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NCT05633810

NCT05633810
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are a man or woman between 55 and 80 years old
  • You have been diagnosed with type 2 diabetes and are being treated for it according to standard medical guidelines
  • You have never had a heart attack, angina, or any other heart-related event caused by blocked coronary arteries
  • You also have at least one of the following risk factors:
    • You have had type 2 diabetes for 5 years or more
    • Your blood sugar control (HbA1c) has been 8.0% or higher at some point in the last 2 years
    • You currently smoke cigarettes
    • You have a high level of a marker of inflammation in your blood called hs-CRP (confirm with trial site)
    • You have a high calcium buildup score in your heart arteries (confirm with trial site)
    • You have high triglyceride (fat) levels in your blood even while taking cholesterol-lowering medication
    • You have high LDL ("bad") cholesterol or high non-HDL cholesterol levels even while taking cholesterol-lowering medication
    • You have high levels of a protein called Apolipoprotein B in your blood (confirm with trial site)
    • You have low HDL ("good") cholesterol levels
    • You have high levels of a protein called Lp(a) in your blood (confirm with trial site)
    • You have significant narrowing or previous surgery to open up arteries in your legs or other limbs
    • You have significant narrowing or previous surgery to open up arteries leading to your brain
    • You have diabetes-related eye damage or nerve damage
    • You have a mild or moderate level of protein detected in your urine
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at the start of the study and agree to use a reliable form of birth control throughout the study (such as the pill, an implant, an IUD, condoms with spermicide, abstinence, or having a sterilised partner)
  • If you are a woman who cannot become pregnant — because you have had your uterus or fallopian tubes removed, or you have gone through menopause (no periods for 12 months) — this condition does not apply to you
  • You are able to understand the study and give your own consent to take part

Who may not be able to join:

  • You have ever had a heart attack, chest pain (angina), a procedure to open blocked heart arteries, a stroke, a mini-stroke (TIA), significant narrowing of the heart arteries, or heart failure
  • Your kidneys are not working well enough, based on a specific blood test measurement (confirm with trial site)
  • You have been diagnosed with cancer or a blood/lymph system disease in the last 3 years — with some exceptions for certain successfully treated skin cancers, a localised cervical condition, or low-grade prostate cancer
  • You have inflammatory bowel disease (Crohn's disease or ulcerative colitis) or ongoing long-term diarrhoea
  • You have had a stomach ulcer in the last 2 years, or have previously had serious bleeding in your digestive system (minor haemorrhoidal bleeding more than 5 years ago may be allowed — confirm with trial site)
  • You have a pre-existing progressive muscle or nerve disease, or your muscle enzyme levels (CPK) in your blood are significantly elevated
  • You have certain abnormal blood test results, including low red blood cells (anaemia), low white blood cells, low platelets, or elevated liver markers (confirm specific values with trial site)
  • You have cirrhosis, ongoing active hepatitis, or severe liver disease
  • You are pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months of finishing the study medication
  • You have had a significant problem with drug or alcohol misuse in the past year
  • You are currently taking, or plan to take, long-term steroid tablets or injections during the study (steroid creams, inhalers, or replacement therapy for adrenal conditions are generally allowed)
  • You are currently taking aspirin or another blood-thinning antiplatelet medicine on a regular basis (you may still be eligible for part of the study — confirm with trial site)
  • You are currently taking a regular anticoagulant (blood-thinning) medicine (you may

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Montreal Heart Institute
Registry
clinicaltrials_gov
Start date
21 December 2022
Est. completion
1 December 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇬🇷 Greece 🇮🇹 Italy 🇵🇹 Portugal

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

First event of the composite of cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, or urgent hospitalization for angina requiring coronary revascularization.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov