Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes (REC1TE)

July 10, 2026 updated by: Asger Lund, MD

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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/)

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Colchicine
Colchicine tablet 0.5 mg once-daily
Drug: Colchicine 0.5 MG Oral Tablet
Colchicine 0.5 mg once-daily
Other Names:
  • Colrefuz
Placebo Comparator: Placebo
Placebo tablet once-daily
Drug: Placebo
Placebo tablet once-daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From week 0 (baseline) to week 26 (end of treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
%-point
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)
%-point
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)
(% of 24 hours)
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)
(% of 24 hours)
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)
(% of 24 hours)
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)
(% of 24 hours)
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)
(% of 24 hours)
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)
Number of units/day (both long- and short-acting insulin analogues)
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)
%-point
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)
%-point
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)
%-point
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)
%-point
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)
%-point
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)
Serious adverse events (SAE), events of severe hypoglycemia, events of diabetic ketoacidosis
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change left ventricular (LV) mass index evaluated by cardiovascular ultrasonography (g/m^2)
Time Frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
From week 0 (baseline) to week 26 (end of treatment)
Change left ventricular (LV) septal wall thickness evaluated by cardiovascular ultrasonography (mm)
Time Frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
From week 0 (baseline) to week 26 (end of treatment)
Change left ventricular (LV) posterior wall thickness evaluated by cardiovascular ultrasonography (mm)
Time Frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
From week 0 (baseline) to week 26 (end of treatment)
Change left ventricular (LV) ejection fraction (LVEF) evaluated by cardiovascular ultrasonography (%)
Time Frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
From week 0 (baseline) to week 26 (end of treatment)
Change ratio of peak velocity blood flow from left ventricular relaxation in early diastole (E) to peak velocity flow in late diastole caused by atrial contraction (A) (E/A ratio) evaluated by cardiovascular ultrasonography
Time Frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
From week 0 (baseline) to week 26 (end of treatment)
Change early diastolic mitral inflow velocity (e') evaluated by cardiovascular ultrasonography (m/sec)
Time Frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
From week 0 (baseline) to week 26 (end of treatment)
Change ratio of early diastolic mitral inflow velocity (e') to early diastolic mitral annulus velocity (E) (E/e' ratio) evaluated by cardiovascular ultrasonography
Time Frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
From week 0 (baseline) to week 26 (end of treatment)
Change ratio of early mitral inflow velocity (E) to global diastolic strain rate (e' sr) (E/e'sr ratio) evaluated by cardiovascular ultrasonography
Time Frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
From week 0 (baseline) to week 26 (end of treatment)
Change left atrial volume (LAVi) evaluated by cardiovascular ultrasonography (mL)
Time Frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
From week 0 (baseline) to week 26 (end of treatment)
Change global longitudinal strain (GLS) evaluated by cardiovascular ultrasonography (%)
Time Frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
From week 0 (baseline) to week 26 (end of treatment)
Change aortic distensibility evaluated by cardiovascular ultrasonography (mmHg^-1)
Time Frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
From week 0 (baseline) to week 26 (end of treatment)
Change aortic strain evaluated by cardiovascular ultrasonography (%)
Time Frame: From week 0 (baseline) to week 26 (end of treatment)
%-point
From week 0 (baseline) to week 26 (end of treatment)
Change in fasting serum/plasma concentrations of fibrinogen (µmol/L)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of serum amyloid A (mg/L)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of haptoglobin (g/L)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of interleukin (IL)-1β (pg/mL)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of interleukin (IL)-2 (pg/mL)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of intercellular adhesion molecule 1 (ICAM-1) (pg/mL)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of vascular cell adhesion molecule 1 (VCAM-1) (pg/mL)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of total leukocyte count, including neutrophil, lymphocyte, basophil and eosinophil counts (10^9/L)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in neutrophil:lymphocyte ratio
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of very low-density lipoprotein (VLDL) cholesterol (mmol/L)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of high-density lipoprotein (HDL) cholesterol (mmol/L)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of total cholesterol (mmol/L)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to 56 weeks (extension)
Change in fasting serum/plasma concentrations of triglycerides (mmol/L)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to week 56 (extension)
Change in fasting serum/plasma concentrations of lipoprotein (a) (mg/L)
Time Frame: From week 0 (baseline) to week 30 (safety follow-up) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (safety follow-up) or to week 56 (extension)
Change in thrombocyte function measured by thromboelastography
