Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44313   clinical trials with a EudraCT protocol, of which   7357   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Effect of colchicine on cardiovascular target organ damage in patients with type 2 diabetes - A randomized placebo-controlled trial

    Summary
    EudraCT number
    		 2021-003525-30
    Trial protocol
    		 DK  
    Global end of trial date
    11 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Oct 2024
    First version publication date
    02 Oct 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    COLCAD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital, Steno Diabetes Center Aarhus
    Sponsor organisation address
    Palle Juul-Jensens Blvd. 11, Aarhus N, Denmark, 8200
    Public contact
    Medical/Steno Aarhus Research Lab, Aarhus University Hospital, Steno Diabetes Center Aarhus, baier@clin.au.dk
    Scientific contact
    Medical/Steno Aarhus Research Lab, Aarhus University Hospital, Steno Diabetes Center Aarhus, baier@clin.au.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Dec 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the effect of colchicine on arterial stiffness assessed as carotid-femoral pulse wave velocity compared to placebo in patients with type 2 diabetes.
    Protection of trial subjects
    Ethical Approval: The trial was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. The study protocol, informed consent forms, and all other study-related documents were reviewed and approved by an independent ethics committee (IEC) or institutional review board (IRB) before the initiation of the trial. Informed Consent: Prior to participation, all subjects were provided with comprehensive information regarding the study’s purpose, procedures, potential risks, and benefits. Written informed consent was obtained from each participant before any study-related procedures were conducted. Participants were informed of their right to withdraw from the study at any time without penalty or loss of benefits to which they were otherwise entitled. Confidentiality: The confidentiality of participants' data was strictly maintained throughout the study. Personal identifiers were replaced with unique codes to protect participants’ identities. Access to the data was restricted to authorized personnel only, and all data handling complied with applicable data protection regulations, including the General Data Protection Regulation (GDPR). Monitoring: The trial was conducted in accordance with Good Clinical practice and was monitored by a local independent GCP-monitoring unit. Any unexpected risks or adverse effects were promptly reported to the IEC/IRB, regulatory authorities, and study participants as necessary. Risk Minimization: The study was designed to minimize risks to participants. Measures included regular monitoring of participants' health, provision of rescue medication or interventions as needed, and pre-specified stopping rules for individual participants or the entire trial in case of significant safety concerns.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    19
    From 65 to 84 years
    81
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The screening process involved identifying potential participants, obtaining informed consent, and assessing eligibility based on inclusion/exclusion criteria through medical history, physical exams, and necessary tests. Ineligible individuals were excluded, and their data were handled confidentially. Only eligible participants proceeded to randomi

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Blinding was implemented by assigning participants to study groups using a computer-generated randomization code, kept confidential by an independent third party. Investigators, participants, and outcome assessors were blinded to group assignments. Colchicine/placeboe were identical in appearance, packaging, and labeling, ensuring that neither participants nor staff could distinguish between them, maintaining blinding integrity throughout the trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Colchicine 0.5 mg once daily
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Colchicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet (0.5 mg) once daily

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo, one tablet once daily

    Number of subjects in period 1
    		Active Placebo
    Started
    50
    50
    Completed
    48
    47
    Not completed
    2
    3
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Colchicine 0.5 mg once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 50 50 100
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 10 9 19
        From 65-84 years
    		 40 41 81
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 70 ( 6 ) 72 ( 7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 7 17
        Male
    		 40 43 83
    History of cardiovascular disease
    Units: Subjects
        Yes
    		 28 35 63
        No
    		 22 15 37
    Current smoking
    Units: Subjects
        Yes
    		 7 5 12
        No
    		 43 45 88
    Renal function stage 1 or 2
    Units: Subjects
        Yes
    		 45 44 89
        No
    		 5 6 11
    Renal function stage 3a
    Units: Subjects
        Yes
    		 5 6 11
        No
    		 45 44 89
    Metformin use
    Units: Subjects
        Yes
    		 44 44 88
        No
    		 6 6 12
    SGLT2i use
    Units: Subjects
        Yes
    		 23 26 49
        No
    		 27 24 51
    GLP-1 RA use
    Units: Subjects
        Yes
    		 22 22 44
        No
    		 28 28 56
    Insulin use
    Units: Subjects
        Yes
    		 13 20 33
        No
    		 37 30 67
    Any lipid lowering agent
    Units: Subjects
        Yes
    		 46 48 94
        No
    		 4 2 6
    Antiplatelet therapy
    Units: Subjects
        Yes
    		 29 33 62
        No
    		 21 17 38
    Anticoagulant
    Units: Subjects
        Yes
    		 7 13 20
        No
    		 43 37 80
    Single antihypertensive agent
    Units: Subjects
        Yes
    		 12 7 19
        No
    		 38 43 81
    Two or more antihypertensive agents
    Units: Subjects
        Yes
    		 38 39 77
        No
    		 12 11 23
    Body mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 29.7 ( 4.8 ) 30.8 ( 4.9 ) -
    Diabetes duration
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 15 (10 to 18) 15 (10 to 20) -
    24 h systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 127 ( 13 ) 126 ( 12 ) -
    24 h diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 76 ( 8 ) 76 ( 7 ) -
    Heart rate
    Units: Beats per minute
        arithmetic mean (standard deviation)
    		 73 ( 14 ) 75 ( 12 ) -
    HbA1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 56 ( 7 ) 56 ( 8 ) -
    LDL Cholesterol
    Units: mmol/l
        median (inter-quartile range (Q1-Q3))
    		 1.5 (1.2 to 1.8) 1.6 (1.2 to 1.9) -
    UACR
    Units: mg/g
        median (inter-quartile range (Q1-Q3))
    		 12 (3 to 90) 16 (5 to 93) -
    hsCRP
    Units: mg/l
        median (inter-quartile range (Q1-Q3))
    		 1.0 (0.4 to 2.3) 0.9 (0.5 to 2.1) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Colchicine 0.5 mg once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Change in MAP-adjusted cfPWV

