Diabetes Type 2 study: Canagliflozin
Official title Canagliflozin Targeting Vascular Inflammation
ClinicalTrials.gov ID: NCT05427084
What this study is testing
What is Canagliflozin?
This is an investigational tablet being studied to see if it can reduce inflammation in the aorta for people with type 2 diabetes and stable coronary artery disease. It is designed to help the kidneys remove extra sugar from the blood through urine.
Also referred to as Invokana.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if taking canagliflozin lowers signs of inflammation in the aorta (the main artery from the heart) compared to a sugar pill.
- Who it's for
- The study is looking for people with Type 2 diabetes and stable coronary artery disease who had a heart attack more than 60 days ago.
- What's involved
- Participants will take either canagliflozin or a placebo daily for 6 months. They will undergo scans to measure inflammation in their aorta at the start and at the end of the study.
- Time commitment
- The study lasts 6 months and requires visits for testing at the beginning and end of the treatment period.
- Phase 3: a large, late-stage study
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1) Stable CAD (over 60 days post-myocardial infarction).
- 2) Diabetes
- 3) given informed consent.
You likely can't join if
- severe LV dysfunction (EF\<50%);
- decompensated heart failure;
- active infection (e.g. pneumonia, active skin infections, and on antibiotics);
- active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g.
- pregnancy (all women of child bearing potential will have a negative BHCG test;
- breastfeeding;
See the full eligibility criteria
- 1) Stable CAD (over 60 days post-myocardial infarction).
- 2) Diabetes
- 3) given informed consent.
- severe LV dysfunction (EF\<50%);
- decompensated heart failure;
- active infection (e.g. pneumonia, active skin infections, and on antibiotics);
- active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));
- pregnancy (all women of child bearing potential will have a negative BHCG test;
- breastfeeding;
- Women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of...
- glomerular filtration rate (GFR) \<50 ml/min/1.72m2;
- Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, clarithromycin, or ketoconazole);
- Hemoglobin \< 105(women) \<110 (men) g/L; WBC \< 3.0x 10(9)/L, platelet count\< 110x 10(9)/L;
- Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease or with alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal.
- unable to give informed consent;
The study team makes the final eligibility decision.
Where it is enrolling
- Ottawa, Ontario, Canada
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ottawa, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.