Clinical trial NCT03315143: Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Failure
Type 2 Diabetes Mellitus
Chronic Kidney Diseases
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2017-10-19
Enrollment: 10584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
timeFrame: Up to 30 months
Secondary outcomes:
measure: Total Number of Occurrences of HHF and Urgent HF Visits
timeFrame: Up to 30 months
measure: Number of Deaths From Cardiovascular Causes
timeFrame: Up to 30 months
measure: Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
timeFrame: Up to 30 months
measure: Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
timeFrame: Up to 30 months
measure: 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)
timeFrame: Up to 30 months
measure: Number of Deaths From Any Cause
timeFrame: Up to 30 months
measure: Total Number of Occurrences of CV Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 8400017
state: Alabama
city: Sheffield
country: United States
facility: Investigational Site Number 8400096
state: Alabama
city: Mesa
country: United States
facility: Investigational Site Number 8400004
state: Arizona
city: Mesa
country: United States
facility: Investigational Site Number 8400059
state: Arizona
city: Peoria
country: United States
facility: Investigational Site Number 8400021
state: Arizona
city: Surprise
country: United States
facility: Investigational Site Number 8400014
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site Number 8400071
state: Arkansas
city: Beverly Hills
country: United States
facility: Investigational Site Number 8400039
state: California
city: Concord
country: United States
facility: Investigational Site Number 8400042
state: California
city: Fresno
country: United States
facility: Investigational Site Number 8400089
state: California
city: Huntington Park
country: United States
facility: Investigational Site Number 8400006
state: California
city: Long Beach
country: United States
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state: California
city: Los Angeles
country: United States
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state: California
city: Los Angeles
country: United States
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state: California
city: Los Gatos
country: United States
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state: California
city: Northridge
country: United States
facility: Investigational Site Number 8400043
state: California
city: Sacramento
country: United States
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state: California
city: San Dimas
country: United States
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state: California
city: Temecula
country: United States
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state: California
city: Waterbury
country: United States
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state: Connecticut
city: Bradenton
country: United States
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state: Florida
city: Clearwater
country: United States
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state: Florida
city: Clearwater
country: United States
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state: Florida
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country: United States
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state: Florida
city: Hialeah
country: United States
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state: Florida
city: Hollywood
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jacksonville
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state: Florida
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state: Florida
city: Miami
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state: Florida
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state: Florida
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state: Florida
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state: Florida
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state: Florida
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country: United States
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city: Chicago
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state: Illinois
city: Chicago
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state: Illinois
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state: Illinois
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state: Illinois
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state: Illinois
city: Michigan City
country: United States
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state: Indiana
city: Valparaiso
country: United States
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state: Indiana
city: Des Moines
country: United States
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state: Iowa
city: Topeka
country: United States
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state: Kansas
city: Louisville
country: United States
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state: Kentucky
city: Bangor
country: United States
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state: Maine
city: Flint
country: United States
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state: Michigan
city: Flint
country: United States
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state: Michigan
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state: Michigan
city: Saint Cloud
country: United States
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state: Minnesota
city: Kansas City
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city: Saint Louis
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state: Missouri
city: Omaha
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state: Nebraska
city: Las Vegas
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state: Nevada
city: Albany
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state: New York
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state: North Carolina
city: Morehead City
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country: United States
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country: United States
