Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 0 0
2017-002644-32
Secondary ID [2] 0 0
EFC14875
Universal Trial Number (UTN)
Trial acronym
SCORED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Type 2 Diabetes Mellitus 0 0
Chronic Kidney Diseases 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [1] 0 0
Total Number of Occurrences of HHF and Urgent HF Visits
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [2] 0 0
Number of Deaths From Cardiovascular Causes
Timepoint [2] 0 0
Up to 30 months
Secondary outcome [3] 0 0
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
Timepoint [3] 0 0
Up to 30 months
Secondary outcome [4] 0 0
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
Timepoint [4] 0 0
Up to 30 months
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
Up to 30 months
Secondary outcome [6] 0 0
Number of Deaths From Any Cause
Timepoint [6] 0 0
Up to 30 months
Secondary outcome [7] 0 0
Total Number of Occurrences of CV Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Timepoint [7] 0 0
Up to 30 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/07/2020
Sample size
Target
Accrual to date
Final
10584
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 0360014 - Adelaide
Recruitment hospital [2] 0 0
Investigational Site Number 0360004 - Box Hill
Recruitment hospital [3] 0 0
Investigational Site Number 0360015 - Elizabeth Vale
Recruitment hospital [4] 0 0
Investigational Site Number 0360005 - Fitzroy
Recruitment hospital [5] 0 0
Investigational Site Number 0360018 - Fremantle
Recruitment hospital [6] 0 0
Investigational Site Number 0360007 - Fullarton
Recruitment hospital [7] 0 0
Investigational Site Number 0360002 - Gosford
Recruitment hospital [8] 0 0
Investigational Site Number 0360016 - Heidelberg
Recruitment hospital [9] 0 0
Investigational Site Number 0360010 - Herston
Recruitment hospital [10] 0 0
Investigational Site Number 0360009 - Liverpool
Recruitment hospital [11] 0 0
Investigational Site Number 0360017 - Melbourne
Recruitment hospital [12] 0 0
Investigational Site Number 0360001 - Merewether
Recruitment hospital [13] 0 0
Investigational Site Number 0360012 - Oaklands Park
Recruitment hospital [14] 0 0
Investigational Site Number 0360011 - Parkville
Recruitment hospital [15] 0 0
Investigational Site Number 0360008 - Redcliffe
Recruitment hospital [16] 0 0
Investigational Site Number 0360013 - Sherwood
Recruitment hospital [17] 0 0
Investigational Site Number 0360019 - St Leonards
Recruitment hospital [18] 0 0
Investigational Site Number 0360006 - Wollongong
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
Recruitment postcode(s) [6] 0 0
5063 - Fullarton
Recruitment postcode(s) [7] 0 0
2250 - Gosford
Recruitment postcode(s) [8] 0 0
3081 - Heidelberg
Recruitment postcode(s) [9] 0 0
4029 - Herston
Recruitment postcode(s) [10] 0 0
2170 - Liverpool
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
2291 - Merewether
Recruitment postcode(s) [13] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [14] 0 0
3050 - Parkville
Recruitment postcode(s) [15] 0 0
4020 - Redcliffe
Recruitment postcode(s) [16] 0 0
4075 - Sherwood
Recruitment postcode(s) [17] 0 0
2065 - St Leonards
Recruitment postcode(s) [18] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Maine
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
Nevada
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
North Dakota
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Vermont
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
