Phase 2 Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have had Type 1 diabetes for more than five years (diagnosed using World Health Organization standards) and have a very low level of c-peptide (a marker of insulin production) below 200 pmol/L
• People aged between 18 and 80 years old
• People who already use a continuous glucose monitor (a device that tracks blood sugar levels throughout the day)
• People whose HbA1c (a measure of average blood sugar over roughly three months) falls between 42 and 75 mmol/mol
• People who have been on a stable insulin routine for at least three months — meaning no changes to their insulin brand and no newly started insulin pump or injection therapy — and, if applicable, no changes to their glucose monitoring technology during that time
• People whose kidneys are functioning at a sufficient level, measured by a test called eGFR (confirm with trial site for exact value)
• People who show signs of insulin resistance or use a relatively high daily dose of insulin (confirm with trial site for exact values)
• People who have a raised level of a blood marker of inflammation called high-sensitivity CRP (hsCRP), at 2 mg/L or above

Who may not be able to join:

• People who cannot feel or recognise when their blood sugar drops dangerously low (known as hypoglycaemia unawareness), unless they use a continuous glucose monitor that has an alarm function
• People with liver disease where a liver enzyme called ALT is more than three times the normal upper limit
• People with a history of cirrhosis, long-term active hepatitis, or serious liver disease
• People with inflammatory bowel disease or ongoing chronic diarrhoea
• People with a pre-existing progressive muscle or nerve disease, or who have a muscle enzyme (creatinine kinase) level more than three times the normal upper limit
• People with cancer or blood cancer, unless they have been in complete remission for more than five years
• People with certain blood or bone marrow disorders (such as myelodysplastic syndromes)
• People with a white blood cell count below a certain level (confirm with trial site)
• People with a platelet count below a certain level (confirm with trial site)
• People who take medications that suppress the immune system, or who have a condition causing chronic immune deficiency, including HIV infection
• People who are currently taking or have recently taken anti-inflammatory medications such as NSAIDs (e.g. ibuprofen), aspirin at certain doses, or steroid tablets applied to the whole body — though inhaled steroids are allowed, short courses of oral NSAIDs of three days or fewer are allowed, and aspirin up to 1000 mg daily is allowed
• People who have taken a medication called colchicine within 60 days before the screening visit
• People with a known or suspected allergy or sensitivity to colchicine
• People who are currently taking or have recently taken blood sugar–lowering medications other than insulin (such as GLP-1 receptor agonists, metformin, or SGLT2 inhibitors)
• People who are receiving kidney dialysis treatment (haemodialysis or peritoneal dialysis)
• People who take certain medications that interact with colchicine, including some antibiotics (e.g. azithromycin, clarithromycin) and certain heart or antiviral medications (e.g. verapamil, ritonavir)
• People who regularly drink grapefruit juice
• People with another illness or treatment that the study doctor considers would make participation unsuitable
• People with alcohol or drug misuse issues, as assessed by the study doctor
• Women who are pregnant, planning to become pregnant, or breastfeeding
• Women of childbearing potential who are not willing or able to use a highly effective form of contraception throughout the trial and for three months after it ends (confirm with trial site for the full list of accepted methods)
• Male participants whose partners could become pregnant, who are not willing to use a condom or ensure their partner uses a highly effective contraceptive method during the trial and for six months after it ends
• People who are unable to speak or understand Danish
• People who have taken part in another clinical drug trial within the 30 days before the first visit
• People who are currently participating in another clinical intervention trial at the same time

Important: Always verify eligibility with the trial site directly before applying.