Study Stopped
study terminated due to business decision
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
SCORED
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
3 other identifiers
interventional
10,584
42 countries
740
Brief Summary
The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure \[HHF\], and urgent visit for heart failure \[HF\] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 heart-failure
Started Dec 2017
740 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2017
CompletedFirst Posted
Study publicly available on registry
October 19, 2017
CompletedStudy Start
First participant enrolled
December 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2020
CompletedResults Posted
Study results publicly available
October 28, 2022
CompletedOctober 28, 2022
September 1, 2022
2.6 years
October 16, 2017
September 30, 2022
September 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Up to 30 months
Secondary Outcomes (7)
Total Number of Occurrences of HHF and Urgent HF Visits
Up to 30 months
Number of Deaths From Cardiovascular Causes
Up to 30 months
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
Up to 30 months
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
Up to 30 months
Number of Occurrences After Randomization of the Composite of Sustained ≥50% Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline (for ≥30 Days), Chronic Dialysis, Renal Transplant, or Sustained eGFR <15 mL/Min/1.73 m^2 (for ≥30 Days)
Up to 30 months
- +2 more secondary outcomes
Study Arms (2)
Sotagliflozin
EXPERIMENTALSotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
Placebo
PLACEBO COMPARATORMatching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
Interventions
Sotagliflozin was administered as a tablet(s), orally once daily.
Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) ≥7%.
- Estimated glomerular filtration rate (eGFR) ≥25 and ≤60 milliliter/minute (mL/min)/1.73 square meter (m\^2).
- 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.
You may not qualify if:
- 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 participant's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lexicon Pharmaceuticalslead
- Sanoficollaborator
Study Sites (754)
Investigational Site Number 8400017
Birmingham, Alabama, 35205, United States
Investigational Site Number 8400096
Sheffield, Alabama, 35660, United States
Investigational Site Number 8400004
Mesa, Arizona, 85206, United States
Investigational Site Number 8400059
Mesa, Arizona, 85210, United States
Investigational Site Number 8400021
Peoria, Arizona, 85381, United States
Investigational Site Number 8400014
Surprise, Arizona, 85374, United States
Investigational Site Number 8400071
Little Rock, Arkansas, 72211, United States
Investigational Site Number 8400039
Beverly Hills, California, 90211, United States
Investigational Site Number 8400042
Concord, California, 94520, United States
Investigational Site Number 8400089
Fresno, California, 93720, United States
Investigational Site Number 8400006
Huntington Park, California, 90255, United States
Investigational Site Number 8400036
Long Beach, California, 90807, United States
Investigational Site Number 8400073
Los Angeles, California, 90017, United States
Investigational Site Number 8400084
Los Angeles, California, 90022-4302, United States
Investigational Site Number 8400035
Los Gatos, California, 95032, United States
Investigational Site Number 8400043
Northridge, California, 91325, United States
Investigational Site Number 8400025
Sacramento, California, 95821, United States
Investigational Site Number 8400018
San Dimas, California, 91713, United States
Investigational Site Number 8400070
Temecula, California, 92591, United States
Investigational Site Number 8400013
Waterbury, Connecticut, 06708, United States
Investigational Site Number 8400095
Bradenton, Florida, 34209, United States
Investigational Site Number 8400090
Clearwater, Florida, 33756, United States
Investigational Site Number 8400121
Clearwater, Florida, 33756, United States
Investigational Site Number 8400049
Cooper City, Florida, 33024, United States
Investigational Site Number 8400092
Hialeah, Florida, 33012, United States
Investigational Site Number 8400026
Hollywood, Florida, 33024, United States
Investigational Site Number 8400134
Jacksonville, Florida, 32204, United States
Investigational Site Number 8400055
Jacksonville, Florida, 32207-4966, United States
Investigational Site Number 8400056
Jacksonville, Florida, 32216, United States
Investigational Site Number 8400031
Jacksonville, Florida, 32277, United States
Investigational Site Number 8400037
Maitland, Florida, 32751, United States
Investigational Site Number 8400078
Miami, Florida, 33126, United States
Investigational Site Number 8400117
Miami, Florida, 33135, United States
Investigational Site Number 8400119
Miami, Florida, 33135, United States
Investigational Site Number 8400118
Miami, Florida, 33165, United States
Investigational Site Number 8400105
Miami, Florida, 33174, United States
Investigational Site Number 8400120
Miami, Florida, 33176, United States
Investigational Site Number 8400088
North Miami Beach, Florida, 33162, United States
Investigational Site Number 8400106
Opa-locka, Florida, 33054, United States
Investigational Site Number 8400063
Ormond Beach, Florida, 32174, United States
Investigational Site Number 8400087
Palm Harbor, Florida, 34684-3609, United States
Investigational Site Number 8400108
Spring Hill, Florida, 34609, United States
Investigational Site Number 8400058
St. Petersburg, Florida, 33713, United States
Investigational Site Number 8400051
Tampa, Florida, 33624, United States
Investigational Site Number 8400123
Atlanta, Georgia, 30303, United States
Investigational Site Number 8400076
Roswell, Georgia, 30076, United States
Investigational Site Number 8400033
Honolulu, Hawaii, 96814, United States
Investigational Site Number 8400085
Arlington Heights, Illinois, 60005, United States
Investigational Site Number 8400104
Chicago, Illinois, 60611, United States
Investigational Site Number 8400027
Chicago, Illinois, 60612, United States
Investigational Site Number 8400124
Chicago, Illinois, 60612, United States
Investigational Site Number 8400001
Chicago, Illinois, 60616, United States
Investigational Site Number 8400052
Crystal Lake, Illinois, 60012, United States
Investigational Site Number 8400028
Springfield, Illinois, 62711, United States
Investigational Site Number 8400125
Michigan City, Indiana, 46360, United States
Investigational Site Number 8400098
Valparaiso, Indiana, 46383, United States
