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    Clinical Trial Results:
    The impact of Rimonabant in overweight women with prior gestational diabetes

    Summary
    EudraCT number
    		 2007-000907-13
    Trial protocol
    		 AT  
    Global end of trial date
    04 Nov 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jun 2019
    First version publication date
    06 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2007-24-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Prof. Dr. Alexandra Kautzky-Willer , Department of Medicine III, Devision of Endocrinology and Metabolism, alexandra.kautzy-willer@meduniwien.ac.at
    Scientific contact
    Prof. Dr. Alexandra Kautzky-Willer , Department of Medicine III, Devision of Endocrinology and Metabolism, alexandra.kautzy-willer@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
    06 Aug 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Aug 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2008
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Aim of this study is to test the hypothesis that drug therapy with Rimonabant (20 mg/day) for 6 months in overweight women with prior gestational diabetes and impaired glucose tolerance at the postpartum reclassification will i) improve dyslipidemia, insulin sensitivity, beta cell-function and ii) reduce abdominal obesity or body weight and thus iii) convert glucose tolerance or iiii) reduce risk for progression to diabetes and iiiii) will also improve the cardiovascular risk profile compared to age and BMI matched women with prior gestational diabetes but without drug therapy.
    Protection of trial subjects
    Laboratory assessments at the beginning of the study and three and six months after initiation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Dec 2007
    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: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    4
    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)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 30 women will be recruited from the outpatient clinic of the Department of Internal Medicine III, Division of Endocrinology and Metabolism, University Clinic of Vienna.

    Pre-assignment
    Screening details
    		 Inclusion criteria: Age: 20-50 years BMI: >30kg/m2 or 27kg/m2 if additional cardivaskular risk parameters are present: prediabetes or diabetes, metabolic syndrome (WHO-Criteria), lipids: HDL cholesterol: <50mg/dl or triglycerides >150mg/dl Exclusion criteria: kidney or liver disease, any chronic disease, acute or chronic inflammatory disease

    Pre-assignment period milestones
    Number of subjects started
    		 4
    Number of subjects completed
    		 4

    Period 1
    Period 1 title
    Baseline Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Rimonabant Group
    Arm description
    		 Obese women with insulin resistance and/or prediabetes (IGT/IFG), type 2 diabetes or dyslipidemia who have finished lactation will be assigned to therapy with Rimonabant.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Rimonabant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20mg/daily

    Number of subjects in period 1
    		Rimonabant Group
    Started
    4
    Completed
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rimonabant Group
    Reporting group description
    		 Obese women with insulin resistance and/or prediabetes (IGT/IFG), type 2 diabetes or dyslipidemia who have finished lactation will be assigned to therapy with Rimonabant.

    Reporting group values
    		 Rimonabant Group Total
    Number of subjects
    		 4 4
    Age categorical
    AGE 20-50 years
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 4 4
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Rimonabant Group
    Reporting group description
    		 Obese women with insulin resistance and/or prediabetes (IGT/IFG), type 2 diabetes or dyslipidemia who have finished lactation will be assigned to therapy with Rimonabant.

    Primary: reduce weight

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    End point title
    		 reduce weight [1]
    End point description
    End point type
    Primary
    End point timeframe
    baseline - after 3 months - at the end of the study (6 months)
    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: Because of the termination at the initial phase of the trial NO evaluation of the results was possible.
    End point values
    		 Rimonabant Group
    Number of subjects analysed
    0 [2]
    Units: kg
    Notes
    [2] - Because of the early termination of the trial NO evaluation of the results was possible.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    SAE reporting: <24 hours non-serious-AE reporting: 5 calendar days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Frequency threshold for reporting non-serious adverse events: 0%
    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: The study was terminated earlier, because approval of Rimonabant was suspended and the BASG recommended to stop all trials with Rimonabant. During this very short study duration there were NO non-serious adverse events recorded.

    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? Yes
    Date
    Interruption
    Restart date
    04 Nov 2008
    The study was terminated earlier, because approval of Rimonabant (Acomplia) was suspended and the BASG recommended to stop all trials with Rimonabant.
    -

    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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