
Investigational Site Number 6430026
Sochi, Russian Federation, 354057
Investigational Site Number 6430027
Sochi, Russian Federation, 354057
Investigational Site Number 6430041
St-Petersburg, Russian Federation, 193312
Investigational Site Number 6430006
St-Petersburg, Russian Federation, 194044
Investigational Site Number 6430008
St-Petersburg, Russian Federation, 194044
Investigational Site Number 6430030
St-Petersburg, Russian Federation, 194044
Investigational Site Number 6430014
St-Petersburg, Russian Federation, 197341
Investigational Site Number 6430017
St-Petersburg, Russian Federation, 197341
Investigational Site Number 6430004
St-Petersburg, Russian Federation, 199106
Investigational Site Number 6430011
Tomsk, Russian Federation, 634012
Investigational Site Number 6430038
Tomsk, Russian Federation, 634050
Investigational Site Number 6430032
Tyumen, Russian Federation, 625000
Investigational Site Number 6430023
Vladimir, Russian Federation, 600020
Investigational Site Number 6430022
Vladimir, Russian Federation, 600023
Investigational Site Number 6430031
Yaroslavl, Russian Federation, 150002
Serbia
Investigational Site Number 6880002
Belgrade, Serbia, 11000
Investigational Site Number 6880003
Belgrade, Serbia, 11000
Investigational Site Number 6880004
Belgrade, Serbia, 11000
Investigational Site Number 6880005
Kragujevac, Serbia, 34000
Investigational Site Number 6880001
Nis, Serbia, 18000
Investigational Site Number 6880006
Nis, Serbia, 18000
Investigational Site Number 6880007
Nis, Serbia, 18000
Slovakia
Investigational Site Number 7030006
Bardejov, Slovakia, 085 01
Investigational Site Number 7030012
Bratislava, Slovakia, 813 69
Investigational Site Number 7030011
Kosice, Slovakia, 040 01
Investigational Site Number 7030001
Lubochna, Slovakia, 034 91
Investigational Site Number 7030008
Lucenec, Slovakia, 984 39
Investigational Site Number 7030009
Lucenec, Slovakia, 98401
Investigational Site Number 7030010
Lucenec, Slovakia, 98401
Investigational Site Number 7030004
Moldava Nad Bodvou, Slovakia, 04525
Investigational Site Number 7030013
Presov, Slovakia, 080 01
Investigational Site Number 7030003
Roznava, Slovakia, 04801
Investigational Site Number 7030002
Sabinov, Slovakia, 083 01
Investigational Site Number 7030007
Svidnik, Slovakia, 089 01
South Africa
Investigational Site Number 7100005
Brits, South Africa, 0250
Investigational Site Number 7100009
Cape Town, South Africa, 7530
Investigational Site Number 7100006
Cape Town, South Africa, 7570
Investigational Site Number 7100001
Parow, South Africa, 7500
Investigational Site Number 7100012
Pinelands, South Africa, 7405
Investigational Site Number 7100011
Pretoria, South Africa, 0002
Investigational Site Number 7100014
Pretoria, South Africa, 0083
Investigational Site Number 7100008
Pretoria, South Africa, 0157
Investigational Site Number 7100010
Rivonia, South Africa, 2128
Investigational Site Number 7100007
Soweto, South Africa, 1818
Investigational Site Number 7100002
Umkomaas, South Africa, 4170
Investigational Site Number 7100013
Vosloorus, South Africa, 1475
Investigational Site Number 7100003
Western Cape, South Africa, 7130
Spain
Investigational Site Number 7240003
Almería, Spain, 04120
Investigational Site Number 7240014
Barcelona, Spain, 08035
Investigational Site Number 7240011
Barcelona, Spain, 08041
Investigational Site Number 7240009
Córdoba, Spain, 14004
Investigational Site Number 7240024
El Puerto De Santa Maria, Spain, 11500
Investigational Site Number 7240016
Granada, Spain, 18016
Investigational Site Number 7240015
La Coruña, Spain, 15006
Investigational Site Number 7240001
Madrid, Spain, 28023
Investigational Site Number 7240019
Madrid, Spain, 28034
Investigational Site Number 7240006
Madrid, Spain, 28040
Investigational Site Number 7240010
Madrid, Spain, 28046
Investigational Site Number 7240020
Madrid, Spain, 28046
Investigational Site Number 7240025
Sabadell, Spain, 08208
Investigational Site Number 7240023
Sanlúcar De Barrameda, Spain, 11540
Investigational Site Number 7240013
Santa Cruz De Tenerife, Spain, 38320
Investigational Site Number 7240007
Santiago De Compostela, Spain, 15706
Investigational Site Number 7240026
Sevilla, Spain, 41014
Investigational Site Number 7240012
Sevilla, Spain, 41071
Investigational Site Number 7240004
Valencia, Spain, 46010
Investigational Site Number 7240002
Vigo, Spain, 36312
Investigational Site Number 7240022
Villamartín, Spain, 11650
Investigational Site Number 7240008
Zaragoza, Spain, 50009
Sweden
Investigational Site Number 7520007
Falun, Sweden, 791 82
Investigational Site Number 7520005
Lund, Sweden, 221 85
Investigational Site Number 7520004
Mölndal, Sweden, 43180
Investigational Site Number 7520003
Rättvik, Sweden, 79530
Investigational Site Number 7520008
Stockholm, Sweden, 112 21
Investigational Site Number 7520002
Stockholm, Sweden, 118 83
Investigational Site Number 7520006
Stockholm, Sweden, 14186
Investigational Site Number 7520001
Uppsala, Sweden, 751 85
Switzerland
Investigational Site Number 7560001
Olten, Switzerland, 4600
Investigational Site Number 7560002
Zollikerberg, Switzerland, 8125
Taiwan
Investigational Site Number 1580005
Hsinchu, Taiwan, 30071
Investigational Site Number 1580008
Kaohsiung, Taiwan, 807
Investigational Site Number 1580004
Linkou, Taiwan
Investigational Site Number 1580006
Taichung, Taiwan, 40447
Investigational Site Number 1580002
Tainan, Taiwan, 704
Investigational Site Number 1580007
Tainan, Taiwan, 710
Investigational Site Number 1580003
Taipei, Taiwan, 100
Investigational Site Number 1580001
Taipei, Taiwan, 112
Turkey
Investigational Site Number 7920018
Antalya, Turkey, 07070
Investigational Site Number 7920010
Aydın, Turkey, 09100
Investigational Site Number 7920004
Corum, Turkey, 19200
Investigational Site Number 7920016
Gaziantep, Turkey, 27310
Investigational Site Number 7920011
Istanbul, Turkey, 34034
Investigational Site Number 7920009
Istanbul, Turkey, 34390
Investigational Site Number 7920001
Istanbul, Turkey
Investigational Site Number 7920007
Istanbul, Turkey
Investigational Site Number 7920017
Istanbul, Turkey
Investigational Site Number 7920003
Izmir, Turkey, 35340
Investigational Site Number 7920013
Kayseri, Turkey, 38039
Investigational Site Number 7920014
Kocaeli, Turkey, 41380
Investigational Site Number 7920005
Kutahya, Turkey
Investigational Site Number 7920015
Malatya, Turkey
Investigational Site Number 7920008
Mersin, Turkey, 33169
Investigational Site Number 7920002
Sivas, Turkey, 58140
Ukraine
Investigational Site Number 8040020
Dnipro, Ukraine, 49005
Investigational Site Number 8040006
Dnipro, Ukraine, 49600
Investigational Site Number 8040009
Ivano-Frankivsk, Ukraine, 76000
Investigational Site Number 8040012
Ivano-Frankivsk, Ukraine, 76018
Investigational Site Number 8040021
Kharkiv, Ukraine, 61039
Investigational Site Number 8040011
Kharkiv, Ukraine, 61058
Investigational Site Number 8040008
Kharkiv, Ukraine, 61166
Investigational Site Number 8040002
Kiev, Ukraine, 02091
Investigational Site Number 8040024
Kiev, Ukraine, 02660
Investigational Site Number 8040003
Kyiv, Ukraine, 03049
Investigational Site Number 8040015
Kyiv, Ukraine, 03115
Investigational Site Number 8040019
Kyiv, Ukraine, 04050
Investigational Site Number 8040010
Kyiv, Ukraine, 04114
Investigational Site Number 8040026
Kyiv, Ukraine
Investigational Site Number 8040023
Lutsk, Ukraine, 43005
Investigational Site Number 8040025
Lutsk, Ukraine, 43024
Investigational Site Number 8040022
Lviv, Ukraine, 79011
Investigational Site Number 8040001
Ternopil, Ukraine, 46000
Investigational Site Number 8040016
Vinnitsya, Ukraine, 21018
Investigational Site Number 8040007
Vinnitsya, Ukraine, 21100
Investigational Site Number 8040004
Vinnytsya, Ukraine, 21001
Investigational Site Number 8040018
Zhytomyr, Ukraine
United Kingdom
Investigational Site Number 8260003
Belfast, United Kingdom, BT12 6BA
Investigational Site Number 8260007
Chippenham, United Kingdom, SN14 6GT
Investigational Site Number 8260009
Davyhulme, Manchester, United Kingdom, M41 5SL
Investigational Site Number 8260010
Glasgow, United Kingdom, G21 3UW
Investigational Site Number 8260004
Hayle, United Kingdom, TR27 5DT
Investigational Site Number 8260011
Inverness, United Kingdom, IV2 3UJ
Investigational Site Number 8260002
Ipswich, United Kingdom, IP4 5PD
Investigational Site Number 8260006
Maidstone, United Kingdom, ME16 9QQ
Investigational Site Number 8260001
Swansea, United Kingdom, SA2 8PP
Sponsors and Collaborators
Lexicon Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03315143    
Other Study ID Numbers: EFC14875
2017-002644-32
U1111-1187-8703 ( Other Identifier: UTN )
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: January 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. 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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
(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