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    Clinical Trial Results:
    The effects of GLP-1 in Maturity- onset diabetes of the young (MODY)

    Summary
    EudraCT number
    		 2012-000592-17
    Trial protocol
    		 DK  
    Global end of trial date
    23 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2021
    First version publication date
    03 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MODY-TREAT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01610934
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Diabetes Research Division
    Sponsor organisation address
    Niels Andersens vej , Gentofte, Denmark, 2820
    Public contact
    Clinical trials information, Signe H. Østoft, Diabetes Research Division, +45 21230343, s.ostoft@dadlnet.dk
    Scientific contact
    Clinical trials information, Signe H. Østoft, Diabetes Research Division, +45 21230343, s.ostoft@dadlnet.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
    23 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study is to investigate long term (6 weeks) effects of liraglutide compared to glimepiride on Fasting Plasma Glucose in patients with MODY3 in a double-blind, randomised cross-over trial.
    Protection of trial subjects
    No specific measures, besides blood glucose monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 Glimepiride was at that time standard treatment for MODY patients, but with high risk of hypoglycaemia. Liraglutide (GLP-1 RA) was chosen due to low risk of hypoglycaemia.
    Actual start date of recruitment
    01 Aug 2012
    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
    Denmark: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    13
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited in the period of Aug 2012-May 2013. All patients recruited in Denmark.

    Pre-assignment
    Screening details
    		 Patients were screened at a pre-treatment evaluation according to in- and exclusion criteria. Eligible pt's had 1 week wash-out before starting trial medication. Cross-over design with 2 weeks washout efore corssing over.

    Period 1
    Period 1 title
    Full trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Double blinded double dummy cross-over design. Glimepiride covered in capsules and liraglutide with placebo from company. Unblinding only after data analysis.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Sulphonylurea (SU)
    Arm description
    		 Pt's treated with glimepiride (SU)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    glimepiride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose according to blood glucose response (Titration). Glimepiride/placebo is administered orally (glimepirid, tablet ½ mg and 1 mg).

    Arm title
    		 GLP-1 RA
    Arm description
    		 Pt's treated with liraglutide (GLP-1 RA)
    Arm type
    		 Experimental

    Investigational medicinal product name
    liraglutide
    Investigational medicinal product code
    Other name
    Victoza
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Victoza®/placebo is administered subcutaneously one time daily in the entire treatment period (Day 8­‐49/57­‐98) and up­‐titrated as follows: Day8-­14/57‐63: 0.6 mg Victoza®/placebo; Day 15-­21/64-­70: 1.2mg Victoza/placebo; Day 22-­49/71-­98: 1.8 mg Victoza®/placebo). Patients who, due to adverse events, do not tolerate up­‐titration to1.8 mg liraglutide will remain on 1.2 mg of liraglutide. The patients are instructed in injection technique.

    Arm title
    		 Baseline
    Arm description
    		 16 patients entered the baseline period before being randomised to SU or GLP-1RA in a cross-over design.
    Arm type
    		 Baseline

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Sulphonylurea (SU) GLP-1 RA Baseline
    Started
    15
    15
    15
    Completed
    15
    15
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Full trial
    Reporting group description
    		 16 patients entered a cross-over study, being their own control. One patient dropped out due to side effects to liraglutide (vomiting/diarrhea). Therefore data is reported on 15 patients in cross-over design (30 in total)

    Reporting group values
    		 Full trial Total
    Number of subjects
    		 15 15
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 13 13
        From 65-84 years
    		 2 2
    Age continuous
    Units: years
        log mean (standard deviation)
    		 38.9 ( 16.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Sulphonylurea (SU)
    Reporting group description
    		 Pt's treated with glimepiride (SU)

    Reporting group title
    GLP-1 RA
    Reporting group description
    		 Pt's treated with liraglutide (GLP-1 RA)

    Reporting group title
    Baseline
    Reporting group description
    		 16 patients entered the baseline period before being randomised to SU or GLP-1RA in a cross-over design.

    Primary: Fasting PLasma Glucose (FPG)

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    End point title
    		 Fasting PLasma Glucose (FPG)
    End point description
    End point type
    Primary
    End point timeframe
    FPG was meassured at 3 clinic visists: at baseline, and in the end of each treatment period (after 6 weeks treatment with glimepiride and liraglutide resp.)
    End point values
    		 Sulphonylurea (SU) GLP-1 RA Baseline
    Number of subjects analysed
    15 [1]
    15 [2]
    15
    Units: mmol/L
        log mean (standard error)
    7.2 ( 0.6 )
    8.2 ( 0.8 )
    9.9 ( 0.8 )
    Attachments
    		 Publication MODY-TREAT
    MODY-TREAT protocol
    MODY-TREAT Plasma Glucose
    Notes
    [1] - 16 subj were treated with glimepiride. 1 subj withdrew on liraglutide. Data reported on 15 subj.
    [2] - 16 subj were treated with glimepiride. 1 subj withdrew on liraglutide. Data reported on 15 subj.
    Statistical analysis title
    		 Linear mixed-effect modeling
    Statistical analysis description
    Linear mixed-effect modeling was used for analysis of repeated measures using R statistical software. Data were transformed according to distribution pattern. A “top-down” modeling strategy, with family identity as random variable, was used. A homogeneous or heterogeneous residual variance structure was chosen according to likelihood ratios. Bonferroni adjustments were used as post hoc analysis. Values are expressed as mean +/- SEM.
    Comparison groups
    Sulphonylurea (SU) v GLP-1 RA
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.05 [4]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [3] - Each treatment was compared with baseline, and not with eachother, from repeated-measures ANOVA for variations between treatments and baseline.
    [4] - Differences resulting in P-values < 0.05 were considered significant.

    Secondary: Fructosamine

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    End point title
    		 Fructosamine
    End point description
    End point type
    Secondary
    End point timeframe
    Fructosamine was measured 3 times: at baseline and in the end of each treatment period (glimepiride and liraglutide respectively)
    End point values
    		 Sulphonylurea (SU) GLP-1 RA Baseline
    Number of subjects analysed
    15
    15
    15
    Units: micromole(s)/litre
        log mean (standard error)
    273 ( 14 )
    296 ( 20 )
    294 ( 16 )
    Attachments
    		 Untitled (Filename: MODY-TREAT Fructosamine BL Glime Lira_EuDraCT.xlsx)
    Statistical analysis title
    		 Linear mixed-effect modelling
    Statistical analysis description
    Linear mixed-effect modeling was used for analysis of repeated measures using R statistical software. Data were transformed according to distribution pattern. A “top-down” modeling strategy, with family identity as random variable, was used. A homogeneous or heterogeneous residual variance structure was chosen according to likelihood ratios. Bonferroni adjustments were used as post hoc analysis. Values are expressed as mean +/- SEM.
    Comparison groups
    Sulphonylurea (SU) v GLP-1 RA
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.05 [6]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [5] - Each treatment was compared with baseline, and not with eachother, from repeated-measures ANOVA for variations between treatments and baseline.
    [6] - P-values <0.05 were considered significant.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE's were assessed in the full trial period from Aug-01-2012 to Aug-23-2013.
    Adverse event reporting additional description
    A total of 23 AEs were reported, consisting of primarily events of hypoglycaemia (19 reports). Other reported events: Tiredness (1 report), reduced appetite (2 reports), heartburn (1 report), nausea (1 report) and vomiting/diarrhea (1 report). All the reported AEs were estimated as related to the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Local hospital
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Glimepiride
    Reporting group description
    		 -

    Reporting group title
    liraglutide
    Reporting group description
    		 -

    Serious adverse events
    		 Glimepiride liraglutide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (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
    		 Glimepiride liraglutide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 15 (66.67%)
    1 / 15 (6.67%)
    Endocrine disorders
    Hypoglycaemia
    Additional description: Totally 19 events of hypoglycaemia were reported. All were mild. 17 events with BG 3.2-3.9 mM; 2 events with BG 2.0-3.0 mM. 3 episodes in 1 patient on liraglutide. 16 events in patients on glimepiride.
         subjects affected / exposed
    10 / 15 (66.67%)
    1 / 15 (6.67%)
         occurrences all number
    16
    3

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24929431
    http://www.ncbi.nlm.nih.gov/pubmed/25953829
    http://www.ncbi.nlm.nih.gov/pubmed/24677712
    http://www.ncbi.nlm.nih.gov/pubmed/26324089
    http://www.ncbi.nlm.nih.gov/pubmed/14575972
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