Time Frame: From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
%-point
From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
Change in fasting serum/plasma concentrations of N-terminal pro-brain natriuretic peptide (pro-BNP) (pmol/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in consultation blood pressure (mmHg)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in heart rate (beats/minute)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of estimated glomerular filtration rate (eGFR) (mL/min/1.73 m2)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of albumin (g/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in urine albumin-to-creatinine ratio (mg/g)
Time Frame: From week 0 (baseline) to week 26 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 26 (end of treatment) or to week 56 (extension)
Change in mean glucose evaluated by a continous glucose monitor (mmol/L)
Time Frame: From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
%-point
From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
Change in standard deviation evaluated by a continous glucose monitor (mmol/L)
Time Frame: From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
%-point
From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
Change in coefficient of variance evaluated by a continous glucose monitor (> 0.36 defined as glycemic variability)
Time Frame: From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
%-point
From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
Change in glycemic variability (continuous overall net glycemic action (CONGA)) evaluated by a continous glucose monitor
Time Frame: From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
%-point
From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
Change in mean amplitude of glycemic excursion evaluated by a continous glucose monitor
Time Frame: From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
%-point
From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
Change in diabetes treatment satisfactory questionnaire, status version (DTSQs) (From 0 (min) to 6 (max), higher scores indicate a better outcome )
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in diabetes treatment satisfactory questionnaire, change version (DTSQc) (From -3 (min) to 3 (max), higher scores indicate a better outcome)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in audit of diabetes-dependent quality of life questionnaire (ADDQoL) (From -9 (min) to 9 (max), higher scores indicate a better outcome )
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of ketones (mmol/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Adverse events
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
As reported by participants
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in liver fat content as per the CAP score (dB/m) measured by FibroScan®
Time Frame: From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
%-point
From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
Change in liver fibrosis score (kPa) measured by FibroScan®
Time Frame: From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
%-point
From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
Change in fibrosis-4 (FIB-4) score (numerical scale, higher scores indicate a higher risk of fibrosis)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fatty liver index (FLI) score (numerical scale, higher scores indicate a higher risk of fibrosis)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of hemoglobin (mmol/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of thrombocytes (10^9/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of glucose (mmol/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of potassium (mmol/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of sodium (mmol/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of creatinine (umol/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of alanine aminotransferase (U/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of aspartate aminotransferase (U/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of bilirubin (umol/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of amylase (units/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of creatine kinase (U/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of C-peptide (pmol/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of glucagon (pmol/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of C-terminal telopeptide (ng/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in fasting serum/plasma concentrations of procollagen type 1 N-terminal propeptide (ng/L)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in body composition by bioimpedance analysis
Time Frame: From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
%-point (fat free mass, total fat mass, muscle mass, bone mass)
From week 0 (baseline) to week 26 (end of treatment) or to week 52 (extension)
Change in body mass index (kg/m^2)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in waist circumference (cm)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in hip circumference (cm)
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in waist:hip ratio
Time Frame: From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 30 (end of treatment) or to week 56 (extension)
Change in interleukin messenger ribonucleic acid (mRNA) expression measured by quantitative polymerase chain reaction
Time Frame: From week 0 (baseline) to week 26 (end of treatment) or to week 56 (extension)
%-point
From week 0 (baseline) to week 26 (end of treatment) or to week 56 (extension)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asger Lund, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Juvenile Diabetes Research Foundation
University of Copenhagen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Asger B. Lund, MD, PhD, Center for Clinical Metabolic Research, Gentofte Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-502038-23-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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