Diabetes Type 2Phase 2/3CANTORSINGNCT05427084
Canagliflozin Targeting Vascular Inflammation
A Phase 2/3 study testing Canagliflozin in people with Diabetes Type 2 and Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
CANTOR SING is a pilot single center double blinded randomized study. The investigators will compare the effect of canagliflozin (300 mg daily - intervention arm) vs. placebo (control group) on the FDG aortic uptake in patients with stable CAD (over 60 days post-myocardial infarction) after a 6-month period of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2, Coronary Artery Disease
- What is being tested?
- Canagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2024to Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Stable CAD (over 60 days post-myocardial infarction).
- 2) Diabetes
- 3) given informed consent.
Who cannot join
- 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;
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- 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 fathering a child who refuse to use contraception.
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Chantal L, 6136967000 ext. 18817, clefebvre@ottawaheart.ca
About this study
Official title: Canagliflozin Targeting Vascular Inflammation: An Ottawa Imaging Study - A Pilot Study
CANTOR SING is a pilot single center double blinded randomized study. The investigators will compare the effect of canagliflozin (300 mg daily - intervention arm) vs. placebo (control group) on the FDG aortic uptake in patients with stable CAD (over 60 days post-myocardial infarction) after a 6-month period of treatment. The investigators plan to enroll 8 patients in each arm (total sample size: 16 patients). Primary endpoint is the change in FDG aortic uptake between baseline and 6 months in each arm.
Read the detailed description
CANTOR SING is a pilot single center double blinded randomized study to determine the effect of targeted anti-inflammation therapy using canagliflozin, on aortic inflammation using imaging, i.e. ascending aortic FDG uptake. The current proposal uses a randomized design to evaluate the effect of canagliflozin vs. placebo on aortic inflammation activity over 6 months measured using FDG PET.
At the University of Ottawa Heart Institute (UOHI) patients with diabetes and stable CAD (defined as patients over 60 days post-myocardial infarction) will be recruited.
Patients who meet inclusion/exclusion criteria will undergo clinical evaluation, FDG PET imaging with contrast-CT, and blood sample collection. HbA1C, Fasting Blood Sugar (FBS), lipids, C-reactive protein (CRP), creatinine (CR), glomerular filtration rate (GFR), complete blood count (CBC), hemoglobin, liver function tests - AST, ALT, creatine kinase (CK) will be collected from the patient's clinical data or if not available may be collected as part of the study.
Patients recruited into the CANTOR SING study will be randomized to receive either an oral canagliflozin 300 mg capsule or placebo capsule administered once daily for 6 months. Patients will take the medication for 6 months. The study will be conducted in a double-blinded fashion.
Patients will be followed up every 3 months for the 6-month evaluation period. Clinical evaluation and blood collection for labs (CBC, electrolytes, CPK, ALT, AST, creatinine) will performed at baseline and will be repeated every 3 months for a a total of 6 months of follow-up. FDG PET imaging with contrast-CT will be repeated at 6 months. Finally, blood will be collected at baseline and 6 months.
- Conditions
- Diabetes Type 2, Coronary Artery Disease
- Being tested
- Canagliflozin, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanagliflozinDrug
Also called Invokana
Canagliflozin tablet 300mg PO daily
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Canagliflozin 300mg PO daily Receives: Drug: Canagliflozin |
| Placebo | Placebo comparator | Placebo PO daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBR (Tissue-to-blood ratio) of the most-diseased segment (MDS) of the ascending aorta
TBR (Tissue-to-blood ratio) is a marker of arterial plaque inflammation. It will be measured in the maximum disease segment (MDS)(the segment with the highest FDG uptake at baseline) in the aorta
Measured: 6 months
Secondary outcomes (2)
Change in inflammatory biomarkers
The investigators will measure inflammatory biomarkers (hsCRP, IL-6, IL-7, IL-8, MCP) at baseline and on study completion (pg/mL)
Measured: 6 months
Change in monocyte marker expression
Change in monocyte marker expression (% positive cells) of CD14++CD16-, CD14++CD16+, CD14+CD16+, CD14+CD16-, CD127, and CCR2 from baseline to follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start15 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Boczar, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427084
- Sponsor's protocol ID
- 20220176-01H
- Acronym
- CANTORSING
- Status last verified
- Apr 2026
- First submitted
- 1 Jun 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canagliflozin Targeting Vascular Inflammation: An Ottawa Imaging Study - A Pilot Study
- ClinicalTrials.gov ID
- NCT05427084
- Acronym / sponsor ID
- CANTORSING / 20220176-01H
- Conditions
- Diabetes Type 2, Coronary Artery Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CANTOR SING is a pilot single center double blinded randomized study. The investigators will compare the effect of canagliflozin (300 mg daily - intervention arm) vs. placebo (control group) on the FDG aortic uptake in patients with stable CAD (over 60 days post-myocardial infarction) after a 6-month period of treatment. The investigators plan to enroll 8 patients in each arm (total sample size: 16 patients). Primary endpoint is the change in FDG aortic uptake between baseline and 6 months in each arm.
Detailed description
CANTOR SING is a pilot single center double blinded randomized study to determine the effect of targeted anti-inflammation therapy using canagliflozin, on aortic inflammation using imaging, i.e. ascending aortic FDG uptake. The current proposal uses a randomized design to evaluate the effect of canagliflozin vs. placebo on aortic inflammation activity over 6 months measured using FDG PET.
At the University of Ottawa Heart Institute (UOHI) patients with diabetes and stable CAD (defined as patients over 60 days post-myocardial infarction) will be recruited.
Patients who meet inclusion/exclusion criteria will undergo clinical evaluation, FDG PET imaging with contrast-CT, and blood sample collection. HbA1C, Fasting Blood Sugar (FBS), lipids, C-reactive protein (CRP), creatinine (CR), glomerular filtration rate (GFR), complete blood count (CBC), hemoglobin, liver function tests - AST, ALT, creatine kinase (CK) will be collected from the patient's clinical data or if not available may be collected as part of the study.
Patients recruited into the CANTOR SING study will be randomized to receive either an oral canagliflozin 300 mg capsule or placebo capsule administered once daily for 6 months. Patients will take the medication for 6 months. The study will be conducted in a double-blinded fashion.
Patients will be followed up every 3 months for the 6-month evaluation period. Clinical evaluation and blood collection for labs (CBC, electrolytes, CPK, ALT, AST, creatinine) will performed at baseline and will be repeated every 3 months for a a total of 6 months of follow-up. FDG PET imaging with contrast-CT will be repeated at 6 months. Finally, blood will be collected at baseline and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: CanagliflozinCanagliflozin 300mg PO daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo PO daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1) Stable CAD (over 60 days post-myocardial infarction).
- 2) Diabetes
- 3) given informed consent.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanagliflozinAlso: InvokanaCanagliflozin tablet 300mg PO daily | Drug | Active |
| PlaceboPlacebo tablet | Drug | Placebo |
Primary outcome
TBR (Tissue-to-blood ratio) of the most-diseased segment (MDS) of the ascending aorta
Time frame: 6 months
TBR (Tissue-to-blood ratio) is a marker of arterial plaque inflammation. It will be measured in the maximum disease segment (MDS)(the segment with the highest FDG uptake at baseline) in the aorta
2 secondary outcomes
Change in inflammatory biomarkers
Time frame: 6 months
Change in monocyte marker expression
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Boczar, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Canagliflozin in people with Diabetes Type 2 and Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Boczar, MD (613 696 7000, kboczar@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TBR (Tissue-to-blood ratio) of the most-diseased segment (MDS) of the ascending aorta (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.