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    Clinical Trial Results:
    Metformin and its Effects on Myocardial Dimension and Left ventricular hypertrophy in normotensive patients with Coronary Artery Disease.

    Summary
    EudraCT number
    		 2014-003189-26
    Trial protocol
    		 GB  
    Global end of trial date
    30 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jul 2019
    First version publication date
    03 Jul 2019
    Other versions
    Summary report(s)
    		 Manuscript

    Trial information

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    Trial identification
    Sponsor protocol code
    Version 5.4
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02226510
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sponsor Reference: 2013CV08
    Sponsors
    Sponsor organisation name
    University of Dundee
    Sponsor organisation address
    Nethergate, Dundee, United Kingdom,
    Public contact
    Dr Stephen McSwiggan, University of Dundee, Tayside Clinical Trials Unit, 01382 383233, s.j.mcswiggan@dundee.ac.uk
    Scientific contact
    Dr Stephen McSwiggan, University of Dundee, Tayside Clinical Trials Unit, 01382 383233, s.j.mcswiggan@dundee.ac.uk
    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
    30 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal research question is to find out if metformin can cause regression of left ventricular hypertrophy (LVH) in participants with coronary artery heart disease (CAD) who are insulin resistant/pre-diabetes and on optimal current evidence based therapy for CAD.
    Protection of trial subjects
    The CI and study staff involved with this study will comply with the requirements of the Data Protection Act 1998 with regard to the collection, storage, processing and disclosure of personal information and will uphold the Act’s core principles. Access to collated participant data will be restricted to those clinicians treating the participants. Computers used to collate the data will have limited access measures via user names and passwords. Published results will not contain any personal data that could allow identification of individual participants. All the participants were clinically periodically monitored while in the study. Any AE's and SAE's were reported to the pharmacovigilance department of the sponsor and ensured all was resolved.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 68
    Worldwide total number of subjects
    68
    EEA total number of subjects
    68
    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)
    31
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 187 subjects were screened between March 2014 and September 2016 from Tayside, Scotland and 68 patients who full filled eligibility criteria were recruited in the study

    Pre-assignment
    Screening details
    		 187 subjects were screened between March 2014 and September 2016 from Tayside, Scotland, using research databases, hospital records, and local general practices.

    Period 1
    Period 1 title
    April 2014 -September 2016 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Metformin Arm
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg bid

    Arm title
    		 Placebo Arm
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg bid

    Number of subjects in period 1
    		Metformin Arm Placebo Arm
    Started
    34
    34
    Completed
    31
    32
    Not completed
    3
    2
         Consent withdrawn by subject
    1
    -
         Physician decision
    1
    -
         Unable to undergo MRI due to claustrophobia
    1
    -
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Metformin Arm
    Reporting group description
    		 -

    Reporting group title
    Placebo Arm
    Reporting group description
    		 -

    Reporting group values
    		 Metformin Arm Placebo Arm Total
    Number of subjects
    		 34 34 68
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 18 16 34
        From 65-84 years
    		 16 18 34
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 11 16
        Male
    		 29 23 52

    End points

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    End points reporting groups
    Reporting group title
    Metformin Arm
    Reporting group description
    		 -

    Reporting group title
    Placebo Arm
    Reporting group description
    		 -

    Primary: Baseline LVMI

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    End point title
    		 Baseline LVMI
    End point description
    Change in Left Ventricular Mass Index
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Metformin Arm Placebo Arm
    Number of subjects analysed
    31
    32
    Units: 47.3
        number (not applicable)
    48.7
    46
    Statistical analysis title
    		 METREMODEL SAP
    Comparison groups
    Metformin Arm v Placebo Arm
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.5
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire duration of study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Metformin Arm
    Reporting group description
    		 -

    Reporting group title
    Placebo Arm
    Reporting group description
    		 -

    Serious adverse events
    		 Metformin Arm Placebo Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 31 (19.35%)
    4 / 32 (12.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Metformin Arm Placebo Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 31 (61.29%)
    15 / 32 (46.88%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    15 / 31 (48.39%)
    3 / 32 (9.38%)
         occurrences all number
    15
    3
    Flatulence
         subjects affected / exposed
    8 / 31 (25.81%)
    2 / 32 (6.25%)
         occurrences all number
    8
    2
    Abdominal discomfort
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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    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.

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