CANVAS - CANagliflozin cardioVascular Assessment Study
Summary
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.
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).
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Diabetes Mellitus, Type 2
Intervention
Placebo on background standard of care for diabetes, Canagliflozin on background standard of care for diabetes
Location
Birmingham
Alabama
United States
Status
Recruiting
Source
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01032629
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Angiography, Digital Subtraction
A method of delineating blood vessels by subtracting a tissue background image from an image of tissue plus intravascular contrast material that attenuates the X-ray photons. The background image is determined from a digitized image taken a few moments before injection of the contrast material. The resulting angiogram is a high-contrast image of the vessel. This subtraction technique allows extraction of a high-intensity signal from the superimposed background information. The image is thus the result of the differential absorption of X-rays by different tissues.
Animals, Congenic
Inbred strains of animals that are genetically identical except at a single locus, or a few specified loci, so that their known genetic differences are expressed in the same genetic background. A congenic strain is produced by outbreeding a strain and then eliminating the background by many generations of backcrosses while maintaining the desired genetic differences by selection of progeny. (Dorland, 28th ed)
Standard Of Care
The minimum acceptable patient care, based on statutes, court decisions, policies, or professional guidelines.
Laryngeal Masks
A type of oropharyngeal airway that provides an alternative to endotracheal intubation and standard mask anesthesia in certain patients. It is introduced into the hypopharynx to form a seal around the larynx thus permitting spontaneous or positive pressure ventilation without penetration of the larynx or esophagus. It is used in place of a facemask in routine anesthesia. The advantages over standard mask anesthesia are better airway control, minimal anesthetic gas leakage, a secure airway during patient transport to the recovery area, and minimal postoperative problems.
Interview
Work consisting of a conversation with an individual regarding his or her background and other personal and professional details, opinions on specific subjects posed by the interviewer, etc.
Clinical Trials
The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with typ...
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidn...
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes...
The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving tre...
This is a 10-week placebo-controlled randomized study to investigate the effect of injectable IL-1B antagonist canakinumab in patients with impaired glucose tolerance or Type 2 Diabetes (T...
PubMed Articles
This study characterized single- and multiple-dose pharmacokinetics of canagliflozin and its O-glucuronide metabolites (M5 and M7) and pharmacodynamics (renal threshold for glucose [RTG ], urinary glu...
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AIMS/HYPOTHESIS: To assess the feasibility and effectiveness of an active real-life primary care lifestyle intervention in preventing type 2 diabetes within a high-risk Mediterra...
The impact of the NSF for Diabetes on patient empowerment.
The National Service Framework (NSF) for Diabetes was developed by the UK government to tackle variations in care for patients with diabetes. This article critically analyses the impact of this policy...
We discovered that C-glucosides 4 bearing a heteroaromatic ring formed metabolically more stable inhibitors for sodium-dependent glucose cotransporter 2 (SGLT2) than the O-glucoside, 2 (T-1095). A nov...
