Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

NCT ID: NCT03315143

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 10584 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-19
• Study Completion Date: 2020-07-08

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.

Conditions

Heart Failure; Type 2 Diabetes Mellitus; Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Sotagliflozin

Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.

Group Type: EXPERIMENTAL

Sotagliflozin

Intervention Type: DRUG

Sotagliflozin was administered as a tablet(s), orally once daily.

Placebo

Matching 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.

Interventions

Sotagliflozin

Sotagliflozin was administered as a tablet(s), orally once daily.

Intervention Type: DRUG

Placebo

Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.

Intervention Type: DRUG

Other Intervention Names

SAR439954

Eligibility Criteria

Inclusion Criteria

• 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.

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 participant's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suman Wason, MD

Role: STUDY_DIRECTOR

Lexicon Pharmaceuticals, Inc.

Locations

Investigational Site Number 8400017

Birmingham, Alabama, United States

Investigational Site Number 8400096

Sheffield, Alabama, United States

Investigational Site Number 8400004

Mesa, Arizona, United States

Investigational Site Number 8400059

Mesa, Arizona, United States

Investigational Site Number 8400021

Peoria, Arizona, United States

Investigational Site Number 8400014

Surprise, Arizona, United States

Investigational Site Number 8400071

Little Rock, Arkansas, United States

Investigational Site Number 8400039

Beverly Hills, California, United States

Investigational Site Number 8400042

Concord, California, United States

Investigational Site Number 8400089

Fresno, California, United States

Investigational Site Number 8400006

Huntington Park, California, United States

Investigational Site Number 8400036

Long Beach, California, United States

Investigational Site Number 8400073

Los Angeles, California, United States

Investigational Site Number 8400084

Los Angeles, California, United States

Investigational Site Number 8400035

Los Gatos, California, United States

Investigational Site Number 8400043

Northridge, California, United States

Investigational Site Number 8400025

Sacramento, California, United States

Investigational Site Number 8400018

San Dimas, California, United States

Investigational Site Number 8400070

Temecula, California, United States

Investigational Site Number 8400013

Waterbury, Connecticut, United States

Investigational Site Number 8400095

Bradenton, Florida, United States

Investigational Site Number 8400090

Clearwater, Florida, United States

Investigational Site Number 8400121

Clearwater, Florida, United States

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Cooper City, Florida, United States

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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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North Miami Beach, Florida, United States

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Opa-locka, Florida, United States

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Ormond Beach, Florida, United States

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Palm Harbor, Florida, United States

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Spring Hill, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Roswell, Georgia, United States

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Honolulu, Hawaii, United States

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Arlington Heights, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Crystal Lake, Illinois, United States

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Springfield, Illinois, United States

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Michigan City, Indiana, United States

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Valparaiso, Indiana, United States

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Des Moines, Iowa, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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Bangor, Maine, United States

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Flint, Michigan, United States

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Flint, Michigan, United States

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Troy, Michigan, United States

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Saint Cloud, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Washington, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Albany, New York, United States

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Laurelton, New York, United States

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New York, New York, United States

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Rosedale, New York, United States

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Smithtown, New York, United States

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Greenville, North Carolina, United States

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Morehead City, North Carolina, United States

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Morehead City, North Carolina, United States

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Morganton, North Carolina, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Lorain, Ohio, United States

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Mentor, Ohio, United States

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Bend, Oregon, United States

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Beaver, Pennsylvania, United States

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Greensburg, Pennsylvania, United States

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Indiana, Pennsylvania, United States

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Levittown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Anderson, South Carolina, United States

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Greer, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Memphis, Tennessee, United States

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Arlington, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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Mesquite, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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Bountiful, Utah, United States

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Ogden, Utah, United States

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Bennington, Vermont, United States

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South Burlington, Vermont, United States

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Danville, Virginia, United States

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Fairfax, Virginia, United States

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Falls Church, Virginia, United States

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Manassas, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Federal Way, Washington, United States

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Spokane, Washington, United States