Argentina
State/province [33] 0 0
Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Caba
Country [35] 0 0
Argentina
State/province [35] 0 0
Capital Federal
Country [36] 0 0
Argentina
State/province [36] 0 0
Ciudad Autonoma De Bs.As
Country [37] 0 0
Argentina
State/province [37] 0 0
Ciudad Autonoma De Buenos Aire
Country [38] 0 0
Argentina
State/province [38] 0 0
Ciudadela
Country [39] 0 0
Argentina
State/province [39] 0 0
Cordoba
Country [40] 0 0
Argentina
State/province [40] 0 0
Coronel Suarez
Country [41] 0 0
Argentina
State/province [41] 0 0
Corrientes
Country [42] 0 0
Argentina
State/province [42] 0 0
La Plata
Country [43] 0 0
Argentina
State/province [43] 0 0
Mar Del Plata
Country [44] 0 0
Argentina
State/province [44] 0 0
Merlo
Country [45] 0 0
Argentina
State/province [45] 0 0
Ramos Mejia
Country [46] 0 0
Argentina
State/province [46] 0 0
Rosario
Country [47] 0 0
Argentina
State/province [47] 0 0
Salta
Country [48] 0 0
Argentina
State/province [48] 0 0
San Miguel De Tucuman
Country [49] 0 0
Argentina
State/province [49] 0 0
Santa Fe
Country [50] 0 0
Argentina
State/province [50] 0 0
Temperley
Country [51] 0 0
Argentina
State/province [51] 0 0
Villa Maria
Country [52] 0 0
Belgium
State/province [52] 0 0
Bonheiden
Country [53] 0 0
Belgium
State/province [53] 0 0
Gent
Country [54] 0 0
Belgium
State/province [54] 0 0
Kortrijk
Country [55] 0 0
Belgium
State/province [55] 0 0
La-Louvière
Country [56] 0 0
Belgium
State/province [56] 0 0
Leuven
Country [57] 0 0
Brazil
State/province [57] 0 0
Blumenau
Country [58] 0 0
Brazil
State/province [58] 0 0
Brasilia
Country [59] 0 0
Brazil
State/province [59] 0 0
Campinas
Country [60] 0 0
Brazil
State/province [60] 0 0
Canoas
Country [61] 0 0
Brazil
State/province [61] 0 0
Curitiba
Country [62] 0 0
Brazil
State/province [62] 0 0
Fortaleza
Country [63] 0 0
Brazil
State/province [63] 0 0
Passo Fundo
Country [64] 0 0
Brazil
State/province [64] 0 0
Porto Alegre
Country [65] 0 0
Brazil
State/province [65] 0 0
Recife
Country [66] 0 0
Brazil
State/province [66] 0 0
Rio De Janeiro
Country [67] 0 0
Brazil
State/province [67] 0 0
Sao Jose Do Rio Preto
Country [68] 0 0
Brazil
State/province [68] 0 0
Sao Jose Dos Campos
Country [69] 0 0
Brazil
State/province [69] 0 0
Sao Paulo
Country [70] 0 0
Brazil
State/province [70] 0 0
São Paulo
Country [71] 0 0
Brazil
State/province [71] 0 0
Vitoria
Country [72] 0 0
Bulgaria
State/province [72] 0 0
Blagoevgrad
Country [73] 0 0
Bulgaria
State/province [73] 0 0
Dobrich
Country [74] 0 0
Bulgaria
State/province [74] 0 0
Gabrovo
Country [75] 0 0
Bulgaria
State/province [75] 0 0
Plovdiv
Country [76] 0 0
Bulgaria
State/province [76] 0 0
Ruse
Country [77] 0 0
Bulgaria
State/province [77] 0 0
Silistra
Country [78] 0 0
Bulgaria
State/province [78] 0 0
Smolyan
Country [79] 0 0
Bulgaria
State/province [79] 0 0
Sofia
Country [80] 0 0
Bulgaria
State/province [80] 0 0
Stara Zagora
Country [81] 0 0
Canada
State/province [81] 0 0
Brampton
Country [82] 0 0
Canada
State/province [82] 0 0
Burlington
Country [83] 0 0
Canada
State/province [83] 0 0
Calgary
Country [84] 0 0
Canada
State/province [84] 0 0
Concord
Country [85] 0 0
Canada
State/province [85] 0 0
Edmonton
Country [86] 0 0
Canada
State/province [86] 0 0
Halifax
Country [87] 0 0
Canada
State/province [87] 0 0
Hamilton
Country [88] 0 0
Canada
State/province [88] 0 0
London
Country [89] 0 0
Canada
State/province [89] 0 0
Montreal
Country [90] 0 0
Canada
State/province [90] 0 0
Newmarket
Country [91] 0 0
Canada
State/province [91] 0 0
Oshawa
Country [92] 0 0
Canada
State/province [92] 0 0
Ottawa
Country [93] 0 0
Canada
State/province [93] 0 0
Quebec
Country [94] 0 0
Canada
State/province [94] 0 0
Saint-Charles-Borromee
Country [95] 0 0
Canada
State/province [95] 0 0
St-Marc-Des-Carrieres
Country [96] 0 0
Canada
State/province [96] 0 0
St. John'S
Country [97] 0 0
Canada
State/province [97] 0 0
Sudbury
Country [98] 0 0
Canada
State/province [98] 0 0
Surrey
Country [99] 0 0
Canada
State/province [99] 0 0
Toronto
Country [100] 0 0
Canada
State/province [100] 0 0
Trois-Rivieres
Country [101] 0 0
Canada
State/province [101] 0 0
Vancouver
Country [102] 0 0
Canada
State/province [102] 0 0
Victoria
Country [103] 0 0
Chile
State/province [103] 0 0
Concepción
Country [104] 0 0
Chile
State/province [104] 0 0
Osorno
Country [105] 0 0
Chile
State/province [105] 0 0
Punta Arenas
Country [106] 0 0
Chile
State/province [106] 0 0
Santiago
Country [107] 0 0
Chile
State/province [107] 0 0
Talca
Country [108] 0 0
Chile
State/province [108] 0 0
Temuco
Country [109] 0 0
Chile
State/province [109] 0 0
Viña Del Mar
Country [110] 0 0
China
State/province [110] 0 0
Beijing
Country [111] 0 0
China
State/province [111] 0 0
Changchun
Country [112] 0 0
China
State/province [112] 0 0
Changsha
Country [113] 0 0
China
State/province [113] 0 0
Chengdu
Country [114] 0 0
China
State/province [114] 0 0
Dalian
Country [115] 0 0
China
State/province [115] 0 0
Guangzhou
Country [116] 0 0
China
State/province [116] 0 0
Haikou
Country [117] 0 0
China
State/province [117] 0 0
Hengyang
Country [118] 0 0
China
State/province [118] 0 0
Hohhot
Country [119] 0 0
China
State/province [119] 0 0
Huai'An
Country [120] 0 0
China
State/province [120] 0 0
Jinan
Country [121] 0 0
China
State/province [121] 0 0
Jining
Country [122] 0 0
China
State/province [122] 0 0
Nanchang
Country [123] 0 0
China
State/province [123] 0 0
Nanjing
Country [124] 0 0
China
State/province [124] 0 0
Shanghai
Country [125] 0 0
China
State/province [125] 0 0
Shenyang
Country [126] 0 0
China
State/province [126] 0 0
Siping
Country [127] 0 0
China
State/province [127] 0 0
Suzhou
Country [128] 0 0
China
State/province [128] 0 0
Taizhou
Country [129] 0 0
China
State/province [129] 0 0
Tianjin
Country [130] 0 0
China
State/province [130] 0 0
Wuhan
Country [131] 0 0
China
State/province [131] 0 0
Xi'An
Country [132] 0 0
China
State/province [132] 0 0
Xinxiang
Country [133] 0 0
China
State/province [133] 0 0
Zhenjiang
Country [134] 0 0
Czechia
State/province [134] 0 0
Brno
Country [135] 0 0
Czechia
State/province [135] 0 0
Broumov
Country [136] 0 0
Czechia
State/province [136] 0 0
Humpolec
Country [137] 0 0
Czechia
State/province [137] 0 0
Liberec
Country [138] 0 0
Czechia
State/province [138] 0 0
Marianske Lazne
Country [139] 0 0
Czechia
State/province [139] 0 0
Mestec Kralove
Country [140] 0 0
Czechia
State/province [140] 0 0
Plzen
Country [141] 0 0
Czechia
State/province [141] 0 0
Praha 10
Country [142] 0 0
Czechia
State/province [142] 0 0
Praha 1
Country [143] 0 0
Czechia
State/province [143] 0 0
Praha 2
Country [144] 0 0
Czechia
State/province [144] 0 0
Praha 4
Country [145] 0 0
Czechia
State/province [145] 0 0
Praha 6
Country [146] 0 0
Czechia
State/province [146] 0 0
Praha 8
Country [147] 0 0
Czechia
State/province [147] 0 0
Revnice
Country [148] 0 0
Czechia
State/province [148] 0 0
Slany
Country [149] 0 0
Czechia
State/province [149] 0 0
Trutnov
Country [150] 0 0
Czechia
State/province [150] 0 0
Vsetin
Country [151] 0 0
