CANVAS - CANagliflozin cardioVascular Assessment Study - Full Text View

Sponsor:	Janssen Research & Development, LLC
Collaborator:	George Institute, Sydney, Australia
Information provided by:	Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT01032629

Purpose

The study will assess canagliflozin in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events. Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Cardiovascular Diseases Risk Factors	Drug: Canagliflozin on background standard of care for diabetes Drug: Placebo on background standard of care for diabetes	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/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 JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

U.S. FDA Resources

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

Primary Outcome Measures:

Major adverse cardiovascular events, including CV death, nonfatal MI, and nonfatal stroke [ Time Frame: Time to event (approximately 4 years) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

a standard measure of fasting insulin secretion [ Time Frame: end of treatment (approximately 4 years) ] [ Designated as safety issue: No ]
progression of albumin in the urine [ Time Frame: end of treatment (approximately 4 years) ] [ Designated as safety issue: Yes ]
effectiveness of lowering blood glucose (in substudies of patients who are also taking specific commonly-used diabetes agents) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Enrollment:	4351
Study Start Date:	November 2009
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 001 Placebo on background standard of care for diabetes once daily for up to 4 years or longer for individual patients	Drug: Placebo on background standard of care for diabetes once daily for up to 4 years or longer for individual patients
Experimental: 002 Canagliflozin on background standard of care for diabetes 100 or 300 mg once daily for up to 4 years or longer for individual patients	Drug: Canagliflozin on background standard of care for diabetes 100 or 300 mg once daily for up to 4 years or longer for individual patients

Detailed Description:

The study will evaluate canagliflozin compared to placebo on CV events including CV death, heart attack, and stroke in patients with T2DM, whose diabetes is not well controlled at the beginning of the study and who have a history of CV events or have a high risk for CV events. The study includes 3 substudies which will compare the effectiveness of lowering blood glucose and assess the safety of canagliflozin relative to placebo in patients receiving specific commonly-used diabetes agents. The patients will receive capsules of canagliflozin (either 100 or 300 mg), or matching placebo, taken by mouth, with study duration for individual patients of up to 4 years or longer (additional patients may be recruited and/or a longer study duration planned based on an analysis and recommendation by an independent data monitoring committee).

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have a diagnosis of T2DM and a history of or a high risk for CV disease
Patients must have inadequate diabetes control (as defined by HbA1c greater than or equal to 7.0% to less than or equal to 10.5% at screening) and be either (1) not currently on diabetes drug therapy or (2) on therapy with any approved class of diabetes drugs

Exclusion Criteria:

A 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 (ie, very low blood sugar) episode within 6 months before screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032629

Show 302 Study Locations

Sponsors and Collaborators

Janssen Research & Development, LLC

George Institute, Sydney, Australia

Investigators

Study Director:

Janssen Research & Development, LLC C. Clinical Trial

Janssen Research & Development, LLC

More Information

No publications provided

Responsible Party:	Clinical Leader, Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT01032629 History of Changes
Other Study ID Numbers:	CR016627, 28431754DIA3008
Study First Received:	December 10, 2009
Last Updated:	May 21, 2012
Health Authority:	United States: Food and Drug Administration Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines Ukraine: State Pharmacological Center - Ministry of Health United States: Federal Government

Keywords provided by Janssen Research & Development, LLC:

Diabetes
Cardiovascular Outcomes
Type 2 diabetes mellitus
Canagliflozin
Placebo

Additional relevant MeSH terms:

Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2

Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2012