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CANVAS - CANagliflozin cardioVascular Assessment Study (CANVAS)
This study has been completed.
Sponsor:
Janssen Research & Development, LLC
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: July 10, 2017
Last verified: July 2017
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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 integrated 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: Placebo Drug: Canagliflozin (JNJ-28431754) 100 mg Drug: Canagliflozin (JNJ-28431754) 300 mg | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, 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:
- Time to First Occurrence of Major Adverse Cardiovascular Events, Including CV Death, Nonfatal Myocardial Infarction (MI), and Nonfatal Stroke [ Time Frame: Baseline, time to event up to end of study (approximately 8 years) ]
Secondary Outcome Measures:
- A Standard Masure of Fasting Insulin Secretion [ Time Frame: Baseline up to end of study (approximately 8 years) ]
- Time to First Occurrence of Progression of Albumin in the Urine [ Time Frame: Baseline, time to event up to end of study (approximately 8 years) ]
- Change in Urinary Albumin/Creatinine Ratio From Baseline at End of Treatment [ Time Frame: Baseline, end of treatment (approximately 369 weeks) ]
- Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline at End of Treatment [ Time Frame: Baseline, end of treatment (approximately 369 weeks) ]
- Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 18 and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
- Change in Fasting Plasma Glucose (FPG) From Baseline at Week 18 and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
- Change in Body Weight From Baseline at Week 18 and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
- Change in Systolic Blood Pressure From Baseline at Week 18and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
- Change in Diastolic Blood Pressure From Baseline at Week 18 and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
- Percent Change in Fasting Plasma Lipid Levels From Baseline at Week 18 and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]Fasting plasma lipids included triglycerides, high-density lipoprotein-cholesterol [HDL-C], low-density lipoprotein-cholesterol [LDL-C], and total cholesterol.
- Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio From Baseline at Week 18 and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
- 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 ]
| Enrollment: | 4330 |
| Actual Study Start Date: | December 9, 2009 |
| Study Completion Date: | February 22, 2017 |
| Primary Completion Date: | February 22, 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) 100 mg
One 100 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) 300 mg
One 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. The completion target was reached in February 2017.
Eligibility| Ages Eligible for Study: | 30 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have a diagnosis of type 2 diabetes mellitus and greater than or equal to (>=) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with high risk of CV events
- 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
Show 313 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032629
Show 313 Study Locations
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
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 ( Other Identifier: Janssen Research & Development, LLC ) 2009-012140-16 ( EudraCT Number ) |
| Study First Received: | December 10, 2009 |
| Last Updated: | July 10, 2017 |
| Studies a U.S. FDA-regulated Device Product: | No | |
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 Canagliflozin Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 17, 2017