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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/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
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
Secondary ID [1] 0 0
2013-003050-25
Secondary ID [2] 0 0
CR102647
Universal Trial Number (UTN)
Trial acronym
CANVAS-R
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Albuminuria 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

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

Outcomes
Primary outcome [1] 0 0
Progression of Albuminuria
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [2] 0 0
Cardiovascular (CV) Death
Timepoint [2] 0 0
Approximately 3 years

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

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 4
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
16/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/02/2017
Sample size
Target
Accrual to date
Final
5813
Recruitment in Australia
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- Box Hill
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- Cairns
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- Daw Park
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- Woden
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Welwyn Garden City

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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01989754
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/NCT01989754