Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Addition of liraglutide to overweight patients with type 2 diabetes treated with multiple daily insulin injections (MDI) with inadequate glycaemic control

    Summary
    EudraCT number
    		 2012-001941-42
    Trial protocol
    		 SE  
    Global end of trial date
    29 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jun 2021
    First version publication date
    23 Jun 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MDILiraglutid01/2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Västra Götalandsregionen
    Sponsor organisation address
    Fjällvägen 9, Uddevalla, Sweden, 45180
    Public contact
    Uddevalla Hospital, Medicinkliniken, Västra Götalandsregionen, +46 738311742,
    Scientific contact
    Uddevalla Hospital, Medicinkliniken, Västra Götalandsregionen, +46 738311742,
    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 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine whether liraglutide, compared to placebo reduces the HbA1c level for type 2 diabetes patients with inadequate glycaemic control treated with multiple daily insulin injections.
    Protection of trial subjects
    Rescue criteria excisted if patients had very high glucose levels during the trial. Patients were then allowed to recieve other glucose lowering agents than the insulin they were already treated with and Liraglutide/placebo.
    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?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 124
    Worldwide total number of subjects
    124
    EEA total number of subjects
    124
    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)
    70
    From 65 to 84 years
    54
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 February 2013-februray 2014 in Sweden

    Pre-assignment
    Screening details
    		 180 patients Randomiserad

    Period 1
    Period 1 title
    main study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Liraglutide
    Arm description
    		 Recieved Liraglutide as an add on treatment to Insuliin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide was administered once Daily 0,6mmg the first week, 1,2mg the second week and 1,8mg from the third week

    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
    Liraglutide was administered once Daily 0,6mmg the first week, 1,2mg the second week and 1,8mg from the third week

    Number of subjects in period 1
    		Liraglutide Placebo
    Started
    64
    60
    Completed
    63
    60
    Not completed
    1
    0
         Lost to follow-up
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 Recieved Liraglutide as an add on treatment to Insuliin

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Liraglutide Placebo Total
    Number of subjects
    		 64 60 124
    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)
    		 36 34 70
        From 65-84 years
    		 28 26 54
        85 years and over
    		 0 0 0
    Age continuous
    Mean (SD) for each arm
    Units: years
        arithmetic mean (standard deviation)
    		 63.7 ( 8.2 ) 63.5 ( 7.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 20 44
        Male
    		 40 40 80
    Subject analysis sets

    Subject analysis set title
    Full Analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set

    Subject analysis sets values
    		 Full Analysis set
    Number of subjects
    122
    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)
    69
        From 65-84 years
    53
        85 years and over
    0
    Age continuous
    Mean (SD) for each arm
    Units: years
        arithmetic mean (standard deviation)
    63.6 ( 8.0 )
    Gender categorical
    Units: Subjects
        Female
    43
        Male
    79

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 Recieved Liraglutide as an add on treatment to Insuliin

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Full Analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set

    Primary: Change in HbA1c

    		 Close Top of page
    End point title
    		 Change in HbA1c
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to week 24
    End point values
    		 Liraglutide Placebo Full Analysis set
    Number of subjects analysed
    63 [1]
    59 [2]
    122
    Units: HbA1c
        arithmetic mean (standard deviation)
    16.9 ( 10.34 )
    4.6 ( 9.73 )
    12.3 ( 14.1 )
    Notes
    [1] - Liraglutide
    [2] - Placebo
    Statistical analysis title
    		 Ancova
    Comparison groups
    Placebo v Liraglutide
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.8
         upper limit
    		 -8.8
    Variability estimate
    Standard deviation
    Dispersion value
    14.1

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    August -December 2014
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 -

    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Serious adverse events
    		 placebo Liraglutide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 60 (6.67%)
    3 / 64 (4.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Generalised oedema
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hip surgery
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Vitreous detachment
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Cholecystitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 placebo Liraglutide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 60 (20.00%)
    54 / 64 (84.38%)
    Gastrointestinal disorders
    gastrointenstinal
         subjects affected / exposed
    8 / 60 (13.33%)
    30 / 64 (46.88%)
         occurrences all number
    8
    30
    Nausea
         subjects affected / exposed
    1 / 60 (1.67%)
    21 / 64 (32.81%)
         occurrences all number
    1
    21
    Diarrhoea
         subjects affected / exposed
    3 / 60 (5.00%)
    5 / 64 (7.81%)
         occurrences all number
    3
    5

    More information

    		 Close Top of page

    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/26512041
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 26 13:27:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA