Back to resultsA Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (CANVAS-R)
Primary Purpose
Diabetes Mellitus, Type 2, Albuminuria
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Placebo
Canagliflozin, 100 mg
Canagliflozin, 300 mg
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Albuminuria, Canagliflozin, Cardiovascular outcomes, Type 2 Diabetes Mellitus, T2DM, JNJ-28431754, Antihyperglycemic Agent
Eligibility Criteria
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.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Canagliflozin (JNJ-28431754)
Placebo
Arm Description
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.
Each patient will receive placebo (inactive medication) once daily.
Outcomes
Primary Outcome Measures
Progression of Albuminuria
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.
Secondary Outcome Measures
Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure
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.
Cardiovascular (CV) Death
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.
Full Information
NCT ID
NCT01989754
First Posted
October 17, 2013
Last Updated
November 19, 2018
Sponsor
Janssen Research & Development, LLC
Collaborators
The George Institute for Global Health, Australia
1. Study Identification
Unique Protocol Identification Number
NCT01989754
Brief Title
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
Acronym
CANVAS-R
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 16, 2014 (Actual)
Primary Completion Date
February 23, 2017 (Actual)
Study Completion Date
February 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
The George Institute for Global Health, Australia
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The study will be conducted in adult participants with Type 2 Diabetes Mellitus (T2DM), receiving standard of care for hyperglycemia and cardiovascular (CV) risk factors, who have either a history of a prior CV event or 2 or more risk factors for a CV event. Participants will be randomly assigned in a 1:1 ratio to canagliflozin or matching placebo to be taken once daily. Canagliflozin will be provided at a dose of 100 mg/day through Week 13 and then increased at the discretion of the investigator to a dose of 300 mg/day, if the participant requires additional glycemic control and is tolerating the 100 mg dose.
The study consists of a 2-week screening period and a double-blind treatment period lasting between 78 and 156 weeks; study completion is targeted for when the last subject randomized has approximately 78 weeks of follow-up or when 688 major adverse cardiovascular events are accumulated between CANVAS and CANVAS-R. A total of 5,700 participants are targeted to be recruited into the study. Participants can be either drug naïve to antihyperglycemic agents, using monotherapy, or using combination of antihyperglycemic therapy for the control of blood glucose levels.
The completion target was reached in February 2017.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Albuminuria
Keywords
Albuminuria, Canagliflozin, Cardiovascular outcomes, Type 2 Diabetes Mellitus, T2DM, JNJ-28431754, Antihyperglycemic Agent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5813 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canagliflozin (JNJ-28431754)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Each patient will receive placebo (inactive medication) once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One placebo capsule taken orally (by mouth) once daily for 156 weeks
Intervention Type
Drug
Intervention Name(s)
Canagliflozin, 100 mg
Intervention Description
One 100 mg capsule taken orally (by mouth) once daily
Intervention Type
Drug
Intervention Name(s)
Canagliflozin, 300 mg
Intervention Description
One 300 mg capsule taken orally (by mouth) once daily
Primary Outcome Measure Information:
Title
Progression of Albuminuria
Description
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure
Description
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.
Time Frame
Approximately 3 years
Title
Cardiovascular (CV) Death
Description
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.
Time Frame
Approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
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Chieri (Torino)
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Samara
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Saratov
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Smolensk
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St Petersburg
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Sweden
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Sweden
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Sweden
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Sweden
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Sweden
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12. IPD Sharing Statement
Citations:
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Learn more about this trial
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
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