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La Plata, , Argentina

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Mar del Plata, , Argentina

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Ramos Mejía, , Argentina

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Rosario, , Argentina

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Rosario, , Argentina

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Salta, , Argentina

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Santa Fe, , Argentina

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Adelaide, , Australia

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Fitzroy, , Australia

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Fremantle, , Australia

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Fullarton, , Australia

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Gosford, , Australia

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Herston, , Australia

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Liverpool, , Australia

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Melbourne, , Australia

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Merewether, , Australia

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Oaklands Park, , Australia

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Parkville, , Australia

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Redcliffe, , Australia

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Sherwood, , Australia

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St Leonards, , Australia

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Wollongong, , Australia

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Bonheiden, , Belgium

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Ghent, , Belgium

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Kortrijk, , Belgium

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Leuven, , Belgium

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Blumenau, , Brazil

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Brasília, , Brazil

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Campinas, , Brazil

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Fortaleza, , Brazil

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Passo Fundo, , Brazil

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Recife, , Brazil

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Rio de Janeiro, , Brazil

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São José do Rio Preto, , Brazil

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São José dos Campos, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Vitória, , Brazil

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Blagoevgrad, , Bulgaria

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Dobrich, , Bulgaria

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Gabrovo, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Silistra, , Bulgaria

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Smolyan, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Stara Zagora, , Bulgaria

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Brampton, , Canada

Investigational Site Number 1240013

Burlington, , Canada

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Calgary, , Canada

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Calgary, , Canada

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Concord, , Canada

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Edmonton, , Canada

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Edmonton, , Canada

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Greater Sudbury, , Canada

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Halifax, , Canada

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Hamilton, , Canada

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London, , Canada

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Montreal, , Canada

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Montreal, , Canada

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Montreal, , Canada

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Newmarket, , Canada

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Oshawa, , Canada

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Oshawa, , Canada

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Ottawa, , Canada

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Québec, , Canada

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Québec, , Canada

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Québec, , Canada

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Québec, , Canada

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Saint-Charles-Borromée, , Canada

Investigational Site Number 1240032

Saint-Marc-des-Carrieres, , Canada

Investigational Site Number 1240033

St. John's, , Canada

Investigational Site Number 1240031

Surrey, , Canada

Investigational Site Number 1240028

Toronto, , Canada

Investigational Site Number 1240015

Trois-Rivières, , Canada

Investigational Site Number 1240001

Vancouver, , Canada

Investigational Site Number 1240030

Victoria, , Canada

Investigational Site Number 1520015

Concepción, , Chile

Investigational Site Number 1520003

Osorno, , Chile

Investigational Site Number 1520012

Punta Arenas, , Chile

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Santiago, , Chile

Investigational Site Number 1520018

Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Talca, , Chile

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Temuco, , Chile

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Temuco, , Chile

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Temuco, , Chile

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Viña del Mar, , Chile

Investigational Site Number 1560019

Beijing, , China

Investigational Site Number 1560001

Beijing, , China

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Beijing, , China

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Beijing, , China

Investigational Site Number 1560032

Beijing, , China

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Changchun, , China

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Changchun, , China

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Changchun, , China

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Changsha, , China

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Chengdu, , China

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Dalian, , China

Investigational Site Number 1560010

Dalian, , China

Investigational Site Number 1560007

Guangzhou, , China

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Haikou, , China

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Hengyang, , China

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Hohhot, , China

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Huai'an, , China

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Jinan, , China

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Jining, , China

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Nanchang, , China

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Nanjing, , China

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Shanghai, , China

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Shenyang, , China

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Siping, , China

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Suzhou, , China

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Suzhou, , China

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Taizhou, , China

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Tianjin, , China

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Tianjin, , China

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Wuhan, , China

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Xi'an, , China

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Xinxiang, , China

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Zhenjiang, , China

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Brno, , Czechia

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Brno, , Czechia

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Broumov, , Czechia

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Humpolec, , Czechia

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Liberec, , Czechia

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Mariánské Lázně, , Czechia

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Městec Králové, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Řevnice, , Czechia

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Slaný, , Czechia

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Trutnov, , Czechia

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Vsetín, , Czechia

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Aarhus N, , Denmark

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Aarhus N, , Denmark

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Gentofte Municipality, , Denmark

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Herlev, , Denmark

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Hvidovre, , Denmark

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København NV, , Denmark

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Slagelse, , Denmark

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Svendborg, , Denmark

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Corbeil-Essonnes, , France

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La Rochelle, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Toulouse, , France

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Vénissieux, , France

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Batumi, , Georgia

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Kutaisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Berlin, , Germany

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Essen, , Germany

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Kassel, , Germany

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Leipzig, , Germany

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Münster, , Germany

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Oldenburg in Holstein, , Germany

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Athens, , Greece

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Ioannina, , Greece

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Larissa, , Greece

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Piraeus, , Greece

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Thessaloniki, , Greece

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Guatemala City, , Guatemala

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Guatemala City, , Guatemala

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Guatemala City, , Guatemala

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Guatemala City, , Guatemala

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Guatemala City, , Guatemala

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Guatemala City, , Guatemala

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Quetzaltenango, , Guatemala

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Quetzaltenango, , Guatemala

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Quetzaltenango, , Guatemala

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Békéscsaba, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Debrecen, , Hungary

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Kaposvár, , Hungary

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Nyíregyháza, , Hungary

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Nyíregyháza, , Hungary

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Székesfehérvár, , Hungary

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Zalaegerszeg, , Hungary

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Ahmedabad, , India

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Aurangabad, , India

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Bangalore, , India

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Bangalore, , India

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Belagavi, , India

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Bengaluru, , India

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Chandigarh, , India

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Gurgaon, , India

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Gurgaon, , India

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Hyderabad, , India

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Hyderabad, , India

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Hyderabad, , India

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Jaipur, , India

Investigational Site Number 3560024

Kochi, , India

Investigational Site Number 3560016

Kolkata, , India

Investigational Site Number 3560030

Kozhikode, , India

Investigational Site Number 3560006

Ludhiana, , India

Investigational Site Number 3560027

Mangalore, , India

Investigational Site Number 3560028

Mangalore, , India

Investigational Site Number 3560017

Mumbai, , India

Investigational Site Number 3560037

Mysore, , India

Investigational Site Number 3560013

Nagpur, , India

Investigational Site Number 3560014

Nagpur, , India

