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    Clinical Trial Results:
    Treatment of antipsychotic associated obesity with a GLP-1 Analogue: the TAO study

    Summary
    EudraCT number
    		 2012-005404-17
    Trial protocol
    		 DK  
    Global end of trial date
    13 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2021
    First version publication date
    08 May 2021
    Other versions
    Summary report(s)
    		 1
    2
    3
    4
    5
    6

    Trial information

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    Trial identification
    Sponsor protocol code
    TAO-EX-2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Region Hovedstadens psykiatri
    Sponsor organisation address
    Kristineberg 3, 4., København Ø, Denmark, 2100
    Public contact
    Psychiatric Center Glostrup, Center for Neuropsychiatric Schizophrenia Research, 0045 2613 3832, bebdrup@cnsr.dk
    Scientific contact
    Psychiatric Center Glostrup, Center for Neuropsychiatric Schizophrenia Research, 0045 2613 3832, bebdrup@cnsr.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
    05 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate if 3 months treatment with a GLP-1-analogue can reduce antipsychotic associated obesity in non-diabetic patients with a diagnosis within the schizophrenic spectrum
    Protection of trial subjects
    Full medication compliance was ensured by giving all subsequent injections in the home of the patient.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2013
    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
    Denmark: 45
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    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)
    45
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In short, antipsychotic treated, clinically stable schizophrenia spectrum patients (ICD-10 diagnoses F20.x and F25.x) between 18 and 65 years of age with obesity were recruited from psychiatric clinics in the capital region of Copenhagen, Denmark. Exclusion criteria included diabetes, current substance dependency and pregnancy.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 exenatide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    exenatide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A subcutaneous injection with either exenatide 2 mg (fixed dose) or placebo once-weekly, was administered by unblinded trial personnel

    Arm title
    		 placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo once-weekly injections, was administered by unblinded trial personnel. Placebo injections were solvent from the Bydureon kit (without exenatide).

    Number of subjects in period 1
    		exenatide placebo
    Started
    23
    22
    Completed
    20
    20
    Not completed
    3
    2
         Adverse event, non-fatal
    2
    2
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 45 45
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.4 ( 10.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 21 21

    End points

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    End points reporting groups
    Reporting group title
    exenatide
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Primary: WEIGHT LOSS

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    End point title
    		 WEIGHT LOSS
    End point description
    The primary outcome was loss of body weight after 3 months of treatment with exenatide once-weekly compared to placebo. Patients received no instructions on diet and exercise during the trial. Our power calculation was based on an expected difference in weight loss of 2.5 +/- 2.5 kg in the exenatide group vs 0 +/- 2.5 kg in the placebo group, and showed that, to reach a power of 0.8, a sample size of 16 patients in each group was needed.
    End point type
    Primary
    End point timeframe
    End of trial
    End point values
    		 exenatide placebo
    Number of subjects analysed
    20
    20
    Units: kilogram(s)
        number (confidence interval 95%)
    2.2 (-1.1 to 5.5)
    2.2 (-2.2 to 6.6)
    Statistical analysis title
    		 rmANOVA
    Statistical analysis description
    Primary and secondary outcomes were tested using rmANOVA. The between-subject factor, ie exenatide vs placebo, was denoted “Group,” and the within-subject factor between time points was denoted “Time.” A significant “Time × Group interaction” indicates a difference in response between the two treatment groups.
    Comparison groups
    exenatide v placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded at patient visits by carer. At baseline and once a week for the remainder of the trial.
    Adverse event reporting additional description
    The exenatide group reported more diarrhea (n = 5, 21.7%; P = .02) and fatigue (n = 4, 17.4%; P = .04) compared to 0% in the placebo group . No other differences in adverse events were observed (P values > 0.16). A total of 6 serious adverse events were registered during the trial, but none were regarded as related to trial medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    exenatide
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Serious adverse events
    		 exenatide placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 22 (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
    		 exenatide placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 23 (39.13%)
    2 / 22 (9.09%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 23 (21.74%)
    0 / 22 (0.00%)
         occurrences all number
    5
    0
    Psychiatric disorders
    Fatigue
         subjects affected / exposed
    4 / 23 (17.39%)
    0 / 22 (0.00%)
         occurrences all number
    4
    0
    psychotic deterioation
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1

    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/30745885
    http://www.ncbi.nlm.nih.gov/pubmed/29316175
    http://www.ncbi.nlm.nih.gov/pubmed/28846820
    http://www.ncbi.nlm.nih.gov/pubmed/28260235
    http://www.ncbi.nlm.nih.gov/pubmed/27717222
    http://www.ncbi.nlm.nih.gov/pubmed/24401727
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