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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

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Other Sites

Site Name City Country Status
Gentofte Hospital Hellerup Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
03.11.2025

Trial locations

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.

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 ID:
2025-522528-29-00
Trial Phase:
Therapeutic exploratory (Phase II)

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