Investigational Site Number 3560021

Nashik, , India

Investigational Site Number 3560041

New Delhi, , India

Investigational Site Number 3560034

New Delhi, , India

Investigational Site Number 3560019

Pune, , India

Investigational Site Number 3560035

Pune, , India

Investigational Site Number 3560042

Pune, , India

Investigational Site Number 3560038

Pune, , India

Investigational Site Number 3560012

Pune, , India

Investigational Site Number 3560043

Varanasi, , India

Investigational Site Number 3560020

Vellore, , India

Investigational Site Number 3560015

Wardha, , India

Investigational Site Number 3760008

Beersheba, , Israel

Investigational Site Number 3760005

Haifa, , Israel

Investigational Site Number 3760007

Haifa, , Israel

Investigational Site Number 3760001

Jerusalem, , Israel

Investigational Site Number 3760002

Jerusalem, , Israel

Investigational Site Number 3760004

Nahariya, , Israel

Investigational Site Number 3760003

Tel Aviv, , Israel

Investigational Site Number 3760006

Tel Litwinsky, , Israel

Investigational Site Number 3800006

Catanzaro, , Italy

Investigational Site Number 3800010

Catanzaro, , Italy

Investigational Site Number 3800009

Chieri, , Italy

Investigational Site Number 3800007

Livorno, , Italy

Investigational Site Number 3800002

Milan, , Italy

Investigational Site Number 3800008

Milan, , Italy

Investigational Site Number 3800005

Orbassano, , Italy

Investigational Site Number 3800011

Ravenna, , Italy

Investigational Site Number 3800004

Roma, , Italy

Investigational Site Number 3800001

Verona, , Italy

Investigational Site Number 4280004

Daugavpils, , Latvia

Investigational Site Number 4280002

Liepāja, , Latvia

Investigational Site Number 4280007

Ogre, , Latvia

Investigational Site Number 4280006

Riga, , Latvia

Investigational Site Number 4280001

Riga, , Latvia

Investigational Site Number 4280005

Riga, , Latvia

Investigational Site Number 4280003

Sigulda, , Latvia

Investigational Site Number 4400006

Kaunas, , Lithuania

Investigational Site Number 4400003

Kaunas, , Lithuania

Investigational Site Number 4400009

Kaunas, , Lithuania

Investigational Site Number 4400008

Kėdainiai, , Lithuania

Investigational Site Number 4400004

Klaipėda, , Lithuania

Investigational Site Number 4400002

Klaipėda, , Lithuania

Investigational Site Number 4400007

Ukmerge, , Lithuania

Investigational Site Number 4400005

Utena, , Lithuania

Investigational Site Number 4400001

Vilnius, , Lithuania

Investigational Site Number 4840009

Actopan, , Mexico

Investigational Site Number 4840013

Aguascalientes, , Mexico

Investigational Site Number 4840019

Aguascalientes, , Mexico

Investigational Site Number 4840005

Celaya, , Mexico

Investigational Site Number 4840002

Cuernavaca, , Mexico

Investigational Site Number 4840025

Distrito Federal, , Mexico

Investigational Site Number 4840007

Durango, , Mexico

Investigational Site Number 4840023

Durango, , Mexico

Investigational Site Number 4840033

Guadalajara, , Mexico

Investigational Site Number 4840024

Guadalajara, , Mexico

Investigational Site Number 4840003

Guadalajara, , Mexico

Investigational Site Number 4840011

Guadalajara, , Mexico

Investigational Site Number 4840027

Guadalajara, , Mexico

Investigational Site Number 4840004

Guadalajara, , Mexico

Investigational Site Number 4840010

Guadalajara, , Mexico

Investigational Site Number 4840030

Guadalajara, , Mexico

Investigational Site Number 4840018

Mexico City, , Mexico

Investigational Site Number 4840028

Mérida, , Mexico

Investigational Site Number 4840034

Mérida, , Mexico

Investigational Site Number 4840021

Monterrey, , Mexico

Investigational Site Number 4840020

Monterrey, , Mexico

Investigational Site Number 4840001

Monterrey, , Mexico

Investigational Site Number 4840014

Querétaro, , Mexico

Investigational Site Number 4840015

Toluca, , Mexico

Investigational Site Number 4840008

Veracruz, , Mexico

Investigational Site Number 4840016

Xalapa, , Mexico

Investigational Site Number 4840026

Zapopan, , Mexico

Investigational Site Number 5280004

Almelo, , Netherlands

Investigational Site Number 5280001

Groningen, , Netherlands

Investigational Site Number 5280003

Hoogeveen, , Netherlands

Investigational Site Number 5280005

Meppel, , Netherlands

Investigational Site Number 5280002

Rotterdam, , Netherlands

Investigational Site Number 5540014

Auckland, , New Zealand

Investigational Site Number 5540006

Birkenhead, , New Zealand

Investigational Site Number 5540009

Birkenhead, , New Zealand

Investigational Site Number 5540002

Christchurch, , New Zealand

Investigational Site Number 5540003

Christchurch, , New Zealand

Investigational Site Number 5540012

Christchurch, , New Zealand

Investigational Site Number 5540007

Dunedin, , New Zealand

Investigational Site Number 5540016

Hamilton, , New Zealand

Investigational Site Number 5540013

New Plymouth, , New Zealand

Investigational Site Number 5540015

Palmerston North, , New Zealand

Investigational Site Number 5540005

Rotorua, , New Zealand

Investigational Site Number 5540010

Takapuna, , New Zealand

Investigational Site Number 5540008

Tauranga, , New Zealand

Investigational Site Number 5540011

Tauranga, , New Zealand

Investigational Site Number 5540004

Wellington, , New Zealand

Investigational Site Number 8070003

Skopje, , North Macedonia

Investigational Site Number 8070005

Struga, , North Macedonia

Investigational Site Number 8070001

Tetovo, , North Macedonia

Investigational Site Number 8070004

Tetovo, , North Macedonia

Investigational Site Number 5780005

Hamar, , Norway

Investigational Site Number 5780001

Hønefoss, , Norway

Investigational Site Number 5780003

Oslo, , Norway

Investigational Site Number 5780002

Oslo, , Norway

Investigational Site Number 5780004

Skedsmokorset, , Norway

Investigational Site Number 6040004

Arequipa, , Peru

Investigational Site Number 6040006

Callao, , 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, , Peru

Investigational Site Number 6040025

Lima, , Peru

Investigational Site Number 6040016

Lima, , Peru

Investigational Site Number 6040020

Lima, , Peru

Investigational Site Number 6040013

Lima, , Peru

Investigational Site Number 6040023

Lima, , Peru

Investigational Site Number 6040007

Lima, , Peru

Investigational Site Number 6040019

Lima, , Peru

Investigational Site Number 6040022

Lima, , Peru

Investigational Site Number 6040012

Lima, , Peru

Investigational Site Number 6040017

Lima, , Peru

Investigational Site Number 6040014

Lima Lima, , Peru

Investigational Site Number 6040011

Piura, , Peru

Investigational Site Number 6040002

Trujillo, , Peru

Investigational Site Number 6160027

Bialystok, , Poland

Investigational Site Number 6160011

Bialystok, , Poland

Investigational Site Number 6160029

Bydgoszcz, , Poland

Investigational Site Number 6160030

Bydgoszcz, , Poland

Investigational Site Number 6160006

Bydgoszcz, , Poland

Investigational Site Number 6160018

Bytom, , Poland

Investigational Site Number 6160002

Czeladź, , Poland

Investigational Site Number 6160003

Gdynia, , Poland

Investigational Site Number 6160005

Gdynia, , Poland

Investigational Site Number 6160008

Grodzisk Mazowiecki, , Poland

Investigational Site Number 6160031

Grodzisk Mazowiecki, , Poland

Investigational Site Number 6160023

Katowice, , Poland

Investigational Site Number 6160026

Katowice, , Poland

Investigational Site Number 6160022

Kielce, , Poland

Investigational Site Number 6160019

Krakow, , Poland

Investigational Site Number 6160024

Krakow, , Poland

Investigational Site Number 6160010

Krakow, , Poland

Investigational Site Number 6160016

Lodz, , Poland

Investigational Site Number 6160013

Lodz, , Poland

Investigational Site Number 6160015

Lodz, , Poland

Investigational Site Number 6160007

Lublin, , Poland

Investigational Site Number 6160033

Poznan, , Poland

Investigational Site Number 6160021

Puławy, , Poland

Investigational Site Number 6160028

Staszów, , Poland

Investigational Site Number 6160020

Torun, , Poland

Investigational Site Number 6160014

Warsaw, , Poland

Investigational Site Number 6160025

Warsaw, , Poland

Investigational Site Number 6160001

Warsaw, , Poland

Investigational Site Number 6160004

Warsaw, , Poland

Investigational Site Number 6160012

Wroclaw, , Poland

Investigational Site Number 6160017

Zabrze, , Poland

Investigational Site Number 6160032

Zamość, , Poland

Investigational Site Number 6200004

Almada, , Portugal

Investigational Site Number 6200005

Caldas da Rainha, , Portugal

Investigational Site Number 6200009

Carnaxide, , Portugal

