CANVAS - CANagliflozin cardioVascular Assessment Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The George Institute for Global Health, Australia
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01032629
First received: December 10, 2009
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin.

The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified meta-analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Risk Factors
Drug: Canagliflozin (JNJ-28431754)
Drug: Placebo
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:


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

Primary Outcome Measures:
  • Major adverse cardiovascular events, including CV death, nonfatal myocardial infarction (MI), and nonfatal stroke [ Time Frame: Baseline, time to event (up to April 2017) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A standard measure of fasting insulin secretion [ Time Frame: Baseline, up to end of treatment (up to April 2017) ] [ Designated as safety issue: No ]
  • Progression of albumin in the urine [ Time Frame: Baseline, up to end of treatment (up to April 2017) ] [ 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: Baseline, up to Week 18 ] [ Designated as safety issue: No ]

Enrollment: 4330
Study Start Date: December 2009
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Each patient will receive placebo (inactive medication) on background standard of care for diabetes once daily for the duration of the study
Drug: Placebo
One placebo capsule taken orally (by mouth) once daily
Experimental: Canagliflozin (JNJ-28431754) 100 mg
Each patient will receive canagliflozin (JNJ-28431754) 100 mg once daily on background standard of care for diabetes once daily for the duration of the study
Drug: Canagliflozin (JNJ-28431754)
One 100 mg or 300 mg capsule taken orally (by mouth) once daily
Experimental: Canagliflozin (JNJ-28431754) 300 mg
Each patient will receive canagliflozin (JNJ-28431754) 300 mg once daily on background standard of care for diabetes once daily for the duration of the study
Drug: Canagliflozin (JNJ-28431754)
One 100 mg or 300 mg capsule taken orally (by mouth) once daily

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. 4,330 participants will be randomly assigned to treatment with 1 of 2 doses of canagliflozin (100 or 300 mg) or placebo, in a 1:1:1 ratio. This study was originally designed to last for up to 9 years. As per FDA post-marketing requirements for canagliflozin, the study's last subject last visit will now occur when enough MACE events (ie, CV death, nonfatal myocardial infarction, nonfatal stroke) are accumulated between the CANVAS (this study) and CANVAS-R studies, and is projected to occur prior to April 2017.

  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 type 2 diabetes mellitus and a history of, or a high risk for, cardiovascular disease
  • Patients must have inadequate diabetes control (as defined by glycosylated hemoglobin 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Green Valley, Arizona, United States
Mesa, Arizona, United States
United States, California
La Mesa, California, United States
Los Gatos, California, United States
Pismo Beach, California, United States
Stockton, California, United States
Walnut Creek, California, United States
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Doral, Florida, United States
Hollywood, Florida, United States
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New Zealand
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Norway
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Moss, Norway
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Ukraine
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Leicester, United Kingdom
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Londonderry, United Kingdom
Manchester, United Kingdom
Randalstown, United Kingdom
Salford, United Kingdom
York, United Kingdom
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

No publications provided by Janssen Research & Development, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01032629     History of Changes
Other Study ID Numbers: CR016627, 28431754DIA3008, 2009-012140-16
Study First Received: December 10, 2009
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Ukraine: State Pharmacological Center - Ministry of Health
Russia: Ministry of Health of the Russian Federation
Canada: Health Canada
Netherlands: Healthcare Inspectorate
Belgium: Federal Agency for Medicinal Products and Health Products
France: Agence Nationale de Securite du Medicament et des Produits de Sante
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Germany: Federal Institute for Drugs and Medical Devices
Luxembourg: Ministère de la Santé
Mexico: Federal Commission for Protection Against Health Risks
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Columbia: Subdireccion de Medicamentos y Productos Biologicos/Grupo de Farmacovigilancia
Malaysia: National Pharmaceutical Control Bureau
Australia: Therapeutic Goods Administration
New Zealand: Medicines and Medical Devices Safety Authority
India: Central Drugs Standard Control Organization
Estonia: The State Agency of Medicine
Czech Republic: State Institute for Drug Control
Israel: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Janssen Research & Development, LLC:
Diabetes
Type 2 diabetes mellitus
Cardiovascular risk
Cardiovascular outcomes
Canagliflozin (JNJ-28431754)
Placebo

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014