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A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (CANVAS-R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01989754
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
The George Institute for Global Health, Australia
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Albuminuria Drug: Placebo Drug: Canagliflozin, 100 mg Drug: Canagliflozin, 300 mg Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5813 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : January 16, 2014
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Placebo
One placebo capsule taken orally (by mouth) once daily for 156 weeks

Primary Outcome Measures :
  1. Progression of Albuminuria [ Time Frame: Up to 3 years ]
    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 :
  1. Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure [ Time Frame: Approximately 3 years ]
    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.

  2. Cardiovascular (CV) Death [ Time Frame: Approximately 3 years ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01989754

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Sponsors and Collaborators
Janssen Research & Development, LLC
The George Institute for Global Health, Australia
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:
Study Protocol  [PDF] September 1, 2016
Statistical Analysis Plan  [PDF] March 20, 2017

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC Identifier: NCT01989754     History of Changes
Other Study ID Numbers: CR102647
2013-003050-25 ( EudraCT Number )
28431754DIA4003 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: November 21, 2013    Key Record Dates
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Cardiovascular outcomes
Type 2 Diabetes Mellitus
Antihyperglycemic Agent

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs