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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03315143
Registration number
NCT03315143
Ethics application status
Date submitted
16/10/2017
Date registered
19/10/2017
Titles & IDs
Public title
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
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Scientific 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
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Secondary ID [1]
0
0
2017-002644-32
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Secondary ID [2]
0
0
EFC14875
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Universal Trial Number (UTN)
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Trial acronym
SCORED
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
0
0
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Type 2 Diabetes Mellitus
0
0
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Chronic Kidney Diseases
0
0
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Condition category
Condition code
Renal and Urogenital
0
0
0
0
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Kidney disease
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Renal and Urogenital
0
0
0
0
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Other renal and urogenital disorders
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Metabolic and Endocrine
0
0
0
0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sotagliflozin
Treatment: Drugs - Placebo
Experimental: 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.
Placebo comparator: 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.
Treatment: Drugs: Sotagliflozin
Sotagliflozin was administered as a tablet(s), orally once daily.
Treatment: Drugs: Placebo
Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
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Assessment method [1]
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Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
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Timepoint [1]
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Up to 30 months
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Secondary outcome [1]
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Total Number of Occurrences of HHF and Urgent HF Visits
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Assessment method [1]
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Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
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Timepoint [1]
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0
Up to 30 months
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Secondary outcome [2]
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Number of Deaths From Cardiovascular Causes
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Assessment method [2]
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0
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
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Timepoint [2]
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Up to 30 months
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Secondary outcome [3]
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Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
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Assessment method [3]
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Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
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Timepoint [3]
0
0
Up to 30 months
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Secondary outcome [4]
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Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
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Assessment method [4]
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0
Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomization of HHF, urgent HF visits, CV Death, and HF while hospitalized. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
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Timepoint [4]
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Up to 30 months
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Secondary outcome [5]
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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)
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Assessment method [5]
0
0
Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
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Timepoint [5]
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Up to 30 months
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Secondary outcome [6]
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Number of Deaths From Any Cause
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Assessment method [6]
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0
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
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Timepoint [6]
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0
Up to 30 months
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Secondary outcome [7]
0
0
Total Number of Occurrences of CV Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
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Assessment method [7]
0
0
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
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Timepoint [7]
0
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Up to 30 months
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/12/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/07/2020
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Sample size
Target
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Accrual to date
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Final
10584
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 0360014 - Adelaide
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Recruitment hospital [2]
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Investigational Site Number 0360004 - Box Hill
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Recruitment hospital [3]
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Investigational Site Number 0360015 - Elizabeth Vale
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Investigational Site Number 0360005 - Fitzroy
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Investigational Site Number 0360018 - Fremantle
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Investigational Site Number 0360007 - Fullarton
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Investigational Site Number 0360002 - Gosford
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Investigational Site Number 0360016 - Heidelberg
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Investigational Site Number 0360010 - Herston
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Investigational Site Number 0360009 - Liverpool
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Investigational Site Number 0360017 - Melbourne
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Investigational Site Number 0360001 - Merewether
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Investigational Site Number 0360012 - Oaklands Park
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Investigational Site Number 0360011 - Parkville
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Investigational Site Number 0360008 - Redcliffe
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Investigational Site Number 0360013 - Sherwood
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Investigational Site Number 0360019 - St Leonards
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Investigational Site Number 0360006 - Wollongong
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3128 - Box Hill
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Recruitment postcode(s) [3]
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5112 - Elizabeth Vale
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3065 - Fitzroy
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6160 - Fremantle
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5063 - Fullarton
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Recruitment postcode(s) [7]
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2250 - Gosford
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3081 - Heidelberg
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Recruitment postcode(s) [9]
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4029 - Herston
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2170 - Liverpool
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Recruitment postcode(s) [11]
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3004 - Melbourne
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Recruitment postcode(s) [12]
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2291 - Merewether
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Recruitment postcode(s) [13]
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5046 - Oaklands Park
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3050 - Parkville
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4020 - Redcliffe
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Recruitment postcode(s) [16]
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4075 - Sherwood
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Recruitment postcode(s) [17]
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2065 - St Leonards
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Recruitment postcode(s) [18]
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2500 - Wollongong
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Recruitment outside Australia
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Canada
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State/province [99]
0
0
Toronto
Query!
Country [100]
0
0
Canada
Query!
State/province [100]
0
0
Trois-Rivieres
Query!
Country [101]
0
0
Canada
Query!
State/province [101]
0
0
Vancouver
Query!
