A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (CANVAS-R)
|ClinicalTrials.gov Identifier: NCT01989754|
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : February 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Albuminuria||Drug: Placebo Drug: Canagliflozin, 100 mg Drug: Canagliflozin, 300 mg||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5813 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||January 16, 2014|
|Actual Primary Completion Date :||February 23, 2017|
|Actual Study Completion Date :||February 23, 2017|
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 daily
Drug: 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
- Time to First Occurrence of Progression of Albuminuria [ Time Frame: Baseline, Week 26, 52, 78, 104, 156 ]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.
- Composite Endpoint of Death From Cardiovascular (CV) Causes or Hospitalization for Heart Failure [ Time Frame: Baseline, time to event up to end of study (approximately 3 years) ]
- Death from CV Causes [ Time Frame: Baseline, time to event up to end of study (approximately 3 years) ]
- Major adverse cardiovascular (CV) events [ Time Frame: Baseline, time to event up to end of study (approximately 3 years) ]Cardiovascular safety data from this study will be combined with the data from the other large-scale study of the effects of canagliflozin compared to placebo (CANVAS) in a pre-specified meta-analysis of cardiovascular safety outcomes. Cardiovascular safety data will be evaluated as the time to first occurrence of major adverse cardiovascular events, including CV death, nonfatal myocardial infarction (MI), and nonfatal stroke.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989754
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|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|