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    Clinical Trial Results:
    The impact of free fatty acid (FFA-) suppression on myocardial lipids and function in patients with type 2 diabetes

    Summary
    EudraCT number
    		 2013-002656-32
    Trial protocol
    		 AT  
    Global end of trial date
    04 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Aug 2020
    First version publication date
    21 Aug 2020
    Other versions
    Summary report(s)
    		 Healthy
    Diabetes

    Trial information

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    Trial identification
    Sponsor protocol code
    HYPOTESIS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Wien
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Yvonne Winhofer, MUW, Univ.Klinik für Innere Medizin III, Abt.f.Endokrinologie und Stoffwechsel, 0043 1404004311, yvonne.winhofer@meduniwien.ac.at
    Scientific contact
    Yvonne Winhofer, MUW, Univ.Klinik für Innere Medizin III, Abt.f.Endokrinologie und Stoffwechsel, 0043 1404004311, yvonne.winhofer@meduniwien.ac.at
    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
    04 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Changes in myocardial lipids and function related to suppression of free fatty acids
    Protection of trial subjects
    constant supervision by physician
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jul 2013
    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
    Austria: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    16
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was performed by local advertisement in the diabetes outpatient department

    Pre-assignment
    Screening details
    		 Patients were recruited from the diabetes outpatient’s service at the Medical University of Vienna

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Myocardial Lipid Content Acipimox-Diabetes
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Acipimox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2x250 mg (0 minutes and 180 minutes)

    Arm title
    		 Hypoglycemia with Acipimox-Healthy
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Acipimox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2x250 mg (0 minutes and 180 minutes)

    Number of subjects in period 1
    		Myocardial Lipid Content Acipimox-Diabetes Hypoglycemia with Acipimox-Healthy
    Started
    8
    10
    Completed
    8
    9
    Not completed
    0
    1
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Myocardial Lipid Content Acipimox-Diabetes
    Reporting group description
    		 -

    Reporting group title
    Hypoglycemia with Acipimox-Healthy
    Reporting group description
    		 -

    Reporting group values
    		 Myocardial Lipid Content Acipimox-Diabetes Hypoglycemia with Acipimox-Healthy Total
    Number of subjects
    		 8 10 18
    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)
    		 6 10 16
        From 65-84 years
    		 2 0 2
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 0 2
        Male
    		 6 10 16
    Subject analysis sets

    Subject analysis set title
    Normoglycemia with Acipimox-Healthy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Normoglycemia with Acipimox-Healthy

    Subject analysis set title
    Myocardial Lipid Content Acipimax-Diabetes
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Myocardial Lipid Content-Diabetes

    Subject analysis set title
    Normoglycemia with Placebo-Healthy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Normoglycemia with Placebo-Healthy

    Subject analysis set title
    Hypoglycemia with Acipimox-Healthy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Hypoglycemia with Acipimox-Healthy

    Subject analysis set title
    Hypoglycemia with Placebo-Healthy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Hypoglycemia with Placebo-Healthy

    Subject analysis set title
    Myocardial Lipid Content Placebo-Diabetes
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Myocardial Lipid Content Placebo-Diabetes

    Subject analysis sets values
    		 Normoglycemia with Acipimox-Healthy Myocardial Lipid Content Acipimax-Diabetes Normoglycemia with Placebo-Healthy Hypoglycemia with Acipimox-Healthy Hypoglycemia with Placebo-Healthy Myocardial Lipid Content Placebo-Diabetes
    Number of subjects
    10
    8
    10
    10
    10
    8
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    10
    6
    10
    10
    10
    6
        From 65-84 years
    2
    2
        85 years and over
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    2
        Male
    10
    6

    End points

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    End points reporting groups
    Reporting group title
    Myocardial Lipid Content Acipimox-Diabetes
    Reporting group description
    		 -

    Reporting group title
    Hypoglycemia with Acipimox-Healthy
    Reporting group description
    		 -

    Subject analysis set title
    Normoglycemia with Acipimox-Healthy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Normoglycemia with Acipimox-Healthy