Investigational Site Number 8400003
Des Moines, Iowa, 50314, United States
Investigational Site Number 8400081
Topeka, Kansas, 66606, United States
Investigational Site Number 8400041
Louisville, Kentucky, 40213, United States
Investigational Site Number 8400080
Bangor, Maine, 04401, United States
Investigational Site Number 8400002
Flint, Michigan, 48504, United States
Investigational Site Number 8400069
Flint, Michigan, 48532-3447, United States
Investigational Site Number 8400016
Troy, Michigan, 48098, United States
Investigational Site Number 8400023
Saint Cloud, Minnesota, 56303, United States
Investigational Site Number 8400066
Kansas City, Missouri, 64111, United States
Investigational Site Number 8400024
St Louis, Missouri, 63136, United States
Investigational Site Number 8400130
Washington, Missouri, 63090, United States
Investigational Site Number 8400045
Omaha, Nebraska, 68198-4100, United States
Investigational Site Number 8400009
Las Vegas, Nevada, 89148, United States
Investigational Site Number 8400101
Albany, New York, 12206, United States
Investigational Site Number 8400061
Laurelton, New York, 11413, United States
Investigational Site Number 8400046
New York, New York, 10029-6501, United States
Investigational Site Number 8400112
Rosedale, New York, 11422, United States
Investigational Site Number 8400062
Smithtown, New York, 11787, United States
Investigational Site Number 8400079
Greenville, North Carolina, 27834-5704, United States
Investigational Site Number 8400020
Morehead City, North Carolina, 28557, United States
Investigational Site Number 8400048
Morehead City, North Carolina, 28557, United States
Investigational Site Number 8400010
Morganton, North Carolina, 28655, United States
Investigational Site Number 8400072
Fargo, North Dakota, 58103, United States
Investigational Site Number 8400038
Cincinnati, Ohio, 45219, United States
Investigational Site Number 8400007
Cincinnati, Ohio, 45241, United States
Investigational Site Number 8400015
Columbus, Ohio, 43210, United States
Investigational Site Number 8400113
Lorain, Ohio, 44053, United States
Investigational Site Number 8400011
Mentor, Ohio, 44060, United States
Investigational Site Number 8400109
Bend, Oregon, 97702, United States
Investigational Site Number 8400047
Beaver, Pennsylvania, 15009, United States
Investigational Site Number 8400019
Greensburg, Pennsylvania, 15601, United States
Investigational Site Number 8400097
Indiana, Pennsylvania, 15701-3578, United States
Investigational Site Number 8400032
Levittown, Pennsylvania, 19056-2404, United States
Investigational Site Number 8400053
Philadelphia, Pennsylvania, 19107, United States
Investigational Site Number 8400012
Pittsburgh, Pennsylvania, 15212, United States
Investigational Site Number 8400064
Anderson, South Carolina, 29621, United States
Investigational Site Number 8400030
Greer, South Carolina, 29651, United States
Investigational Site Number 8400029
Myrtle Beach, South Carolina, 29572, United States
Investigational Site Number 8400040
Memphis, Tennessee, 38163, United States
Investigational Site Number 8400114
Arlington, Texas, 76015, United States
Investigational Site Number 8400067
Corpus Christi, Texas, 78814, United States
Investigational Site Number 8400082
Dallas, Texas, 75231, United States
Investigational Site Number 8400022
El Paso, Texas, 79935, United States
Investigational Site Number 8400099
Houston, Texas, 77043, United States
Investigational Site Number 8400103
Houston, Texas, 77070, United States
Investigational Site Number 8400086
Katy, Texas, 77450, United States
Investigational Site Number 8400100
Mesquite, Texas, 75150, United States
Investigational Site Number 8400094
Plano, Texas, 75093, United States
Investigational Site Number 8400116
San Antonio, Texas, 78224, United States
Investigational Site Number 8400091
Waco, Texas, 76710, United States
Investigational Site Number 8400065
Bountiful, Utah, 84010-7717, United States
Investigational Site Number 8400131
Ogden, Utah, 84405, United States
Investigational Site Number 8400093
Bennington, Vermont, 05201, United States
Investigational Site Number 8400060
South Burlington, Vermont, 05403, United States
Investigational Site Number 8400133
Danville, Virginia, 24541-2834, United States
Investigational Site Number 8400054
Fairfax, Virginia, 22039, United States
Investigational Site Number 8400132
Falls Church, Virginia, 22044, United States
Investigational Site Number 8400034
Manassas, Virginia, 20110, United States
Investigational Site Number 8400050
Norfolk, Virginia, 23510, United States
Investigational Site Number 8400044
Richmond, Virginia, 23235, United States
Investigational Site Number 8400111
Richmond, Virginia, 23249, United States
Investigational Site Number 8400083
Federal Way, Washington, 98003, United States
Investigational Site Number 8400068
Spokane, Washington, 99207, United States
Investigational Site Number 0320016
Buenos Aires, Argentina
Investigational Site Number 0320029
Buenos Aires, Argentina
Investigational Site Number 0320017
Caba, 1120, Argentina
Investigational Site Number 0320002
Caba, C1093AAS, Argentina
Investigational Site Number 0320004
Caba, C1118AAE, Argentina
Investigational Site Number 0320018
Caba, C1119ACN, Argentina
Investigational Site Number 0320025
Caba, C1128AAF, Argentina
Investigational Site Number 0320019
Caba, Argentina
Investigational Site Number 0320027
Capital Federal, C1056ABJ, Argentina
Investigational Site Number 0320015
Capital Federal, C1179AAB, Argentina
Investigational Site Number 0320014
Ciudad Autonoma de Bs.As, C1428DCO, Argentina
Investigational Site Number 0320023
Ciudad Autonoma de Buenos Aire, C1204AAD, Argentina
Investigational Site Number 0320009
Ciudadela, B1702BML, Argentina
Investigational Site Number 0320008
Coronel Suárez, B7540GHD, Argentina
Investigational Site Number 0320011
Corrientes, W3400AMZ, Argentina
Investigational Site Number 0320001
Córdoba, X5000AAX, Argentina
Investigational Site Number 0320028
La Plata, B1900AXI, Argentina
Investigational Site Number 0320006
La Plata, B1906ESC, Argentina
Investigational Site Number 0320024
Mar del Plata, B7600FZN, Argentina
Investigational Site Number 0320003
Mar del Plata, B7600, Argentina
Investigational Site Number 0320020
Merlo, B1722COV, Argentina
Investigational Site Number 0320007
Ramos Mejía, B1704ETD, Argentina
Investigational Site Number 0320030
Rosario, S2000CVD, Argentina
Investigational Site Number 0320026
Rosario, S2000DEJ, Argentina
Investigational Site Number 0320012
Salta, 4400, Argentina
Investigational Site Number 0320021
