Related Experiment Video

Updated: May 9, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)--a

Bruce Neal1, Vlado Perkovic, Dick de Zeeuw

  • 1The George Institute for Global Health and University of Sydney, Sydney, New South Wales, Australia. bneal@georgeinstitute.org.au

American Heart Journal
|July 31, 2013
PubMed

Insights

Sodium glucose co-transporter 2 inhibition with canagliflozin shows potential for managing type 2 diabetes. The CANVAS trial evaluated its cardiovascular effects and safety in high-risk patients.

Area of Science:

  • Cardiology
  • Endocrinology
  • Pharmacology

Background:

  • Sodium glucose co-transporter 2 (SGLT2) inhibitors represent a new class of drugs for type 2 diabetes mellitus (T2DM).
  • Canagliflozin, an SGLT2 inhibitor, demonstrated benefits in lowering glucose, blood pressure, and weight in Phase 2 studies, alongside an increased risk of urogenital infections.
  • The impact of SGLT2 inhibitors on macrovascular complications in diabetes requires further investigation.

Purpose of the Study:

  • To evaluate the cardiovascular effects of canagliflozin in patients with T2DM and elevated cardiovascular risk.
  • To assess the safety and tolerability of canagliflozin in the target patient population.
  • To investigate the effects of canagliflozin on key biomarkers related to cardiovascular health.

Main Methods:

  • The CANVAS trial was a double-blind, placebo-controlled study.
  • 4,330 patients with inadequately controlled T2DM and increased cardiovascular risk were randomized to placebo, canagliflozin 100 mg, or canagliflozin 300 mg.
  • Follow-up was planned for approximately 2 years to assess cardiovascular outcomes and safety.

Main Results:

  • The study accrued 7174 patient-years of follow-up by September 2012.
  • Mean baseline characteristics included age 62 years, diabetes duration 13 years, HbA1c 8.2%, fasting plasma glucose 9.3 mmol/L, and BMI 32 kg/m(2).
  • Participants had a mean age of 62, with 34% female and 57% with a history of atherosclerotic vascular disease.

Conclusions:

  • The CANVAS trial aimed to provide data on the cardiovascular safety of canagliflozin.
  • The study focused on achieving primary safety and tolerability objectives.
  • The planned second phase of the trial was not undertaken, but the collected data will inform on biomarker effects and cardiovascular safety parameters.

Related Concept Videos

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Imaging Studies for Cardiovascular System VI: Calcium -Scoring CT01:25

Imaging Studies for Cardiovascular System VI: Calcium -Scoring CT

Calcium-Scoring CT ScanA calcium-scoring CT scan, also known as coronary artery calcium (CAC) scan, detects calcium deposits in the coronary arteries. This test assesses the risk of coronary artery disease (CAD), which can lead to cardiovascular events such as angina, heart failure, and sudden cardiac arrest.A calcium-scoring CT scan is generally recommended for individuals at intermediate risk of CAD without symptoms. It includes:Men aged 40-75 and women aged 50-75: Especially those with a...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Hypertension III: Clinical Manifestations and Diagnostic Studies01:30

Hypertension III: Clinical Manifestations and Diagnostic Studies

Hypertension is asymptomatic and also referred to as the "silent killer" until it progresses to a severe stage or causes target organ disease. Patients may experience symptoms stemming from the strain on blood vessels and tissues in various organs or the heart's increased workload.Physical exams might show no abnormalities other than high blood pressure. Signs of vascular damage, when present, correspond to the organs supplied by the affected vessels, leading to target organ damage. For...