Colchicine for Primary Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes

NCT07837934 | Recruiting Phase 2 DMC

• 1 other identifier: NHG Health DSRB Ref: 2024-3120
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Atherosclerosis; Cardiovascular Diseases

Keywords

Colchicine; Inflammation; Neutrophils; Carotid Intima-Media Thickness; Primary Prevention

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Mean-Maximum Carotid Intima-Media Thickness (Mean-Maximum CIMT)

  Mean-maximum CIMT is defined as the average of the maximum CIMT values obtained from the far wall of the left and right common carotid arteries, each derived from six measurements taken across three projections (lateral, anterior, and posterior) at 1 cm proximal to the carotid bifurcation, measured by high-resolution B-mode carotid ultrasonography.

  Baseline and 24 weeks

Secondary Outcomes (25)

• Change from Baseline in Mean Carotid Intima-Media Thickness (avgCIMT)

  Baseline and 24 weeks

• Change from Baseline in Carotid Plaque Volume

  Baseline and 24 weeks

• Change from Baseline in Endothelial Function (Flow-Mediated Dilation)

  Baseline and 24 weeks

• Change from Baseline in Microvascular Reactivity (Reactive Hyperaemia Index)

  Baseline and 24 weeks

• Change from Baseline in Arterial Stiffness (Pulse Wave Velocity)

  Baseline and 24 weeks

Other Outcomes (3)

• Change from Baseline in Gut Microbiome Composition

  Baseline and 24 weeks

• Change from Baseline in Plasma Metabolite Profile (Metabolomics)

  Baseline and 24 weeks

• Incidence of Adverse Events and Serious Adverse Events

  From randomisation through 24 weeks

Study Arms (2)

Colchicine

EXPERIMENTAL

Colchicine 0.5 mg orally once daily for 24 weeks, in addition to usual risk-factor-based therapy

Drug: Colchicine 0.5 MG Oral Tablet Once Daily

Placebo

PLACEBO COMPARATOR

Matched placebo orally once daily for 24 weeks, in addition to usual risk-factor-based therapy

Drug: Placebo

Interventions

Colchicine 0.5 MG Oral Tablet Once Daily DRUG

For 24 weeks

Colchicine

Placebo DRUG

Matched placebo tablets (identical in size, shape, taste, and packaging to colchicine), once daily, for 24 weeks

Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Nanyang Technological University: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore, 308433, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Atherosclerosis; Cardiovascular Diseases; Inflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Rinkoo Dalan, MD, PhD

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanchalika Acharyya, PhD, MPH

CONTACT

96150202; sanchalika.acharyya@nhghealth.com.sg

Shirley Lin Shangmei

CONTACT

ttsh.p2p.research@nhghealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 24, 2026
• Study Start: July 24, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)