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state: North Dakota
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state: Ohio
city: Cincinnati
country: United States
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state: Ohio
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country: United States
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state: Ohio
city: Mentor
country: United States
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state: Ohio
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country: United States
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state: Oregon
city: Beaver
country: United States
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state: Pennsylvania
city: Greensburg
country: United States
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state: Pennsylvania
city: Indiana
country: United States
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state: Pennsylvania
city: Levittown
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Anderson
country: United States
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state: South Carolina
city: Greer
country: United States
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state: South Carolina
city: Myrtle Beach
country: United States
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state: South Carolina
city: Memphis
country: United States
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state: Tennessee
city: Arlington
country: United States
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state: Texas
city: Corpus Christi
country: United States
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state: Texas
city: Dallas
country: United States
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city: El Paso
country: United States
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state: Texas
city: Houston
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state: Texas
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country: United States
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state: Texas
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country: United States
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state: Texas
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country: United States
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state: Texas
city: Plano
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Waco
country: United States
facility: Investigational Site Number 8400091
state: Texas
city: Bountiful
country: United States
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state: Utah
city: Ogden
country: United States
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state: Utah
city: Bennington
country: United States
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state: Vermont
city: South Burlington
country: United States
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state: Vermont
city: Danville
country: United States
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state: Virginia
city: Fairfax
country: United States
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state: Virginia
city: Falls Church
country: United States
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state: Virginia
city: Manassas
country: United States
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state: Virginia
city: Norfolk
country: United States
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state: Virginia
city: Richmond
country: United States
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state: Virginia
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country: United States
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state: Virginia
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country: United States
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state: Washington
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state: Washington
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country: Argentina
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country: Argentina
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country: Argentina
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country: Argentina
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country: Argentina
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country: Argentina
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city: Villa Maria
country: Argentina
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country: Australia
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city: Box Hill
country: Australia
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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country: Belgium
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country: Belgium
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country: Belgium
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country: Bulgaria
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country: Canada
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country: Canada
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city: St. John'S
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city: Sudbury
country: Canada
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country: Canada
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city: Toronto
country: Canada
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country: Canada
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city: Vancouver
country: Canada
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country: Canada
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city: Talca
country: Chile
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city: Temuco
country: Chile
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city: Temuco
country: Chile
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city: Temuco
country: Chile
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city: Viña Del Mar
country: Chile
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city: Beijing
country: China
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city: Beijing
country: China
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city: Beijing
country: China
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country: China
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country: China
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city: Changchun
country: China
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city: Changchun
country: China
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city: Changchun
country: China
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city: Changsha
country: China
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city: Chengdu
country: China
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city: Dalian
country: China
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city: Dalian
country: China
facility: Investigational Site Number 1560010
city: Guangzhou
country: China
facility: Investigational Site Number 1560007
city: Haikou
country: China
facility: Investigational Site Number 1560016
city: Hengyang
country: China
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city: Hohhot
country: China
facility: Investigational Site Number 1560038
city: Huai'An
country: China
facility: Investigational Site Number 1560005
city: Jinan
country: China
facility: Investigational Site Number 1560009
city: Jining
country: China
facility: Investigational Site Number 1560037
city: Nanchang
country: China
facility: Investigational Site Number 1560031
city: Nanjing
country: China
facility: Investigational Site Number 1560004
city: Shanghai
country: China
facility: Investigational Site Number 1560006
city: Shenyang
country: China
facility: Investigational Site Number 1560036
city: Siping
country: China
facility: Investigational Site Number 1560020
city: Suzhou
country: China
facility: Investigational Site Number 1560025
city: Suzhou
country: China
facility: Investigational Site Number 1560014
city: Taizhou
country: China
facility: Investigational Site Number 1560026
city: Tianjin
country: China
facility: Investigational Site Number 1560028
city: Tianjin
country: China
facility: Investigational Site Number 1560029
city: Wuhan
country: China
facility: Investigational Site Number 1560024
city: Xi'An
country: China
facility: Investigational Site Number 1560027
city: Xinxiang
country: China
facility: Investigational Site Number 1560035
city: Zhenjiang
country: China
facility: Investigational Site Number 1560008
city: Brno
country: Czechia
facility: Investigational Site Number 2030012
city: Brno
country: Czechia
facility: Investigational Site Number 2030002
city: Broumov
country: Czechia
facility: Investigational Site Number 2030021
city: Humpolec
country: Czechia
facility: Investigational Site Number 2030017
city: Liberec
country: Czechia
facility: Investigational Site Number 2030014
city: Marianske Lazne
country: Czechia
facility: Investigational Site Number 2030007
city: Mestec Kralove
country: Czechia
facility: Investigational Site Number 2030015
city: Plzen
country: Czechia
facility: Investigational Site Number 2030009
city: Praha 10
country: Czechia
facility: Investigational Site Number 2030016
city: Praha 1
country: Czechia
facility: Investigational Site Number 2030019
city: Praha 2
country: Czechia
facility: Investigational Site Number 2030006
city: Praha 4
country: Czechia
facility: Investigational Site Number 2030005
city: Praha 6
country: Czechia
facility: Investigational Site Number 2030011
city: Praha 8
country: Czechia
facility: Investigational Site Number 2030018
city: Revnice
country: Czechia
facility: Investigational Site Number 2030010
city: Slany
country: Czechia
facility: Investigational Site Number 2030020
city: Trutnov
country: Czechia
facility: Investigational Site Number 2030001
city: Vsetin
country: Czechia
facility: Investigational Site Number 2030008
city: Aarhus N
country: Denmark
facility: Investigational Site Number 2080003
city: Aarhus N
country: Denmark
facility: Investigational Site Number 2080005
city: Gentofte
country: Denmark
facility: Investigational Site Number 2080009
city: Herlev
country: Denmark
facility: Investigational Site Number 2080004
city: Hvidovre
country: Denmark
facility: Investigational Site Number 2080008
city: København Nv
country: Denmark
facility: Investigational Site Number 2080002
city: Slagelse
country: Denmark
facility: Investigational Site Number 2080007
city: Svendborg
country: Denmark
facility: Investigational Site Number 2080006
city: Tallinn
country: Estonia
facility: Investigational Site Number 2330003
city: Tallinn
country: Estonia
facility: Investigational Site Number 2330001
city: Tartu
country: Estonia
facility: Investigational Site Number 2330002
city: Corbeil-Essonnes
country: France
facility: Investigational Site Number 2500003
city: La Rochelle Cedex
country: France
facility: Investigational Site Number 2500002
city: Paris Cedex 18
country: France
facility: Investigational Site Number 2500001
city: Paris
country: France
facility: Investigational Site Number 2500005
city: Paris
country: France
facility: Investigational Site Number 2500006
city: Toulouse Cedex 9
country: France
facility: Investigational Site Number 2500004
city: Venissieux
country: France
facility: Investigational Site Number 2500007
city: Batumi
country: Georgia
facility: Investigational Site Number 2680004
city: Kutaisi
country: Georgia
facility: Investigational Site Number 2680001
city: Tbilisi
country: Georgia
facility: Investigational Site Number 2680007
city: Tbilisi
country: Georgia
facility: Investigational Site Number 2680005
city: Tbilisi
country: Georgia
facility: Investigational Site Number 2680003
city: Tbilisi
country: Georgia
facility: Investigational Site Number 2680006
city: Tbilisi
country: Georgia
facility: Investigational Site Number 2680002
city: Berlin
country: Germany
facility: Investigational Site Number 2760008
city: Essen
country: Germany
facility: Investigational Site Number 2760005
city: Freiburg
country: Germany
facility: Investigational Site Number 2760001
city: Hamburg
country: Germany
facility: Investigational Site Number 2760007
city: Kassel
country: Germany
facility: Investigational Site Number 2760002
city: Leipzig
country: Germany
facility: Investigational Site Number 2760006
city: Münster
country: Germany
facility: Investigational Site Number 2760003
city: Oldenburg In Holstein
country: Germany
facility: Investigational Site Number 2760009
city: Athens
country: Greece
facility: Investigational Site Number 3000001
city: Ioannina
country: Greece
facility: Investigational Site Number 3000002
city: Larissa
country: Greece
facility: Investigational Site Number 3000004
city: Pireas
country: Greece
facility: Investigational Site Number 3000003
city: Thessaloniki
country: Greece
facility: Investigational Site Number 3000005
city: Guatemala
country: Guatemala
facility: Investigational Site Number 3200007
city: Guatemala
country: Guatemala
facility: Investigational Site Number 3200013
city: Guatemala
country: Guatemala
facility: Investigational Site Number 3200001
city: Guatemala
country: Guatemala
facility: Investigational Site Number 3200002
city: Guatemala
country: Guatemala
facility: Investigational Site Number 3200009
city: Guatemala
country: Guatemala
facility: Investigational Site Number 3200010
city: Quetzaltenango
country: Guatemala
facility: Investigational Site Number 3200006
city: Quetzaltenango
country: Guatemala
facility: Investigational Site Number 3200014
city: Quetzaltenango
country: Guatemala
facility: Investigational Site Number 3200004
city: Budapest
country: Hungary
facility: Investigational Site Number 3480017
city: Budapest
country: Hungary
facility: Investigational Site Number 3480004
city: Budapest
country: Hungary
facility: Investigational Site Number 3480011
city: Budapest
country: Hungary
facility: Investigational Site Number 3480001
city: Budapest
country: Hungary
facility: Investigational Site Number 3480010
city: Budapest
country: Hungary
facility: Investigational Site Number 3480012
city: Budapest
country: Hungary
facility: Investigational Site Number 3480016
city: Budapest
country: Hungary
facility: Investigational Site Number 3480018
city: Békéscsaba
country: Hungary
facility: Investigational Site Number 3480006
city: Debrecen
country: Hungary
facility: Investigational Site Number 3480002
city: Debrecen
country: Hungary
facility: Investigational Site Number 3480008
city: Kaposvár
country: Hungary
facility: Investigational Site Number 3480013
city: Nyíregyháza
country: Hungary
facility: Investigational Site Number 3480014
city: Nyíregyháza
country: Hungary
facility: Investigational Site Number 3480015
city: Szekesfehervar
country: Hungary
facility: Investigational Site Number 3480003
city: Zalaegerszeg
country: Hungary
facility: Investigational Site Number 3480007
city: Ahmedabad
country: India
facility: Investigational Site Number 3560025
city: Aurangabad
country: India
facility: Investigational Site Number 3560040
city: Bangalore
country: India
facility: Investigational Site Number 3560010
city: Bangalore
country: India
facility: Investigational Site Number 3560026
city: Belgaum
country: India
facility: Investigational Site Number 3560005
city: Bengaluru
country: India
facility: Investigational Site Number 3560008
city: Chandigarh
country: India
facility: Investigational Site Number 3560022
city: Gurgaon
country: India
facility: Investigational Site Number 3560003
city: Gurgaon
country: India
facility: Investigational Site Number 3560004
city: Hyderabad
country: India
facility: Investigational Site Number 3560018
city: Hyderabad
country: India
facility: Investigational Site Number 3560001
city: Hyderabad
country: India
facility: Investigational Site Number 3560007
city: Jaipur
country: India
facility: Investigational Site Number 3560002
city: Kochi
country: India
facility: Investigational Site Number 3560024
city: Kolkata
country: India
facility: Investigational Site Number 3560016
city: Kozhikode
country: India
facility: Investigational Site Number 3560030
city: Ludhiana
country: India
facility: Investigational Site Number 3560006
city: Mangalore
country: India
facility: Investigational Site Number 3560027
city: Mangalore
country: India
facility: Investigational Site Number 3560028
city: Mumbai
country: India
facility: Investigational Site Number 3560017
city: Mysore
country: India
facility: Investigational Site Number 3560037
city: Nagpur
country: India
facility: Investigational Site Number 3560013
city: Nagpur
country: India
facility: Investigational Site Number 3560014
city: Nashik
country: India
facility: Investigational Site Number 3560021
city: New Delhi
country: India
facility: Investigational Site Number 3560041
city: New Delhi
country: India
facility: Investigational Site Number 3560034
city: Pune
country: India
facility: Investigational Site Number 3560019
city: Pune
country: India
facility: Investigational Site Number 3560035
city: Pune
country: India
facility: Investigational Site Number 3560042
city: Pune
country: India
facility: Investigational Site Number 3560038
city: Pune
country: India
facility: Investigational Site Number 3560012
city: Varanasi
country: India
facility: Investigational Site Number 3560043
city: Vellore
country: India
facility: Investigational Site Number 3560020
city: Wardha
country: India
facility: Investigational Site Number 3560015
city: Beer Sheva
country: Israel
facility: Investigational Site Number 3760008
city: Haifa
country: Israel
facility: Investigational Site Number 3760005
city: Haifa
country: Israel
facility: Investigational Site Number 3760007
city: Jerusalem
country: Israel
facility: Investigational Site Number 3760001
city: Jerusalem
country: Israel
facility: Investigational Site Number 3760002
city: Nahariya
country: Israel
facility: Investigational Site Number 3760004
city: Tel Aviv
country: Israel
facility: Investigational Site Number 3760003
city: Tel Hashomer
country: Israel
facility: Investigational Site Number 3760006
city: Catanzaro
country: Italy
facility: Investigational Site Number 3800006
city: Catanzaro
country: Italy
facility: Investigational Site Number 3800010
city: Chieri
country: Italy
facility: Investigational Site Number 3800009
city: Livorno
country: Italy
facility: Investigational Site Number 3800007
city: Milano
country: Italy
facility: Investigational Site Number 3800002
city: Milano
country: Italy
facility: Investigational Site Number 3800008
city: Orbassano
country: Italy
facility: Investigational Site Number 3800005
city: Ravenna
country: Italy
facility: Investigational Site Number 3800011
city: Roma
country: Italy
facility: Investigational Site Number 3800004
city: Verona
country: Italy
facility: Investigational Site Number 3800001
city: Bucheon-Si
country: Korea, Republic of
facility: Investigational Site Number 4100011
city: Busan
country: Korea, Republic of
facility: Investigational Site Number 4100005
city: Gwangju
country: Korea, Republic of
facility: Investigational Site Number 4100007
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number 4100001
city: Seongnam-Si
country: Korea, Republic of
facility: Investigational Site Number 4100002
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100003
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100006
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100008
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100004
city: Uijeongbu-Si
country: Korea, Republic of
facility: Investigational Site Number 4100010
city: Daugavpils
country: Latvia
facility: Investigational Site Number 4280004
city: Liepāja
country: Latvia
facility: Investigational Site Number 4280002
city: Ogre
country: Latvia
facility: Investigational Site Number 4280007
city: Riga
country: Latvia
facility: Investigational Site Number 4280006
city: Riga
country: Latvia
facility: Investigational Site Number 4280001
city: Riga
country: Latvia
facility: Investigational Site Number 4280005
city: Sigulda
country: Latvia
facility: Investigational Site Number 4280003
city: Kaunas
country: Lithuania
facility: Investigational Site Number 4400006
city: Kaunas
country: Lithuania
facility: Investigational Site Number 4400003
city: Kaunas
country: Lithuania
facility: Investigational Site Number 4400009
city: Kedainiai
country: Lithuania
facility: Investigational Site Number 4400008
city: Klaipeda
country: Lithuania
facility: Investigational Site Number 4400004
city: Klaipeda
country: Lithuania
facility: Investigational Site Number 4400002
city: Ukmerge
country: Lithuania
facility: Investigational Site Number 4400007
city: Utena
country: Lithuania
facility: Investigational Site Number 4400005
city: Vilnius
country: Lithuania
facility: Investigational Site Number 4400001
city: Actopan
country: Mexico
facility: Investigational Site Number 4840009
city: Aguascalientes
country: Mexico
facility: Investigational Site Number 4840013
city: Aguascalientes
country: Mexico
facility: Investigational Site Number 4840019
city: Cdmx
country: Mexico
facility: Investigational Site Number 4840018
city: Celaya
country: Mexico
facility: Investigational Site Number 4840005
city: Cuernavaca
country: Mexico
facility: Investigational Site Number 4840002
city: Distrito Federal
country: Mexico
facility: Investigational Site Number 4840025
city: Durango
country: Mexico
facility: Investigational Site Number 4840007
city: Durango
country: Mexico
facility: Investigational Site Number 4840023
city: Guadalajara
country: Mexico
facility: Investigational Site Number 4840033
city: Guadalajara
country: Mexico
facility: Investigational Site Number 4840024
city: Guadalajara
country: Mexico
facility: Investigational Site Number 4840003
city: Guadalajara
country: Mexico
facility: Investigational Site Number 4840011
city: Guadalajara
country: Mexico
facility: Investigational Site Number 4840027
city: Guadalajara
country: Mexico
facility: Investigational Site Number 4840004
city: Guadalajara
country: Mexico
facility: Investigational Site Number 4840010
city: Guadalajara
country: Mexico
facility: Investigational Site Number 4840030
city: Merida
country: Mexico
facility: Investigational Site Number 4840034
city: Monterrey
country: Mexico
facility: Investigational Site Number 4840021
city: Monterrey
country: Mexico
facility: Investigational Site Number 4840020
city: Monterrey
country: Mexico
facility: Investigational Site Number 4840001
city: Mérida
country: Mexico
facility: Investigational Site Number 4840028
city: Queretaro
country: Mexico
facility: Investigational Site Number 4840014
city: Toluca
country: Mexico
facility: Investigational Site Number 4840015
city: Veracruz
country: Mexico
facility: Investigational Site Number 4840008
city: Xalapa
country: Mexico
facility: Investigational Site Number 4840016
city: Zapopan
country: Mexico
facility: Investigational Site Number 4840026
city: Almelo
country: Netherlands
facility: Investigational Site Number 5280004
city: Groningen
country: Netherlands
facility: Investigational Site Number 5280001
city: Hoogeveen
country: Netherlands
facility: Investigational Site Number 5280003
city: Meppel
country: Netherlands
facility: Investigational Site Number 5280005
city: Rotterdam
country: Netherlands
facility: Investigational Site Number 5280002
city: Auckland
country: New Zealand
facility: Investigational Site Number 5540014
city: Birkenhead
country: New Zealand
facility: Investigational Site Number 5540006
city: Birkenhead
country: New Zealand
facility: Investigational Site Number 5540009
city: Christchurch
country: New Zealand
facility: Investigational Site Number 5540002
city: Christchurch
country: New Zealand
facility: Investigational Site Number 5540003
city: Christchurch
country: New Zealand
facility: Investigational Site Number 5540012
city: Dunedin
country: New Zealand
facility: Investigational Site Number 5540007
city: Hamilton
country: New Zealand
facility: Investigational Site Number 5540016
city: New Plymouth
country: New Zealand
facility: Investigational Site Number 5540013
city: Palmerston North
country: New Zealand
facility: Investigational Site Number 5540015
city: Rotorua
country: New Zealand
facility: Investigational Site Number 5540005
city: Takapuna
country: New Zealand
facility: Investigational Site Number 5540010
city: Tauranga
country: New Zealand
facility: Investigational Site Number 5540008
city: Tauranga
country: New Zealand
facility: Investigational Site Number 5540011
city: Wellington
country: New Zealand
facility: Investigational Site Number 5540004
city: Skopje
country: North Macedonia
facility: Investigational Site Number 8070003
city: Struga
country: North Macedonia
facility: Investigational Site Number 8070005
city: Tetovo
country: North Macedonia
facility: Investigational Site Number 8070001
city: Tetovo
country: North Macedonia
facility: Investigational Site Number 8070004
city: Hamar
country: Norway
facility: Investigational Site Number 5780005
city: Hønefoss
country: Norway
facility: Investigational Site Number 5780001
city: Oslo
country: Norway
facility: Investigational Site Number 5780003
city: Oslo
country: Norway
facility: Investigational Site Number 5780002
city: Skedsmokorset
country: Norway
facility: Investigational Site Number 5780004
city: Arequipa
country: Peru
facility: Investigational Site Number 6040004
city: Callao
country: Peru
facility: Investigational Site Number 6040006
city: Callao
country: Peru
facility: Investigational Site Number 6040009
city: Chancay
country: Peru
facility: Investigational Site Number 6040024
city: Chiclayo
country: Peru
facility: Investigational Site Number 6040005
city: Cuzco
country: Peru
facility: Investigational Site Number 6040010
city: Lima Lima
country: Peru
facility: Investigational Site Number 6040014
city: Lima
country: Peru
facility: Investigational Site Number 6040001
city: Lima
country: Peru
facility: Investigational Site Number 6040025
city: Lima
country: Peru
facility: Investigational Site Number 6040016
city: Lima
country: Peru
facility: Investigational Site Number 6040020
city: Lima
country: Peru
facility: Investigational Site Number 6040013
city: Lima
country: Peru
facility: Investigational Site Number 6040023
city: Lima
country: Peru
facility: Investigational Site Number 6040007
city: Lima
country: Peru
facility: Investigational Site Number 6040019
city: Lima
country: Peru
facility: Investigational Site Number 6040022
city: Lima
country: Peru
facility: Investigational Site Number 6040012
city: Lima
country: Peru
facility: Investigational Site Number 6040017
city: Piura
country: Peru
facility: Investigational Site Number 6040011
city: Trujillo
country: Peru
facility: Investigational Site Number 6040002
city: Bialystok
country: Poland
facility: Investigational Site Number 6160027
city: Bialystok
country: Poland
facility: Investigational Site Number 6160011
city: Bydgoszcz
country: Poland
facility: Investigational Site Number 6160029
city: Bydgoszcz
country: Poland
facility: Investigational Site Number 6160030
city: Bydgoszcz
country: Poland
facility: Investigational Site Number 6160006
city: Bytom
country: Poland
facility: Investigational Site Number 6160018
city: Czeladz
country: Poland
facility: Investigational Site Number 6160002
city: Gdynia
country: Poland
facility: Investigational Site Number 6160003
city: Gdynia
country: Poland
facility: Investigational Site Number 6160005
city: Grodzisk Mazowiecki
country: Poland
facility: Investigational Site Number 6160008
city: Grodzisk Mazowiecki
country: Poland
facility: Investigational Site Number 6160031
city: Katowice
country: Poland
facility: Investigational Site Number 6160023
city: Katowice
country: Poland
facility: Investigational Site Number 6160026
city: Kielce
country: Poland
facility: Investigational Site Number 6160022
city: Krakow
country: Poland
facility: Investigational Site Number 6160019
city: Krakow
country: Poland
facility: Investigational Site Number 6160024
city: Krakow
country: Poland
facility: Investigational Site Number 6160010
city: Lodz
country: Poland
facility: Investigational Site Number 6160016
city: Lodz
country: Poland
facility: Investigational Site Number 6160013
city: Lodz
country: Poland
facility: Investigational Site Number 6160015
city: Lublin
country: Poland
facility: Investigational Site Number 6160007
city: Poznan
country: Poland
facility: Investigational Site Number 6160033
city: Pulawy
country: Poland
facility: Investigational Site Number 6160021
city: Staszow
country: Poland
facility: Investigational Site Number 6160028
city: Torun
country: Poland
facility: Investigational Site Number 6160020
city: Warszawa
country: Poland
facility: Investigational Site Number 6160014
city: Warszawa
country: Poland
facility: Investigational Site Number 6160025
city: Warszawa
country: Poland
facility: Investigational Site Number 6160001
city: Warszawa
country: Poland
facility: Investigational Site Number 6160004
city: Wroclaw
country: Poland
facility: Investigational Site Number 6160012
city: Zabrze
country: Poland
facility: Investigational Site Number 6160017
city: Zamosc
country: Poland
facility: Investigational Site Number 6160032
city: Almada
country: Portugal
facility: Investigational Site Number 6200004
city: Caldas Da Rainha
country: Portugal
facility: Investigational Site Number 6200005
city: Carnaxide
country: Portugal
facility: Investigational Site Number 6200009
city: Coimbra
country: Portugal
facility: Investigational Site Number 6200002
city: Leiria
country: Portugal
facility: Investigational Site Number 6200008
city: Lisboa
country: Portugal
facility: Investigational Site Number 6200001
city: Loures
country: Portugal
facility: Investigational Site Number 6200007
city: Porto
country: Portugal
facility: Investigational Site Number 6200003
city: San Juan
country: Puerto Rico
facility: Investigational Site Number 8400122
city: Bacau
country: Romania
facility: Investigational Site Number 6420008
city: Baia Mare, Maramures
country: Romania
facility: Investigational Site Number 6420005
city: Brasov
country: Romania
facility: Investigational Site Number 6420009
city: Bucuresti
country: Romania
facility: Investigational Site Number 6420013
city: Bucuresti
country: Romania
facility: Investigational Site Number 6420014
city: Bucuresti
country: Romania
facility: Investigational Site Number 6420012
city: Bucuresti
country: Romania
facility: Investigational Site Number 6420011
city: Craiova
country: Romania
facility: Investigational Site Number 6420002
city: Oradea
country: Romania
facility: Investigational Site Number 6420003
city: Oradea
country: Romania
facility: Investigational Site Number 6420004
city: Ploiesti
country: Romania
facility: Investigational Site Number 6420010
city: Targoviste, Dambovita
country: Romania
facility: Investigational Site Number 6420001
city: Targu Mures, Mures
country: Romania
facility: Investigational Site Number 6420006
city: Targu Mures, Mures
country: Romania
facility: Investigational Site Number 6420007