Investigational Site Number 6200002

Coimbra, , Portugal

Investigational Site Number 6200008

Leiria, , Portugal

Investigational Site Number 6200001

Lisbon, , Portugal

Investigational Site Number 6200007

Loures, , Portugal

Investigational Site Number 6200003

Porto, , Portugal

Investigational Site Number 8400122

San Juan, , Puerto Rico

Investigational Site Number 6420008

Bacau, , Romania

Investigational Site Number 6420005

Baia Mare, Maramures, , Romania

Investigational Site Number 6420009

Brasov, , Romania

Investigational Site Number 6420013

Bucharest, , Romania

Investigational Site Number 6420014

Bucharest, , Romania

Investigational Site Number 6420012

Bucharest, , Romania

Investigational Site Number 6420011

Bucharest, , Romania

Investigational Site Number 6420002

Craiova, , Romania

Investigational Site Number 6420003

Oradea, , Romania

Investigational Site Number 6420004

Oradea, , Romania

Investigational Site Number 6420010

Ploieşti, , Romania

Investigational Site Number 6420001

Targoviste, Dambovita, , Romania

Investigational Site Number 6420006

Targu Mures, Mures, , Romania

Investigational Site Number 6420007

Targu Mures, Mures, , Romania

Investigational Site Number 6430028

Kaliningrad, , Russia

Investigational Site Number 6430018

Kazan', , Russia

Investigational Site Number 6430001

Kemerovo, , Russia

Investigational Site Number 6430035

Kemerovo, , Russia

Investigational Site Number 6430025

Krasnodar, , Russia

Investigational Site Number 6430040

Krasnodar, , Russia

Investigational Site Number 6430010

Krasnodar, , Russia

Investigational Site Number 6430015

Moscow, , Russia

Investigational Site Number 6430016

Moscow, , Russia

Investigational Site Number 6430046

Moscow, , Russia

Investigational Site Number 6430003

Moscow, , Russia

Investigational Site Number 6430036

Moscow, , Russia

Investigational Site Number 6430005

Moscow, , Russia

Investigational Site Number 6430039

Moscow, , Russia

Investigational Site Number 6430021

Moscow, , Russia

Investigational Site Number 6430002

Moscow, , Russia

Investigational Site Number 6430020

Moscow, , Russia

Investigational Site Number 6430024

Moscow, , Russia

Investigational Site Number 6430033

Nizhny Novgorod, , Russia

Investigational Site Number 6430037

Novosibirsk, , Russia

Investigational Site Number 6430034

Novosibirsk, , Russia

Investigational Site Number 6430007

Perm, , Russia

Investigational Site Number 6430019

Rostov-on-Don, , Russia

Investigational Site Number 6430012

Saint Petersburg, , Russia

Investigational Site Number 6430041

Saint Petersburg, , Russia

Investigational Site Number 6430006

Saint Petersburg, , Russia

Investigational Site Number 6430008

Saint Petersburg, , Russia

Investigational Site Number 6430030

Saint Petersburg, , Russia

Investigational Site Number 6430044

Saint Petersburg, , Russia

Investigational Site Number 6430045

Saint Petersburg, , Russia

Investigational Site Number 6430014

Saint Petersburg, , Russia

Investigational Site Number 6430017

Saint Petersburg, , Russia

Investigational Site Number 6430043

Saint Petersburg, , Russia

Investigational Site Number 6430004

Saint Petersburg, , Russia

Investigational Site Number 6430009

Saratov, , Russia

Investigational Site Number 6430013

Saratov, , Russia

Investigational Site Number 6430042

Saratov, , Russia

Investigational Site Number 6430026

Sochi, , Russia

Investigational Site Number 6430027

Sochi, , Russia

Investigational Site Number 6430011

Tomsk, , Russia

Investigational Site Number 6430038

Tomsk, , Russia

Investigational Site Number 6430032

Tyumen, , Russia

Investigational Site Number 6430023

Vladimir, , Russia

Investigational Site Number 6430022

Vladimir, , Russia

Investigational Site Number 6430031

Yaroslavl, , Russia

Investigational Site Number 6880002

Belgrade, , Serbia

Investigational Site Number 6880003

Belgrade, , Serbia

Investigational Site Number 6880004

Belgrade, , Serbia

Investigational Site Number 6880005

Kragujevac, , Serbia

Investigational Site Number 6880001

Niš, , Serbia

Investigational Site Number 6880006

Niš, , Serbia

Investigational Site Number 6880007

Niš, , Serbia

Investigational Site Number 7030006

Bardejov, , Slovakia

Investigational Site Number 7030012

Bratislava, , Slovakia

Investigational Site Number 7030011

Košice, , Slovakia

Investigational Site Number 7030008

Lučenec, , Slovakia

Investigational Site Number 7030009

Lučenec, , Slovakia

Investigational Site Number 7030010

Lučenec, , Slovakia

Investigational Site Number 7030001

Ľubochňa, , Slovakia

Investigational Site Number 7030004

Moldava nad Bodvou, , Slovakia

Investigational Site Number 7030013

Prešov, , Slovakia

Investigational Site Number 7030003

Rožňava, , Slovakia

Investigational Site Number 7030002

Sabinov, , Slovakia

Investigational Site Number 7030007

Svidník, , Slovakia

Investigational Site Number 7100005

Brits, , South Africa

Investigational Site Number 7100009

Cape Town, , South Africa

Investigational Site Number 7100006

Cape Town, , South Africa

Investigational Site Number 7100002

eMkhomazi, , South Africa

Investigational Site Number 7100001

Parow, , South Africa

Investigational Site Number 7100012

Pinelands, , South Africa

Investigational Site Number 7100011

Pretoria, , South Africa

Investigational Site Number 7100014

Pretoria, , South Africa

Investigational Site Number 7100008

Pretoria, , South Africa

Investigational Site Number 7100010

Rivonia, , South Africa

Investigational Site Number 7100007

Soweto, , South Africa

Investigational Site Number 7100013

Vosloorus, , South Africa

Investigational Site Number 7100003

Western Cape, , South Africa

Investigational Site Number 4100011

Bucheon-si, , South Korea

Investigational Site Number 4100005

Busan, , South Korea

Investigational Site Number 4100007

Gwangju, , South Korea

Investigational Site Number 4100001

Incheon, , South Korea

Investigational Site Number 4100002

Seongnam-si, , South Korea

Investigational Site Number 4100003

Seoul, , South Korea

Investigational Site Number 4100006

Seoul, , South Korea

Investigational Site Number 4100008

Seoul, , South Korea

Investigational Site Number 4100004

Seoul, , South Korea

Investigational Site Number 4100010

Uijeongbu-si, , South Korea

Investigational Site Number 7240015

A Coruña, , Spain

Investigational Site Number 7240003

Almería, , Spain

Investigational Site Number 7240014

Barcelona, , Spain

Investigational Site Number 7240011

Barcelona, , Spain

Investigational Site Number 7240009

Córdoba, , Spain

Investigational Site Number 7240024

El Puerto de Santa María, , Spain

Investigational Site Number 7240016

Granada, , Spain

Investigational Site Number 7240001

Madrid, , Spain

Investigational Site Number 7240019

Madrid, , Spain

Investigational Site Number 7240006

Madrid, , Spain

Investigational Site Number 7240010

Madrid, , Spain

Investigational Site Number 7240020

Madrid, , Spain

Investigational Site Number 7240025

Sabadell, , Spain

Investigational Site Number 7240023

Sanlúcar de Barrameda, , Spain

Investigational Site Number 7240013

Santa Cruz de Tenerife, , Spain

Investigational Site Number 7240007

Santiago de Compostela, , Spain

Investigational Site Number 7240026

Seville, , Spain

Investigational Site Number 7240012

Seville, , Spain

Investigational Site Number 7240004

Valencia, , Spain

Investigational Site Number 7240002

Vigo, , Spain

Investigational Site Number 7240022

Villamartín, , Spain

Investigational Site Number 7240008

Zaragoza, , Spain

Investigational Site Number 7520007

Falun, , Sweden

Investigational Site Number 7520005

Lund, , Sweden

Investigational Site Number 7520004

Mölndal, , Sweden

Investigational Site Number 7520003

Rättvik, , Sweden

Investigational Site Number 7520008

Stockholm, , Sweden

Investigational Site Number 7520002

Stockholm, , Sweden

Investigational Site Number 7520006

Stockholm, , Sweden

Investigational Site Number 7520001

Uppsala, , Sweden

Investigational Site Number 7560001

Olten, , Switzerland

Investigational Site Number 7560002

Zollikerberg, , Switzerland

Investigational Site Number 1580005

Hsinchu, , Taiwan

Investigational Site Number 1580008

Kaohsiung City, , Taiwan

Investigational Site Number 1580004

Linkou District, , Taiwan

Investigational Site Number 1580006

Taichung, , Taiwan

Investigational Site Number 1580002

Tainan City, , Taiwan

Investigational Site Number 1580007

Tainan City, , Taiwan

Investigational Site Number 1580003

Taipei, , Taiwan

Investigational Site Number 1580001

Taipei, , Taiwan

Investigational Site Number 7920018

Antalya, , Turkey (Türkiye)

