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    Clinical Trial Results:
    Effect of liraglutide on physical performance: a randomised, double-blind, controlled study in patiens with type 2 diabetes.

    Summary
    EudraCT number
    		 2012-005197-63
    Trial protocol
    		 ES  
    Global end of trial date
    31 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jun 2022
    First version publication date
    27 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    U1111-1128-8762
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1128-8762
    Sponsors
    Sponsor organisation name
    Complejo Hospitalario Universitario Insular Materno-Infantil
    Sponsor organisation address
    Av Marítima s/n, Las Palmas, Spain, 35016
    Public contact
    David Valido, CRAnarias Investigación y Desarrollo, S.L., david.valido@cranarias.com
    Scientific contact
    Ana M Wägner, Complejo Hospitalario Universitario Insular Materno-Infantil, awagfah@gobiernodecanarias.org
    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
    27 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this trial is to assess the effect of a GLP1 agonist on clinically relevant measures of myocardial function.
    Protection of trial subjects
    In patients with an HbA1c above 8% at the 3-month visit, one dose of insulin may be started (at 0.1-0.2 ui/Kg, and adjusted to achieve morning/pre-dinner glycaemic concentrations between 70-130mg/dl) in those not receiving insulin already, if lifestyle measures cannot be improved. In those participants receiving insulin treatment already, its dose will be adjusted to achieve the mentioned glycaemic target. An additional intermediate or long-acting insulin injection may be prescribed if deemed necessary in those patients treated with one injection only. Concomitant oral agents will not be modified during the duration of the trial unless hypoglycaemia occurs.
    Background therapy
    		 Metformin if tolerated and not contraindicated, a maximum of 2 intermediate-long acting insulin injections per day or a combination of both
    Evidence for comparator
    		 Patients with type 2 diabetes with insufficient glycaemic control despite treatment with lifestyle measures, oral treatments including metformin and/or 1-2 intermediate or long-acting insulin injections. Previous studies assessing the effects of GLP1 on heart function have been performed in patients with clinically significant ischaemia (Nikolaidis et al 2004, Read et al 2011). To our knowledge, no equivalent reports are available which have been performed in the average patient receiving GLP1 agonists.
    Actual start date of recruitment
    20 Jun 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
    Spain: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    21
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited at one single centre, a university hospital, mostly from the Endocrinology outpatient clinic, if they fulfilled the inclusion criteria Type 2 diabetes on oral agents (including metformin if tolerated and not contraindicated), a maximum of 2 intermediate-long acting insulin injections per day or a combination HbA1c 7-10%

    Pre-assignment
    Screening details
    		 Patients will be assessed at a screening visit, after having received oral information and having signed a written informed consent. If they fulfill all of the inclusion criteria and none of the exclusion criteria, a baseline visit will be performed within one month of the screening visit and randomisation will proceed.

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer
    Blinding implementation details
    Both the active drug and the identically-looking placebo were provided by Novo Nordisk in pre-filled injection pens. Neither the patient nor the investigators were aware of the content of the injections. Novo Nordisk sent the computer-generated randomisation code to the unblinded pharmacist and she arranged study drug dispensation according to randomisation. Sealed, sequentially numbered, opaque containers with information about the assigned treatment were provided by Novo Nordisk

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 Liraglutide 1.8 mg vs placebo administered once daily injection for 26 weeks. Liraglutide 1.8 mg, will be administered subcutaneously, from a pre-filled, multidose, injection pen, containing 3 ml (18mg) of liraglutide at a concentration of 6mg/ml. The same volume of placebo, from an identical pre-filled, injection pen, will be administered to the control group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Victoza
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide 1.8 mg, administered subcutaneously, from a pre-filled, multidose, injection pen, containing 3 ml (18mg) of liraglutide at a concentration of 6mg/ml.

    Arm title
    		 Placebo
    Arm description
    		 COntrol arm
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Identical to experimental group

    Number of subjects in period 1
    		Intervention Placebo
    Started
    12
    12
    Completed
    11
    10
    Not completed
    1
    2
         Adverse event, non-fatal
    1
    -
         Fear of adverse events
    -
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Liraglutide 1.8 mg vs placebo administered once daily injection for 26 weeks. Liraglutide 1.8 mg, will be administered subcutaneously, from a pre-filled, multidose, injection pen, containing 3 ml (18mg) of liraglutide at a concentration of 6mg/ml. The same volume of placebo, from an identical pre-filled, injection pen, will be administered to the control group.

    Reporting group title
    Placebo
    Reporting group description
    		 COntrol arm

    Reporting group values
    		 Intervention Placebo Total
    Number of subjects
    		 12 12 24
    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)
    		 53.2 ± 9.7 52.6 ± 13.8 -
    Gender categorical
    Units: Subjects
        Female
    		 7 8 15
        Male
    		 5 4 9
    VO2 max
    Primary outcome: maximal oxygen consumption.
    Units: ml/Kg/min
        arithmetic mean (standard deviation)
    		 16.96 ± 4.32 15.88 ± 4.91 -

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Liraglutide 1.8 mg vs placebo administered once daily injection for 26 weeks. Liraglutide 1.8 mg, will be administered subcutaneously, from a pre-filled, multidose, injection pen, containing 3 ml (18mg) of liraglutide at a concentration of 6mg/ml. The same volume of placebo, from an identical pre-filled, injection pen, will be administered to the control group.

    Reporting group title
    Placebo
    Reporting group description
    		 COntrol arm

    Primary: VO2 max

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    End point title
    		 VO2 max
    End point description
    The primary endpoint was physical fitness or performance as defined by maximum oxygen consumption (VO2max), using BreezeSuite 6.4 software (MGC Diagnostics Corporation, St Paul, MN, USA), during a cycle ergometer test (ergoselect, ergoline GmbH, Bitz, Germany) performed at the end of the study. An incremental protocol was used: the first 3 min were without resistance, but thereafter increased by 10–20 W/min. Total duration of the test rarely exceeded 10–12 min. Ergometry and VO2max measurements were performed according to international guidelines at our Rehabilitation and Physical Medicine Department at baseline and at the end of the study
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    12
    12
    Units: ml/min/Kg
    arithmetic mean (standard deviation)
        VO2max
    17.98 ± 4.80
    15.90 ± 4.96
    Statistical analysis title
    		 Student's t
    Statistical analysis description
    At the final external monitoring on completing the study, the treatment assignment list was opened by an individual external to the study, thereby allowing the two treatment groups to be separated for blinded analyses by study investigators. These were performed on an intention-to-treat (ITT) and per-protocol (PP) basis, as described in the statistical plan (see publications for complete information)
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months
    Adverse event reporting additional description
    The occurrence of AEs sought and recorded at every visit during the study, though they may be detected when they are spontaneously referred by the patient, a laboratory test, or other assessments. Adverse event reporting using Novo Nordisk standard forms.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Non-specified
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Liraglutide 1.8 mg vs placebo administered once daily injection for 26 weeks. Liraglutide 1.8 mg, will be administered subcutaneously, from a pre-filled, multidose, injection pen, containing 3 ml (18mg) of liraglutide at a concentration of 6mg/ml. The same volume of placebo, from an identical pre-filled, injection pen, will be administered to the control group.

    Reporting group title
    Placebo
    Reporting group description
    		 COntrol arm

    Serious adverse events
    		 Intervention Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (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
    		 Intervention Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 12 (100.00%)
    7 / 12 (58.33%)
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 12 (16.67%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    Nausea, vomitting or diarrhoea
         subjects affected / exposed
    12 / 12 (100.00%)
    3 / 12 (25.00%)
         occurrences all number
    12
    3
    Infections and infestations
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 12 (25.00%)
    2 / 12 (16.67%)
         occurrences all number
    3
    2

    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/30223083
    http://www.ncbi.nlm.nih.gov/pubmed/29736469
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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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