San Miguel de Tucumán, T4000ICL, Argentina
Investigational Site Number 0320013
Santa Fe, S3000FWO, Argentina
Investigational Site Number 0320022
Temperley, 1842, Argentina
Investigational Site Number 0320005
Villa María, X5900JKA, Argentina
Investigational Site Number 0360014
Adelaide, 5000, Australia
Investigational Site Number 0360004
Box Hill, 3128, Australia
Investigational Site Number 0360015
Elizabeth Vale, 5112, Australia
Investigational Site Number 0360005
Fitzroy, 3065, Australia
Investigational Site Number 0360018
Fremantle, 6160, Australia
Investigational Site Number 0360007
Fullarton, 5063, Australia
Investigational Site Number 0360002
Gosford, 2250, Australia
Investigational Site Number 0360016
Heidelberg, 3081, Australia
Investigational Site Number 0360010
Herston, 4029, Australia
Investigational Site Number 0360009
Liverpool, 2170, Australia
Investigational Site Number 0360017
Melbourne, 3004, Australia
Investigational Site Number 0360001
Merewether, 2291, Australia
Investigational Site Number 0360012
Oaklands Park, 5046, Australia
Investigational Site Number 0360011
Parkville, 3050, Australia
Investigational Site Number 0360008
Redcliffe, 4020, Australia
Investigational Site Number 0360013
Sherwood, 4075, Australia
Investigational Site Number 0360019
St Leonards, 2065, Australia
Investigational Site Number 0360006
Wollongong, 2500, Australia
Investigational Site Number 0560004
Bonheiden, 2820, Belgium
Investigational Site Number 0560005
Ghent, 9000, Belgium
Investigational Site Number 0560003
Kortrijk, 8500, Belgium
Investigational Site Number 0560002
La Louvière, 7100, Belgium
Investigational Site Number 0560001
Leuven, 3000, Belgium
Investigational Site Number 0760017
Blumenau, 89020-430, Brazil
Investigational Site Number 0760015
Brasília, 70200-730, Brazil
Investigational Site Number 0760026
Brasília, 70390-903, Brazil
Investigational Site Number 0760008
Campinas, 13015-001, Brazil
Investigational Site Number 0760005
Campinas, 13060-080, Brazil
Investigational Site Number 0760018
Canoas, 92425-900, Brazil
Investigational Site Number 0760019
Curitiba, 80030-110, Brazil
Investigational Site Number 0760011
Curitiba, 80230-130, Brazil
Investigational Site Number 0760007
Curitiba, 80730-150, Brazil
Investigational Site Number 0760010
Fortaleza, 60115-282, Brazil
Investigational Site Number 0760002
Fortaleza, 60170-320, Brazil
Investigational Site Number 0760004
Fortaleza, 60430-350, Brazil
Investigational Site Number 0760014
Passo Fundo, 99010-180, Brazil
Investigational Site Number 0760025
Porto Alegre, 90020-090, Brazil
Investigational Site Number 0760016
Porto Alegre, 90430-001, Brazil
Investigational Site Number 0760024
Recife, 52051-380, Brazil
Investigational Site Number 0760023
Rio de Janeiro, 22271-100, Brazil
Investigational Site Number 0760001
São José do Rio Preto, 15090-000, Brazil
Investigational Site Number 0760012
São José dos Campos, 12243-280, Brazil
Investigational Site Number 0760003
São Paulo, 01.228-000, Brazil
Investigational Site Number 0760020
São Paulo, 01228-200, Brazil
Investigational Site Number 0760013
São Paulo, 04038-002, Brazil
Investigational Site Number 0760022
São Paulo, 04266-010, Brazil
Investigational Site Number 0760006
São Paulo, 05403-000, Brazil
Investigational Site Number 0760009
São Paulo, 05403-000, Brazil
Investigational Site Number 0760021
Vitória, 29055 450, Brazil
Investigational Site Number 1000015
Blagoevgrad, 2700, Bulgaria
Investigational Site Number 1000008
Dobrich, MULTIPROFILE HOSPITA, Bulgaria
Investigational Site Number 1000013
Gabrovo, 5300, Bulgaria
Investigational Site Number 1000003
Plovdiv, 4002, Bulgaria
Investigational Site Number 1000016
Rousse, 7002, Bulgaria
Investigational Site Number 1000014
Silistra, 7500, Bulgaria
Investigational Site Number 1000007
Smolyan, 4700, Bulgaria
Investigational Site Number 1000011
Sofia, 1233, Bulgaria
Investigational Site Number 1000004
Sofia, 1431, Bulgaria
Investigational Site Number 1000006
Sofia, 1431, Bulgaria
Investigational Site Number 1000012
Sofia, 1632, Bulgaria
Investigational Site Number 1000005
Sofia, 1750, Bulgaria
Investigational Site Number 1000017
Sofia, 1784, Bulgaria
Investigational Site Number 1000001
Stara Zagora, 6000, Bulgaria
Investigational Site Number 1000018
Stara Zagora, 6000, Bulgaria
Investigational Site Number 1240002
Brampton, L6S0C6, Canada
Investigational Site Number 1240013
Burlington, L7M 4Y1, Canada
Investigational Site Number 1240021
Calgary, T2T 5C7, Canada
Investigational Site Number 1240005
Calgary, T2V 4J2, Canada
Investigational Site Number 1240029
Concord, L4K 4M2, Canada
Investigational Site Number 1240004
Edmonton, T5A 4L8, Canada
Investigational Site Number 1240010
Edmonton, T6H 2L4, Canada
Investigational Site Number 1240008
Greater Sudbury, P3E 4H5, Canada
Investigational Site Number 1240027
Halifax, B3H 2Y9, Canada
Investigational Site Number 1240023
Hamilton, L8N 3Z5, Canada
Investigational Site Number 1240011
London, N6A 4V2, Canada
Investigational Site Number 1240019
Montreal, H1T 1C8, Canada
Investigational Site Number 1240017
Montreal, H4A 2C6, Canada
Investigational Site Number 1240018
Montreal, H4N 2W2, Canada
Investigational Site Number 1240007
Newmarket, L3Y 5G8, Canada
Investigational Site Number 1240026
Oshawa, L1G 2B9, Canada
Investigational Site Number 1240016
Oshawa, L1J 2K1, Canada
Investigational Site Number 1240006
Ottawa, K1H7W9, Canada
Investigational Site Number 1240022
Québec, G1G 3Z4, Canada
Investigational Site Number 1240025
Québec, G1V 4G5, Canada
Investigational Site Number 1240014
Québec, G1V 4W2, Canada
Investigational Site Number 1240003
Québec, G1W-4R4, Canada
Investigational Site Number 1240034
Saint-Charles-Borromée, J6E 6J2, Canada
Investigational Site Number 1240032
Saint-Marc-des-Carrieres, G0A 4B0, Canada
Investigational Site Number 1240033
St. John's, A1B 3V6, Canada
Investigational Site Number 1240031
Surrey, V3V 0C6, Canada
Investigational Site Number 1240028
Toronto, M6G 1M2, Canada
Investigational Site Number 1240015
Trois-Rivières, G8Z 3R9, Canada
Investigational Site Number 1240001
Vancouver, V5Y 3W2, Canada
Investigational Site Number 1240030
Victoria, V8R 1B2, Canada
Investigational Site Number 1520015
Concepción, 4070566, Chile
Investigational Site Number 1520003
Osorno, 5311092, Chile
Investigational Site Number 1520012
Punta Arenas, 6210490, Chile
Investigational Site Number 1520013
Santiago, 7500571, Chile
Investigational Site Number 1520018
Santiago, 7500588, Chile
Investigational Site Number 1520001
Santiago, 7500710, Chile
Investigational Site Number 1520004
Santiago, 7500710, Chile
Investigational Site Number 1520006
Santiago, 7500739, Chile
Investigational Site Number 1520014
Santiago, 7591047, Chile
Investigational Site Number 1520016
Santiago, 7650568, Chile
Investigational Site Number 1520017
Santiago, 7770086, Chile
Investigational Site Number 1520020
Santiago, 7770086, Chile
Investigational Site Number 1520009
Santiago, 8053095, Chile
Investigational Site Number 1520011
Santiago, 8207257, Chile
Investigational Site Number 1520026
Santiago, 833-0024, Chile
Investigational Site Number 1520010
Santiago, 8330336, Chile
Investigational Site Number 1520007
Santiago, 8380456, Chile
Investigational Site Number 1520021
Santiago, 8900132, Chile
Investigational Site Number 1520022
Santiago, 8910131, Chile
Investigational Site Number 1520002
Santiago, Chile
Investigational Site Number 1520024
Talca, Chile
Investigational Site Number 1520019
Temuco, 4781156, Chile
Investigational Site Number 1520025
Temuco, 4781173, Chile
Investigational Site Number 1520005
Temuco, 4813299, Chile
Investigational Site Number 1520008
Viña del Mar, Chile
Investigational Site Number 1560019
Beijing, 100034, China
Investigational Site Number 1560001
Beijing, 100037, China
Investigational Site Number 1560002
Beijing, 100044, China
Investigational Site Number 1560003
Beijing, 100730, China
Investigational Site Number 1560032
Beijing, 100730, China
Investigational Site Number 1560012
Changchun, 130021, China
Investigational Site Number 1560023
Changchun, 130021, China
Investigational Site Number 1560034
Changchun, 130033, China
Investigational Site Number 1560022
Changsha, 410013, China
Investigational Site Number 1560021
Chengdu, 610041, China
Investigational Site Number 1560018
Dalian, 116011, China
Investigational Site Number 1560010
Dalian, 116033, China
Investigational Site Number 1560007
Guangzhou, 510080, China
Investigational Site Number 1560016
Haikou, 570102, China
Investigational Site Number 1560033
Hengyang, 421001, China
Investigational Site Number 1560038
Hohhot, 010020, China
Investigational Site Number 1560005
Huai'an, 223300, China
Investigational Site Number 1560009
Jinan, 250013, China
Investigational Site Number 1560037
Jining, China
Investigational Site Number 1560031
Nanchang, 330006, China
Investigational Site Number 1560004
Nanjing, 210008, China
Investigational Site Number 1560006
Shanghai, 200120, China
Investigational Site Number 1560036
Shenyang, 110016, China
Investigational Site Number 1560020
Siping, 136000, China
Investigational Site Number 1560025
Suzhou, 215004, China
Investigational Site Number 1560014
Suzhou, 215006, China
Investigational Site Number 1560026
Taizhou, 317000, China
Investigational Site Number 1560028
Tianjin, 300121, China
Investigational Site Number 1560029
Tianjin, 300211, China
Investigational Site Number 1560024
Wuhan, 430033, China
Investigational Site Number 1560027
Xi'an, 710061, China
Investigational Site Number 1560035
Xinxiang, 453000, China
Investigational Site Number 1560008
Zhenjiang, 212001, China
Investigational Site Number 2030012
Brno, 62500, Czechia
Investigational Site Number 2030002
Brno, 63900, Czechia
Investigational Site Number 2030021
Broumov, 550 01, Czechia
Investigational Site Number 2030017
Humpolec, 396 01, Czechia
Investigational Site Number 2030014
Liberec, 46063, Czechia
Investigational Site Number 2030007
Mariánské Lázně, 353 01, Czechia
Investigational Site Number 2030015
Městec Králové, 28903, Czechia
Investigational Site Number 2030009
Pilsen, 301 00, Czechia
Investigational Site Number 2030016
Prague, 10800, Czechia
Investigational Site Number 2030019
Prague, 11694, Czechia
Investigational Site Number 2030006
Prague, 12808, Czechia
Investigational Site Number 2030005
Prague, 14021, Czechia
Investigational Site Number 2030011
Prague, 16900, Czechia
Investigational Site Number 2030018
Prague, 18100, Czechia
Investigational Site Number 2030010
Řevnice, 25230, Czechia
Investigational Site Number 2030020
Slaný, 27401, Czechia
Investigational Site Number 2030001
Trutnov, 54101, Czechia
Investigational Site Number 2030008
Vsetín, 75501, Czechia
Investigational Site Number 2080003
Aarhus N, 8200, Denmark
Investigational Site Number 2080005
Aarhus N, 8200, Denmark
Investigational Site Number 2080009
Gentofte Municipality, 2900, Denmark
Investigational Site Number 2080004
Herlev, 2730, Denmark
Investigational Site Number 2080008
Hvidovre, 2650, Denmark
Investigational Site Number 2080002
København NV, 2400, Denmark
Investigational Site Number 2080007
Slagelse, 4200, Denmark
Investigational Site Number 2080006
Svendborg, 5700, Denmark
Investigational Site Number 2330003
Tallinn, 10138, Estonia
Investigational Site Number 2330001
Tallinn, 13419, Estonia
Investigational Site Number 2330002
Tartu, 51014, Estonia
Investigational Site Number 2500003
Corbeil-Essonnes, 91106, France
Investigational Site Number 2500002
La Rochelle, 17019, France
Investigational Site Number 2500005
Paris, 75010, France
Investigational Site Number 2500006
Paris, 75018, France
Investigational Site Number 2500001
Paris, 75877, France
Investigational Site Number 2500004
Toulouse, 31059, France
Investigational Site Number 2500007
Vénissieux, 69200, France
Investigational Site Number 2680004
Batumi, 6010, Georgia
Investigational Site Number 2680001
Kutaisi, Georgia
Investigational Site Number 2680007
Tbilisi, 0159, Georgia
Investigational Site Number 2680005
Tbilisi, 102, Georgia
Investigational Site Number 2680003
Tbilisi, 159, Georgia
Investigational Site Number 2680006
Tbilisi, 159, Georgia
Investigational Site Number 2680002
Tbilisi, Georgia
Investigational Site Number 2760008
Berlin, 12351, Germany
Investigational Site Number 2760005
Essen, 45136, Germany
Investigational Site Number 2760001
Freiburg im Breisgau, 79106, Germany
Investigational Site Number 2760007
Hamburg, 22041, Germany
Investigational Site Number 2760002
Kassel, 34121, Germany
Investigational Site Number 2760006
Leipzig, 04103, Germany
Investigational Site Number 2760003
Münster, 48149, Germany
Investigational Site Number 2760009
Oldenburg in Holstein, 23758, Germany
Investigational Site Number 3000001
Athens, 11527, Greece
Investigational Site Number 3000002
Ioannina, 45500, Greece
Investigational Site Number 3000004
Larissa, 41110, Greece
Investigational Site Number 3000003
Piraeus, 18454, Greece
Investigational Site Number 3000005
Thessaloniki, 54629, Greece
Investigational Site Number 3200007
Guatemala City, 01001, Guatemala
Investigational Site Number 3200013
Guatemala City, 01010, Guatemala
Investigational Site Number 3200001
