CClinicalTrials.gg
Sign In
RecruitingNCT07247734INS1GHTUpdated Dec 23, 2025

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

A Phase 2 interventional study of Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks and Placebo once daily for two weeks, then twice daily for two weeks in Type 1 Diabetes, Chronic Inflammation and Insulin Sensitivity, sponsored by Asger Lund, MD. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by Asger Lund, MD · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 1 Diabetes
  • Chronic Inflammation
  • Insulin Sensitivity
03

In context

Diabetes Mellitus, Type 1

3,521 studies on the registry are indexed under Diabetes Mellitus, Type 1; 576 are open to participants now.

This study's planned enrollment of 26 is below the median of 40 across 2,648 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Asger Lund, MD is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
26 participants (estimated)

Study arms

  • Active comparator
    Colchicine first period, placebo second period

    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

  • Active comparator
    Placebo first period, colchicine second period

    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

  • DrugColchicin 0.5 mg once daily for two weeks, then twice daily for two weeks

    Colchicine treatment in the first period

    Also known as: Colrefuz

  • DrugPlacebo once daily for two weeks, then twice daily for two weeks

    Placebo treatment in the first period

  • DrugColchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks

    Colchicine treatment in the second period

  • DrugPlacebo once daily for two weeks, then twice daily for two weeks

    Placebo treatment in the second period

06

What researchers measure

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

    Time frame: Four weeks of treatment comparing colchicine to placebo.

Secondary outcomes

  1. Mean difference in M-value

    Measured in mg/m²/min. Adjusted to body surface area (BSA)

    Time frame: After four weeks of placebo/colchicine

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

    Measured in mg/kg FFM/min

    Time frame: After four weeks of placebo/colchicine

  3. Mean difference in Insulin Sensitivity Index (ISI)

    Glucose infusion rate / Plasma insulin in steady state

    Time frame: After four weeks of placebo/colchicine

  4. Mean difference in average daily insulin dosage

    Units/day. Total daily dose, short acting, long acting

    Time frame: During four weeks of placebo/colchicine

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

    Ratio. It is calculated using clinical variables such as waist circumference, hypertension status, and HbA1c. Higher eGDR values indicate better insulin sensitivity

    Time frame: After four weeks of placebo/colchicine

  6. Fold difference in fasting serum/plasma concentrations of C-reactive protein (CRP) measured by a high-sensitivity assay (hsCRP) (mg/L)

    Ratio

    Time frame: After four weeks of placebo/colchicine

  7. Fold difference in in fasting serum/plasma concentrations iInterleukin 6 (IL-6) (pg/mL)

    Ratio

    Time frame: After four weeks of placebo/colchicine

  8. Fold difference in in fasting serum/plasma concentrations of tumour necrosis factor alpha (TNF alpha)

    Ratio

    Time frame: After four weeks of placebo/colchicine

Other outcomes

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

    Ratio

    Time frame: After four weeks of placebo/colchicine

  2. Adipocyte tissue biopsies

    Ratio. Fold difference in Adipocyte size, Inflammation, Glucose metabolism, Extracellular matrix, Oxygen consumption, Transcriptomics, Proteomics

    Time frame: After four weeks of placebo/colchicine

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

    Measured in % of 24 hours.

    Time frame: The last 7 days of each treatment period.

  4. Time spent in tight range (3.9 - 7.8 mmol/L) evaluated by a continous glucose monitor (CGM)

    Measured in % of 24 hours.

    Time frame: The last 7 days of each treatment period.

  5. Time spent in hyperglycemia level 1 (10-13.9 mmol/L) evaluated by a continous glucose monitor (CGM)

    Measured in % of 24 hours.

    Time frame: The last 7 days of each treatment period.

  6. Time spent in hyperglycemia level 2 (> 13.9 mmol/L) evaluated by a continous glucose monitor (CGM)

    Measured in % of 24 hours.

    Time frame: The last 7 days of each treatment period.

  7. Time spent in hypoglycemia level 1 (3.0-3.8 mmol/L) evaluated by a continous glucose monitor (CGM)

    Measured in % of 24 hours.

    Time frame: The last 7 days of each treatment period.

  8. Time spent in hypoglycemia level 2 (< 3.0 mmol/L)evaluated by a continous glucose monitor (CGM)

    Measured in % of 24 hours.

    Time frame: The last 7 days of each treatment period.

