CANVAS - CANagliflozin cardioVascular Assessment Study - Full Text View

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. 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 (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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Canagliflozin

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 (up to 9 years) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

A standard measure of fasting insulin secretion [ Time Frame: Up to end of treatment (approximately 9 years) ] [ Designated as safety issue: No ]
Progression of albumin in the urine [ Time Frame: Up to end of treatment (approximately 9 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: 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:	June 2018 (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 up to 9 years	Drug: Placebo One placebo capsule taken orally (by mouth) once daily for up to 9 years
Experimental: Canagliflozin (JNJ-28431754) 100 mg Each patient will receive canagliflozin (JNJ-28431754) 100 mg once daily on background standard of care for diabetes for up to 9 years	Drug: Canagliflozin (JNJ-28431754) One 100 mg or 300 mg capsule taken orally (by mouth) once daily for up to 9 years
Experimental: Canagliflozin (JNJ-28431754) 300 mg Each patient will receive canagliflozin (JNJ-28431754) 300 mg once daily on background standard of care for diabetes for up to 9 years	Drug: Canagliflozin (JNJ-28431754) One 100 mg or 300 mg capsule taken orally (by mouth) once daily for up to 9 years

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 9 years.

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

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

Show 311 Study Locations

Sponsors and Collaborators

Janssen Research & Development, LLC

George Institute, Sydney, Australia

Investigators

Study Director:

Janssen Research & Development, LLC Clinical Trial

Janssen Research & Development, LLC

More Information

No publications provided

Responsible Party:	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:	June 14, 2013
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

Keywords provided by Janssen Research & Development, LLC:

Diabetes
Type 2 diabetes mellitus
Cardiovascular risk

Cardiovascular outcomes
Canagliflozin (JNJ-28431754)
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 June 18, 2013