Country [102]
0
0
Canada
Query!
State/province [102]
0
0
Victoria
Query!
Country [103]
0
0
Chile
Query!
State/province [103]
0
0
Concepción
Query!
Country [104]
0
0
Chile
Query!
State/province [104]
0
0
Osorno
Query!
Country [105]
0
0
Chile
Query!
State/province [105]
0
0
Punta Arenas
Query!
Country [106]
0
0
Chile
Query!
State/province [106]
0
0
Santiago
Query!
Country [107]
0
0
Chile
Query!
State/province [107]
0
0
Talca
Query!
Country [108]
0
0
Chile
Query!
State/province [108]
0
0
Temuco
Query!
Country [109]
0
0
Chile
Query!
State/province [109]
0
0
Viña Del Mar
Query!
Country [110]
0
0
China
Query!
State/province [110]
0
0
Beijing
Query!
Country [111]
0
0
China
Query!
State/province [111]
0
0
Changchun
Query!
Country [112]
0
0
China
Query!
State/province [112]
0
0
Changsha
Query!
Country [113]
0
0
China
Query!
State/province [113]
0
0
Chengdu
Query!
Country [114]
0
0
China
Query!
State/province [114]
0
0
Dalian
Query!
Country [115]
0
0
China
Query!
State/province [115]
0
0
Guangzhou
Query!
Country [116]
0
0
China
Query!
State/province [116]
0
0
Haikou
Query!
Country [117]
0
0
China
Query!
State/province [117]
0
0
Hengyang
Query!
Country [118]
0
0
China
Query!
State/province [118]
0
0
Hohhot
Query!
Country [119]
0
0
China
Query!
State/province [119]
0
0
Huai'An
Query!
Country [120]
0
0
China
Query!
State/province [120]
0
0
Jinan
Query!
Country [121]
0
0
China
Query!
State/province [121]
0
0
Jining
Query!
Country [122]
0
0
China
Query!
State/province [122]
0
0
Nanchang
Query!
Country [123]
0
0
China
Query!
State/province [123]
0
0
Nanjing
Query!
Country [124]
0
0
China
Query!
State/province [124]
0
0
Shanghai
Query!
Country [125]
0
0
China
Query!
State/province [125]
0
0
Shenyang
Query!
Country [126]
0
0
China
Query!
State/province [126]
0
0
Siping
Query!
Country [127]
0
0
China
Query!
State/province [127]
0
0
Suzhou
Query!
Country [128]
0
0
China
Query!
State/province [128]
0
0
Taizhou
Query!
Country [129]
0
0
China
Query!
State/province [129]
0
0
Tianjin
Query!
Country [130]
0
0
China
Query!
State/province [130]
0
0
Wuhan
Query!
Country [131]
0
0
China
Query!
State/province [131]
0
0
Xi'An
Query!
Country [132]
0
0
China
Query!
State/province [132]
0
0
Xinxiang
Query!
Country [133]
0
0
China
Query!
State/province [133]
0
0
Zhenjiang
Query!
Country [134]
0
0
Czechia
Query!
State/province [134]
0
0
Brno
Query!
Country [135]
0
0
Czechia
Query!
State/province [135]
0
0
Broumov
Query!
Country [136]
0
0
Czechia
Query!
State/province [136]
0
0
Humpolec
Query!
Country [137]
0
0
Czechia
Query!
State/province [137]
0
0
Liberec
Query!
Country [138]
0
0
Czechia
Query!
State/province [138]
0
0
Marianske Lazne
Query!
Country [139]
0
0
Czechia
Query!
State/province [139]
0
0
Mestec Kralove
Query!
Country [140]
0
0
Czechia
Query!
State/province [140]
0
0
Plzen
Query!
Country [141]
0
0
Czechia
Query!
State/province [141]
0
0
Praha 10
Query!
Country [142]
0
0
Czechia
Query!
State/province [142]
0
0
Praha 1
Query!
Country [143]
0
0
Czechia
Query!
State/province [143]
0
0
Praha 2
Query!
Country [144]
0
0
Czechia
Query!
State/province [144]
0
0
Praha 4
Query!
Country [145]
0
0
Czechia
Query!
State/province [145]
0
0
Praha 6
Query!
Country [146]
0
0
Czechia
Query!
State/province [146]
0
0
Praha 8
Query!
Country [147]
0
0
Czechia
Query!
State/province [147]
0
0
Revnice
Query!
Country [148]
0
0
Czechia
Query!
State/province [148]
0
0
Slany
Query!
Country [149]
0
0
Czechia
Query!
State/province [149]
0
0
Trutnov
Query!
Country [150]
0
0
Czechia
Query!
State/province [150]
0
0
Vsetin
Query!
Country [151]
0
0
Denmark
Query!
State/province [151]
0
0
Aarhus N
Query!
Country [152]
0
0
Denmark
Query!
State/province [152]
0
0
Gentofte
Query!
Country [153]
0
0
Denmark
Query!
State/province [153]
0
0
Herlev
Query!
Country [154]
0
0
Denmark
Query!
State/province [154]
0
0
Hvidovre
Query!
Country [155]
0
0
Denmark
Query!
State/province [155]
0
0
København Nv
Query!
Country [156]
0
0
Denmark
Query!
State/province [156]
0
0
Slagelse
Query!
Country [157]
0
0
Denmark
Query!
State/province [157]
0
0
Svendborg
Query!
Country [158]
0
0
Estonia
Query!
State/province [158]
0
0
Tallinn
Query!
Country [159]
0
0
Estonia
Query!
State/province [159]
0
0
Tartu
Query!
Country [160]
0
0
France
Query!
State/province [160]
0
0
Corbeil-Essonnes
Query!
Country [161]
0
0
France
Query!
State/province [161]
0
0
La Rochelle Cedex
Query!
Country [162]
0
0
France
Query!
State/province [162]
0
0
Paris Cedex 18
Query!
Country [163]
0
0
France
Query!
State/province [163]
0
0
Paris
Query!
Country [164]
0
0
France
Query!
State/province [164]
0
0
Toulouse Cedex 9
Query!
Country [165]
0
0
France
Query!
State/province [165]
0
0
Venissieux
Query!
Country [166]
0
0
Georgia
Query!
State/province [166]
0
0
Batumi
Query!
Country [167]
0
0
Georgia
Query!
State/province [167]
0
0
Kutaisi
Query!
Country [168]
0
0
Georgia
Query!
State/province [168]
0
0
Tbilisi
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Berlin
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Essen
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Freiburg
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Hamburg
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Kassel
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Leipzig
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Münster
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Oldenburg In Holstein
Query!
Country [177]
0
0
Greece
Query!
State/province [177]
0
0
Athens
Query!
Country [178]
0
0
Greece
Query!
State/province [178]
0
0
Ioannina
Query!
Country [179]
0
0
Greece
Query!
State/province [179]
0
0
Larissa
Query!
Country [180]
0
0
Greece
Query!
State/province [180]
0
0
Pireas
Query!
Country [181]
0
0
Greece
Query!
State/province [181]
0
0
Thessaloniki
Query!
Country [182]
0
0
Guatemala
Query!
State/province [182]
0
0
Guatemala
Query!
Country [183]
0
0
Guatemala
Query!
State/province [183]
0
0
Quetzaltenango
Query!
Country [184]
0
0
Hungary
Query!
State/province [184]
0
0
Budapest
Query!
Country [185]
0
0
Hungary
Query!
State/province [185]
0
0
Békéscsaba
Query!
Country [186]
0
0
Hungary
Query!
State/province [186]
0
0
Debrecen
Query!
Country [187]
0
0
Hungary
Query!
State/province [187]
0
0
Kaposvár
Query!
Country [188]
0
0
Hungary
Query!
State/province [188]
0
0
Nyíregyháza
Query!
Country [189]
0
0
Hungary
Query!
State/province [189]
0
0
Szekesfehervar
Query!
Country [190]
0
0
Hungary
Query!
State/province [190]
0
0
Zalaegerszeg
Query!
Country [191]
0
0
India
Query!
State/province [191]
0
0
Ahmedabad
Query!
Country [192]
0
0
India
Query!
State/province [192]
0
0
Aurangabad
Query!
Country [193]
0
0
India
Query!
State/province [193]
0
0
Bangalore
Query!
Country [194]
0
0
India
Query!
State/province [194]
0
0
Belgaum
Query!
Country [195]
0
0
India
Query!
State/province [195]
0
0
Bengaluru
Query!
Country [196]
0
0
India
Query!
State/province [196]
0
0
Chandigarh
Query!
Country [197]
0
0
India
Query!
State/province [197]
0
0
Gurgaon
Query!
Country [198]
0
0
India
Query!
State/province [198]
0
0
Hyderabad
Query!
Country [199]
0
0
India
Query!
