Type 1 DiabetesPhase 2REC1TENCT05949281
Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes
A Phase 2 study testing Colchicine 0.5 MG Oral Tablet in people with Type 1 Diabetes and Cardiovascular Diseases, run by Asger Lund, MD at 1 site in Denmark.
Trial summary
The aim of this clinical trial is to evaluate if colchicine in addition to standard of care improves markers of inflammation and cardiovascular disease in persons with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 1 Diabetes, Cardiovascular Diseases, Chronic Inflammation
- What is being tested?
- Colchicine 0.5 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Aug 2023to 15 Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes for more than five years according to World Health Organization criteria
- Age 18-80 years
- Hemoglobin A1c < 80 mmol/mol
- Stable insulin therapy (defined as no change in insulin brand and no newly initiated continous subcutaneus insulin infusion (CSII) or multiple-daily injection (MDI) therapy) and, if applicable, stable usage of glucose monitoring technology (e.g., continous glucose monitor (CGM) or intermittently scanned CGM) ≥ 3 months with either MDI or CSII
- CRP ≥ 2 mg/L (measured by high-sensitivity assay)
- eGFR > 50 mL/min/L/1.73 m^2
- Either stable arteriosclerotic cardiovascular disease (ASCVD) (as defined by ischemic heart disease including previous acute myocardial infarction, acute coronary syndrome and coronary revascularization; other arterial revascularization procedures; stroke and transient ischemic attack; aortic aneurysm; peripheral arterial disease, including carotid atherosclerosis)
- and/or risk of cardiovascular (CV) death > 5 % within 10 years (i.e., high or very high CV risk) as defined by the European Society of Cardiology or 10-year CV risk ≥ 20 % (i.e., high CV risk) as according to 'Steno Type 1 Diabetes Risk Engine' (https://steno.shinyapps.io/T1RiskEngine/)
Who cannot join
- Hypoglycemia unawareness (inability to register low blood glucose) am modum Pedersen-Bjergaard, unless usage of CGM with alarm function
- Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at screening 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 diarrhea
- Pre-existing progressive neuromuscular disease or persons with creatinine kinase levels > three times the upper limit of normal (measured at screening 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
Show all 22Show fewer
- Immunosuppressive therapy or state of chronic immunodeficiency, including infection with human immunodeficiency virus (HIV)
- Blood dyscrasias (e.g., myelodysplastic syndromes or related hematological disorders)
- Leukocyte cell count < 3.0 X 10^9/L
- Thrombocyte count < 110 X 10^9/L
- Systemic (oral or intravenous), long-term steroid therapy (topical or inhaled steroids are allowed)
- Hemodialysis or peritoneal dialysis therapy (since colchicine cannot be removed by dialysis or exchange transfusion)
- Renal or hepatic impairment treated with a P-gp inhibitor or a strong CYP3A4 inhibitor
- Intake of grapefruit juice during trial participation
- Other concomitant disease or treatment that according to the investigator's assessment makes the person unsuitable for study participation
- Alcohol/drug abuse
- Fertile women not using hormonal (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormone intrauterine devices (IUD), hormonal vaginal ring or transdermal hormonal patch), chemical (copper IUD) or mechanical (condom, femidom, sterilization) contraceptives
- Pregnant or nursing women
- On permanent treatment with colchicine that is not discontinued within 30 days of screening visit
- Known or suspected hypersensitivity to colchicine
- Receipt of any investigational drug within 30 days prior to screening visit
- Simultaneous participation in any other clinical intervention trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Capital Region, 2900
About this study
Official title: Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes: A Randomized, Double-blind, Placebo-controlled, Investigator-initiated Trial
The aim of this clinical trial is to evaluate if colchicine in addition to standard of care improves markers of inflammation and cardiovascular disease in persons with type 1 diabetes. Participants will be assigned to either 0,5 mg colchicine daily or placebo in a 1:1 ratio for 26 weeks with the possibility of an additional 26 week extension of the intervention period. After the treatment period, there will a 5-year follow-up on all available outcome measures via electronic patient records for those who took part in the extension.
Read the detailed description
The current study aims to evaluate the efficacy of 0.5 mg colchicine once-daily added to existing standard of care in persons with established type 1 diabetes, existing arteriosclerotic cardiovascular disease (CVD) or at high risk thereof and C-reactive protein (CRP) ≥ 2 mg/L. Specifically, the primary objective is to determine the effect of colchicine (0.5 mg/daily) on levels of CRP (as assessed by high-sensitivity assays) as compared with placebo following 26-52 weeks of treatment. Additionally, the study will investigate the short and long-term effects of colchicine treatment on other markers of CVD and inflammation, markers of metabolism and markers of glycemic control in type 1 diabetes, including glycated hemoglobin (HbA1c), time spent in hypoglycemia (level 1 glucose readings 3.0-3.8 mmol/L and level 2 glucose readings < 3.0 mmol/L), target glycemia (glucose readings 3.9-10 mmol/L) and hyperglycemia (level 1 glucose readings 10.1-13.9 mmol/L and level 2 glucose readings > 13.9 mmol/L) together with measures of glycemic variability evaluated by continuous glucose monitoring (CGM), insulin dosage, risk of hypoglycemia, risk of diabetic ketoacidosis and body weight. During the 5-year follow-up, we will collect all available outcome measures via electronic patient records.
