A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (CANVAS-R)
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.
Diabetes Mellitus, Type 2
Drug: Canagliflozin, 100 mg
Drug: Canagliflozin, 300 mg
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Number of participants with progression of albuminuria [ Time Frame: Baseline, Week 26, 52, 78, 104, 156 ] [ Designated as safety issue: No ]Progression of albuminuria is defined as the development of microalbuminuria or macroalbuminuria in a participant with baseline normoalbuminuria or the development of macroalbuminuria in a participant with baseline microalbuminuria, accompanied by an urinary albumin/creatinine ratio (ACR) value increase of greater than or equal to 30% from baseline.
- Number of participants with regression of albuminuria [ Time Frame: Baseline, Week 26, 52, 78, 104, 156 ] [ Designated as safety issue: No ]Regression of albuminuria is defined as the development of normoalbuminuria in a participant with baseline microalbuminuria or macroalbuminuria, or the development of microalbuminuria in a participant with baseline macroalbuminuria, accompanied by a decrease in the urinary ACR value of greater than or equal to 30% from baseline.
- Change in estimated glomerular filtration rate (eGFR) from baseline to the last off-treatment measurement [ Time Frame: Baseline, up to Day 30 of post treatment follow-up ] [ Designated as safety issue: No ]
- Urinary albumin/creatinine ratio at last on-treatment visit [ Time Frame: Baseline, Week 156 ] [ Designated as safety issue: No ]
- Major adverse cardiovascular (CV) events [ Time Frame: Baseline, up to April 2017 ] [ Designated as safety issue: Yes ]Cardiovascular safety data will be evaluated as the number of major adverse cardiovascular events, including CV death, nonfatal myocardial infarction (MI), and nonfatal stroke.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
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.
Drug: Canagliflozin, 100 mg
One 100 mg capsule taken orally (by mouth) once dailyDrug: Canagliflozin, 300 mg
One 300 mg capsule taken orally (by mouth) once daily
Placebo Comparator: Placebo
Each patient will receive placebo (inactive medication) once daily.
One placebo capsule taken orally (by mouth) once daily for 156 weeks
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 will consist of a 2-week screening period and a double-blind treatment period lasting between 78 and 156 weeks with study completion in April 2017. A total of 5,700 participants will be recruited into the study; the maximum duration of the study for each participant can be up to 3.5 years. Participants can be either drug naïve to antihyperglycemic agents, using monotherapy, or using combination of antihyperglycemic therapy for the control of blood glucose levels.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01989754
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|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|