city: Kaliningrad
country: Russian Federation
facility: Investigational Site Number 6430028
city: Kazan
country: Russian Federation
facility: Investigational Site Number 6430018
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 6430001
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 6430035
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 6430025
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 6430040
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 6430010
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430015
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430016
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430046
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430003
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430036
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430005
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430039
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430021
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430002
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430020
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430024
city: Nizhniy Novgorod
country: Russian Federation
facility: Investigational Site Number 6430033
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 6430037
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 6430034
city: Perm
country: Russian Federation
facility: Investigational Site Number 6430007
city: Rostov-Na-Donu
country: Russian Federation
facility: Investigational Site Number 6430019
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430012
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430044
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430045
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430043
city: Saratov
country: Russian Federation
facility: Investigational Site Number 6430009
city: Saratov
country: Russian Federation
facility: Investigational Site Number 6430013
city: Saratov
country: Russian Federation
facility: Investigational Site Number 6430042
city: Sochi
country: Russian Federation
facility: Investigational Site Number 6430026
city: Sochi
country: Russian Federation
facility: Investigational Site Number 6430027
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430041
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430006
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430008
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430030
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430014
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430017
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 6430004
city: Tomsk
country: Russian Federation
facility: Investigational Site Number 6430011
city: Tomsk
country: Russian Federation
facility: Investigational Site Number 6430038
city: Tyumen
country: Russian Federation
facility: Investigational Site Number 6430032
city: Vladimir
country: Russian Federation
facility: Investigational Site Number 6430023
city: Vladimir
country: Russian Federation
facility: Investigational Site Number 6430022
city: Yaroslavl
country: Russian Federation
facility: Investigational Site Number 6430031
city: Belgrade
country: Serbia
facility: Investigational Site Number 6880002
city: Belgrade
country: Serbia
facility: Investigational Site Number 6880003
city: Belgrade
country: Serbia
facility: Investigational Site Number 6880004
city: Kragujevac
country: Serbia
facility: Investigational Site Number 6880005
city: Nis
country: Serbia
facility: Investigational Site Number 6880001
city: Nis
country: Serbia
facility: Investigational Site Number 6880006
city: Nis
country: Serbia
facility: Investigational Site Number 6880007
city: Bardejov
country: Slovakia
facility: Investigational Site Number 7030006
city: Bratislava
country: Slovakia
facility: Investigational Site Number 7030012
city: Kosice
country: Slovakia
facility: Investigational Site Number 7030011
city: Lubochna
country: Slovakia
facility: Investigational Site Number 7030001
city: Lucenec
country: Slovakia
facility: Investigational Site Number 7030008
city: Lucenec
country: Slovakia
facility: Investigational Site Number 7030009
city: Lucenec
country: Slovakia
facility: Investigational Site Number 7030010
city: Moldava Nad Bodvou
country: Slovakia
facility: Investigational Site Number 7030004
city: Presov
country: Slovakia
facility: Investigational Site Number 7030013
city: Roznava
country: Slovakia
facility: Investigational Site Number 7030003
city: Sabinov
country: Slovakia
facility: Investigational Site Number 7030002
city: Svidnik
country: Slovakia
facility: Investigational Site Number 7030007
city: Brits
country: South Africa
facility: Investigational Site Number 7100005
city: Cape Town
country: South Africa
facility: Investigational Site Number 7100009
city: Cape Town
country: South Africa
facility: Investigational Site Number 7100006
city: Parow
country: South Africa
facility: Investigational Site Number 7100001
city: Pinelands
country: South Africa
facility: Investigational Site Number 7100012
city: Pretoria
country: South Africa
facility: Investigational Site Number 7100011
city: Pretoria
country: South Africa
facility: Investigational Site Number 7100014
city: Pretoria
country: South Africa
facility: Investigational Site Number 7100008
city: Rivonia
country: South Africa
facility: Investigational Site Number 7100010
city: Soweto
country: South Africa
facility: Investigational Site Number 7100007
city: Umkomaas
country: South Africa
facility: Investigational Site Number 7100002
city: Vosloorus
country: South Africa
facility: Investigational Site Number 7100013
city: Western Cape
country: South Africa
facility: Investigational Site Number 7100003
city: Almería
country: Spain
facility: Investigational Site Number 7240003
city: Barcelona
country: Spain
facility: Investigational Site Number 7240014
city: Barcelona
country: Spain
facility: Investigational Site Number 7240011
city: Córdoba
country: Spain
facility: Investigational Site Number 7240009
city: El Puerto De Santa Maria
country: Spain
facility: Investigational Site Number 7240024
city: Granada
country: Spain
facility: Investigational Site Number 7240016
city: La Coruña
country: Spain
facility: Investigational Site Number 7240015
city: Madrid
country: Spain
facility: Investigational Site Number 7240001
city: Madrid
country: Spain
facility: Investigational Site Number 7240019
city: Madrid
country: Spain
facility: Investigational Site Number 7240006
city: Madrid
country: Spain
facility: Investigational Site Number 7240010
city: Madrid
country: Spain
facility: Investigational Site Number 7240020
city: Sabadell
country: Spain
facility: Investigational Site Number 7240025
city: Sanlúcar De Barrameda
country: Spain
facility: Investigational Site Number 7240023
city: Santa Cruz De Tenerife
country: Spain
facility: Investigational Site Number 7240013
city: Santiago De Compostela
country: Spain
facility: Investigational Site Number 7240007
city: Sevilla
country: Spain
facility: Investigational Site Number 7240026
city: Sevilla
country: Spain
facility: Investigational Site Number 7240012
city: Valencia
country: Spain
facility: Investigational Site Number 7240004
city: Vigo
country: Spain
facility: Investigational Site Number 7240002
city: Villamartín
country: Spain
facility: Investigational Site Number 7240022
city: Zaragoza
country: Spain
facility: Investigational Site Number 7240008
city: Falun
country: Sweden
facility: Investigational Site Number 7520007
city: Lund
country: Sweden
facility: Investigational Site Number 7520005
city: Mölndal
country: Sweden
facility: Investigational Site Number 7520004
city: Rättvik
country: Sweden
facility: Investigational Site Number 7520003
city: Stockholm
country: Sweden
facility: Investigational Site Number 7520008
city: Stockholm
country: Sweden
facility: Investigational Site Number 7520002
city: Stockholm
country: Sweden
facility: Investigational Site Number 7520006
city: Uppsala
country: Sweden
facility: Investigational Site Number 7520001
city: Olten
country: Switzerland
facility: Investigational Site Number 7560001
city: Zollikerberg
country: Switzerland
facility: Investigational Site Number 7560002
city: Hsinchu
country: Taiwan
facility: Investigational Site Number 1580005
city: Kaohsiung
country: Taiwan
facility: Investigational Site Number 1580008
city: Linkou
country: Taiwan
facility: Investigational Site Number 1580004
city: Taichung
country: Taiwan
facility: Investigational Site Number 1580006
city: Tainan
country: Taiwan
facility: Investigational Site Number 1580002
city: Tainan
country: Taiwan
facility: Investigational Site Number 1580007
city: Taipei
country: Taiwan
facility: Investigational Site Number 1580003
city: Taipei
country: Taiwan
facility: Investigational Site Number 1580001
city: Antalya
country: Turkey
facility: Investigational Site Number 7920018
city: Aydın
country: Turkey
facility: Investigational Site Number 7920010
city: Corum
country: Turkey
facility: Investigational Site Number 7920004
city: Gaziantep
country: Turkey
facility: Investigational Site Number 7920016
city: Istanbul
country: Turkey
facility: Investigational Site Number 7920011
city: Istanbul
country: Turkey
facility: Investigational Site Number 7920009
city: Istanbul
country: Turkey
facility: Investigational Site Number 7920001
city: Istanbul
country: Turkey
facility: Investigational Site Number 7920007
city: Istanbul
country: Turkey
facility: Investigational Site Number 7920017
city: Izmir
country: Turkey
facility: Investigational Site Number 7920003
city: Kayseri
country: Turkey
facility: Investigational Site Number 7920013
city: Kocaeli
country: Turkey
facility: Investigational Site Number 7920014
city: Kutahya
country: Turkey
facility: Investigational Site Number 7920005
city: Malatya
country: Turkey
facility: Investigational Site Number 7920015
city: Mersin
country: Turkey
facility: Investigational Site Number 7920008
city: Sivas
country: Turkey
facility: Investigational Site Number 7920002
city: Dnipro
country: Ukraine
facility: Investigational Site Number 8040020
city: Dnipro
country: Ukraine
facility: Investigational Site Number 8040006
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number 8040009
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number 8040012
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 8040021
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 8040011
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 8040008
city: Kiev
country: Ukraine
facility: Investigational Site Number 8040002
city: Kiev
country: Ukraine
facility: Investigational Site Number 8040024
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040003
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040015
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040019
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040010
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8040026
city: Lutsk
country: Ukraine
facility: Investigational Site Number 8040023
city: Lutsk
country: Ukraine
facility: Investigational Site Number 8040025
city: Lviv
country: Ukraine
facility: Investigational Site Number 8040022
city: Ternopil
country: Ukraine
facility: Investigational Site Number 8040001
city: Vinnitsya
country: Ukraine
facility: Investigational Site Number 8040016
city: Vinnitsya
country: Ukraine
facility: Investigational Site Number 8040007
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number 8040004
city: Zhytomyr
country: Ukraine
facility: Investigational Site Number 8040018
city: Belfast
country: United Kingdom
facility: Investigational Site Number 8260003
city: Chippenham
country: United Kingdom
facility: Investigational Site Number 8260007
city: Davyhulme, Manchester
country: United Kingdom
facility: Investigational Site Number 8260009
city: Glasgow
country: United Kingdom
facility: Investigational Site Number 8260010
city: Hayle
country: United Kingdom
facility: Investigational Site Number 8260004
city: Inverness
country: United Kingdom
facility: Investigational Site Number 8260011
city: Ipswich
country: United Kingdom
facility: Investigational Site Number 8260002
city: Maidstone
country: United Kingdom
facility: Investigational Site Number 8260006
city: Swansea
country: United Kingdom
facility: Investigational Site Number 8260001
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Suman Wason, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.