    Subject analysis set title
    Myocardial Lipid Content Acipimax-Diabetes
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Myocardial Lipid Content-Diabetes

    Subject analysis set title
    Normoglycemia with Placebo-Healthy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Normoglycemia with Placebo-Healthy

    Subject analysis set title
    Hypoglycemia with Acipimox-Healthy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Hypoglycemia with Acipimox-Healthy

    Subject analysis set title
    Hypoglycemia with Placebo-Healthy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Hypoglycemia with Placebo-Healthy

    Subject analysis set title
    Myocardial Lipid Content Placebo-Diabetes
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Myocardial Lipid Content Placebo-Diabetes

    Primary: myocardial lipid content - Acipimox-Diabetes

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    End point title
    		 myocardial lipid content - Acipimox-Diabetes
    End point description
    End point type
    Primary
    End point timeframe
    480 minutes after Acipimox or placebo
    End point values
    		 Myocardial Lipid Content Acipimax-Diabetes Myocardial Lipid Content Placebo-Diabetes
    Number of subjects analysed
    8
    8
    Units: % of water signal
        arithmetic mean (standard deviation)
    0.32 ± 0.1
    0.48 ± 0.2
    Statistical analysis title
    		 Anova
    Comparison groups
    Myocardial Lipid Content Acipimax-Diabetes v Myocardial Lipid Content Placebo-Diabetes
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 5
    Method
    		 ANOVA
    Confidence interval

    Primary: hypoglycemia with placebo – healthy

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    End point title
    		 hypoglycemia with placebo – healthy
    End point description
    End point type
    Primary
    End point timeframe
    0 - 405 min
    End point values
    		 Normoglycemia with Acipimox-Healthy Normoglycemia with Placebo-Healthy Hypoglycemia with Acipimox-Healthy Hypoglycemia with Placebo-Healthy
    Number of subjects analysed
    10
    10
    10
    10
    Units: change in myocardial lipids %
        median (confidence interval 95%)
    48.5 (28.5 to 62.9)
    15.2 (1.8 to 28.3)
    40.5 (13.7 to 58.9)
    6.1 (3.7 to 15.7)
    Statistical analysis title
    		 Anova
    Comparison groups
    Normoglycemia with Acipimox-Healthy v Normoglycemia with Placebo-Healthy v Hypoglycemia with Acipimox-Healthy v Hypoglycemia with Placebo-Healthy
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 5
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Study day, 0- 480 min
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    healthy subjects
    Reporting group description
    		 healthy subjects

    Reporting group title
    Typ-2 diabetes
    Reporting group description
    		 Typ-2 diabetes

    Serious adverse events
    		 healthy subjects Typ-2 diabetes
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (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: 5%
    Non-serious adverse events
    		 healthy subjects Typ-2 diabetes
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (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: During to the short exposure/observation time (7h) no non-serious or serious adverse events occurred.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2013
    According to our preliminary analyses there is evidence that inhibition of FFA-release by acipimox is associated with a significant decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as a marker of systolic left ventricular function) in healthy subjects, indicating, that the heart is dependent on a constant supply of free fatty acids in order to guarantee normal cardiac function, and it further indicates, that the heart is not able to cover its energy demand by switching to glucose oxidation. Since that phenomenon, better known as “metabolic inflexibility” has been mainly described in patients with diabetes, the aim of the current study extension/amendment is to investigate the impact of FFA-inhibition on MYCL and cardiac function in patients with diabetes. Therefore, up to 14 patients with type 2 diabetes will be asked to participate in this study, which includes 2 study days. On each study day patients will start at 7 a.m. in the morning with the first MR-examination, which will be repeated after 180 and 420 minutes as well as after 24 hours. They will receive acipimox (orally) at 0 and 180 minutes. Blood samples for the measurement of glucose, free fatty acids, insulin, C-peptide and proBNP will be taken every 30 minutes. At fasting, additional blood samples will be taken for the measurement of HbA1C, cholesterol, HDL and LDL. Blood glucose excursions (hyperglycemia, hypoglycemia) will be corrected by a short acting insulin (according to routine care) or oral glucose administration.

    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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