Could a common gout drug help people with type 1 diabetes?
NCT ID NCT07247734
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether colchicine, a drug used for gout, can improve how the body uses insulin in people with type 1 diabetes who have low-grade inflammation. 26 adults will receive either colchicine or a placebo for four weeks, and their insulin sensitivity will be measured using a clamp procedure. The goal is to see if reducing inflammation can help manage blood sugar better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- colchicine
- What this could lead to
- If it works, this could point toward a new way to improve insulin sensitivity in people with type 1 diabetes, potentially reducing complications.
- What could go wrong
- This is a small, early-phase trial with only 26 participants. The effect may be small or not clinically meaningful, and colchicine can cause gastrointestinal side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Type 1 diabetes for more than five years according to World Health Organization criteria and c-peptid \<200 pmol/L * Age 18-80 years * User of a continuous glucose monitor (CGM) system * Glycated hemoglobin A1c (HbA1c) 42-75 mmol/mol * Stable insulin therapy (defined as no change in insulin brand and no newly initiated Continuous subcutaneous insulin infusion (CSII) or Multiple dose injection (MDI) therapy) and, if applicable, stable usage of glucose monitoring technology (e.g., continuous glucose monitor or intermittently scanned continuous glucose monitor) ≥ 3 months with either multiple daily injections or continuous subcutaneous insulin infusion * Estimated glomerular filtration rate ≥ 60 mL/min/L/1.73 m² * Estimated glucose disposal rate (eGDR)\* \< 8 mg/kg/min OR insulin usage of ≥1 IU/kg pr day * C-reactive protein (CRP) hsCRP ≥ 2 mg/L, (measured by high-sensitivity assay)\*\* Exclusion Criteria: * Hypoglycaemia unawareness (inability to register low blood glucose) ad modum Pedersen-Bjergaard, 24 unless the individual uses a continuous glucose monitor with alarm function * Liver disease with elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal (measured at screening visit with the possibility of one repeat analysis within seven days, and the last measured value as being conclusive) * History of cirrhosis, chronic active hepatitis, or severe hepatic disease * Inflammatory bowel disease or chronic diarrhoea * Pre-existing progressive neuromuscular disease or individuals with creatinine kinase levels \> three times the upper limit of normal (measured at screening visit with the possibility of one repeat analysis within a week, and the last measured value as being conclusive) * Cancer or lymphoproliferative disease unless in complete remission for \> 5 years * Blood dyscrasias (e.g., myelodysplastic syndromes or related haematological disorders) * Leukocyte cell count \< 3.0 X 109/L * Thrombocyte count \< 110 X 109/L * Immunosuppressive therapy or state of chronic immunodeficiency, including infection with human immunodeficiency virus (HIV) * Treatment with anti-inflammatory drugs (e.g., non-steroidal anti-inflammatory drugs (NSAID), acetylsalicylic acid (ASA), prednisone) or whole-body topical steroid during the study or within four weeks before study start. Inhaled steroids are allowed. Short term oral NSAID treatment (≤ 3 days) within four weeks before study start or during the study period is allowed. Treatment of ASA is allowed for up to 1000 mg daily. * Treatment with colchicine within 60 days of screening visit * Known or suspected hypersensitivity to colchicine * Treatment with glucose lowering drugs other than insulin (e.g., Glucagon Like Peptide 1 (GLP-1) receptor agonists, metformin, selective sodium glucose cotransporter-2 (SGLT2)-inhibitors) during the study period or within four weeks before study start * Haemodialysis or peritoneal dialysis therapy (since colchicine cannot be removed by dialysis or exchange transfusion) * Treatment with a P-glycoprotein inhibitor (e.g., azithromycin and verapamil) or a strong CYP3A4 inhibitor (e.g., clarithromycin and ritonavir) * Intake of grapefruit juice * Other concomitant disease or treatment that according to the investigator's assessment makes the individual unsuitable for study participation * Alcohol/drug abuse (assessed by the investigator) * Regarding fertile women: * A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. * Sterilised or postmenopausal women (no menses for 12 months without an alternative medical cause) can be included without the human chorionic gonadotrophin (hCG)-testing during the trial period * Women who are pregnant, intend to become pregnant, or are breastfeeding will not be included in the study * Female of childbearing potential: must use highly effective contraceptives during the trial and three months after the trial. To exclude pregnancy, urine hCG tests are performed in relation to all visits (V1-V5) and to the phone call in the washout period (P2) and there will be instructions to ensure monthly testing three months after the end of the trial. * The following contraceptive methods are considered highly effective and thus adequate for study enrolment for females if maintained throughout the study duration and three months after the trial: Combined hormonal contraception associated with inhibition of ovulation (containing estrogen and progestogen administered oral, intravaginal or transdermal). Progestogen-only hormonal contraception associated with inhibition of ovulation (admninistered oral, injectable or implantable). Intrauterine device (IUD). Intrauterine hormone-releasing system. Bilateral tubal occlusion. Vasectomised partner. Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject). * Male participants with partners of childbearing potential: must either use a condom or ensure that their partner uses a highly effective contraceptive method during the trial and six months after the trial. * Pregnant or nursing women * Participants unable to speak or understand Danish * Receipt of any investigational drug within 30 days prior to visit 1 * Simultaneous participation in any other clinical intervention trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Center for Clinical Metabolic Research, Gentofte Hospital, Hellerup, Capital Region 2900
RECRUITINGGentofte Municipality, 2400, Denmark
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