Investigational Site Number 7920010

Aydin, , Turkey (Türkiye)

Investigational Site Number 7920004

Çorum, , Turkey (Türkiye)

Investigational Site Number 7920016

Gaziantep, , Turkey (Türkiye)

Investigational Site Number 7920011

Istanbul, , Turkey (Türkiye)

Investigational Site Number 7920009

Istanbul, , 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, , Turkey (Türkiye)

Investigational Site Number 7920013

Kayseri, , Turkey (Türkiye)

Investigational Site Number 7920014

Kocaeli, , Turkey (Türkiye)

Investigational Site Number 7920005

Kütahya, , Turkey (Türkiye)

Investigational Site Number 7920015

Malatya, , Turkey (Türkiye)

Investigational Site Number 7920008

Mersin, , Turkey (Türkiye)

Investigational Site Number 7920002

Sivas, , Turkey (Türkiye)

Investigational Site Number 8040020

Dnipro, , Ukraine

Investigational Site Number 8040006

Dnipro, , Ukraine

Investigational Site Number 8040009

Ivano-Frankivsk, , Ukraine

Investigational Site Number 8040012

Ivano-Frankivsk, , Ukraine

Investigational Site Number 8040021

Kharkiv, , Ukraine

Investigational Site Number 8040011

Kharkiv, , Ukraine

Investigational Site Number 8040008

Kharkiv, , Ukraine

Investigational Site Number 8040002

Kiev, , Ukraine

Investigational Site Number 8040024

Kiev, , Ukraine

Investigational Site Number 8040003

Kyiv, , Ukraine

Investigational Site Number 8040015

Kyiv, , Ukraine

Investigational Site Number 8040019

Kyiv, , Ukraine

Investigational Site Number 8040010

Kyiv, , Ukraine

Investigational Site Number 8040026

Kyiv, , Ukraine

Investigational Site Number 8040023

Lutsk, , Ukraine

Investigational Site Number 8040025

Lutsk, , Ukraine

Investigational Site Number 8040022

Lviv, , Ukraine

Investigational Site Number 8040001

Ternopil, , Ukraine

Investigational Site Number 8040016

Vinnitsya, , Ukraine

Investigational Site Number 8040007

Vinnitsya, , Ukraine

Investigational Site Number 8040004

Vinnytsia, , Ukraine

Investigational Site Number 8040018

Zhytomyr, , Ukraine

Investigational Site Number 8260003

Belfast, , United Kingdom

Investigational Site Number 8260007

Chippenham, , United Kingdom

Investigational Site Number 8260009

Davyhulme, Manchester, , United Kingdom

Investigational Site Number 8260010

Glasgow, , United Kingdom

Investigational Site Number 8260004

Hayle, , United Kingdom

Investigational Site Number 8260011

Inverness, , United Kingdom

Investigational Site Number 8260002

Ipswich, , United Kingdom

Investigational Site Number 8260006

Maidstone, , United Kingdom

Investigational Site Number 8260001

Swansea, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Bulgaria; Canada; Chile; China; Czechia; Denmark; Estonia; France; Georgia; Germany; Greece; Guatemala; Hungary; India; Israel; Italy; Latvia; Lithuania; Mexico; Netherlands; New Zealand; North Macedonia; Norway; Peru; Poland; Portugal; Puerto Rico; Romania; Russia; Serbia; Slovakia; South Africa; South Korea; Spain; Sweden; Switzerland; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39961315 (View on PubMed)

Natale 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.

Reference Type: DERIVED

PMID: 38770818 (View on PubMed)

Sridhar 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.

Reference Type: DERIVED

PMID: 38277468 (View on PubMed)

Bhatt 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.

Reference Type: DERIVED

PMID: 33200891 (View on PubMed)

Cefalo 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.

Reference Type: DERIVED

PMID: 30819210 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-002644-32

Identifier Type: -

Identifier Source: secondary_id

U1111-1187-8703

Identifier Type: OTHER

Identifier Source: secondary_id

EFC14875

Identifier Type: -

Identifier Source: org_study_id