    		 Close Top of page
    End point title
    		 Change in MAP-adjusted cfPWV
    End point description
    End point type
    Primary
    End point timeframe
    26 weeks
    End point values
    		 Active Placebo
    Number of subjects analysed
    46
    47
    Units: m/s
        arithmetic mean (confidence interval 95%)
    -0.2 (-0.7 to 0.2)
    0.5 (0.0 to 0.9)
    Statistical analysis title
    		 Change in MAP-adjusted cfPWV
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.03
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.1

    Secondary: Change in 24h systolic blood pressure

    		 Close Top of page
    End point title
    		 Change in 24h systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Active Placebo
    Number of subjects analysed
    41
    45
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    -1 (-3 to 2)
    -4 (-6 to -1)
    Statistical analysis title
    		 Change in 24 h systolic blood pressure
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.1
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 6

    Secondary: Change in 24 h diastolic blood pressure

    		 Close Top of page
    End point title
    		 Change in 24 h diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Active Placebo
    Number of subjects analysed
    41
    45
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    -1 (-2 to 1)
    -2 (-4 to -1)
    Statistical analysis title
    		 Change in 24h diastolic blood pressure
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.17
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 3

    Secondary: Change in office systolic BP

    		 Close Top of page
    End point title
    		 Change in office systolic BP
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Active Placebo
    Number of subjects analysed
    48
    47
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    -1 (-5 to 2)
    -9 (-12 to -5)
    Statistical analysis title
    		 Change in systolic office BP
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.005
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 12

    Secondary: Change in office diastolic BP

    		 Close Top of page
    End point title
    		 Change in office diastolic BP
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Active Placebo
    Number of subjects analysed
    48
    47
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    -1 (-3 to 1)
    -4 (-6 to -2)
    Statistical analysis title
    		 change in office diastolic BP
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 5

    Secondary: Percent change in UACR

    		 Close Top of page
    End point title
    		 Percent change in UACR
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Active Placebo
    Number of subjects analysed
    48
    46
    Units: mg/g
        median (inter-quartile range (Q1-Q3))
    17 (10 to 28)
    19 (11 to 31)
    Statistical analysis title
    		 Percent change in UACR
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.98
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.5
         upper limit
    		 40.4

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    May 12 2022 - Jan 29 2024
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 50 (6.00%)
    2 / 50 (4.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Chest pain
    Additional description: Admitted with chest pain - spontaneously resolved
         subjects affected / exposed
    1 / 50 (2.00%)
    2 / 50 (4.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
    Additional description: Admitted with headache and vomiting
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Septic arthritis staphylococcalis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 50 (20.00%)
    11 / 50 (22.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences all number
    2
    2
    Nausea
         subjects affected / exposed
    4 / 50 (8.00%)
    3 / 50 (6.00%)
         occurrences all number
    7
    7
    Vomiting
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences all number
    2
    2
    Diarrhoea
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 50 (6.00%)
         occurrences all number
    4
    4
    Flatulence
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences all number
    2
    2
    Constipation
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Myopathy
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences all number
    2
    2
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 May 2022
    A high-sensitivity C-reactive protein > 2 mg/l was removed as inclusion criterion as of May 2022 due to delayed recruitment. Only one participant had been included prior to this change.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA