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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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- 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
Recruitment postcode(s) [7] 0 0
- East Ringwood
Recruitment postcode(s) [8] 0 0
- Elizabeth Vale
Recruitment postcode(s) [9] 0 0
- Hornsby, Nsw 2077
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- Kippa Ring
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- Launceston
Recruitment postcode(s) [12] 0 0
- Liverpool
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- 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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Bangalore, Karnataka
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Bangalore
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Belgaum
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Calicut
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Ghaziabad
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Hyderabad
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Indore
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Kolkata
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Lucknow
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Mumbai
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Vijayawada
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Israel
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Holon
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Jerusalem
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Israel
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Kfar Saba
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Luxembourg
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Georgetown
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Johor Bahru
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Malaysia
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Kota Bharu
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Malaysia
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Kuala Lumpur N/A
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Malaysia
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Petaling Jaya
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Pulau Pinang
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Malaysia
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Subang Jaya
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Mexico
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Aguascalientes
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Celaya
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Mexico
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Ciudad De Mexico
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Durango
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Guadalajara
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Mexico
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Monterrey
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Netherlands
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Almelo
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Almere
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Amsterdam
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Arnhem
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Delft
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Den Helder
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Dordrecht
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Eindhoven
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Groningen
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Hoorn Nh
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Rotterdam
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Tilburg
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Utrecht
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Zoetermeer
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Auckland
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Christchurch
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Moss
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Krakow
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Lublin
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Plock
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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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Poland
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Wroclaw
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Russian Federation
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Arkhangelsk
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kemerovo
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Russian Federation
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Kirov
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Russian Federation
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Kursk
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Russian Federation
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Moscow N/A
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Novosibirsk
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Omsk
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Penza
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Rostov-On-Don
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Russian Federation
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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
The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2
diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac
events (MACE). Other objectives include evaluating the overall safety, tolerability, and
effectiveness of canagliflozin.

The data from this study will be combined with the data from CANVAS-R study (Study of the
Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a
pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing
requirements for canagliflozin.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01032629
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01032629