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Study of colchicine to improve insulin sensitivity in adults with type 1 diabetes who have low-grade inflammation

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Type 1 diabetes who have low-grade inflammation in their body. The research examines whether a medication called colchicine can improve how well insulin works in the body. The study uses two treatments - colchicine tablets and placebo tablets that look identical but contain only potato starch and lactose.

During the study, participants take medication for four weeks. For the first two weeks, they take one tablet daily, followed by two tablets daily for the next two weeks. The study is designed so that participants receive both colchicine and placebo at different times, but neither they nor their doctors know which treatment they are receiving at any given time.

The main purpose is to determine if colchicine, when added to regular diabetes care, can help the body use insulin more effectively. The medication is being tested because some people with Type 1 diabetes have inflammation in their body that may make it harder for insulin to work properly. The study measures how well the body responds to insulin during treatment with colchicine compared to treatment with placebo.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication phase

    You will receive colchicine tablets or placebo (inactive tablets that look identical to colchicine)

    For the first two weeks, you will take one tablet (0.5 mg) once daily

    For the next two weeks, you will take one tablet (0.5 mg) twice daily

    The total duration of this phase is four weeks

  2. Step 2

    Monitoring phase

    Throughout the study, you will continue using your continuous glucose monitoring (CGM) system

    Your daily insulin usage will be tracked

    You will maintain your regular insulin therapy during the study

  3. Step 3

    Testing procedures

    You will undergo a hyperinsulinemic-euglycemic clamp test (a procedure to measure how your body responds to insulin)

    Blood tests will be conducted to measure inflammation markers

    Your glucose disposal rate will be evaluated

  4. Step 4

    Crossover phase

    If you received colchicine in the first phase, you will switch to placebo, or vice versa

    The same four-week medication schedule will be repeated

    The same monitoring and testing procedures will be performed

Who can join the trial?

7 criteria

  • Diagnosed with Type 1 diabetes for more than five years with a c-peptide level below 200 pmol/L (c-peptide is a substance released with insulin that shows how much insulin your body produces)
  • Age between 18 and 80 years
  • Must use a Continuous Glucose Monitoring (CGM) system (a device that continuously tracks blood sugar levels)
  • HbA1c level between 42-75 mmol/mol (a blood test that shows average blood sugar levels over the past 2-3 months)
  • Must be on a stable insulin treatment plan
  • Kidney function (eGFR) must be at least 60 mL/min/1.73 m² (this measures how well your kidneys are working)
  • Inflammation marker (hsCRP) must be 2 mg/L or higher (this blood test measures the level of inflammation in your body)

Who cannot join the trial?

12 criteria

  • Current age below 18 or above 65 years
  • People who do not have Type 1 diabetes
  • People with normal insulin sensitivity (when body responds well to insulin)
  • People with hsCRP (inflammation marker in blood) levels below 2 mg/dl
  • People using less than 1 unit of insulin per kilogram of body weight per day
  • People with glucose disposal rate (a measure of how well body processes glucose) above 8 mg/kg/min
  • People who cannot take oral medications
  • Pregnant or breastfeeding women
  • People with known allergic reactions to colchicine (the study medication)
  • People currently participating in other clinical trials
  • People with severe kidney or liver problems
  • People taking medications that could interact with colchicine
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Investigated drugs

Colchicine is a medication used to reduce inflammation in the body. In this trial, it is being studied as an additional treatment alongside standard diabetes care. The medication is being tested to see if it can improve how well the body responds to insulin in people with type 1 diabetes who have mild, ongoing inflammation. Colchicine comes in tablet form and is taken by mouth. Standard diabetes care, which includes regular insulin therapy, continues throughout the trial. Insulin is a hormone that helps control blood sugar levels and is essential for people with type 1 diabetes. It is typically given by injection or through an insulin pump.

What is already known about the treatment

Colchicine - An oral medication administered in tablet form that acts as an anti-inflammatory agent, initially prescribed at 0.5 mg once daily, then increased to twice daily dosing. This well-established medication, traditionally used for gout treatment, is being investigated for its potential benefits in type 1 diabetes patients with systemic low-grade inflammation. It works at the molecular level by disrupting microtubule formation and reducing inflammatory cell activity, which may help improve insulin sensitivity in diabetic patients. Colchicine belongs to the pharmacological class of anti-inflammatory agents and microtubule inhibitors, and its unique mechanism of action makes it a promising candidate for addressing inflammation-related insulin resistance.

Investigated diseases

Type 1 diabetes - A chronic condition where the body's immune system attacks and destroys insulin-producing cells in the pancreas. This autoimmune disease typically begins in childhood or young adulthood, leading to insufficient or no insulin production. The body becomes unable to properly regulate blood sugar levels, causing glucose to build up in the bloodstream instead of being distributed to cells for energy. People with this condition experience increased thirst, frequent urination, and fatigue as early symptoms. The condition develops gradually over weeks or months as the pancreas loses its ability to produce insulin.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522528-29-00Estimated enrolment26 patientsSponsorGentofte Hospital

sourced from the EU Clinical Trials Register and site verification

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