Type 2 diabetes is associated with higher rates of macrovascular (large blood vessel) and microvascular (smaller blood vessel) disease and cardiovascular events. Inflammation also appears to be an important link between diabetes and atherosclerosis.
In an earlier study conducted by the Montreal Heart Institute (COLCOT-1), patients with diabetes who had recently suffered a myocardial infarction (heart attack) had significant clinical benefits from taking colchicine to reduce their risk of a second cardiovascular event.
Colchicine 0.5 mg tablets are currently marketed in Canada for the reduction of atherothrombotic events (blood clot formation) in patients with existing heart disease.
A new clinical trial is required to determine the long-term efficacy and safety of low-dose colchicine in preventing the development of cardiovascular events in patients with type 2 diabetes who have never had a cardiovascular event. In addition, in the current COLCOT-T2D study, aspirin is administered with colchicine. Aspirin also has a well-established safety profile and has been used for many years for its antithrombotic properties (decreasing blood clot formation) as one of the main treatments for patients with cardiovascular disease. However, its role in preventing cardiovascular events in patients who have never had a cardiovascular event has recently been re-evaluated based on the results of new scientific studies.
The role of aspirin in the diabetic patient population is under evaluation, as reflected in conflicting recommendations in clinical practice guidelines. Changes in the way the bodies of diabetic patients processes aspirin could lead to drug resistance to aspirin. Small studies have suggested that this resistance may be reversed with twice-daily dosing and with non-enteric preparations of aspirin (i.e. tablets that are not coated with a material that delays the release of the drug until after evacuation from the stomach).
Therefore, a low-dose, non-enteric aspirin preparation will be used in this study to determine its long-term efficacy and safety in preventing the development of cardiovascular events in patients with type 2 diabetes without known coronary heart disease.
The increased blood sugar (glucose) levels seen in diabetic patients damage the blood vessels. Indeed, glucose sticks to the proteins of blood vessels which weakens them. This damage contributes to the development of atherosclerosis. Atherosclerosis occurs when the arteries are blocked by fatty deposits (fatty tissue deposits called plaques). Plaque formation causes a loss of elasticity in the arteries and can lead to blockages. Blood circulation is thus slowed down or even blocked. As a result, diabetes can harm your heart, brain and other organs and increase the risk of high blood pressure, coronary heart disease (heart attack, angina, etc.) and stroke.
References: Diabète Québec and Heart + Stroke websites
People with type 2 diabetes are 2 to 3 times more likely to develop cardiovascular disease compared to people without diabetes.
- Excess weight, especially around the waist
- High blood pressure (hypertension)
- Abnormal blood cholesterol levels
- Lack of regular exercise
- Excessive stress levels
This is a decentralized study (conducted through virtual appointments between the participant and a member of the research team), managed by the Montreal Heart Institute research team located in Quebec, Canada. Therefore, there will be no in-person visits to the Montreal Heart Institute. They will take place by video or telephone.
ELIGIBILITY FOR THE STUDY
No, not if the patient is being treated with colchicine.
Yes, if colchicine treatment is stopped prior to enrollment in the study and all other eligibility criteria are met. There is no withdrawal period (no delay) required between discontinuation of treatment with colchicine and starting study treatment.
Yes, if the patient meets all other eligibility criteria, they can be included in the study, but would only receive colchicine or its placebo. They would not be included in the treatment group receiving aspirin or its placebo.
Every 6 months, you will be contacted by one of the study's research team members. This contact will be made via either video or telephone calls.
The expected duration of individual participation in this research project is estimated to be between 36 and 54 months. The duration will depend on when the participant is included in the research project and when the study ends.
STUDY TREATMENT(S) (STUDY DRUGS)
A placebo is a product that is identical in appearance to the study drug but without the active ingredient.
You will take 1 tablet of colchicine (or its placebo) per day orally, with or without food, and preferably at approximately the same time of day throughout the study.
You will also take 2 aspirin tablets (or its placebo) per day, 1 tablet in the morning and 1 tablet in the evening with food or with a glass of water (240 ml) for the duration of the study.
If you are enrolled in the non-aspirin eligible group, you will take 1 tablet of colchicine (or its placebo) orally per day with or without food, and preferably at approximately the same time of day for the duration of the study.
No. The research project is double-blind, which means that neither you nor the research team will know which treatment group you are in until everyone has completed the study. However, in an emergency, the study doctor can quickly find out which medication you are receiving.
Yes, the research team will inform you of the treatment you received during the study once the study is completed and the results are published.
Colchicine and aspirin have been used for many years and the risks associated with taking these drugs are well known. A member of the research team will discuss any treatment-related risks that may occur with you, including any possible interactions between medications you are already taking and the study drugs.
TYPE 2 DIABETES
Type 2 diabetes is a chronic disease, which means that it cannot be cured, but can be controlled. Diabetes is characterized by blood sugar levels that are above normal. The body controls blood sugar levels with insulin, a hormone produced by the pancreas.
The body uses insulin to move sugar into the cells and control the amount of sugar in the blood. Sugar (glucose) is an important source of energy for tissue, muscle, heart and brain cells. In patients with type 2 diabetes, the body cannot effectively use the insulin it has or it produces less. As a result, sugar builds up in the blood (hyperglycemia). In the long term, if the body is unable to use the sugar it needs for energy, certain complications can develop, especially affecting the eyes, kidneys, heart and blood vessels.
Reference: Diabète Québec website
In 2022, 1.2 million people in Quebec will be affected by diabetes. In Canada, 620 people are diagnosed with diabetes every day. Worldwide, 1 in 10 people lives with diabetes. Type 2 diabetes is the most common form of diabetes (90% of cases).
Reference: Diabète Québec website
To live comfortably with diabetes, it is important to develop a lifestyle that allows you to control the disease as it evolves. Some of the ways type 2 diabetes can be managed are as follows:
- Working with your doctor to develop a treatment plan that works for you;
- Taking diabetes medication, including insulin, if prescribed by your doctor;
- Monitoring your blood sugar with a home glucose meter;
- Aiming for a healthy weight;
- Eating healthy meals and snacks;
- Engaging in regular physical activity;
- Managing stress.
References: Diabète Québec and Diabetes Canada websites.
A clinical study is a scientific research to determine whether a new or existing drug is effective in treating or preventing certain health problems.
It is most often aimed at finding potential new treatments, improved versions of drugs already in use or new indications for existing treatments.
Participant safety is the highest priority in any clinical study. The study must be approved by government authorities and an ethics committee. It must also follow strict rules to protect the safety and privacy of participants.
Most of the time, the clinical study is double-blind and placebo-controlled, which means that neither you, your study doctor, nor the research team will know which treatment group you are in until everyone has completed the study.