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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01989754
Registration number
NCT01989754
Ethics application status
Date submitted
17/10/2013
Date registered
21/11/2013
Date last updated
11/12/2018
Titles & IDs
Public title
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
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Scientific title
A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus
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Secondary ID [1]
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2013-003050-25
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Secondary ID [2]
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CR102647
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Universal Trial Number (UTN)
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Trial acronym
CANVAS-R
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Albuminuria
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Metabolic and Endocrine
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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 - Placebo
Treatment: Drugs - Canagliflozin, 100 mg
Treatment: Drugs - Canagliflozin, 300 mg
Experimental: Canagliflozin (JNJ-28431754) - Each patient will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 13 weeks, then the dose may be increased to 300 mg once daily.
Placebo comparator: Placebo - Each patient will receive placebo (inactive medication) once daily.
Treatment: Drugs: Placebo
One placebo capsule taken orally (by mouth) once daily for 156 weeks
Treatment: Drugs: Canagliflozin, 100 mg
One 100 mg capsule taken orally (by mouth) once daily
Treatment: Drugs: Canagliflozin, 300 mg
One 300 mg capsule taken orally (by mouth) 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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Progression of Albuminuria
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Assessment method [1]
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Progression defined as the development of micro-albuminuria (Urine Albumin Creatinine Ratio \[UACR\] 30 to 300 milligram per gram \[mg/g\]) or macroalbuminuria (Albumin/creatinine ratio \[ACR\] of greater than \[\>\] 300 mg/g) in a participant with baseline normoalbuminuria (ACR less than \[\<\] 30 mg/g) or the development of macro-albuminuria in a participant with baseline microalbuminuria with an ACR increase greater than or equal to (\>=) 30 percent from baseline. Participants with macroalbuminuria at baseline (ACR\>300 mg/g) were excluded from the analysis. Event rate was estimated based on the time to the first occurrence of the event.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [1]
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Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure
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Assessment method [1]
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Analyses were using adjudicated events, that is (i.e.) CV death events or hospitalization due to heart failure, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event.
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Timepoint [1]
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Approximately 3 years
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Secondary outcome [2]
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Cardiovascular (CV) Death
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Assessment method [2]
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Analyses were using adjudicated events, i.e. CV death events, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event.
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Timepoint [2]
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Approximately 3 years
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Eligibility
Key inclusion criteria
* Must have a diagnosis of type 2 diabetes mellitus
* Must have inadequate diabetes control (as defined by glycosylated hemoglobin level >=7.0% to <=10.5% at screening)
* Greater than or equal to (>=) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with high risk of CV events
* Must be either not on antihyperglycemic agents (AHA) therapy, or on AHA monotherapy, or combination AHA therapy with any approved agent for the control of blood glucose levels.
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Minimum age
30
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
* History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* History of one or more severe hypoglycemic episode within 6 months before screening
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
* Ongoing, inadequately controlled thyroid disorder
* Renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant
* Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening.
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Study design
Purpose of the study
Treatment
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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 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
16/01/2014
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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
23/02/2017
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Sample size
Target
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Accrual to date
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Final
5813
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Recruitment in Australia
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Recruitment hospital [1]
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- Box Hill
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- Cairns
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- Daw Park
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- Box Hill
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Italy
Query!
State/province [123]
0
0
Napoli
Query!
Country [124]
0
0
Italy
Query!
State/province [124]
0
0
Ravenna
Query!
Country [125]
0
0
Italy
Query!
State/province [125]
0
0
Roma N/A
Query!
Country [126]
0
0
Italy
Query!
State/province [126]
0
0
Roma
Query!
Country [127]
0
0
Italy
Query!
State/province [127]
0
0
Sesto San Giovanni (Milano)
Query!
Country [128]
0
0
Italy
Query!
State/province [128]
0
0
Verona
Query!
Country [129]
0
0
Korea, Republic of
Query!
State/province [129]
0
0
Ansan
Query!
Country [130]
0
0
Korea, Republic of
Query!
State/province [130]
0
0
Bucheon
Query!
Country [131]
0
0
Korea, Republic of
Query!
State/province [131]
0
0
Busan
Query!
Country [132]
0
0
Korea, Republic of
Query!
State/province [132]
0
0
Changwon
Query!
Country [133]
0
0
Korea, Republic of
Query!
State/province [133]
0
0
Cheongju
Query!
Country [134]
0
0
Korea, Republic of
Query!
State/province [134]
0
0
Daegu
Query!
Country [135]
0
0
Korea, Republic of
Query!
State/province [135]
0
0
Gyeonggi-Do
Query!
Country [136]
0
0
Korea, Republic of
Query!
State/province [136]
0
0
Iksan
Query!
Country [137]
0
0
Korea, Republic of
Query!
State/province [137]
0
0
Incheon
Query!
Country [138]
0
0
Korea, Republic of
Query!
State/province [138]
0
0
Jeonju
Query!
Country [139]
0
0
Korea, Republic of
Query!
State/province [139]
0
0
Seongnam-Si
Query!
Country [140]
0
0
Korea, Republic of
Query!
State/province [140]
0
0
Seoul
Query!
Country [141]
0
0
Korea, Republic of
Query!
State/province [141]
0
0
Suwon
Query!
Country [142]
0
0
Korea, Republic of
Query!
State/province [142]
0
0
Ulsan
Query!
Country [143]
0
0
Korea, Republic of
Query!
State/province [143]
0
0
Wonju-Si
Query!
Country [144]
0
0
Malaysia
Query!
State/province [144]
0
0
Batu Caves
Query!
Country [145]
0
0
Malaysia
Query!
State/province [145]
0
0
Georgetown
Query!
Country [146]
0
0
Malaysia
Query!
State/province [146]
0
0
Ipoh
Query!
Country [147]
0
0
Malaysia
Query!
State/province [147]
0
0
Kelantan
Query!
Country [148]
0
0
Malaysia
Query!
State/province [148]
0
0
Kota Bharu
Query!
Country [149]
0
0
Malaysia
Query!
State/province [149]
0
0
Kuala Lumpur
Query!
Country [150]
0
0
Malaysia
Query!
State/province [150]
0
0
Kuching
Query!
Country [151]
0
0
Mexico
Query!
State/province [151]
0
0
Aguascalientes
Query!
Country [152]
0
0
Mexico
Query!
State/province [152]
0
0
Celaya
Query!
Country [153]
0
0
Mexico
Query!
State/province [153]
0
0
Cuernavaca
Query!
Country [154]
0
0
Mexico
Query!
State/province [154]
0
0
Culiacan
Query!
Country [155]
0
0
Mexico
Query!
State/province [155]
0
0
Guadalajara
Query!
Country [156]
0
0
Mexico
Query!
State/province [156]
0
0
Mexico
Query!
Country [157]
0
0
Mexico
Query!
State/province [157]
0
0
Pachuca De Soto
Query!
Country [158]
0
0
Mexico
Query!
State/province [158]
0
0
Queretaro
Query!
Country [159]
0
0
Mexico
Query!
State/province [159]
0
0
San Luis Potosi
Query!
Country [160]
0
0
Mexico
Query!
State/province [160]
0
0
Tampico
Query!
Country [161]
0
0
Netherlands
Query!
State/province [161]
0
0
Almelo
Query!
Country [162]
0
0
Netherlands
Query!
State/province [162]
0
0
Almere
Query!
Country [163]
0
0
Netherlands
Query!
State/province [163]
0
0
Amersfoort
Query!
Country [164]
0
0
Netherlands
Query!
State/province [164]
0
0
Amsterdam
Query!
Country [165]
0
0
Netherlands
Query!
State/province [165]
0
0
Dordrecht
Query!
Country [166]
0
0
Netherlands
Query!
State/province [166]
0
0
Eindhoven
Query!
Country [167]
0
0
Netherlands
Query!
State/province [167]
0
0
Groningen
Query!
Country [168]
0
0
Netherlands
Query!
State/province [168]
0
0
Hardenberg
Query!
Country [169]
0
0
Netherlands
Query!
State/province [169]
0
0
Hoogeveen
Query!
Country [170]
0
0
Netherlands
Query!
State/province [170]
0
0
Hoogezand
Query!
Country [171]
0
0
Netherlands
Query!
State/province [171]
0
0
Kloosterhaar
Query!
Country [172]
0
0
Netherlands
Query!
State/province [172]
0
0
Leiden
Query!
Country [173]
0
0
Netherlands
Query!
State/province [173]
0
0
Meppel
Query!
Country [174]
0
0
Netherlands
Query!
State/province [174]
0
0
Poortvliet
Query!
Country [175]
0
0
Netherlands
Query!
State/province [175]
0
0
Rotterdam
Query!
Country [176]
0
0
Netherlands
Query!
State/province [176]
0
0
Utrecht
Query!
Country [177]
0
0
Netherlands
Query!
State/province [177]
0
0
Velp
Query!
Country [178]
0
0
Netherlands
Query!
State/province [178]
0
0
Waalwijk
Query!
Country [179]
0
0
Netherlands
Query!
State/province [179]
0
0
Wamel
Query!
Country [180]
0
0
Netherlands
Query!
State/province [180]
0
0
Zoetermeer
Query!
Country [181]
0
0
Netherlands
Query!
State/province [181]
0
0
Zwijndrecht
Query!
Country [182]
0
0
New Zealand
Query!
State/province [182]
0
0
Auckland
Query!
Country [183]
0
0
New Zealand
Query!
State/province [183]
0
0
Christchurch
Query!
Country [184]
0
0
New Zealand
Query!
State/province [184]
0
0
Newtown
Query!
Country [185]
0
0
New Zealand
Query!
State/province [185]
0
0
Palmerston North
Query!
Country [186]
0
0
New Zealand
Query!
State/province [186]
0
0
Rotorua
Query!
Country [187]
0
0
New Zealand
Query!
State/province [187]
0
0
Tauranga
Query!
Country [188]
0
0
New Zealand
Query!
State/province [188]
0
0
Wellington
Query!
Country [189]
0
0
Poland
Query!
State/province [189]
0
0
Bialystok
Query!
Country [190]
0
0
Poland
Query!
State/province [190]
0
0
Bydgoszcz
Query!
Country [191]
0
0
Poland
Query!
State/province [191]
0
0
Chrzanow
Query!
Country [192]
0
0
Poland
Query!
State/province [192]
0
0
Gdansk
Query!
Country [193]
0
0
Poland
Query!
State/province [193]
0
0
Grodzisk Mazowiecki
Query!
Country [194]
0
0
Poland
Query!
State/province [194]
0
0
Katowice
Query!
Country [195]
0
0
Poland
Query!
State/province [195]
0
0
Krakow
Query!
Country [196]
0
0
Poland
Query!
State/province [196]
0
0
Lublin
Query!
Country [197]
0
0
Poland
Query!
State/province [197]
0
0
Oswiecim
Query!
Country [198]
0
0
Poland
Query!
State/province [198]
0
0
Torun
Query!
Country [199]
0
0
Poland
Query!
State/province [199]
0
0
Tychy
Query!
Country [200]
0
0
Poland
Query!
State/province [200]
0
0
Warszawa
Query!
Country [201]
0
0
Poland
Query!
State/province [201]
0
0
Wroclaw
Query!
Country [202]
0
0
Puerto Rico
Query!
State/province [202]
0
0
Ponce Pr
Query!
Country [203]
0
0
Puerto Rico
Query!
State/province [203]
0
0
Trujillo Alto
Query!
Country [204]
0
0
Russian Federation
Query!
State/province [204]
0
0
Arkhangelsk
Query!
Country [205]
0
0
Russian Federation
Query!
State/province [205]
0
0
Barnaul
Query!
Country [206]
0
0
Russian Federation
Query!
State/province [206]
0
0
Chelyabinsk
Query!
Country [207]
0
0
Russian Federation
Query!
State/province [207]
0
0
Kemerovo
Query!
Country [208]
0
0
Russian Federation
Query!
State/province [208]
0
0
Nizhny Novgorod
Query!
Country [209]
0
0
Russian Federation
Query!
State/province [209]
0
0
Penza
Query!
Country [210]
0
0
Russian Federation
Query!
State/province [210]
0
0
Rostov-On-Don
Query!
Country [211]
0
0
Russian Federation
Query!
State/province [211]
0
0
Saint Petersburg
Query!
Country [212]
0
0
Russian Federation
Query!
State/province [212]
0
0
Saint-Petersburg
Query!
Country [213]
0
0
Russian Federation
Query!
State/province [213]
0
0
Samara
Query!
Country [214]
0
0
Russian Federation
Query!
State/province [214]
0
0
Saratov
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
Smolensk
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
St Petersburg
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
0
St-Petersburg
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Syktyvkar
Query!
Country [219]
0
0
Russian Federation
Query!
State/province [219]
0
0
Tyumen
Query!
Country [220]
0
0
Russian Federation
Query!
State/province [220]
0
0
Vsevolzhsk
Query!
Country [221]
0
0
Russian Federation
Query!
State/province [221]
0
0
Yaroslavl
Query!
Country [222]
0
0
Spain
Query!
State/province [222]
0
0
A Coruna
Query!
Country [223]
0
0
Spain
Query!
State/province [223]
0
0
Alcalá De Henares
Query!
Country [224]
0
0
Spain
Query!
State/province [224]
0
0
Alicante
Query!
Country [225]
0
0
Spain
Query!
State/province [225]
0
0
Almeria
Query!
Country [226]
0
0
Spain
Query!
State/province [226]
0
0
Alzira
Query!
Country [227]
0
0
Spain
Query!
State/province [227]
0
0
Barcelona
Query!
Country [228]
0
0
Spain
Query!
State/province [228]
0
0
Ciudad Real
Query!
Country [229]
0
0
Spain
Query!
State/province [229]
0
0
Cordoba
Query!
Country [230]
0
0
Spain
Query!
State/province [230]
0
0
Ferrol
Query!
Country [231]
0
0
Spain
Query!
State/province [231]
0
0
Figueres
Query!
Country [232]
0
0
Spain
Query!
State/province [232]
0
0
Galdakao
Query!
Country [233]
0
0
Spain
Query!
State/province [233]
0
0
Madrid
Query!
Country [234]
0
0
Spain
Query!
State/province [234]
0
0
Malaga
Query!
Country [235]
0
0
Spain
Query!
State/province [235]
0
0
Móstoles
Query!
Country [236]
0
0
Spain
Query!
State/province [236]
0
0
Palma De Mallorca
Query!
Country [237]
0
0
Spain
Query!
State/province [237]
0
0
Sabadell
Query!
Country [238]
0
0
Spain
Query!
State/province [238]
0
0
San Sebastian De Los Reyes
Query!
Country [239]
0
0
Spain
Query!
State/province [239]
0
0
Sant Joan D'Alacant
Query!
Country [240]
0
0
Spain
Query!
State/province [240]
0
0
Santa Cruz De Tenerife
Query!
Country [241]
0
0
Spain
Query!
State/province [241]
0
0
Santiago De Compostela
Query!
Country [242]
0
0
Spain
Query!
State/province [242]
0
0
Segovia
Query!
Country [243]
0
0
Spain
Query!
State/province [243]
0
0
Sevilla N/A
Query!
Country [244]
0
0
Spain
Query!
State/province [244]
0
0
Sevilla
Query!
Country [245]
0
0
Spain
Query!
State/province [245]
0
0
Valencia
Query!
Country [246]
0
0
Spain
Query!
State/province [246]
0
0
Viladecans
Query!
Country [247]
0
0
Sweden
Query!
State/province [247]
0
0
Borås
Query!
Country [248]
0
0
Sweden
Query!
State/province [248]
0
0
Goteborg
Query!
Country [249]
0
0
Sweden
Query!
State/province [249]
0
0
Helsingborg
Query!
Country [250]
0
0
Sweden
Query!
State/province [250]
0
0
Karlstad
Query!
Country [251]
0
0
Sweden
Query!
State/province [251]
0
0
Linköping
Query!
Country [252]
0
0
Sweden
Query!
State/province [252]
0
0
Lund
Query!
Country [253]
0
0
Sweden
Query!
State/province [253]
0
0
Malmo
Query!
Country [254]
0
0
Sweden
Query!
State/province [254]
0
0
Stockholm
Query!
Country [255]
0
0
Sweden
Query!
State/province [255]
0
0
Uddevalla
Query!
Country [256]
0
0
Sweden
Query!
State/province [256]
0
0
Uppsala
Query!
Country [257]
0
0
Sweden
Query!
State/province [257]
0
0
Vallingby
Query!
Country [258]
0
0
Sweden
Query!
State/province [258]
0
0
Västra Frölunda
Query!
Country [259]
0
0
Taiwan
Query!
State/province [259]
0
0
Kaohsiung County
Query!
Country [260]
0
0
Taiwan
Query!
State/province [260]
0
0
Taichung
Query!
Country [261]
0
0
Taiwan
Query!
State/province [261]
0
0
Tainan
Query!
Country [262]
0
0
Taiwan
Query!
State/province [262]
0
0
Taipei
Query!
Country [263]
0
0
Taiwan
Query!
State/province [263]
0
0
Tiachung
Query!
Country [264]
0
0
Taiwan
Query!
State/province [264]
0
0
Xindian
Query!
Country [265]
0
0
Ukraine
Query!
State/province [265]
0
0
Cherkasy
Query!
Country [266]
0
0
Ukraine
Query!
State/province [266]
0
0
Chernivtsy
Query!
Country [267]
0
0
Ukraine
Query!
State/province [267]
0
0
Dnipropetrovsk
Query!
Country [268]
0
0
Ukraine
Query!
State/province [268]
0
0
Ivan-Frankivsk
Query!
Country [269]
0
0
Ukraine
Query!
State/province [269]
0
0
Ivano-Frankovsk
Query!
Country [270]
0
0
Ukraine
Query!
State/province [270]
0
0
Kharkiv
Query!
Country [271]
0
0
Ukraine
Query!
State/province [271]
0
0
Kharkov
Query!
Country [272]
0
0
Ukraine
Query!
State/province [272]
0
0
Kiev
Query!
Country [273]
0
0
Ukraine
Query!
State/province [273]
0
0
Kyiv
Query!
Country [274]
0
0
Ukraine
Query!
State/province [274]
0
0
Lviv
Query!
Country [275]
0
0
Ukraine
Query!
State/province [275]
0
0
Odesa
Query!
Country [276]
0
0
Ukraine
Query!
State/province [276]
0
0
Odessa
Query!
Country [277]
0
0
Ukraine
Query!
State/province [277]
0
0
Poltava
Query!
Country [278]
0
0
Ukraine
Query!
State/province [278]
0
0
Sumy
Query!
Country [279]
0
0
Ukraine
Query!
State/province [279]
0
0
Ternopil
Query!
Country [280]
0
0
Ukraine
Query!
State/province [280]
0
0
Uzhgorod
Query!
Country [281]
0
0
Ukraine
Query!
State/province [281]
0
0
Vinnitsa
Query!
Country [282]
0
0
Ukraine
Query!
State/province [282]
0
0
Vinnytsya
Query!
Country [283]
0
0
Ukraine
Query!
State/province [283]
0
0
Zaporizhzhia
Query!
Country [284]
0
0
Ukraine
Query!
State/province [284]
0
0
Zaporizhzhya
Query!
Country [285]
0
0
United Kingdom
Query!
State/province [285]
0
0
Addlestone
Query!
Country [286]
0
0
United Kingdom
Query!
State/province [286]
0
0
Belfast
Query!
