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    Clinical Trial Results:
    The effect of Pioglitazone on vascular and ventricular function in people with type 2 diabetes PICCOLA

    Summary
    EudraCT number
    		 2007-001222-27
    Trial protocol
    		 GB  
    Global end of trial date
    01 Apr 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jan 2020
    First version publication date
    31 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EU-IIT-006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00485056
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Alun D Hughes, Imperial College London, a.hughes@imperial.ac.uk
    Scientific contact
    Alun D Hughes, Imperial College London, a.hughes@imperial.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
    01 Apr 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study aims to use a novel, sensitive, non-invasive scanning technique to investigate the effects of insulin-sensitizing agent pioglitazone, on heart and artery function.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2008
    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
    United Kingdom: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    22
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with type 2 diabetes, whose diabetes was not controlled (HbA1c>7.5%) on metformin and/or sulfonylurea, were recruited from General Practices in North West London, UK between 2008 and 2010.

    Pre-assignment
    Screening details
    		 A total of 36 individuals were screened; of these 24 eligible participants were randomized to receive pioglitazone (45 mg/day) or placebo for 12 weeks, followed by 2 weeks washout and then crossed-over onto the alternative treatment.

    Period 1
    Period 1 title
    First intervention
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Pioglitazone
    Arm description
    		 Participants received Pioglitazone for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pioglitazone
    Investigational medicinal product code
    Other name
    Actos
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    45mg/ day for 12 weeks

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo for 12 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Actos
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    12 weeks

    Number of subjects in period 1
    		Pioglitazone Placebo
    Started
    12
    12
    Completed
    11
    10
    Not completed
    1
    2
         Consent withdrawn by subject
    1
    2
    Period 2
    Period 2 title
    Second intervention
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Pioglitazone
    Arm description
    		 Participants crossed-over to receive Pioglitazone for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pioglitazone
    Investigational medicinal product code
    Other name
    Actos
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    45mg/ day for 12 weeks

    Arm title
    		 Placebo
    Arm description
    		 Participants crossed-over to receive placebo for 12 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Actos
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    12 weeks

    Number of subjects in period 2
    		Pioglitazone Placebo
    Started
    11
    10
    Completed
    11
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    First intervention
    Reporting group description
    		 -

    Reporting group values
    		 First intervention Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        Age 18-69
    		 24 24
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.5 ± 11 -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 17 17

    End points

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    End points reporting groups
    Reporting group title
    Pioglitazone
    Reporting group description
    		 Participants received Pioglitazone for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo for 12 weeks
    Reporting group title
    Pioglitazone
    Reporting group description
    		 Participants crossed-over to receive Pioglitazone for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Participants crossed-over to receive placebo for 12 weeks

    Primary: Changes in e'

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    End point title
    		 Changes in e' [1]
    End point description
    The early velocity of the mitral annulus in diastole (e′) measured by tissue Doppler echocardiography
    End point type
    Primary
    End point timeframe
    12 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Linear mixed model analyses, p = 0.02
    End point values
    Number of subjects analysed
    Units: cm/s
        arithmetic mean (confidence interval 95%)
    No statistical analyses for this end point

    Secondary: Changes in E/e`

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    End point title
    		 Changes in E/e`
    End point description
    The ratio of the peak velocity of transmitral blood flow velocity during the early filling phase of left ventricular diastole to the peak mitral annular velocity during the early filling phase of left ventricular diastole measured by Transmitral Doppler flow.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    Number of subjects analysed
    Units: ratio
        arithmetic mean (confidence interval 95%)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    27 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Pioglitazone
    Reporting group description
    		 Participants received Pioglitazone for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo for 12 weeks

    Serious adverse events
    		 Pioglitazone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Pioglitazone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse event reported.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22525343
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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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