Guatemala City, 01014, Guatemala
Investigational Site Number 3200002
Guatemala City, 1010, Guatemala
Investigational Site Number 3200009
Guatemala City, 1010, Guatemala
Investigational Site Number 3200010
Guatemala City, Guatemala
Investigational Site Number 3200006
Quetzaltenango, 09001, Guatemala
Investigational Site Number 3200014
Quetzaltenango, 09001, Guatemala
Investigational Site Number 3200004
Quetzaltenango, 9011, Guatemala
Investigational Site Number 3480006
Békéscsaba, 5600, Hungary
Investigational Site Number 3480017
Budapest, 1027, Hungary
Investigational Site Number 3480004
Budapest, 1042, Hungary
Investigational Site Number 3480011
Budapest, 1096, Hungary
Investigational Site Number 3480001
Budapest, 1122, Hungary
Investigational Site Number 3480010
Budapest, 1125, Hungary
Investigational Site Number 3480012
Budapest, 1134, Hungary
Investigational Site Number 3480016
Budapest, 1145, Hungary
Investigational Site Number 3480018
Budapest, 1204, Hungary
Investigational Site Number 3480002
Debrecen, 4032, Hungary
Investigational Site Number 3480008
Debrecen, 4032, Hungary
Investigational Site Number 3480013
Kaposvár, 7400, Hungary
Investigational Site Number 3480014
Nyíregyháza, 4400, Hungary
Investigational Site Number 3480015
Nyíregyháza, 4400, Hungary
Investigational Site Number 3480003
Székesfehérvár, 8000, Hungary
Investigational Site Number 3480007
Zalaegerszeg, 8900, Hungary
Investigational Site Number 3560025
Ahmedabad, 380060, India
Investigational Site Number 3560040
Aurangabad, 431003, India
Investigational Site Number 3560010
Bangalore, 560 034, India
Investigational Site Number 3560026
Bangalore, 560 054., India
Investigational Site Number 3560005
Belagavi, 590010, India
Investigational Site Number 3560008
Bengaluru, 560017, India
Investigational Site Number 3560022
Chandigarh, 160062, India
Investigational Site Number 3560003
Gūrgaon, 122001, India
Investigational Site Number 3560004
Gūrgaon, 122001, India
Investigational Site Number 3560018
Hyderabad, 500001, India
Investigational Site Number 3560001
Hyderabad, 500012, India
Investigational Site Number 3560007
Hyderabad, 500063, India
Investigational Site Number 3560002
Jaipur, 302017, India
Investigational Site Number 3560024
Kochi, India
Investigational Site Number 3560016
Kolkata, 700027, India
Investigational Site Number 3560030
Kozhikode, 673008, India
Investigational Site Number 3560006
Ludhiana, 141008, India
Investigational Site Number 3560027
Mangalore, 575002, India
Investigational Site Number 3560028
Mangalore, 575018, India
Investigational Site Number 3560017
Mumbai, India
Investigational Site Number 3560037
Mysore, 570015, India
Investigational Site Number 3560013
Nagpur, 440009, India
Investigational Site Number 3560014
Nagpur, 440010, India
Investigational Site Number 3560021
Nashik, 42003, India
Investigational Site Number 3560041
New Delhi, 110 029, India
Investigational Site Number 3560034
New Delhi, 110002, India
Investigational Site Number 3560019
Pune, 411001, India
Investigational Site Number 3560035
Pune, 411004, India
Investigational Site Number 3560042
Pune, 411004, India
Investigational Site Number 3560038
Pune, 411010, India
Investigational Site Number 3560012
Pune, 411019, India
Investigational Site Number 3560043
Varanasi, 221 005, India
Investigational Site Number 3560020
Vellore, 632004, India
Investigational Site Number 3560015
Wardha, 442004, India
Investigational Site Number 3760008
Beersheba, 84101, Israel
Investigational Site Number 3760005
Haifa, 31048, Israel
Investigational Site Number 3760007
Haifa, 31096, Israel
Investigational Site Number 3760001
Jerusalem, 91031, Israel
Investigational Site Number 3760002
Jerusalem, 91120, Israel
Investigational Site Number 3760004
Nahariya, 22100, Israel
Investigational Site Number 3760003
Tel Aviv, 64239, Israel
Investigational Site Number 3760006
Tel Litwinsky, 52621, Israel
Investigational Site Number 3800006
Catanzaro, 88100, Italy
Investigational Site Number 3800010
Catanzaro, 88100, Italy
Investigational Site Number 3800009
Chieri, 10023, Italy
Investigational Site Number 3800007
Livorno, 57123, Italy
Investigational Site Number 3800002
Milan, 20132, Italy
Investigational Site Number 3800008
Milan, 20145, Italy
Investigational Site Number 3800005
Orbassano, 10043, Italy
Investigational Site Number 3800011
Ravenna, 48100, Italy
Investigational Site Number 3800004
Roma, 00133, Italy
Investigational Site Number 3800001
Verona, 37126, Italy
Investigational Site Number 4280004
Daugavpils, LV-5417, Latvia
Investigational Site Number 4280002
Liepāja, LV3414, Latvia
Investigational Site Number 4280007
Ogre, LV-5001, Latvia
Investigational Site Number 4280006
Riga, LV-1002, Latvia
Investigational Site Number 4280001
Riga, LV-1011, Latvia
Investigational Site Number 4280005
Riga, LV-1038, Latvia
Investigational Site Number 4280003
Sigulda, LV-2150, Latvia
Investigational Site Number 4400006
Kaunas, 49449, Lithuania
Investigational Site Number 4400003
Kaunas, 51270, Lithuania
Investigational Site Number 4400009
Kaunas, LT-50161, Lithuania
Investigational Site Number 4400008
Kėdainiai, LT-57164, Lithuania
Investigational Site Number 4400004
Klaipėda, 92111, Lithuania
Investigational Site Number 4400002
Klaipėda, LT-92304, Lithuania
Investigational Site Number 4400007
Ukmerge, 20184, Lithuania
Investigational Site Number 4400005
Utena, LT-28151, Lithuania
Investigational Site Number 4400001
Vilnius, 08661, Lithuania
Investigational Site Number 4840009
Actopan, 42500, Mexico
Investigational Site Number 4840013
Aguascalientes, 20230, Mexico
Investigational Site Number 4840019
Aguascalientes, 20230, Mexico
Investigational Site Number 4840005
Celaya, 38000, Mexico
Investigational Site Number 4840002
Cuernavaca, 62250, Mexico
Investigational Site Number 4840025
Distrito Federal, 07760, Mexico
Investigational Site Number 4840007
Durango, 34000, Mexico
Investigational Site Number 4840023
Durango, 34080, Mexico
Investigational Site Number 4840033
Guadalajara, 44150, Mexico
Investigational Site Number 4840024
Guadalajara, 44160, Mexico
Investigational Site Number 4840003
Guadalajara, 44210, Mexico
Investigational Site Number 4840011
Guadalajara, 44210, Mexico
Investigational Site Number 4840027
Guadalajara, 44280, Mexico
Investigational Site Number 4840004
Guadalajara, 44600, Mexico
Investigational Site Number 4840010
Guadalajara, 44650, Mexico
Investigational Site Number 4840030
Guadalajara, Mexico
Investigational Site Number 4840018
Mexico City, 06760, Mexico
Investigational Site Number 4840028
Mérida, 72129, Mexico
Investigational Site Number 4840034
Mérida, 97070, Mexico
Investigational Site Number 4840021
Monterrey, 64020, Mexico
Investigational Site Number 4840020
Monterrey, 64060, Mexico
Investigational Site Number 4840001
Monterrey, 64460, Mexico
Investigational Site Number 4840014
Querétaro, 76000, Mexico
Investigational Site Number 4840015
Toluca, 50130, Mexico
Investigational Site Number 4840008
Veracruz, 91910, Mexico
Investigational Site Number 4840016
Xalapa, 91193, Mexico
Investigational Site Number 4840026
Zapopan, 45116, Mexico
Investigational Site Number 5280004
Almelo, 7609 PP, Netherlands
Investigational Site Number 5280001
Groningen, 9728 NT, Netherlands
Investigational Site Number 5280003
Hoogeveen, 7909 AA, Netherlands
Investigational Site Number 5280005
Meppel, 7943 KA, Netherlands
Investigational Site Number 5280002
Rotterdam, 3045 PM, Netherlands
Investigational Site Number 5540014
Auckland, 1023, New Zealand
Investigational Site Number 5540006
Birkenhead, 0626, New Zealand
Investigational Site Number 5540009
Birkenhead, 0626, New Zealand
Investigational Site Number 5540002
Christchurch, 8011, New Zealand
Investigational Site Number 5540003
Christchurch, New Zealand
Investigational Site Number 5540012
Christchurch, New Zealand
Investigational Site Number 5540007
Dunedin, 9016, New Zealand
Investigational Site Number 5540016
Hamilton, 3240, New Zealand
Investigational Site Number 5540013
New Plymouth, New Zealand
Investigational Site Number 5540015
Palmerston North, 4414, New Zealand
Investigational Site Number 5540005
Rotorua, 3010, New Zealand
Investigational Site Number 5540010
Takapuna, 1309, New Zealand
Investigational Site Number 5540008
Tauranga, 3001, New Zealand
Investigational Site Number 5540011
Tauranga, 3001, New Zealand
Investigational Site Number 5540004
Wellington, 6021, New Zealand
Investigational Site Number 8070003
Skopje, 1000, North Macedonia
Investigational Site Number 8070005
Struga, 6330, North Macedonia
Investigational Site Number 8070001
Tetovo, 1200, North Macedonia
Investigational Site Number 8070004
Tetovo, 1200, North Macedonia
Investigational Site Number 5780005
Hamar, 2317, Norway
Investigational Site Number 5780001
Hønefoss, 3515, Norway
Investigational Site Number 5780003
Oslo, 0514, Norway
Investigational Site Number 5780002
Oslo, 373, Norway
Investigational Site Number 5780004
Skedsmokorset, 2020, Norway
Investigational Site Number 6040004
Arequipa, Peru
Investigational Site Number 6040006
Callao, CALLAO 02, Peru
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 6040001
Lima, 09, Peru
Investigational Site Number 6040025
Lima, 15135, Peru
Investigational Site Number 6040016
Lima, LIMA 01, Peru
Investigational Site Number 6040020
Lima, LIMA 14, Peru
Investigational Site Number 6040013
Lima, Lima 17, Peru
Investigational Site Number 6040023
Lima, LIMA 27, Peru
Investigational Site Number 6040007
Lima, Lima 29, Peru
Investigational Site Number 6040019
Lima, LIMA 31, Peru
Investigational Site Number 6040022
Lima, LIMA 32, Peru
Investigational Site Number 6040012
Lima, Lima 41, Peru
Investigational Site Number 6040017
Lima, Peru
Investigational Site Number 6040014
Lima Lima, Lima 01, Peru
Investigational Site Number 6040011
Piura, 20000, Peru
Investigational Site Number 6040002
Trujillo, Peru
Investigational Site Number 6160027
Bialystok, 15-276, Poland
Investigational Site Number 6160011
Bialystok, 15-435, Poland
Investigational Site Number 6160029
Bydgoszcz, 85-079, Poland
Investigational Site Number 6160030
Bydgoszcz, 85-231, Poland
Investigational Site Number 6160006
Bydgoszcz, 85-822, Poland
Investigational Site Number 6160018
Bytom, 41-902, Poland
Investigational Site Number 6160002
Czeladź, 41-250, Poland
Investigational Site Number 6160003
Gdynia, 81-394, Poland
Investigational Site Number 6160005
Gdynia, 81-472, Poland
Investigational Site Number 6160008
Grodzisk Mazowiecki, 05-825, Poland
Investigational Site Number 6160031
Grodzisk Mazowiecki, 05-825, Poland
Investigational Site Number 6160023
Katowice, 40-611, Poland
Investigational Site Number 6160026
Katowice, 40-748, Poland
Investigational Site Number 6160022
Kielce, 25-525, Poland
Investigational Site Number 6160019
Krakow, 31-135, Poland
Investigational Site Number 6160024
Krakow, 31-261, Poland
Investigational Site Number 6160010
Krakow, 31-548, Poland
Investigational Site Number 6160016
Lodz, 90-242, Poland
Investigational Site Number 6160013
Lodz, 91-347, Poland
Investigational Site Number 6160015
Lodz, Poland
Investigational Site Number 6160007
Lublin, 20-044, Poland
Investigational Site Number 6160033
Poznan, 60-589, Poland
Investigational Site Number 6160021
Puławy, 24-100, Poland
Investigational Site Number 6160028
Staszów, 28-200, Poland
Investigational Site Number 6160020
Torun, 87-100, Poland
Investigational Site Number 6160014
Warsaw, 00-631, Poland
Investigational Site Number 6160025
Warsaw, 02-005, Poland
Investigational Site Number 6160001
Warsaw, 02-097, Poland
Investigational Site Number 6160004
Warsaw, 02-507, Poland
Investigational Site Number 6160012
Wroclaw, 52-416, Poland
Investigational Site Number 6160017
Zabrze, 41-800, Poland
Investigational Site Number 6160032
Zamość, 22-400, Poland
Investigational Site Number 6200004
Almada, 2801-951, Portugal
Investigational Site Number 6200005
Caldas da Rainha, 2500-176, Portugal
Investigational Site Number 6200009
Carnaxide, 2790-134, Portugal
Investigational Site Number 6200002
Coimbra, 3000-075, Portugal
Investigational Site Number 6200008
Leiria, 2410-197, Portugal
Investigational Site Number 6200001
Lisbon, 1250, Portugal
Investigational Site Number 6200007
Loures, 2674-514, Portugal
Investigational Site Number 6200003
Porto, 4099-001, Portugal
Investigational Site Number 8400122
San Juan, 00917, Puerto Rico
Investigational Site Number 6420008
Bacau, 600154, Romania
Investigational Site Number 6420005
Baia Mare, Maramures, 430222, Romania
Investigational Site Number 6420009
Brasov, 500097, Romania
Investigational Site Number 6420013
Bucharest, 010507, Romania
Investigational Site Number 6420014
Bucharest, 010627, Romania
Investigational Site Number 6420012
Bucharest, 020475, Romania
Investigational Site Number 6420011
Bucharest, 022441, Romania
Investigational Site Number 6420002
Craiova, 200349, Romania
Investigational Site Number 6420003
Oradea, 410159, Romania
Investigational Site Number 6420004
Oradea, 410469, Romania
Investigational Site Number 6420010
Ploieşti, 100561, Romania
Investigational Site Number 6420001
Targoviste, Dambovita, 130095, Romania
Investigational Site Number 6420006
Targu Mures, Mures, 540142, Romania
Investigational Site Number 6420007
Targu Mures, Mures, 540142, Romania
Investigational Site Number 6430028
Kaliningrad, 236035, Russia
Investigational Site Number 6430018
Kazan', 420101, Russia
Investigational Site Number 6430001
Kemerovo, 650002, Russia
Investigational Site Number 6430035
Kemerovo, 650070, Russia
Investigational Site Number 6430025
Krasnodar, 350042, Russia
Investigational Site Number 6430040
Krasnodar, 350063, Russia
Investigational Site Number 6430010
Krasnodar, 350086, Russia
Investigational Site Number 6430015
Moscow, 101990, Russia
Investigational Site Number 6430016
Moscow, 101990, Russia
Investigational Site Number 6430046
Moscow, 105554, Russia
Investigational Site Number 6430003
Moscow, 117292, Russia
Investigational Site Number 6430036
Moscow, 119192, Russia
Investigational Site Number 6430005
Moscow, 119991, Russia
Investigational Site Number 6430039
Moscow, 119991, Russia
Investigational Site Number 6430021
Moscow, 121309, Russia
Investigational Site Number 6430002
Moscow, 121374, Russia
Investigational Site Number 6430020
Moscow, 125284, Russia
Investigational Site Number 6430024
Moscow, 127644, Russia
Investigational Site Number 6430033
Nizhny Novgorod, 603005, Russia
Investigational Site Number 6430037
Novosibirsk, 630005, Russia
Investigational Site Number 6430034
Novosibirsk, 630089, Russia
Investigational Site Number 6430007
Perm, 614077, Russia
Investigational Site Number 6430019
Rostov-on-Don, 344068, Russia
Investigational Site Number 6430012
Saint Petersburg, 192242, Russia
Investigational Site Number 6430041
Saint Petersburg, 193312, Russia
Investigational Site Number 6430006
Saint Petersburg, 194044, Russia
Investigational Site Number 6430008
Saint Petersburg, 194044, Russia
Investigational Site Number 6430030
Saint Petersburg, 194044, Russia
Investigational Site Number 6430044
Saint Petersburg, 197110, Russia
Investigational Site Number 6430045
Saint Petersburg, 197110, Russia
Investigational Site Number 6430014
Saint Petersburg, 197341, Russia
Investigational Site Number 6430017
Saint Petersburg, 197341, Russia
Investigational Site Number 6430043
Saint Petersburg, 198205, Russia
Investigational Site Number 6430004
Saint Petersburg, 199106, Russia
Investigational Site Number 6430009
Saratov, 410028, Russia
Investigational Site Number 6430013
Saratov, 410028, Russia
Investigational Site Number 6430042
Saratov, 410039, Russia
Investigational Site Number 6430026
Sochi, 354057, Russia
Investigational Site Number 6430027
Sochi, 354057, Russia
Investigational Site Number 6430011
Tomsk, 634012, Russia
Investigational Site Number 6430038
Tomsk, 634050, Russia
Investigational Site Number 6430032
Tyumen, 625000, Russia
Investigational Site Number 6430023
Vladimir, 600020, Russia
Investigational Site Number 6430022
Vladimir, 600023, Russia
Investigational Site Number 6430031
Yaroslavl, 150002, Russia
Investigational Site Number 6880002
Belgrade, 11000, Serbia
Investigational Site Number 6880003
Belgrade, 11000, Serbia
Investigational Site Number 6880004
Belgrade, 11000, Serbia
Investigational Site Number 6880005
Kragujevac, 34000, Serbia
Investigational Site Number 6880001
Niš, 18000, Serbia
Investigational Site Number 6880006
Niš, 18000, Serbia
Investigational Site Number 6880007
Niš, 18000, Serbia
Investigational Site Number 7030006
Bardejov, 085 01, Slovakia
Investigational Site Number 7030012
Bratislava, 813 69, Slovakia
Investigational Site Number 7030011
Košice, 040 01, Slovakia
Investigational Site Number 7030008
Lučenec, 984 39, Slovakia
Investigational Site Number 7030009
Lučenec, 98401, Slovakia
Investigational Site Number 7030010
Lučenec, 98401, Slovakia
Investigational Site Number 7030001
Ľubochňa, 034 91, Slovakia
Investigational Site Number 7030004
Moldava nad Bodvou, 04525, Slovakia
Investigational Site Number 7030013
Prešov, 080 01, Slovakia
Investigational Site Number 7030003
Rožňava, 04801, Slovakia
Investigational Site Number 7030002
Sabinov, 083 01, Slovakia
Investigational Site Number 7030007
Svidník, 089 01, Slovakia
Investigational Site Number 7100005
Brits, 0250, South Africa
Investigational Site Number 7100009
Cape Town, 7530, South Africa
Investigational Site Number 7100006
Cape Town, 7570, South Africa
Investigational Site Number 7100002
eMkhomazi, 4170, South Africa
Investigational Site Number 7100001
Parow, 7500, South Africa
Investigational Site Number 7100012
Pinelands, 7405, South Africa
Investigational Site Number 7100011
Pretoria, 0002, South Africa
Investigational Site Number 7100014
Pretoria, 0083, South Africa
Investigational Site Number 7100008
Pretoria, 0157, South Africa
Investigational Site Number 7100010
Rivonia, 2128, South Africa
Investigational Site Number 7100007
Soweto, 1818, South Africa
Investigational Site Number 7100013
Vosloorus, 1475, South Africa
Investigational Site Number 7100003
Western Cape, 7130, South Africa
Investigational Site Number 4100011
Bucheon-si, 14647, South Korea
Investigational Site Number 4100005
Busan, 49201, South Korea
Investigational Site Number 4100007
Gwangju, 61469, South Korea
Investigational Site Number 4100001
Incheon, 22332, South Korea
Investigational Site Number 4100002
Seongnam-si, 13620, South Korea
Investigational Site Number 4100003
Seoul, 03080, South Korea
Investigational Site Number 4100006
Seoul, 03722, South Korea
Investigational Site Number 4100008
Seoul, 05505, South Korea
Investigational Site Number 4100004
Seoul, 06351, South Korea
Investigational Site Number 4100010
Uijeongbu-si, 11765, South Korea
Investigational Site Number 7240015
A Coruña, 15006, Spain
Investigational Site Number 7240003
Almería, 04120, Spain
Investigational Site Number 7240014
Barcelona, 08035, Spain
Investigational Site Number 7240011
Barcelona, 08041, Spain
Investigational Site Number 7240009
Córdoba, 14004, Spain
Investigational Site Number 7240024
El Puerto de Santa María, 11500, Spain
Investigational Site Number 7240016
Granada, 18016, Spain
Investigational Site Number 7240001
Madrid, 28023, Spain
Investigational Site Number 7240019
Madrid, 28034, Spain
Investigational Site Number 7240006
Madrid, 28040, Spain
Investigational Site Number 7240010
Madrid, 28046, Spain
Investigational Site Number 7240020
Madrid, 28046, Spain
Investigational Site Number 7240025
Sabadell, 08208, Spain
Investigational Site Number 7240023
Sanlúcar de Barrameda, 11540, Spain
Investigational Site Number 7240013
Santa Cruz de Tenerife, 38320, Spain
Investigational Site Number 7240007
Santiago de Compostela, 15706, Spain
Investigational Site Number 7240026
Seville, 41014, Spain
Investigational Site Number 7240012
Seville, 41071, Spain
Investigational Site Number 7240004
Valencia, 46010, Spain
Investigational Site Number 7240002
Vigo, 36312, Spain
Investigational Site Number 7240022
Villamartín, 11650, Spain
Investigational Site Number 7240008
Zaragoza, 50009, Spain
Investigational Site Number 7520007
Falun, 791 82, Sweden
Investigational Site Number 7520005
Lund, 221 85, Sweden
Investigational Site Number 7520004
Mölndal, 43180, Sweden
Investigational Site Number 7520003
Rättvik, 79530, Sweden
Investigational Site Number 7520008
Stockholm, 112 21, Sweden
Investigational Site Number 7520002
Stockholm, 118 83, Sweden
Investigational Site Number 7520006
Stockholm, 14186, Sweden
Investigational Site Number 7520001
Uppsala, 751 85, Sweden
Investigational Site Number 7560001
Olten, 4600, Switzerland
Investigational Site Number 7560002
Zollikerberg, 8125, Switzerland
Investigational Site Number 1580005
Hsinchu, 30071, Taiwan
Investigational Site Number 1580008
Kaohsiung City, 807, Taiwan
Investigational Site Number 1580004
Linkou District, Taiwan
Investigational Site Number 1580006
Taichung, 40447, Taiwan
Investigational Site Number 1580002
Tainan, 704, Taiwan
Investigational Site Number 1580007
Tainan, 710, Taiwan
Investigational Site Number 1580003
Taipei, 100, Taiwan
Investigational Site Number 1580001
Taipei, 112, Taiwan
Investigational Site Number 7920018
Antalya, 07070, Turkey (Türkiye)
Investigational Site Number 7920010
Aydin, 09100, Turkey (Türkiye)
Investigational Site Number 7920004
Çorum, 19200, Turkey (Türkiye)
Investigational Site Number 7920016
Gaziantep, 27310, Turkey (Türkiye)
Investigational Site Number 7920011
Istanbul, 34034, Turkey (Türkiye)
Investigational Site Number 7920009
Istanbul, 34390, Turkey (Türkiye)
Investigational Site Number 7920001
Istanbul, Turkey (Türkiye)
Investigational Site Number 7920007
Istanbul, Turkey (Türkiye)
Investigational Site Number 7920017
Istanbul, Turkey (Türkiye)
Investigational Site Number 7920003
Izmir, 35340, Turkey (Türkiye)
Investigational Site Number 7920013
Kayseri, 38039, Turkey (Türkiye)
Investigational Site Number 7920014
Kocaeli, 41380, Turkey (Türkiye)
Investigational Site Number 7920005
Kütahya, Turkey (Türkiye)
Investigational Site Number 7920015
Malatya, Turkey (Türkiye)
Investigational Site Number 7920008
Mersin, 33169, Turkey (Türkiye)
Investigational Site Number 7920002
Sivas, 58140, Turkey (Türkiye)
Investigational Site Number 8040020
Dnipro, 49005, Ukraine
Investigational Site Number 8040006
Dnipro, 49600, Ukraine
Investigational Site Number 8040009
Ivano-Frankivsk, 76000, Ukraine
Investigational Site Number 8040012
Ivano-Frankivsk, 76018, Ukraine
Investigational Site Number 8040021
Kharkiv, 61039, Ukraine
Investigational Site Number 8040011
Kharkiv, 61058, Ukraine
Investigational Site Number 8040008
Kharkiv, 61166, Ukraine
Investigational Site Number 8040002
Kiev, 02091, Ukraine
Investigational Site Number 8040024
Kiev, 02660, Ukraine
Investigational Site Number 8040003
Kyiv, 03049, Ukraine
Investigational Site Number 8040015
Kyiv, 03115, Ukraine
Investigational Site Number 8040019
Kyiv, 04050, Ukraine
Investigational Site Number 8040010
Kyiv, 04114, Ukraine
Investigational Site Number 8040026
Kyiv, Ukraine
Investigational Site Number 8040023
Lutsk, 43005, Ukraine
Investigational Site Number 8040025
Lutsk, 43024, Ukraine
Investigational Site Number 8040022
Lviv, 79011, Ukraine
Investigational Site Number 8040001
Ternopil, 46000, Ukraine
Investigational Site Number 8040016
Vinnitsya, 21018, Ukraine
Investigational Site Number 8040007
Vinnitsya, 21100, Ukraine
Investigational Site Number 8040004
Vinnytsia, 21001, Ukraine
Investigational Site Number 8040018
Zhytomyr, Ukraine
Investigational Site Number 8260003
Belfast, BT12 6BA, United Kingdom
Investigational Site Number 8260007
Chippenham, SN14 6GT, United Kingdom
Investigational Site Number 8260009
Davyhulme, Manchester, M41 5SL, United Kingdom
Investigational Site Number 8260010
Glasgow, G21 3UW, United Kingdom
Investigational Site Number 8260004
Hayle, TR27 5DT, United Kingdom
Investigational Site Number 8260011
Inverness, IV2 3UJ, United Kingdom
Investigational Site Number 8260002
Ipswich, IP4 5PD, United Kingdom
Investigational Site Number 8260006
Maidstone, ME16 9QQ, United Kingdom
Investigational Site Number 8260001
Swansea, SA2 8PP, United Kingdom
Related Publications (5)
Aggarwal R, Bhatt DL, Szarek M, Cannon CP, Leiter LA, Inzucchi SE, Lopes RD, McGuire DK, Lewis JB, Riddle MC, Davies MJ, Banks P, Carroll AK, Scirica BM, Ray KK, Kosiborod MN, Cherney DZI, Udell JA, Verma S, Mason RP, Pitt B, Steg PG. Effect of sotagliflozin on major adverse cardiovascular events: a prespecified secondary analysis of the SCORED randomised trial. Lancet Diabetes Endocrinol. 2025 Apr;13(4):321-332. doi: 10.1016/S2213-8587(24)00362-0. Epub 2025 Feb 14.
PMID: 39961315DERIVEDNatale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PMID: 38770818DERIVEDSridhar VS, Bhatt DL, Odutayo A, Szarek M, Davies MJ, Banks P, Pitt B, Steg PG, Cherney DZI. Sotagliflozin and Kidney Outcomes, Kidney Function, and Albuminuria in Type 2 Diabetes and CKD: A Secondary Analysis of the SCORED Trial. Clin J Am Soc Nephrol. 2024 May 1;19(5):557-564. doi: 10.2215/CJN.0000000000000414. Epub 2024 Jan 26.
PMID: 38277468DERIVEDBhatt DL, Szarek M, Pitt B, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Inzucchi SE, Kosiborod MN, Cherney DZI, Dwyer JP, Scirica BM, Bailey CJ, Diaz R, Ray KK, Udell JA, Lopes RD, Lapuerta P, Steg PG; SCORED Investigators. Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease. N Engl J Med. 2021 Jan 14;384(2):129-139. doi: 10.1056/NEJMoa2030186. Epub 2020 Nov 16.
PMID: 33200891DERIVEDCefalo CMA, Cinti F, Moffa S, Impronta F, Sorice GP, Mezza T, Pontecorvi A, Giaccari A. Sotagliflozin, the first dual SGLT inhibitor: current outlook and perspectives. Cardiovasc Diabetol. 2019 Feb 28;18(1):20. doi: 10.1186/s12933-019-0828-y.
PMID: 30819210DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated prematurely due to business decision.
Results Point of Contact
- Title
- Medical Affairs
- Organization
- Lexicon Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Suman Wason, MD
Lexicon Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2017
First Posted
October 19, 2017
Study Start
December 19, 2017
Primary Completion
July 8, 2020
Study Completion
July 8, 2020
Last Updated
October 28, 2022
Results First Posted
October 28, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
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.