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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01989754
First Posted: November 21, 2013
Last Update Posted: July 13, 2017
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.
Collaborator:
The George Institute for Global Health, Australia
Information provided by (Responsible Party):
Janssen Research & Development, LLC
  Purpose
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 Intervention Phase
Diabetes Mellitus, Type 2 Albuminuria Drug: Placebo Drug: Canagliflozin, 100 mg Drug: Canagliflozin, 300 mg Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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) ]

Other Outcome Measures:
  • 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.


Enrollment: 5813
Actual Study Start Date: January 16, 2014
Study Completion Date: February 23, 2017
Primary Completion Date: February 23, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01989754


  Show 340 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
The George Institute for Global Health, Australia
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01989754     History of Changes
Other Study ID Numbers: CR102647
2013-003050-25 ( EudraCT Number )
28431754DIA4003 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: October 17, 2013
First Posted: November 21, 2013
Last Update Posted: July 13, 2017
Last Verified: July 2017

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

Keywords provided by Janssen Research & Development, LLC:
Albuminuria
Canagliflozin
Cardiovascular outcomes
Type 2 Diabetes Mellitus
T2DM
JNJ-28431754
Antihyperglycemic Agent

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