Denmark
State/province [151] 0 0
Aarhus N
Country [152] 0 0
Denmark
State/province [152] 0 0
Gentofte
Country [153] 0 0
Denmark
State/province [153] 0 0
Herlev
Country [154] 0 0
Denmark
State/province [154] 0 0
Hvidovre
Country [155] 0 0
Denmark
State/province [155] 0 0
København Nv
Country [156] 0 0
Denmark
State/province [156] 0 0
Slagelse
Country [157] 0 0
Denmark
State/province [157] 0 0
Svendborg
Country [158] 0 0
Estonia
State/province [158] 0 0
Tallinn
Country [159] 0 0
Estonia
State/province [159] 0 0
Tartu
Country [160] 0 0
France
State/province [160] 0 0
Corbeil-Essonnes
Country [161] 0 0
France
State/province [161] 0 0
La Rochelle Cedex
Country [162] 0 0
France
State/province [162] 0 0
Paris Cedex 18
Country [163] 0 0
France
State/province [163] 0 0
Paris
Country [164] 0 0
France
State/province [164] 0 0
Toulouse Cedex 9
Country [165] 0 0
France
State/province [165] 0 0
Venissieux
Country [166] 0 0
Georgia
State/province [166] 0 0
Batumi
Country [167] 0 0
Georgia
State/province [167] 0 0
Kutaisi
Country [168] 0 0
Georgia
State/province [168] 0 0
Tbilisi
Country [169] 0 0
Germany
State/province [169] 0 0
Berlin
Country [170] 0 0
Germany
State/province [170] 0 0
Essen
Country [171] 0 0
Germany
State/province [171] 0 0
Freiburg
Country [172] 0 0
Germany
State/province [172] 0 0
Hamburg
Country [173] 0 0
Germany
State/province [173] 0 0
Kassel
Country [174] 0 0
Germany
State/province [174] 0 0
Leipzig
Country [175] 0 0
Germany
State/province [175] 0 0
Münster
Country [176] 0 0
Germany
State/province [176] 0 0
Oldenburg In Holstein
Country [177] 0 0
Greece
State/province [177] 0 0
Athens
Country [178] 0 0
Greece
State/province [178] 0 0
Ioannina
Country [179] 0 0
Greece
State/province [179] 0 0
Larissa
Country [180] 0 0
Greece
State/province [180] 0 0
Pireas
Country [181] 0 0
Greece
State/province [181] 0 0
Thessaloniki
Country [182] 0 0
Guatemala
State/province [182] 0 0
Guatemala
Country [183] 0 0
Guatemala
State/province [183] 0 0
Quetzaltenango
Country [184] 0 0
Hungary
State/province [184] 0 0
Budapest
Country [185] 0 0
Hungary
State/province [185] 0 0
Békéscsaba
Country [186] 0 0
Hungary
State/province [186] 0 0
Debrecen
Country [187] 0 0
Hungary
State/province [187] 0 0
Kaposvár
Country [188] 0 0
Hungary
State/province [188] 0 0
Nyíregyháza
Country [189] 0 0
Hungary
State/province [189] 0 0
Szekesfehervar
Country [190] 0 0
Hungary
State/province [190] 0 0
Zalaegerszeg
Country [191] 0 0
India
State/province [191] 0 0
Ahmedabad
Country [192] 0 0
India
State/province [192] 0 0
Aurangabad
Country [193] 0 0
India
State/province [193] 0 0
Bangalore
Country [194] 0 0
India
State/province [194] 0 0
Belgaum
Country [195] 0 0
India
State/province [195] 0 0
Bengaluru
Country [196] 0 0
India
State/province [196] 0 0
Chandigarh
Country [197] 0 0
India
State/province [197] 0 0
Gurgaon
Country [198] 0 0
India
State/province [198] 0 0
Hyderabad
Country [199] 0 0
India
State/province [199] 0 0
Jaipur
Country [200] 0 0
India
State/province [200] 0 0
Kochi
Country [201] 0 0
India
State/province [201] 0 0
Kolkata
Country [202] 0 0
India
State/province [202] 0 0
Kozhikode
Country [203] 0 0
India
State/province [203] 0 0
Ludhiana
Country [204] 0 0
India
State/province [204] 0 0
Mangalore
Country [205] 0 0
India
State/province [205] 0 0
Mumbai
Country [206] 0 0
India
State/province [206] 0 0
Mysore
Country [207] 0 0
India
State/province [207] 0 0
Nagpur
Country [208] 0 0
India
State/province [208] 0 0
Nashik
Country [209] 0 0
India
