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    Clinical Trial Results:
    A bicentric open-label, randomized, two-parallel-group study investigating the impact of combined Lantus®(insulin glargine) and Lyxumia ®(lixisenatide) on insulin secretion and gastric emptying in subjects with Type 2 Diabetes Mellitus not adequately controlled on diet and oral antidiabetic medication

    Summary
    EudraCT number
    		 2013-003171-35
    Trial protocol
    		 DE  
    Global end of trial date
    28 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Feb 2020
    First version publication date
    07 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LanLyx
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01910194
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Profil Institut für Stoffwechselforschung GmbH
    Sponsor organisation address
    Hellersbergstr. 9, Neuss, Germany, 41460
    Public contact
    Regulatory Affairs, Profil Institut für Stoffwechselforschung GmbH, +49 21314018145, regulatory@profil.com
    Scientific contact
    Regulatory Affairs, Profil Institut für Stoffwechselforschung GmbH, +49 21314018145, regulatory@profil.com
    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
    08 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To address in type 2 diabetic patients compared to baseline the effect of repeated doses of Lyxumia® and Lantus® after an eight weeks two-step treatment regimen (four weeks administration of either Lyxumia® or Lantus®, both followed by their combined administration for another four weeks) on intravenous glucose tolerance test (IVGTT) related first phase insulin secretion
    Protection of trial subjects
    Since the launch of GLP-1 receptor agonists, very rare cases of pancreatitis have been reported in subjects receiving this treatment. Therefore, amylase and lipase will be monitored in this study. As this monitoring may be difficult in subjects who already have high values of amylase or lipase, subjects with values above 3 times the upper limit of normal range at screening, will not be entered in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Dec 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
    Germany: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    16
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at two clinical sites in Germany.

    Pre-assignment
    Screening details
    		 In total, 43 subjects were screened and 28 subjects were included in the trial and randomised to one of the two possible treatment arms.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Treatment period 1 - Iglar
    Arm description
    		 Insulin glargine administration
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    60 days of treatment, IMP will be titrated to achieve glycemic targets without hypoglycemia.

    Arm title
    		 Treatment period 2 / Lixi-Iglar
    Arm description
    		 Lixisenatide plus Insulin glargine administration
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lixisenatide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    treatment duration 60 days; up to 20 μg microgram(s)/day

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    60 days of treatment, IMP will be titrated to achieve glycemic targets without hypoglycemia.

    Arm title
    		 Treatment period 1 - Lixi
    Arm description
    		 Lixisenatide administration
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lixisenatide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    treatment duration 60 days; up to 20 μg microgram(s)/day

    Arm title
    		 Treatment period 2 / Iglar-Lixi
    Arm description
    		 Insulin glargine plus Lixisenatide administration
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lixisenatide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    treatment duration 60 days; up to 20 μg microgram(s)/day

    Investigational medicinal product name
    Insulin glargine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    60 days of treatment, IMP will be titrated to achieve glycemic targets without hypoglycemia.

    Number of subjects in period 1
    		Treatment period 1 - Iglar Treatment period 2 / Lixi-Iglar Treatment period 1 - Lixi Treatment period 2 / Iglar-Lixi
    Started
    14
    13
    14
    13
    Completed
    13
    13
    13
    13
    Not completed
    1
    0
    1
    0
         Physician decision
    -
    -
    1
    -
         Adverse event, non-fatal
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 28 28
    Age categorical
    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)
    		 16 16
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 60.2 (30 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    Treatment period 1 - Iglar
    Reporting group description
    		 Insulin glargine administration

    Reporting group title
    Treatment period 2 / Lixi-Iglar
    Reporting group description
    		 Lixisenatide plus Insulin glargine administration

    Reporting group title
    Treatment period 1 - Lixi
    Reporting group description
    		 Lixisenatide administration

    Reporting group title
    Treatment period 2 / Iglar-Lixi
    Reporting group description
    		 Insulin glargine plus Lixisenatide administration

    Primary: AUCISEC(0-10min) - First phase insulin secretion

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    End point title
    		 AUCISEC(0-10min) - First phase insulin secretion
    End point description
    End point type
    Primary
    End point timeframe
    0-10 min
    End point values
    		 Treatment period 1 - Iglar Treatment period 2 / Lixi-Iglar Treatment period 1 - Lixi Treatment period 2 / Iglar-Lixi
    Number of subjects analysed
    13
    13
    13
    11
    Units: pmol h/L
        arithmetic mean (standard deviation)
    0.198 ± 0.1684
    0.741 ± 0.3525
    0.386 ± 0.3334
    0.726 ± 0.5023
    Statistical analysis title
    		 Efficacy Analysis Set - Iglar
    Comparison groups
    Treatment period 1 - Iglar v Treatment period 2 / Iglar-Lixi
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0062
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Efficacy Analysis Set - Lixi
    Comparison groups
    Treatment period 2 / Lixi-Iglar v Treatment period 1 - Lixi
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0394
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 28 (71.43%)
    Investigations
    Troponin I increased
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Lipase increased
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2
    Amylase increased
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 28 (21.43%)
         occurrences all number
    6
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Eye disorders
    Visual field defect
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    2
    Toothache
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    3 / 28 (10.71%)
         occurrences all number
    6
    Gastroenteritis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    3
    Dyspepsia
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Abdominal distension
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    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
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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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