The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation

NCT07247734 | Recruiting Phase 2

• 1 other identifier: 2025-522528-29-00
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim for this clinical trial is to evaluate if colchicine in addition to standard of care improves insulin sensitivity in individuals with type 1 diabetes, systemic low-grade inflammaiton and reduced insulin sensitivity. The insulin sensitivity will be evaluated by a hyperinsulinemic, euglycemic clamp.

Conditions

Type 1 Diabetes; Chronic Inflammation; Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Mean difference in M-value

  Mean difference in insulin sensitivity is measured by the M-value (glucose infusion rate mg/kg/min) during the last 30 minutes of a 180 minutes hyperinsulinemic euglycemic clamp procedure using insulin infusion rate of 60 mU/m²/min

  Four weeks of treatment comparing colchicine to placebo.

Secondary Outcomes (8)

• Mean difference in M-value

  After four weeks of placebo/colchicine

• Mean difference in M-value (adjusted to fat free mass (FFM))

  After four weeks of placebo/colchicine

• Mean difference in Insulin Sensitivity Index (ISI)

  After four weeks of placebo/colchicine

• Mean difference in average daily insulin dosage

  During four weeks of placebo/colchicine

• Fold difference in Insulin sensitivity by estimated glucose disposal rate (eGDR)

  After four weeks of placebo/colchicine

Other Outcomes (52)

• Mean difference in respiratory exchange ratio between basal state and during clamp

  After four weeks of placebo/colchicine

• Adipocyte tissue biopsies

  After four weeks of placebo/colchicine

• Time spent in target blood glucose range (3.9 - 10 mmol/L) evaluated by a continous glucose monitor (CGM)

  The last 7 days of each treatment period.

Study Arms (2)

Colchicine first period, placebo second period

ACTIVE COMPARATOR

Colchicine daily for 4 weeks, followed by an 8-week washout period, then placebo for 4 weeks.

Drug: Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks; Drug: Placebo once daily for two weeks, then twice daily for two weeks

Placebo first period, colchicine second period

ACTIVE COMPARATOR

Placebo for 4 weeks followed by an 8-week washout period, then Colchicine daily for 4 weeks.

Drug: Placebo once daily for two weeks, then twice daily for two weeks; Drug: Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks

Interventions

Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks DRUG

Colchicine treatment in the first period

Also known as: Colrefuz

Colchicine first period, placebo second period

Placebo once daily for two weeks, then twice daily for two weeks DRUG

Placebo treatment in the first period

Placebo first period, colchicine second period

Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks DRUG

Colchicine treatment in the second period

Placebo first period, colchicine second period

Eligibility Criteria

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

You may qualify if:

• 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)\*\*

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Copenhagen: collaborator
• Asger Lund, MD: lead

Study Sites (1)

Center for Clinical Metabolic Research, Gentofte Hospital, Hellerup, Capital Region 2900

Gentofte Municipality, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Asger B Lund, MD, PhD

  Center for Clinical Metabolic Research, Gentofte Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Askee N. Høck, MD

CONTACT

+4561275585; aske.nicolai.hoeck@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ass. Professor, MD, PhD

Model Details: Being a cross-over trial, participants will undergo 2 treatment periods: 4 weeks of treatment with daily colchicine and 4 weeks of treatment with placebo. The order of the treatment periods is randomized 1:1. Each treatment period will be interposed by 8 weeks of wash-out period. In the end of each treatment period the insulin sensitivity will be evaluated by a hyperinsulinemic, euglycemic clamp.

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: November 25, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): June 22, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)