  9. Change in glycaemic variability assessed as coefficient of variance (CV)

    %-point

    Time frame: The last 7 days of each treatment period.

  10. Change in standard deviation evaluated by a continous glucose monitor (mmol/L)

    %-point

    Time frame: The last 7 days of each treatment period.

  11. Mean difference in Body mass index (BMI)

    kg/m²

    Time frame: After four weeks of placebo/colchicine

  12. Fold difference in waist-hip ratio

    After four weeks of placebo/colchicine

    Time frame: ratio

  13. Mean difference in waist circumference

    Cm

    Time frame: After four weeks of placebo/colchicine

  14. Mean difference in systolic blood pressure

    mmHg

    Time frame: After four weeks of placebo/colchicine

  15. Mean difference in diastolic blood pressure

    mmHg

    Time frame: After four weeks of placebo/colchicine

  16. Mean difference in heart rate

    beats per minute

    Time frame: After four weeks of placebo/colchicine

  17. Fold difference in body composition (fat-free mass, total fat mass, visceral fat mass rating and bone mass) as measured by bioimpedance

    Ratio

    Time frame: After four weeks of placebo/colchicine

  18. Fold difference in fasting serum/plasma concentrations of inflammatory biomarkers

    Ratio. Interleukines and other cytokines

    Time frame: After four weeks of placebo/colchicine

  19. Fold difference in fasting serum/plasma concentrations of total leukocyte count, including neutrophil, lymphocyte, basophil and eosinophil counts (10^9/L)

    Ratio.

    Time frame: After four weeks of placebo/colchicine

  20. Fold difference in fasting serum/plasma concentrations of very low-density lipoprotein (VLDL) cholesterol (mmol/L)

    Ratio.

    Time frame: After four weeks of placebo/colchicine

  21. Fold difference in fasting serum/plasma concentrations of hemoglobin A1c (mmol/mol)

    Ratio

    Time frame: After four weeks of placebo/colchicine

  22. Fold difference in fasting serum/plasma concentrations of insulin (pmol/L)

    Ratio

    Time frame: After four weeks of placebo/colchicine

  23. Fold difference fasting serum/plasma concentrations of C-peptide (pmol/L)

    Ratio

    Time frame: After four weeks of placebo/colchicine

  24. Fold difference in fasting serum/plasma concentrations of glucagon (pmol/L)

    Ratio

    Time frame: After four weeks of placebo/colchicine

  25. Mean difference in resting energy expenditure ratio between basal state and during clamp

    Ratio. Participants undergo indirect calorimetry in the basal state and during the clamp (from 120-150 minutes)

    Time frame: After four weeks of placebo/colchicine

  26. Fold difference in FibroScan®-assessed liver steatosis (dB/m)

    Ratio. Measured before- and after each treatment period.

    Time frame: After four weeks of placebo/colchicine

  27. Fold difference in Fatty Liver Index (FLI, range 0-100; higher scores indicate greater likelihood of fatty liver)

    Ratio

    Time frame: After four weeks of placebo/colchicine Ratio

  28. Fold difference in Fibrosis-4 (FIB-4) score

    Ratio. The Fibrosis-4 score is a non-invasive index used to estimate liver fibrosis. It is calculated using age, aspartate aminotransferase, alanine aminotransferase, and platelet count. Scale range: Typically from 0 to greater than 3.25

    Time frame: After four weeks of placebo/colchicine

  29. Fold difference in fasting coagulability as measured by thromboelastography (TEG)

    Ratio. Measured before and after each treatment period.

    Time frame: After four weeks of placebo/colchicine

  30. Fold difference in fasting serum/plasma concentrations of hormones during the HIE clamp

    Ratio. Insulin, C-peptide and other counter-regulatory hormones

    Time frame: After four weeks of placebo/colchicine

  31. Difference in rate of treatment-emergent AEs

    Rate ratio

    Time frame: From signed consent form to last clamp day (week 16-18)

  32. Difference in rate of serious AEs (SAEs)

    Rate ratio

    Time frame: From signed consent form to last clamp day (week 16-18)

  33. Difference in rate of severe hypoglycaemia (defined as hypoglycaemia with need of external assistance)

    Rate ratio

    Time frame: From signed consent form to last clamp day (week 16-18)

  34. Difference in rate of diabetic ketoacidosis

    Rate ratio

    Time frame: From signed consent form to last clamp day (week 16-18)

