Colchicine to Protect Blood Vessels in Adults With Type 2 Diabetes

Trial details

Who runs it

Tan Tock Seng Hospital

Trial code

NCT07837934

Record updated

24 September 2026

Original description

This study will test whether a low-cost anti-inflammatory medicine called colchicine can help protect the blood vessels of people with type 2 diabetes. Diabetes speeds up hardening of the arteries (atherosclerosis), partly because of ongoing low-grade inflammation. Colchicine has already been shown to help prevent heart attacks and strokes in people who already have heart disease; this study looks at whether it can also help prevent early blood vessel damage before heart disease develops. Around 300 adults with type 2 diabetes will be randomly assigned to take colchicine or a placebo (dummy pill) once daily for 24 weeks, in addition to their usual diabetes and heart-risk medications. Neither participants nor the study team will know who is taking colchicine or placebo. The main measurement will be the change in the thickness of the wall of the neck (carotid) artery, measured by ultrasound, which is an early sign of blood vessel disease. The study will also look at markers of inflammation in the blood, blood vessel stiffness and function, and changes in the gut bacteria.Read full original descriptionShow less

The Role of Colchicine in Preventing Atherosclerotic Cardiovascular Disease in Type 2 Diabetes (Col-DM Study)

This study will test whether a low-cost anti-inflammatory medicine called colchicine can help protect the blood vessels of people with type 2 diabetes. Diabetes speeds up hardening of the arteries (atherosclerosis), partly because of ongoing low-grade inflammation. Colchicine has already been shown to help prevent heart attacks and strokes in people who already have heart disease; this study looks at whether it can also help prevent early blood vessel damage before heart disease develops. Around 300 adults with type 2 diabetes will be randomly assigned to take colchicine or a placebo (dummy pill) once daily for 24 weeks, in addition to their usual diabetes and heart-risk medications. Neither participants nor the study team will know who is taking colchicine or placebo. The main measurement will be the change in the thickness of the wall of the neck (carotid) artery, measured by ultrasound, which is an early sign of blood vessel disease. The study will also look at markers of inflammation in the blood, blood vessel stiffness and function, and changes in the gut bacteria.

Inclusion: T2DM on stable diabetes medications (no change in last 3 months); At least one other comorbidity of hypertension, dyslipidaemia and/or obesity (BMI ≥27), with no previous history of ASCVD; Able to provide informed consent.

Exclusion: Current Treatment with corticosteroids or immunosuppressive agents; Taking a strong P-glycoprotein inhibitor (e.g. cyclosporine, ranolazine) or a strong CYP3A4 inhibitor; Currently taking Aspirin; Recent hospitalization or acute infections within last 2 weeks; Pre-existing malignancies or other terminal conditions with limited prognosis; Renal impairment (eGFR< 60ml/min); Liver cirrhosis or ALT/AST >3x ULN; Hypersensitivity to the active substance or to the following excipients: Lactose, Maize starch, Sodium laurilsulfate, Magnesium stearate; Women of childbearing age who are keen to conceive in the next 1 year; Pregnancy; Breastfeeding; Inability to provide written consent; Pharmacogenomics indicative of adverse effects; Known blood dyscrasia; Known myositis with raised creatine kinase with statins (statin myopathy); Gout attack within the last 1 year; Taking any oral contraceptives.

ClinicalTrials.gov NCT07837934