State/province [209] 0 0
New Delhi
Country [210] 0 0
India
State/province [210] 0 0
Pune
Country [211] 0 0
India
State/province [211] 0 0
Varanasi
Country [212] 0 0
India
State/province [212] 0 0
Vellore
Country [213] 0 0
India
State/province [213] 0 0
Wardha
Country [214] 0 0
Israel
State/province [214] 0 0
Beer Sheva
Country [215] 0 0
Israel
State/province [215] 0 0
Haifa
Country [216] 0 0
Israel
State/province [216] 0 0
Jerusalem
Country [217] 0 0
Israel
State/province [217] 0 0
Nahariya
Country [218] 0 0
Israel
State/province [218] 0 0
Tel Aviv
Country [219] 0 0
Israel
State/province [219] 0 0
Tel Hashomer
Country [220] 0 0
Italy
State/province [220] 0 0
Catanzaro
Country [221] 0 0
Italy
State/province [221] 0 0
Chieri
Country [222] 0 0
Italy
State/province [222] 0 0
Livorno
Country [223] 0 0
Italy
State/province [223] 0 0
Milano
Country [224] 0 0
Italy
State/province [224] 0 0
Orbassano
Country [225] 0 0
Italy
State/province [225] 0 0
Ravenna
Country [226] 0 0
Italy
State/province [226] 0 0
Roma
Country [227] 0 0
Italy
State/province [227] 0 0
Verona
Country [228] 0 0
Korea, Republic of
State/province [228] 0 0
Bucheon-Si
Country [229] 0 0
Korea, Republic of
State/province [229] 0 0
Busan
Country [230] 0 0
Korea, Republic of
State/province [230] 0 0
Gwangju
Country [231] 0 0
Korea, Republic of
State/province [231] 0 0
Incheon
Country [232] 0 0
Korea, Republic of
State/province [232] 0 0
Seongnam-Si
Country [233] 0 0
Korea, Republic of
State/province [233] 0 0
Seoul
Country [234] 0 0
Korea, Republic of
State/province [234] 0 0
Uijeongbu-Si
Country [235] 0 0
Latvia
State/province [235] 0 0
Daugavpils
Country [236] 0 0
Latvia
State/province [236] 0 0
Liepaja
Country [237] 0 0
Latvia
State/province [237] 0 0
Ogre
Country [238] 0 0
Latvia
State/province [238] 0 0
Riga
Country [239] 0 0
Latvia
State/province [239] 0 0
Sigulda
Country [240] 0 0
Lithuania
State/province [240] 0 0
Kaunas
Country [241] 0 0
Lithuania
State/province [241] 0 0
Kedainiai
Country [242] 0 0
Lithuania
State/province [242] 0 0
Klaipeda
Country [243] 0 0
Lithuania
State/province [243] 0 0
Ukmerge
Country [244] 0 0
Lithuania
State/province [244] 0 0
Utena
Country [245] 0 0
Lithuania
State/province [245] 0 0
Vilnius
Country [246] 0 0
Mexico
State/province [246] 0 0
Actopan
Country [247] 0 0
Mexico
State/province [247] 0 0
Aguascalientes
Country [248] 0 0
Mexico
State/province [248] 0 0
Cdmx
Country [249] 0 0
Mexico
State/province [249] 0 0
Celaya
Country [250] 0 0
Mexico
State/province [250] 0 0
Cuernavaca
Country [251] 0 0
Mexico
State/province [251] 0 0
Distrito Federal
Country [252] 0 0
Mexico
State/province [252] 0 0
Durango
Country [253] 0 0
Mexico
State/province [253] 0 0
Guadalajara
Country [254] 0 0
Mexico
State/province [254] 0 0
Merida
Country [255] 0 0
Mexico
State/province [255] 0 0
Monterrey
Country [256] 0 0
Mexico
State/province [256] 0 0
Mérida
Country [257] 0 0
Mexico
State/province [257] 0 0
Queretaro
Country [258] 0 0
Mexico
State/province [258] 0 0
Toluca
Country [259] 0 0
Mexico
State/province [259] 0 0
Veracruz
Country [260] 0 0
Mexico
State/province [260] 0 0
Xalapa
Country [261] 0 0
Mexico
State/province [261] 0 0
Zapopan
Country [262] 0 0
Netherlands
State/province [262] 0 0
Almelo
Country [263] 0 0
Netherlands
State/province [263] 0 0
Groningen
Country [264] 0 0
Netherlands
State/province [264] 0 0
Hoogeveen
Country [265] 0 0
Netherlands
State/province [265] 0 0
Meppel
Country [266] 0 0
Netherlands
State/province [266] 0 0
Rotterdam
Country [267] 0 0
New Zealand
State/province [267] 0 0
Auckland
Country [268] 0 0
New Zealand
State/province [268] 0 0
Birkenhead
Country [269] 0 0
New Zealand
State/province [269] 0 0
Christchurch
Country [270] 0 0
New Zealand
State/province [270] 0 0
Dunedin
Country [271] 0 0
New Zealand
State/province [271] 0 0
Hamilton
Country [272] 0 0
New Zealand
State/province [272] 0 0
New Plymouth
Country [273] 0 0
New Zealand
State/province [273] 0 0
Palmerston North
Country [274] 0 0
New Zealand
State/province [274] 0 0
Rotorua
Country [275] 0 0
New Zealand
State/province [275] 0 0
Takapuna
Country [276] 0 0
New Zealand
State/province [276] 0 0
Tauranga
Country [277] 0 0
New Zealand
State/province [277] 0 0
Wellington
Country [278] 0 0
North Macedonia
State/province [278] 0 0
Skopje
Country [279] 0 0
North Macedonia
State/province [279] 0 0
Struga
Country [280] 0 0
North Macedonia
State/province [280] 0 0
Tetovo
Country [281] 0 0
Norway
State/province [281] 0 0
Hamar
Country [282] 0 0
Norway
State/province [282] 0 0
Hønefoss
Country [283] 0 0
Norway
State/province [283] 0 0
Oslo
Country [284] 0 0
Norway
State/province [284] 0 0
Skedsmokorset
Country [285] 0 0
Peru
State/province [285] 0 0
Arequipa
Country [286] 0 0
Peru
State/province [286] 0 0
Callao
Country [287] 0 0
Peru
State/province [287] 0 0
Chancay
Country [288] 0 0
Peru
State/province [288] 0 0
Chiclayo
Country [289] 0 0
Peru
State/province [289] 0 0
Cuzco
Country [290] 0 0
Peru
State/province [290] 0 0
Lima Lima
Country [291] 0 0
Peru
State/province [291] 0 0
Lima
Country [292] 0 0
Peru
State/province [292] 0 0
Piura
Country [293] 0 0
Peru
State/province [293] 0 0
Trujillo
Country [294] 0 0
Poland
State/province [294] 0 0
Bialystok
Country [295] 0 0
Poland
State/province [295] 0 0
Bydgoszcz
Country [296] 0 0
Poland
State/province [296] 0 0
Bytom
Country [297] 0 0
Poland
State/province [297] 0 0
Czeladz
Country [298] 0 0
Poland
State/province [298] 0 0
Gdynia
Country [299] 0 0
Poland
State/province [299] 0 0
Grodzisk Mazowiecki
Country [300] 0 0
Poland
State/province [300] 0 0
Katowice
Country [301] 0 0
Poland
State/province [301] 0 0
Kielce
Country [302] 0 0
Poland
State/province [302] 0 0
Krakow
Country [303] 0 0
Poland
State/province [303] 0 0
Lodz
Country [304] 0 0
Poland
State/province [304] 0 0
Lublin
Country [305] 0 0
Poland
State/province [305] 0 0
Poznan
Country [306] 0 0
Poland
State/province [306] 0 0
Pulawy
Country [307] 0 0
Poland
State/province [307] 0 0
Staszow
Country [308] 0 0
Poland
State/province [308] 0 0
Torun
Country [309] 0 0
Poland
State/province [309] 0 0
Warszawa
Country [310] 0 0
Poland
State/province [310] 0 0
Wroclaw
Country [311] 0 0
Poland
State/province [311] 0 0
Zabrze
Country [312] 0 0
Poland
State/province [312] 0 0
Zamosc
Country [313] 0 0
Portugal
State/province [313] 0 0
Almada
Country [314] 0 0
Portugal
State/province [314] 0 0
Caldas Da Rainha
Country [315] 0 0
Portugal
State/province [315] 0 0
Carnaxide
Country [316] 0 0
Portugal
State/province [316] 0 0
Coimbra
Country [317] 0 0
Portugal
State/province [317] 0 0
Leiria
Country [318] 0 0
Portugal
State/province [318] 0 0
Lisboa
Country [319] 0 0
Portugal
State/province [319] 0 0
Loures
Country [320] 0 0
Portugal
State/province [320] 0 0
Porto
Country [321] 0 0
Puerto Rico
State/province [321] 0 0
San Juan
Country [322] 0 0
Romania
State/province [322] 0 0
Bacau
Country [323] 0 0
Romania
State/province [323] 0 0
Baia Mare, Maramures
Country [324] 0 0
Romania
State/province [324] 0 0
Brasov