State/province [199]
0
0
Jaipur
Query!
Country [200]
0
0
India
Query!
State/province [200]
0
0
Kochi
Query!
Country [201]
0
0
India
Query!
State/province [201]
0
0
Kolkata
Query!
Country [202]
0
0
India
Query!
State/province [202]
0
0
Kozhikode
Query!
Country [203]
0
0
India
Query!
State/province [203]
0
0
Ludhiana
Query!
Country [204]
0
0
India
Query!
State/province [204]
0
0
Mangalore
Query!
Country [205]
0
0
India
Query!
State/province [205]
0
0
Mumbai
Query!
Country [206]
0
0
India
Query!
State/province [206]
0
0
Mysore
Query!
Country [207]
0
0
India
Query!
State/province [207]
0
0
Nagpur
Query!
Country [208]
0
0
India
Query!
State/province [208]
0
0
Nashik
Query!
Country [209]
0
0
India
Query!
State/province [209]
0
0
New Delhi
Query!
Country [210]
0
0
India
Query!
State/province [210]
0
0
Pune
Query!
Country [211]
0
0
India
Query!
State/province [211]
0
0
Varanasi
Query!
Country [212]
0
0
India
Query!
State/province [212]
0
0
Vellore
Query!
Country [213]
0
0
India
Query!
State/province [213]
0
0
Wardha
Query!
Country [214]
0
0
Israel
Query!
State/province [214]
0
0
Beer Sheva
Query!
Country [215]
0
0
Israel
Query!
State/province [215]
0
0
Haifa
Query!
Country [216]
0
0
Israel
Query!
State/province [216]
0
0
Jerusalem
Query!
Country [217]
0
0
Israel
Query!
State/province [217]
0
0
Nahariya
Query!
Country [218]
0
0
Israel
Query!
State/province [218]
0
0
Tel Aviv
Query!
Country [219]
0
0
Israel
Query!
State/province [219]
0
0
Tel Hashomer
Query!
Country [220]
0
0
Italy
Query!
State/province [220]
0
0
Catanzaro
Query!
Country [221]
0
0
Italy
Query!
State/province [221]
0
0
Chieri
Query!
Country [222]
0
0
Italy
Query!
State/province [222]
0
0
Livorno
Query!
Country [223]
0
0
Italy
Query!
State/province [223]
0
0
Milano
Query!
Country [224]
0
0
Italy
Query!
State/province [224]
0
0
Orbassano
Query!
Country [225]
0
0
Italy
Query!
State/province [225]
0
0
Ravenna
Query!
Country [226]
0
0
Italy
Query!
State/province [226]
0
0
Roma
Query!
Country [227]
0
0
Italy
Query!
State/province [227]
0
0
Verona
Query!
Country [228]
0
0
Korea, Republic of
Query!
State/province [228]
0
0
Bucheon-Si
Query!
Country [229]
0
0
Korea, Republic of
Query!
State/province [229]
0
0
Busan
Query!
Country [230]
0
0
Korea, Republic of
Query!
State/province [230]
0
0
Gwangju
Query!
Country [231]
0
0
Korea, Republic of
Query!
State/province [231]
0
0
Incheon
Query!
Country [232]
0
0
Korea, Republic of
Query!
State/province [232]
0
0
Seongnam-Si
Query!
Country [233]
0
0
Korea, Republic of
Query!
State/province [233]
0
0
Seoul
Query!
Country [234]
0
0
Korea, Republic of
Query!
State/province [234]
0
0
Uijeongbu-Si
Query!
Country [235]
0
0
Latvia
Query!
State/province [235]
0
0
Daugavpils
Query!
Country [236]
0
0
Latvia
Query!
State/province [236]
0
0
Liepaja
Query!
Country [237]
0
0
Latvia
Query!
State/province [237]
0
0
Ogre
Query!
Country [238]
0
0
Latvia
Query!
State/province [238]
0
0
Riga
Query!
Country [239]
0
0
Latvia
Query!
State/province [239]
0
0
Sigulda
Query!
Country [240]
0
0
Lithuania
Query!
State/province [240]
0
0
Kaunas
Query!
Country [241]
0
0
Lithuania
Query!
State/province [241]
0
0
Kedainiai
Query!
Country [242]
0
0
Lithuania
Query!
State/province [242]
0
0
Klaipeda
Query!
Country [243]
0
0
Lithuania
Query!
State/province [243]
0
0
Ukmerge
Query!
Country [244]
0
0
Lithuania
Query!
State/province [244]
0
0
Utena
Query!
Country [245]
0
0
Lithuania
Query!
State/province [245]
0
0
Vilnius
Query!
Country [246]
0
0
Mexico
Query!
State/province [246]
0
0
Actopan
Query!
Country [247]
0
0
Mexico
Query!
State/province [247]
0
0
Aguascalientes
Query!
Country [248]
0
0
Mexico
Query!
State/province [248]
0
0
Cdmx
Query!
Country [249]
0
0
Mexico
Query!
State/province [249]
0
0
Celaya
Query!
Country [250]
0
0
Mexico
Query!
State/province [250]
0
0
Cuernavaca
Query!
Country [251]
0
0
Mexico
Query!
State/province [251]
0
0
Distrito Federal
Query!
Country [252]
0
0
Mexico
Query!
State/province [252]
0
0
Durango
Query!
Country [253]
0
0
Mexico
Query!
State/province [253]
0
0
Guadalajara
Query!
Country [254]
0
0
Mexico
Query!
State/province [254]
0
0
Merida
Query!
Country [255]
0
0
Mexico
Query!
State/province [255]
0
0
Monterrey
Query!
Country [256]
0
0
Mexico
Query!
State/province [256]
0
0
Mérida
Query!
Country [257]
0
0
Mexico
Query!
State/province [257]
0
0
Queretaro
Query!
Country [258]
0
0
Mexico
Query!
State/province [258]
0
0
Toluca
Query!
Country [259]
0
0
Mexico
Query!
State/province [259]
0
0
Veracruz
Query!
Country [260]
0
0
Mexico
Query!
State/province [260]
0
0
Xalapa
Query!
Country [261]
0
0
Mexico
Query!
State/province [261]
0
0
Zapopan
Query!
Country [262]
0
0
Netherlands
Query!
State/province [262]
0
0
Almelo
Query!
Country [263]
0
0
Netherlands
Query!
State/province [263]
0
0
Groningen
Query!
Country [264]
0
0
Netherlands
Query!
State/province [264]
0
0
Hoogeveen
Query!
Country [265]
0
0
Netherlands
Query!
State/province [265]
0
0
Meppel
Query!
Country [266]
0
0
Netherlands
Query!
State/province [266]
0
0
Rotterdam
Query!
Country [267]
0
0
New Zealand
Query!
State/province [267]
0
0
Auckland
Query!
Country [268]
0
0
New Zealand
Query!
State/province [268]
0
0
Birkenhead
Query!
Country [269]
0
0
New Zealand
Query!
State/province [269]
0
0
Christchurch
Query!
Country [270]
0
0
New Zealand
Query!
State/province [270]
0
0
Dunedin
Query!
Country [271]
0
0
New Zealand
Query!
State/province [271]
0
0
Hamilton
Query!
Country [272]
0
0
New Zealand
Query!
State/province [272]
0
0
New Plymouth
Query!
Country [273]
0
0
New Zealand
Query!
State/province [273]
0
0
Palmerston North
Query!
Country [274]
0
0
New Zealand
Query!
State/province [274]
0
0
Rotorua
Query!
Country [275]
0
0
New Zealand
Query!
State/province [275]
0
0
Takapuna
Query!
Country [276]
0
0
New Zealand
Query!
State/province [276]
0
0
Tauranga
Query!
Country [277]
0
0
New Zealand
Query!
State/province [277]
0
0
Wellington
Query!
Country [278]
0
0
North Macedonia
Query!
State/province [278]
0
0
Skopje
Query!
Country [279]
0
0
North Macedonia
Query!
State/province [279]
0
0
Struga
Query!
Country [280]
0
0
North Macedonia
Query!
State/province [280]
0
0
Tetovo
Query!
Country [281]
0
0
Norway
Query!
State/province [281]
0
0
Hamar
Query!
Country [282]
0
0
Norway
Query!
State/province [282]
0
0
Hønefoss
Query!
Country [283]
0
0
Norway
Query!
State/province [283]
0
0
Oslo
Query!
Country [284]
0
0
Norway
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State/province [284]
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Lexicon Pharmaceuticals
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Sanofi
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03315143
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Trial related presentations / publications
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. 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.
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Public notes
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Contacts
Principal investigator
Name
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0
Suman Wason, MD
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Address
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Lexicon Pharmaceuticals, Inc.
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Fax
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/43/NCT03315143/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/43/NCT03315143/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03315143