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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01032629




Registration number
NCT01032629
Ethics application status
Date submitted
10/12/2009
Date registered
15/12/2009
Date last updated
7/12/2018

Titles & IDs
Public title
CANVAS - CANagliflozin cardioVascular Assessment Study
Scientific title
A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
28431754DIA3008
Secondary ID [2] 0 0
CR016627
Universal Trial Number (UTN)
Trial acronym
CANVAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Cardiovascular Diseases 0 0
Risk Factors 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Canagliflozin (JNJ-28431754) 100 mg
Treatment: Drugs - Canagliflozin (JNJ-28431754) 300 mg

Placebo comparator: Placebo - Each patient will receive placebo (inactive medication) on background standard of care for diabetes once daily for the duration of the study

Experimental: Canagliflozin (JNJ-28431754) 100 mg - Each patient will receive canagliflozin (JNJ-28431754) 100 mg once daily on background standard of care for diabetes once daily for the duration of the study

Experimental: Canagliflozin (JNJ-28431754) 300 mg - Each patient will receive canagliflozin (JNJ-28431754) 300 mg once daily on background standard of care for diabetes once daily for the duration of the study


Treatment: Drugs: Placebo
One placebo capsule taken orally (by mouth) once daily

Treatment: Drugs: Canagliflozin (JNJ-28431754) 100 mg
One 100 mg capsule taken orally (by mouth) once daily

Treatment: Drugs: Canagliflozin (JNJ-28431754) 300 mg
One 300 mg capsule taken orally (by mouth) once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke
Timepoint [1] 0 0
Up to approximately 8 years
Secondary outcome [1] 0 0
Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT)
Timepoint [1] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [2] 0 0
Percentage of Participants With Progression of Albuminuria at the End-of-Treatment
Timepoint [2] 0 0
End of treatment (approximately 338 weeks)
Secondary outcome [3] 0 0
Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment
Timepoint [3] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [4] 0 0
Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment
Timepoint [4] 0 0
Baseline and End of treatment (approximately 338 weeks)
Secondary outcome [5] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment
Timepoint [5] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [6] 0 0
Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment
Timepoint [6] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [7] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment
Timepoint [7] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [8] 0 0
Percent Change From Baseline in Body Weight at End-of-Treatment
Timepoint [8] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [9] 0 0
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment
Timepoint [9] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [10] 0 0
Change From Baseline in Triglycerides Levels at End-of-Treatment
Timepoint [10] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [11] 0 0
Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment
Timepoint [11] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [12] 0 0
Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment
Timepoint [12] 0 0
Baseline and end of treatment (approximately 338 weeks)

Eligibility
Key inclusion criteria
* Patients must have a diagnosis of type 2 diabetes mellitus and greater than or equal to (>=) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with high risk of CV events
* Patients must have inadequate diabetes control (as defined by glycosylated hemoglobin greater than or equal to 7.0% to less than or equal to 10.5% at screening) and be either (1) not currently on diabetes drug therapy or (2) on therapy with any approved class of diabetes drugs
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* A 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 (ie, very low blood sugar) episode within 6 months before screening

Study design
Purpose of the study
Treatment
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/02/2017
Sample size
Target
Accrual to date
Final
4330
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Auchenflower
Recruitment hospital [2] 0 0
- Box Hill
Recruitment hospital [3] 0 0
- Caboolture
Recruitment hospital [4] 0 0
- Caringbah
Recruitment hospital [5] 0 0
- Clayton
Recruitment hospital [6] 0 0
- Daw Park
Recruitment hospital [7] 0 0
- East Ringwood
Recruitment hospital [8] 0 0
- Elizabeth Vale
Recruitment hospital [9] 0 0
- Hornsby, Nsw 2077
Recruitment hospital [10] 0 0
- Kippa Ring
Recruitment hospital [11] 0 0
- Launceston
Recruitment hospital [12] 0 0
- Liverpool
Recruitment hospital [13] 0 0
- Melbourne
Recruitment hospital [14] 0 0
- Milton
Recruitment hospital [15] 0 0
- Parkville
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- Reservoir
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- Sherwood
Recruitment hospital [18] 0 0
- Southport
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- St Leonards
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- West Heidelberg
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- Wollongong
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- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Auchenflower
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- Box Hill
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- Caboolture
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- Caringbah
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- Clayton
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- Daw Park
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- East Ringwood
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- Elizabeth Vale
Recruitment postcode(s) [9] 0 0
- Hornsby, Nsw 2077
Recruitment postcode(s) [10] 0 0
- Kippa Ring
Recruitment postcode(s) [11] 0 0
- Launceston
Recruitment postcode(s) [12] 0 0
- Liverpool
Recruitment postcode(s) [13] 0 0
- Melbourne
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- Milton
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- Parkville
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- Reservoir
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- Sherwood
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- Southport
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- St Leonards
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- West Heidelberg
Recruitment postcode(s) [21] 0 0
- Wollongong
Recruitment postcode(s) [22] 0 0
- Woolloongabba
Recruitment outside Australia
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Petaling Jaya
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Pulau Pinang
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Poznan
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Rzeszow
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Slawkow
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Torun
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Warszawa
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Wroclaw
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Arkhangelsk
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Ekaterinburg
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Kemerovo
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Kirov
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Kursk
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Moscow N/A
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Moscow
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Russian Federation
State/province [188] 0 0
Penza
Country [189] 0 0
Russian Federation
State/province [189] 0 0
Rostov-On-Don
Country [190] 0 0
Russian Federation
State/province [190] 0 0
Russia
Country [191] 0 0
Russian Federation
State/province [191] 0 0
Ryazan
Country [192] 0 0
Russian Federation
State/province [192] 0 0
Saint Petersburg
Country [193] 0 0
Russian Federation
State/province [193] 0 0
Saint-Petersburg
Country [194] 0 0
Russian Federation
State/province [194] 0 0
Saratov
Country [195] 0 0
Russian Federation
State/province [195] 0 0
Smolensk
Country [196] 0 0
Russian Federation
State/province [196] 0 0
St Petersburg
Country [197] 0 0
Russian Federation
State/province [197] 0 0
Tomsk
Country [198] 0 0
Russian Federation
State/province [198] 0 0
Tula
Country [199] 0 0
Russian Federation
State/province [199] 0 0
Tyumen
Country [200] 0 0
Russian Federation
State/province [200] 0 0
Yaroslavl Nap
Country [201] 0 0
Russian Federation
State/province [201] 0 0
Yaroslavl
Country [202] 0 0
Spain
State/province [202] 0 0
Alicante
Country [203] 0 0
Spain
State/province [203] 0 0
Almeria
Country [204] 0 0
Spain
State/province [204] 0 0
Barcelona
Country [205] 0 0
Spain
State/province [205] 0 0
Figueres
Country [206] 0 0
Spain
State/province [206] 0 0
Madrid
Country [207] 0 0
Spain
State/province [207] 0 0
Málaga
Country [208] 0 0
Spain
State/province [208] 0 0
Oviedo
Country [209] 0 0
Spain
State/province [209] 0 0
Reus
Country [210] 0 0
Spain
State/province [210] 0 0
Sabadell
Country [211] 0 0
Spain
State/province [211] 0 0
San Juan De Alicante
Country [212] 0 0
Spain
State/province [212] 0 0
Santiago De Compostela
Country [213] 0 0
Spain
State/province [213] 0 0
Sevilla N/A
Country [214] 0 0
Spain
State/province [214] 0 0
Valencia
Country [215] 0 0
Spain
State/province [215] 0 0
Viladecans
Country [216] 0 0
Sweden
State/province [216] 0 0
Borås
Country [217] 0 0
Sweden
State/province [217] 0 0
Göteborg
Country [218] 0 0
Sweden
State/province [218] 0 0
Helsingborg
Country [219] 0 0
Sweden
State/province [219] 0 0
Lund
Country [220] 0 0
Sweden
State/province [220] 0 0
Malmö
Country [221] 0 0
Sweden
State/province [221] 0 0
Oskarshamn N/A
Country [222] 0 0
Sweden
State/province [222] 0 0
Piteå
Country [223] 0 0
Sweden
State/province [223] 0 0
Stockholm
Country [224] 0 0
Sweden
State/province [224] 0 0
Uddevalla
Country [225] 0 0
Ukraine
State/province [225] 0 0
Dnepropetrovsk
Country [226] 0 0
Ukraine
State/province [226] 0 0
Donetsk
Country [227] 0 0
Ukraine
State/province [227] 0 0
Kharkov
Country [228] 0 0
Ukraine
State/province [228] 0 0
Kiev
Country [229] 0 0
Ukraine
State/province [229] 0 0
Kyiv
Country [230] 0 0
Ukraine
State/province [230] 0 0
Odessa
Country [231] 0 0
Ukraine
State/province [231] 0 0
Ternopol
Country [232] 0 0
Ukraine
State/province [232] 0 0
Uzhgorod
Country [233] 0 0
Ukraine
State/province [233] 0 0
Vinnitsa
Country [234] 0 0
Ukraine
State/province [234] 0 0
Zaporozhye
Country [235] 0 0
United Kingdom
State/province [235] 0 0
Belfast
Country [236] 0 0
United Kingdom
State/province [236] 0 0
Blackburn
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Bolton
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Chorley
Country [239] 0 0
United Kingdom
State/province [239] 0 0
Derby
Country [240] 0 0
United Kingdom
State/province [240] 0 0
Glasgow
Country [241] 0 0
United Kingdom
State/province [241] 0 0
Hull
Country [242] 0 0
United Kingdom
State/province [242] 0 0
Leicester
Country [243] 0 0
United Kingdom
State/province [243] 0 0
Liverpool
Country [244] 0 0
United Kingdom
State/province [244] 0 0
Londonderry
Country [245] 0 0
United Kingdom
State/province [245] 0 0
London
Country [246] 0 0
United Kingdom
State/province [246] 0 0
Manchester
Country [247] 0 0
United Kingdom
State/province [247] 0 0
Randalstown
Country [248] 0 0
United Kingdom
State/province [248] 0 0
Salford
Country [249] 0 0
United Kingdom
State/province [249] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The George Institute for Global Health, Australia
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
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol https://cdn.clinicaltrials.gov/large-docs/29/NCT01032629/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/29/NCT01032629/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/29/NCT01032629/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/29/NCT01032629/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/29/NCT01032629/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/29/NCT01032629/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/29/NCT01032629/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/29/NCT01032629/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/29/NCT01032629/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/29/NCT01032629/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/NCT01032629