Country [325] 0 0
Romania
State/province [325] 0 0
Bucuresti
Country [326] 0 0
Romania
State/province [326] 0 0
Craiova
Country [327] 0 0
Romania
State/province [327] 0 0
Oradea
Country [328] 0 0
Romania
State/province [328] 0 0
Ploiesti
Country [329] 0 0
Romania
State/province [329] 0 0
Targoviste, Dambovita
Country [330] 0 0
Romania
State/province [330] 0 0
Targu Mures, Mures
Country [331] 0 0
Russian Federation
State/province [331] 0 0
Kaliningrad
Country [332] 0 0
Russian Federation
State/province [332] 0 0
Kazan
Country [333] 0 0
Russian Federation
State/province [333] 0 0
Kemerovo
Country [334] 0 0
Russian Federation
State/province [334] 0 0
Krasnodar
Country [335] 0 0
Russian Federation
State/province [335] 0 0
Moscow
Country [336] 0 0
Russian Federation
State/province [336] 0 0
Nizhniy Novgorod
Country [337] 0 0
Russian Federation
State/province [337] 0 0
Novosibirsk
Country [338] 0 0
Russian Federation
State/province [338] 0 0
Perm
Country [339] 0 0
Russian Federation
State/province [339] 0 0
Rostov-Na-Donu
Country [340] 0 0
Russian Federation
State/province [340] 0 0
Saint-Petersburg
Country [341] 0 0
Russian Federation
State/province [341] 0 0
Saratov
Country [342] 0 0
Russian Federation
State/province [342] 0 0
Sochi
Country [343] 0 0
Russian Federation
State/province [343] 0 0
St-Petersburg
Country [344] 0 0
Russian Federation
State/province [344] 0 0
Tomsk
Country [345] 0 0
Russian Federation
State/province [345] 0 0
Tyumen
Country [346] 0 0
Russian Federation
State/province [346] 0 0
Vladimir
Country [347] 0 0
Russian Federation
State/province [347] 0 0
Yaroslavl
Country [348] 0 0
Serbia
State/province [348] 0 0
Belgrade
Country [349] 0 0
Serbia
State/province [349] 0 0
Kragujevac
Country [350] 0 0
Serbia
State/province [350] 0 0
Nis
Country [351] 0 0
Slovakia
State/province [351] 0 0
Bardejov
Country [352] 0 0
Slovakia
State/province [352] 0 0
Bratislava
Country [353] 0 0
Slovakia
State/province [353] 0 0
Kosice
Country [354] 0 0
Slovakia
State/province [354] 0 0
Lubochna
Country [355] 0 0
Slovakia
State/province [355] 0 0
Lucenec
Country [356] 0 0
Slovakia
State/province [356] 0 0
Moldava Nad Bodvou
Country [357] 0 0
Slovakia
State/province [357] 0 0
Presov
Country [358] 0 0
Slovakia
State/province [358] 0 0
Roznava
Country [359] 0 0
Slovakia
State/province [359] 0 0
Sabinov
Country [360] 0 0
Slovakia
State/province [360] 0 0
Svidnik
Country [361] 0 0
South Africa
State/province [361] 0 0
Brits
Country [362] 0 0
South Africa
State/province [362] 0 0
Cape Town
Country [363] 0 0
South Africa
State/province [363] 0 0
Parow
Country [364] 0 0
South Africa
State/province [364] 0 0
Pinelands
Country [365] 0 0
South Africa
State/province [365] 0 0
Pretoria
Country [366] 0 0
South Africa
State/province [366] 0 0
Rivonia
Country [367] 0 0
South Africa
State/province [367] 0 0
Soweto
Country [368] 0 0
South Africa
State/province [368] 0 0
Umkomaas
Country [369] 0 0
South Africa
State/province [369] 0 0
Vosloorus
Country [370] 0 0
South Africa
State/province [370] 0 0
Western Cape
Country [371] 0 0
Spain
State/province [371] 0 0
Almería
Country [372] 0 0
Spain
State/province [372] 0 0
Barcelona
Country [373] 0 0
Spain
State/province [373] 0 0
Córdoba
Country [374] 0 0
Spain
State/province [374] 0 0
El Puerto De Santa Maria
Country [375] 0 0
Spain
State/province [375] 0 0
Granada
Country [376] 0 0
Spain
State/province [376] 0 0
La Coruña
Country [377] 0 0
Spain
State/province [377] 0 0
Madrid
Country [378] 0 0
Spain
State/province [378] 0 0
Sabadell
Country [379] 0 0
Spain
State/province [379] 0 0
Sanlúcar De Barrameda
Country [380] 0 0
Spain
State/province [380] 0 0
Santa Cruz De Tenerife
Country [381] 0 0
Spain
State/province [381] 0 0
Santiago De Compostela
Country [382] 0 0
Spain
State/province [382] 0 0
Sevilla
Country [383] 0 0
Spain
State/province [383] 0 0
Valencia
Country [384] 0 0
Spain
State/province [384] 0 0
Vigo
Country [385] 0 0
Spain
State/province [385] 0 0
Villamartín
Country [386] 0 0
Spain
State/province [386] 0 0
Zaragoza
Country [387] 0 0
Sweden
State/province [387] 0 0
Falun
Country [388] 0 0
Sweden
State/province [388] 0 0
Lund
Country [389] 0 0
Sweden
State/province [389] 0 0
Mölndal
Country [390] 0 0
Sweden
State/province [390] 0 0
Rättvik
Country [391] 0 0
Sweden
State/province [391] 0 0
Stockholm
Country [392] 0 0
Sweden
State/province [392] 0 0
Uppsala
Country [393] 0 0
Switzerland
State/province [393] 0 0
Olten
Country [394] 0 0
Switzerland
State/province [394] 0 0
Zollikerberg
Country [395] 0 0
Taiwan
State/province [395] 0 0
Hsinchu
Country [396] 0 0
Taiwan
State/province [396] 0 0
Kaohsiung
Country [397] 0 0
Taiwan
State/province [397] 0 0
Linkou
Country [398] 0 0
Taiwan
State/province [398] 0 0
Taichung
Country [399] 0 0
Taiwan
State/province [399] 0 0
Tainan
Country [400] 0 0
Taiwan
State/province [400] 0 0
Taipei
Country [401] 0 0
Turkey
State/province [401] 0 0
Antalya
Country [402] 0 0
Turkey
State/province [402] 0 0
Aydin
Country [403] 0 0
Turkey
State/province [403] 0 0
Corum
Country [404] 0 0
Turkey
State/province [404] 0 0
Gaziantep
Country [405] 0 0
Turkey
State/province [405] 0 0
Istanbul
Country [406] 0 0
Turkey
State/province [406] 0 0
Izmir
Country [407] 0 0
Turkey
State/province [407] 0 0
Kayseri
Country [408] 0 0
Turkey
State/province [408] 0 0
Kocaeli
Country [409] 0 0
Turkey
State/province [409] 0 0
Kutahya
Country [410] 0 0
Turkey
State/province [410] 0 0
Malatya
Country [411] 0 0
Turkey
State/province [411] 0 0
Mersin
Country [412] 0 0
Turkey
State/province [412] 0 0
Sivas
Country [413] 0 0
Ukraine
State/province [413] 0 0
Dnipro
Country [414] 0 0
Ukraine
State/province [414] 0 0
Ivano-Frankivsk
Country [415] 0 0
Ukraine
State/province [415] 0 0
Kharkiv
Country [416] 0 0
Ukraine
State/province [416] 0 0
Kiev
Country [417] 0 0
Ukraine
State/province [417] 0 0
Kyiv
Country [418] 0 0
Ukraine
State/province [418] 0 0
Lutsk
Country [419] 0 0
Ukraine
State/province [419] 0 0
Lviv
Country [420] 0 0
Ukraine
State/province [420] 0 0
Ternopil
Country [421] 0 0
Ukraine
State/province [421] 0 0
Vinnitsya
Country [422] 0 0
Ukraine
State/province [422] 0 0
Vinnytsya
Country [423] 0 0
Ukraine
State/province [423] 0 0
Zhytomyr
Country [424] 0 0
United Kingdom
State/province [424] 0 0
Belfast
Country [425] 0 0
United Kingdom
State/province [425] 0 0
Chippenham
Country [426] 0 0
United Kingdom
State/province [426] 0 0
Davyhulme, Manchester
Country [427] 0 0
United Kingdom
State/province [427] 0 0
Glasgow
Country [428] 0 0
United Kingdom
State/province [428] 0 0
Hayle
Country [429] 0 0
United Kingdom
State/province [429] 0 0
Inverness
Country [430] 0 0
United Kingdom
State/province [430] 0 0
Ipswich
Country [431] 0 0
United Kingdom
State/province [431] 0 0
Maidstone
Country [432] 0 0
United Kingdom
State/province [432] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lexicon Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Suman Wason, MD
Address 0 0
Lexicon Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03315143