  35. Change in diabetes treatment satisfactory questionnaire, status version (DTSQs) (From 0 (min) to 6 (max), higher scores indicate a better outcome )

    %-point

    Time frame: At Visit 2 (week 0), Visit 3 (week 4), Visit 4 (week 12) and Visit 5 (week 16)

  36. Change in diabetes treatment satisfactory questionnaire, change version (DTSQc) (From -3 (min) to 3 (max), higher scores indicate a better outcome

    %-point

    Time frame: At Visit 3 (week 4) and Visit 5 (week 16)

  37. Change in fasting serum/plasma concentrations of hemoglobin (mmol/L)

    %-point

    Time frame: After four weeks of placebo/colchicine

  38. Change in fasting serum/plasma concentrations of thrombocytes (10^9/L)

    %-point

    Time frame: After four weeks of placebo/colchicine

  39. Change in fasting serum/plasma concentrations of albumin (g/L)

    %-point

    Time frame: After four weeks of placebo/colchicine

  40. Change in fasting serum/plasma concentrations of potassium (mmol/L)

    %-point

    Time frame: After four weeks of placebo/colchicine

  41. Change in fasting serum/plasma concentrations of sodium (mmol/L)

    %-point

    Time frame: After four weeks of placebo/colchicine

  42. Change in fasting serum/plasma concentrations of creatinine (umol/L)

    %-point

    Time frame: After four weeks of placebo/colchicine

  43. Change in fasting serum/plasma concentrations of creatine kinase (U/L)

    %-point

    Time frame: After four weeks of placebo/colchicine

  44. Change in fasting serum/plasma concentrations of estimated glomerular filtration rate (eGFR) (mL/min/1.73 m2)

    %-point

    Time frame: After four weeks of placebo/colchicine

  45. Change in fasting serum/plasma concentrations of alanine aminotransferase (U/L)

    %-point

    Time frame: After four weeks of placebo/colchicine

  46. Change in fasting serum/plasma concentrations of aspartate aminotransferase (U/L)

    %-point

    Time frame: After four weeks of placebo/colchicine

  47. Change in fasting serum/plasma concentrations of bilirubin (umol/L)

    %-point

    Time frame: After four weeks of placebo/colchicine

  48. Change in fasting serum/plasma concentrations of amylase (units/L)

    %-point

    Time frame: After four weeks of placebo/colchicine

  49. Fold difference in fasting serum/plasma concentrations of high-density lipoprotein (HDL) cholesterol (mmol/L)

    Ratio.

    Time frame: After four weeks of placebo/colchicine

  50. Fold difference in fasting serum/plasma concentrations of total cholesterol (mmol/L)

    Ratio.

    Time frame: After four weeks of placebo/colchicine

  51. Fold difference in fasting serum/plasma concentrations of triglycerides (mmol/L)

    Ratio.

    Time frame: After four weeks of placebo/colchicine

  52. in fasting serum/plasma concentrations of lipoprotein (a) (mg/L)

    Ratio.

    Time frame: After four weeks of placebo/colchicine

07

Study locations

1 of 1 sites recruiting
  • Center for Clinical Metabolic Research, Gentofte Hospital, Hellerup, Capital Region 2900
    Gentofte Municipality, 2400, Denmark
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — At this stage, no final decision has been made regarding the sharing of individual participant data (IPD). While sharing de-identified data may contribute to transparency, reproducibility, and collaborative progress in type 1 diabetes and metabolic research, several factors must be considered. These include ethical and legal obligations related to participant confidentiality, the need for appropriate data-use agreements, and institutional policies on data governance. The possibility of sharing IPD will be revisited upon study completion, in alignment with ethical approvals, and journal publication policies.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07247734
Lead sponsor
Asger Lund, MD
Collaborators
University of Copenhagen
Responsible party
Asger Lund, MD (Ass. Professor, MD, PhD, University Hospital, Gentofte, Copenhagen) — Sponsor-investigator
First posted
Nov 25, 2025
Start date
Dec 1, 2025
Primary completion
Dec 22, 2026 (estimated)
Completion
Jun 22, 2027 (estimated)
Last update
Dec 23, 2025

Study contacts

Askee N. Høck, MD
Contact
aske.nicolai.hoeck@regionh.dk
+4561275585
Asger B Lund, MD, PhD
principal investigator · Center for Clinical Metabolic Research, Gentofte Hospital, Denmark

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 1→

Other studies from this sponsor

Asger Lund, MD

Start the discussion