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New treatment option for Type 1 Diabetes
Official title The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation
ClinicalTrials.gov ID: NCT07247734
What this study is testing
What is Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks?
Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks is an investigational medicine, being studied as a potential treatment for type 1 diabetes.
Also referred to as Colrefuz.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
You likely can't join if
- Hypoglycaemia unawareness (inability to register low blood glucose) ad modum Pedersen-Bjergaard, 24 unless the individual uses a continuous glucose...
- Liver disease with elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal (measured at screening visit with the...
- 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...
- Cancer or lymphoproliferative disease unless in complete remission for \> 5 years
See the full eligibility 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...
- 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)\ \
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gentofte Municipality, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gentofte Municipality, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.