Country [287]
0
0
United Kingdom
Query!
State/province [287]
0
0
Birmingham
Query!
Country [288]
0
0
United Kingdom
Query!
State/province [288]
0
0
Blackburn
Query!
Country [289]
0
0
United Kingdom
Query!
State/province [289]
0
0
Bristol
Query!
Country [290]
0
0
United Kingdom
Query!
State/province [290]
0
0
Bury St Edmunds
Query!
Country [291]
0
0
United Kingdom
Query!
State/province [291]
0
0
Chesterfield
Query!
Country [292]
0
0
United Kingdom
Query!
State/province [292]
0
0
Derby
Query!
Country [293]
0
0
United Kingdom
Query!
State/province [293]
0
0
Doncaster
Query!
Country [294]
0
0
United Kingdom
Query!
State/province [294]
0
0
Ipswich
Query!
Country [295]
0
0
United Kingdom
Query!
State/province [295]
0
0
Leicester
Query!
Country [296]
0
0
United Kingdom
Query!
State/province [296]
0
0
Liverpool
Query!
Country [297]
0
0
United Kingdom
Query!
State/province [297]
0
0
Manchester
Query!
Country [298]
0
0
United Kingdom
Query!
State/province [298]
0
0
Salford
Query!
Country [299]
0
0
United Kingdom
Query!
State/province [299]
0
0
Taunton
Query!
Country [300]
0
0
United Kingdom
Query!
State/province [300]
0
0
Torquay
Query!
Country [301]
0
0
United Kingdom
Query!
State/province [301]
0
0
Truro
Query!
Country [302]
0
0
United Kingdom
Query!
State/province [302]
0
0
Wellingborough
Query!
Country [303]
0
0
United Kingdom
Query!
State/province [303]
0
0
Welwyn Garden City
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
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The George Institute for Global Health, Australia
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Summary
Brief summary
The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.
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Trial website
https://clinicaltrials.gov/study/NCT01989754
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Trial related presentations / publications
Young TK, Li JW, Kang A, Heerspink HJL, Hockham C, Arnott C, Neuen BL, Zoungas S, Mahaffey KW, Perkovic V, de Zeeuw D, Fulcher G, Neal B, Jardine M. Effects of canagliflozin compared with placebo on major adverse cardiovascular and kidney events in patient groups with different baseline levels of HbA1c, disease duration and treatment intensity: results from the CANVAS Program. Diabetologia. 2021 Nov;64(11):2402-2414. doi: 10.1007/s00125-021-05524-1. Epub 2021 Aug 26. Yu J, Li J, Leaver PJ, Arnott C, Huffman MD, Udell JA, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Rosenthal N, Neal B, Figtree GA. Effects of canagliflozin on myocardial infarction: a post hoc analysis of the CANVAS programme and CREDENCE trial. Cardiovasc Res. 2022 Mar 16;118(4):1103-1114. doi: 10.1093/cvr/cvab128. Yu J, Arnott C, Neuen BL, Heersprink HL, Mahaffey KW, Cannon CP, Khan SS, Baldridge AS, Shah SJ, Huang Y, Li C, Figtree GA, Perkovic V, Jardine MJ, Neal B, Huffman MD. Cardiovascular and renal outcomes with canagliflozin according to baseline diuretic use: a post hoc analysis from the CANVAS Program. ESC Heart Fail. 2021 Apr;8(2):1482-1493. doi: 10.1002/ehf2.13236. Epub 2021 Feb 17. Erratum In: ESC Heart Fail. 2021 Aug;8(4):3447. doi: 10.1002/ehf2.13408. Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Blais J, Li Q, Jardine MJ, Perkovic V, Wheeler DC. Relative and Absolute Risk Reductions in Cardiovascular and Kidney Outcomes With Canagliflozin Across KDIGO Risk Categories: Findings From the CANVAS Program. Am J Kidney Dis. 2021 Jan;77(1):23-34.e1. doi: 10.1053/j.ajkd.2020.06.018. Epub 2020 Sep 21. Oshima M, Neal B, Toyama T, Ohkuma T, Li Q, de Zeeuw D, Heerspink HJL, Mahaffey KW, Fulcher G, Canovatchel W, Matthews DR, Perkovic V. Different eGFR Decline Thresholds and Renal Effects of Canagliflozin: Data from the CANVAS Program. J Am Soc Nephrol. 2020 Oct;31(10):2446-2456. doi: 10.1681/ASN.2019121312. Epub 2020 Jul 21. Matthews DR, Wysham C, Davies M, Slee A, Alba M, Lee M, Perkovic V, Mahaffey KW, Neal B. Effects of canagliflozin on initiation of insulin and other antihyperglycaemic agents in the CANVAS Program. Diabetes Obes Metab. 2020 Nov;22(11):2199-2203. doi: 10.1111/dom.14143. Epub 2020 Aug 24. Li J, Woodward M, Perkovic V, Figtree GA, Heerspink HJL, Mahaffey KW, de Zeeuw D, Vercruysse F, Shaw W, Matthews DR, Neal B. Mediators of the Effects of Canagliflozin on Heart Failure in Patients With Type 2 Diabetes. JACC Heart Fail. 2020 Jan;8(1):57-66. doi: 10.1016/j.jchf.2019.08.004. Epub 2019 Oct 29. Zhou Z, Jardine M, Perkovic V, Matthews DR, Mahaffey KW, de Zeeuw D, Fulcher G, Desai M, Oh R, Simpson R, Watts NB, Neal B. Canagliflozin and fracture risk in individuals with type 2 diabetes: results from the CANVAS Program. Diabetologia. 2019 Oct;62(10):1854-1867. doi: 10.1007/s00125-019-4955-5. Epub 2019 Aug 10. Figtree GA, Radholm K, Barrett TD, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Neal B. Effects of Canagliflozin on Heart Failure Outcomes Associated With Preserved and Reduced Ejection Fraction in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2591-2593. doi: 10.1161/CIRCULATIONAHA.119.040057. Epub 2019 Mar 17. No abstract available. Zhou Z, Lindley RI, Radholm K, Jenkins B, Watson J, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Shaw W, Oh R, Desai M, Matthews DR, Neal B. Canagliflozin and Stroke in Type 2 Diabetes Mellitus. Stroke. 2019 Feb;50(2):396-404. doi: 10.1161/STROKEAHA.118.023009. Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Desai M, Li Q, Deng H, Rosenthal N, Jardine MJ, Bakris G, Perkovic V. Cardiovascular and Renal Outcomes With Canagliflozin According to Baseline Kidney Function. Circulation. 2018 Oct 9;138(15):1537-1550. doi: 10.1161/CIRCULATIONAHA.118.035901. Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Erondu N, Shaw W, Barrett TD, Weidner-Wells M, Deng H, Matthews DR, Neal B. Canagliflozin and renal outcomes in type 2 diabetes: results from the CANVAS Program randomised clinical trials. Lancet Diabetes Endocrinol. 2018 Sep;6(9):691-704. doi: 10.1016/S2213-8587(18)30141-4. Epub 2018 Jun 21. Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145. Radholm K, Figtree G, Perkovic V, Solomon SD, Mahaffey KW, de Zeeuw D, Fulcher G, Barrett TD, Shaw W, Desai M, Matthews DR, Neal B. Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus: Results From the CANVAS Program. Circulation. 2018 Jul 31;138(5):458-468. doi: 10.1161/CIRCULATIONAHA.118.034222. Mahaffey KW, Neal B, Perkovic V, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Fabbrini E, Sun T, Li Q, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin for Primary and Secondary Prevention of Cardiovascular Events: Results From the CANVAS Program (Canagliflozin Cardiovascular Assessment Study). Circulation. 2018 Jan 23;137(4):323-334. doi: 10.1161/CIRCULATIONAHA.117.032038. Epub 2017 Nov 13. Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.
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Public notes
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Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/54/NCT01989754/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/54/NCT01989754/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/NCT01989754
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