- Being tested
- Colchicine 0.5 MG Oral Tablet, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MG Oral TabletDrug
Also called Colrefuz
Colchicine 0.5 mg once-daily
PlaceboDrug
Placebo tablet once-daily
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Active comparator | Colchicine tablet 0.5 mg once-daily Receives: Drug: Colchicine 0.5 MG Oral Tablet |
| Placebo | Placebo comparator | Placebo tablet once-daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting serum/plasma concentrations of C-reactive protein (CRP) measured by a high-sensitivity assay (hsCRP) (mg/L)
%-point
Measured: From week 0 (baseline) to week 26 (end of treatment)
Secondary outcomes (14)
Change in fasting serum/plasma concentrations of C-reactive protein (CRP) measured by a high-sensitivity assay (hsCRP) (mg/L)
%-point
Measured: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of hemoglobin A1c (mmol/mol)
%-point
Measured: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Time spent in target blood glucose range (3.9 - 10 mmol/L) evaluated by a continous glucose monitor (CGM)
(% of 24 hours)
Measured: From week 0 (baseline) to week 26 (end of treatment) or to 52 weeks (extension)
Time spent in hyperglycemia level 1 (10-13.9 mmol/L) evaluated by a continous glucose monitor (CGM)
(% of 24 hours)
Measured: From week 0 (baseline) to week 26 (end of treatment) or to 52 weeks (extension)
Time spent in hyperglycemia level 2 (> 13.9 mmol/L) evaluated by a continous glucose monitor (CGM)
(% of 24 hours)
Measured: From week 0 (baseline) to week 26 (end of treatment) or to 52 weeks (extension)
Time spent in hypoglycemia level 1 (3.0-3.8 mmol/L) evaluated by a continous glucose monitor (CGM)
(% of 24 hours)
Measured: From week 0 (baseline) to week 26 (end of treatment) or to 52 weeks (extension)
Time spent in hypoglycemia level 2 (< 3.0 mmol/L)evaluated by a continous glucose monitor (CGM)
(% of 24 hours)
Measured: From week 0 (baseline) to week 26 (end of treatment) or to 52 weeks (extension)
Insulin dosage
Number of units/day (both long- and short-acting insulin analogues)
Measured: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in body weight (kg)
%-point
Measured: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in waist:hip ratio
%-point
Measured: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of low-density lipoprotein cholesterol (LDL) (mmol/L)
%-point
Measured: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of interleukin (IL)-6 (pg/mL)
%-point
Measured: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of tumor necrosis factor alpha (pg/mL)
%-point
Measured: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Safety-related events
Serious adverse events (SAE), events of severe hypoglycemia, events of diabetic ketoacidosis
Measured: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start29 Aug 2023
- Primary completion15 Jan 2031 (estimated)
- Study completion15 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asger Lund, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor-investigator, Asger Lund, MD, University Hospital, Gentofte, Copenhagen
- Investigators
- Asger B. Lund, MD, PhD, Principal investigator, Center for Clinical Metabolic Research, Gentofte Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949281
- Sponsor's protocol ID
- 2022-502038-23-00
- Acronym
- REC1TE
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol has previously been published \[DOI: 10.1111/dom.70139\]. De-identified individual participant data will be available from publication of this article indefinitely upon request to the corresponding author from researchers who provide a methodologically sound proposal. To gain access to the data, the researchers will need to sign a data sharing agreement and/or collaborative agreement.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes: A Randomized, Double-blind, Placebo-controlled, Investigator-initiated Trial
- ClinicalTrials.gov ID
- NCT05949281
- Acronym / sponsor ID
- REC1TE / 2022-502038-23-00
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Asger Lund, MDUniversity, hospital or other
- Collaborators
- University of Copenhagen, Juvenile Diabetes Research Foundation
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 15 Jan 2031 (estimated)
- Study completion
- 15 Jan 2031 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial is to evaluate if colchicine in addition to standard of care improves markers of inflammation and cardiovascular disease in persons with type 1 diabetes. Participants will be assigned to either 0,5 mg colchicine daily or placebo in a 1:1 ratio for 26 weeks with the possibility of an additional 26 week extension of the intervention period. After the treatment period, there will a 5-year follow-up on all available outcome measures via electronic patient records for those who took part in the extension.
Detailed description
The current study aims to evaluate the efficacy of 0.5 mg colchicine once-daily added to existing standard of care in persons with established type 1 diabetes, existing arteriosclerotic cardiovascular disease (CVD) or at high risk thereof and C-reactive protein (CRP) ≥ 2 mg/L. Specifically, the primary objective is to determine the effect of colchicine (0.5 mg/daily) on levels of CRP (as assessed by high-sensitivity assays) as compared with placebo following 26-52 weeks of treatment. Additionally, the study will investigate the short and long-term effects of colchicine treatment on other markers of CVD and inflammation, markers of metabolism and markers of glycemic control in type 1 diabetes, including glycated hemoglobin (HbA1c), time spent in hypoglycemia (level 1 glucose readings 3.0-3.8 mmol/L and level 2 glucose readings < 3.0 mmol/L), target glycemia (glucose readings 3.9-10 mmol/L) and hyperglycemia (level 1 glucose readings 10.1-13.9 mmol/L and level 2 glucose readings > 13.9 mmol/L) together with measures of glycemic variability evaluated by continuous glucose monitoring (CGM), insulin dosage, risk of hypoglycemia, risk of diabetic ketoacidosis and body weight. During the 5-year follow-up, we will collect all available outcome measures via electronic patient records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Active comparator | Drug: Colchicine 0.5 MG Oral TabletColchicine tablet 0.5 mg once-daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet once-daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 1 diabetes for more than five years according to World Health Organization criteria
- Age 18-80 years
- Hemoglobin A1c < 80 mmol/mol
- Stable insulin therapy (defined as no change in insulin brand and no newly initiated continous subcutaneus insulin infusion (CSII) or multiple-daily injection (MDI) therapy) and, if applicable, stable usage of glucose monitoring technology (e.g., continous glucose monitor (CGM) or intermittently scanned CGM) ≥ 3 months with either MDI or CSII
- CRP ≥ 2 mg/L (measured by high-sensitivity assay)
Key exclusion criteria (22 listed)
- Hypoglycemia unawareness (inability to register low blood glucose) am modum Pedersen-Bjergaard, unless usage of CGM with alarm function
- Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at screening 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 diarrhea
- Pre-existing progressive neuromuscular disease or persons with creatinine kinase levels > three times the upper limit of normal (measured at screening with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 MG Oral TabletAlso: ColrefuzColchicine 0.5 mg once-daily | Drug | Colchicine |
| PlaceboPlacebo tablet once-daily | Drug | Placebo |
Primary outcome
Change in fasting serum/plasma concentrations of C-reactive protein (CRP) measured by a high-sensitivity assay (hsCRP) (mg/L)
Time frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
14 secondary outcomes
Change in fasting serum/plasma concentrations of C-reactive protein (CRP) measured by a high-sensitivity assay (hsCRP) (mg/L)
Time frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of hemoglobin A1c (mmol/mol)
Time frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Time spent in target blood glucose range (3.9 - 10 mmol/L) evaluated by a continous glucose monitor (CGM)
Time frame: From week 0 (baseline) to week 26 (end of treatment) or to 52 weeks (extension)
Time spent in hyperglycemia level 1 (10-13.9 mmol/L) evaluated by a continous glucose monitor (CGM)
Time frame: From week 0 (baseline) to week 26 (end of treatment) or to 52 weeks (extension)
Time spent in hyperglycemia level 2 (> 13.9 mmol/L) evaluated by a continous glucose monitor (CGM)
Time frame: From week 0 (baseline) to week 26 (end of treatment) or to 52 weeks (extension)
Time spent in hypoglycemia level 1 (3.0-3.8 mmol/L) evaluated by a continous glucose monitor (CGM)
Time frame: From week 0 (baseline) to week 26 (end of treatment) or to 52 weeks (extension)
Time spent in hypoglycemia level 2 (< 3.0 mmol/L)evaluated by a continous glucose monitor (CGM)
Time frame: From week 0 (baseline) to week 26 (end of treatment) or to 52 weeks (extension)
Insulin dosage
Time frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in body weight (kg)
Time frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in waist:hip ratio
Time frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of low-density lipoprotein cholesterol (LDL) (mmol/L)
Time frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of interleukin (IL)-6 (pg/mL)
Time frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of tumor necrosis factor alpha (pg/mL)
Time frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Safety-related events
Time frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. The study protocol has previously been published [DOI: 10.1111/dom.70139]. De-identified individual participant data will be available from publication of this article indefinitely upon request to the corresponding author from researchers who provide a methodologically sound proposal. To gain access to the data, the researchers will need to sign a data sharing agreement and/or collaborative agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asger B. Lund, MD, PhD principal investigator
Center for Clinical Metabolic Research, Gentofte Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine 0.5 MG Oral Tablet in people with Type 1 Diabetes and Cardiovascular Diseases, run by Asger Lund, MD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting serum/plasma concentrations of C-reactive protein (CRP) measured by a high-sensitivity assay (hsCRP) (mg/L) (time frame: From week 0 (baseline) to week 26 (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.