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    Clinical Trial Results:
    The impact of the combination of the GLP-1 analogue liraglutide (Victoza) and laparoscopic adjustable gastric banding (LAGB) on diabetes control

    Summary
    EudraCT number
    		 2011-001538-41
    Trial protocol
    		 GB  
    Global end of trial date
    04 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Aug 2020
    First version publication date
    28 Aug 2020
    Other versions
    Summary report(s)
    		 Summary - 2011-001538-41

    Trial information

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    Trial identification
    Sponsor protocol code
    RG_11-056
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Birmingham
    Sponsor organisation address
    Edgbaston, Birmingham, United Kingdom,
    Public contact
    Research Governance Team, University of Birmingham, researchgovernance@contacts.bham.ac.uk
    Scientific contact
    Research Governance Team, University of Birmingham, researchgovernance@contacts.bham.ac.uk
    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
    04 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jun 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The study will seek to address the following major questions regarding liraglutide combined with the gastric band: When compared with band alone, will the combination treatment result in greater - 1. diabetes resolution 2. weight loss and reduction in body fat 3. change in quality of life 4. reduction in cardiovascular risk Planned Interventions Laparoscopic gastric band plus subcutaneous daily: 1. Placebo: Solution for injection in 3 mL pre-filled pen 2. Liraglutide 6.0 mg/mL solution for injection in 3 mL pre-filled pen Primary Outcome The primary outcome will be the percentage of patients with diabetes resolution defined as fasting plasma glucose of <7.0 mmol/L (WHO) and off all diabetes medications.
    Protection of trial subjects
    Inclusion criteria - All adult diabetes patients (type 2 diabetes, 18-70 y, male and female, HbA1c ≥ 6.5% and < 11%) with BMI equal or above 35 Kg/m2 who are undergoing LAGB based on NICE criteria and multidisciplinary assessment and clinically suitable for liraglutide therapy will be included. A full medical history (including medications) and a medical examination will be carried out at enrolment. Exclusion criteria - 1. Patients who refuse or unable to have injectable treatment post operatively 2. Patients with disability preventing use of treatment 3. Patients who cannot give consent 4. Patients with known delayed gastric emptying (diagnosed by clinical history and judgment) 5. Patients taking any medications that may interact with the trial medication (DPP4- inhibitors and exenetide) 6. Any contraindication stated in the BNF to liraglutide use (inflammatory bowel disease, ketosis, diabetic gastroparesis (based on clinical assessment), pregnancy and breast-feeding, renal impairment (eGFR < 60mL/min/1.73m2) and hepatic impairment; discontinue treatment if symptoms of acute pancreatitis (persistent, severe abdominal pain)) 7. Previous treatment with GLP-1 8. Purely diet controlled or insulin treatment ≥ 5 years 9. Patients with HbA1C ≥ 11% 10. Pregnancy or breastfeeding or planning to become pregnant during the study period 11. Personal or family history of thyroid cancer or multiple endocrine neoplasia 12. History of previous pancreatitis Withdrawal criteria - 1. Participants can withdraw from the study at any time 2. Inability to tolerate trial treatment 3. Pregnancy 4. Severe episodes of hypoglycaemia despite stoppage of hypoglycaemic medication 5. Acute pancreatitis 6. Deterioration in renal function (eGFR<60mL/min)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jun 2014
    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
    United Kingdom: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants as no participants were enrolled/recruited to this trial.

    Pre-assignment
    Screening details
    		 This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants as no participants were enrolled/recruited to this trial.

    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
    Blinding implementation details
    This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants as no participants were enrolled/recruited to this trial.

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants as no participants were enrolled/recruited to this trial.
    Arm type
    		 Overall

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants as no participants were enrolled/recruited to this trial.

    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
    This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants as no participants were enrolled/recruited to this trial.

    Number of subjects in period 1
    		Overall trial
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants as no participants were enrolled/recruited to this trial.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 99999 99999
    Age categorical
    This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants as no participants were enrolled/recruited to this trial.
    Units: Subjects
        Not applicable
    		 99999 99999
    Gender categorical
    This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants.
    Units: Subjects
        Not applicable
    		 99999 99999

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants as no participants were enrolled/recruited to this trial.

    Primary: Not applicable

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    End point title
    		 Not applicable [1]
    End point description
    This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants.
    End point type
    Primary
    End point timeframe
    This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants.
    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: No statistical analyses have been specified as the trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants.
    End point values
    		 Overall trial
    Number of subjects analysed
    99999 [2]
    Units: Not applicable
    99999
    Notes
    [2] - Regarding recruitment data for the purposes of data entry 99999 is referring to not applicable or 0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    This section is not applicable. The trial was terminated early and did not recruit or enrol any participants.
    Adverse event reporting additional description
    This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 N/A.
    Dictionary version
    0
    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: No adverse events have been specified as the trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants.

    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.
    This trial was terminated early. No patients were approached, screened, recruited or randomised to the trial. Regarding recruitment data, for the purposes of data entry 99999 is referring to not applicable or 0 participants.
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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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