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    Clinical Trial Results:
    Blood Glucose Response After Oral Intake of Lactulose (Laevolac®) in Mildly Constipated Patients with Diabetes Mellitus Type 2

    Summary
    EudraCT number
    		 2018-002359-14
    Trial protocol
    		 AT  
    Global end of trial date
    08 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jun 2020
    First version publication date
    10 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Lact-004-CP4
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03666546
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fresenius Kabi Deutschland GmbH
    Sponsor organisation address
    Else-Kröner-Straße 1, Bad Homburg, Germany, 61346
    Public contact
    Medical Affairs & Clinical Operations Parenteral Nutrition & Keto-Analogues, Fresenius Kabi Deutschland GmbH, trial-disclosure@fresenius-kabi.com
    Scientific contact
    Medical Affairs & Clinical Operations Parenteral Nutrition & Keto-Analogues, Fresenius Kabi Deutschland GmbH, trial-disclosure@fresenius-kabi.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
    23 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial is to investigate whether lactulose, given orally as powder or liquid, increases blood glucose levels in patients with diabetes mellitus type 2. The dose of lactulose given in the trial is normally used for treatment of constipation.
    Protection of trial subjects
    Subject protection was ensured by high medical and ethical standards in accordance with Declaration of Helsinki, Good Clinical Practice and applicable national and local laws and regulations. The signed informed consent was obtained from the patient prior to inclusion in the study.
    Background therapy
    		 All study patients had non-insulin requiring diabetes mellitus type 2 and were treated with diet and oral antidiabetic drugs and/or Glucagon-like peptide(GLP)-1 receptor agonists. Diabetes mellitus treatment had to be stable, without any changes in diabetes mellitus related medication within the last 3 months. On days with study treatment, the intake of the antidiabetic medication in the morning was postponed until was postponed until breakfast after the test. Study products were consumed orally as single dose after overnight fast. Over a period of 180 minutes, when blood glucose levels were monitored in capillary blood, patients had to stay fasting and only water was served.
    Evidence for comparator
    		 Water (placebo) was chosen as comparator to estimate normal physiologic variability of capillary blood glucose level over the Observation period of 180 minutes after intake of the study products. A dose of 30 g glucose (active comparator) was used as reference to evaluate the blood glucose level increase, this dose was chosen because it was considered as a comparable amount to the highest dose of Laevolac®.
    Actual start date of recruitment
    19 Nov 2018
    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
    Austria: 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)
    13
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screened were non-insulin requiring patients with diabetes mellitus type 2, treated with diet and oral antidiabetics and/or GLP1 receptor agonists - Age 18 - 75 years - Glycosylated haemoglobin (HbA1c) ≤ 7.5 % - No change in diabetes mellitus related medication within the last 3 months - Mild functional constipation for the last 3 months

    Period 1
    Period 1 title
    Treatment Phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    The preparation of study products (blinding, reconstitution and labelling of drinking flasks) was done by unblinded staff by four-eyes principle. Test and control products were dissolved in 250 mL still water in non-transparent dark drinking flasks. The flasks had to bear the same blinded study specific labels which precluded unblinding by visual inspection. The flasks were provided to the blinded site personnel and Investigator to preserve the blind for Investigator and study patients.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Laevolac® liquid 20 g
    Arm description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 17 received Laevolac® liquid 20 g as one of 4 different study treatments.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Laevolac® liquid
    Investigational medicinal product code
    Other name
    Lactulose
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Laevolac® liquid 20 g was dissolved in 250 mL still water. Solution was consumed orally as single dose after overnight fast within 5 minutes.

    Arm title
    		 Laevolac® liquid 30 g
    Arm description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 15 received Laevolac® liquid 30 g as one of 4 different study treatments.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Laevolac® liquid
    Investigational medicinal product code
    Other name
    Lactulose
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Laevolac® liquid 30 g was dissolved in 250 mL still water. Solution was consumed orally as single dose after overnight fast within 5 minutes.

    Arm title
    		 Laevolac® crystals 20 g
    Arm description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 16 received Laevolac® crystals 20 g as one of 4 different study treatments.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Laevolac® crystals
    Investigational medicinal product code
    Other name
    Lactulose
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Laevolac® crystals 20 g was dissolved in 250 mL still water. Solution was consumed orally as single dose after overnight fast within 5 minutes.

    Arm title
    		 Laevolac® crystals 30 g
    Arm description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 16 received Laevolac® crystals 30 g as one of 4 different study treatments.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Laevolac® crystals
    Investigational medicinal product code
    Other name
    Lactulose
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Laevolac® crystals 30 g was dissolved in 250 mL still water. Solution was consumed orally as single dose after overnight fast within 5 minutes.

    Arm title
    		 Glucose 30 g
    Arm description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 16 received Glucose 30 g as one of 4 different study treatments.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glucose monohydrate
    Investigational medicinal product code
    Other name
    Glucose
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Glucose 30 g (Glucose monohydrate 33 g) was dissolved in 250 mL still water. Solution was consumed orally as single dose after overnight fast within 5 minutes.

    Arm title
    		 Water
    Arm description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 16 received Water as one of 4 different study treatments.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Still water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    250 mL still water was consumed orally as single dose after overnight fast within 5 minutes.

    Number of subjects in period 1
    		Laevolac® liquid 20 g Laevolac® liquid 30 g Laevolac® crystals 20 g Laevolac® crystals 30 g Glucose 30 g Water
    Started
    17
    15
    16
    16
    16
    16
    Completed
    17
    15
    16
    16
    16
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Phase
    Reporting group description
    		 The study was performed as 4-period cross-over with incomplete block design, stratified by gender. 24 patients were enrolled. Patients were randomized to one of 6 treatment sequences; each patient received 4 of the 6 different study products (6 arms).

    Reporting group values
    		 Treatment Phase Total
    Number of subjects
    		 24 24
    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)
    		 13 13
        From 65-84 years
    		 11 11
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.2 ( 7.61 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 16 16

    End points

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    End points reporting groups
    Reporting group title
    Laevolac® liquid 20 g
    Reporting group description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 17 received Laevolac® liquid 20 g as one of 4 different study treatments.

    Reporting group title
    Laevolac® liquid 30 g
    Reporting group description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 15 received Laevolac® liquid 30 g as one of 4 different study treatments.

    Reporting group title
    Laevolac® crystals 20 g
    Reporting group description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 16 received Laevolac® crystals 20 g as one of 4 different study treatments.

    Reporting group title
    Laevolac® crystals 30 g
    Reporting group description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 16 received Laevolac® crystals 30 g as one of 4 different study treatments.

    Reporting group title
    Glucose 30 g
    Reporting group description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 16 received Glucose 30 g as one of 4 different study treatments.

    Reporting group title
    Water
    Reporting group description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 16 received Water as one of 4 different study treatments.

    Primary: Capillary blood glucose levels as baseline corrected AUC: AUCbaseline_c (0-180 min)

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    End point title
    		 Capillary blood glucose levels as baseline corrected AUC: AUCbaseline_c (0-180 min)
    End point description
    Baseline corrected area under curve (AUC) of blood glucose concentrations from time 0 to 180 minutes after intake of the study products. (AUCbaseline_c is defined as AUC(0-180 min) - (baseline*180 min).
    End point type
    Primary
    End point timeframe
    From 5 min before (blood glucose baseline value) to 180 min after ingestion of study product. Further blood glucose measurements 15, 30, 45, 60, 90, 150 and 180 min after ingestion of study product.
    End point values
    		 Laevolac® liquid 20 g Laevolac® liquid 30 g Laevolac® crystals 20 g Laevolac® crystals 30 g Glucose 30 g Water
    Number of subjects analysed
    17
    15
    16
    16
    16
    16
    Units: min*mg/dL
        arithmetic mean (standard deviation)
    -443.8 ( 1291.52 )
    -743.8 ( 1577.91 )
    -964.2 ( 1321.89 )
    -484.2 ( 1280.63 )
    8440 ( 2636.0 )
    -758.0 ( 1320.23 )
    Statistical analysis title
    		 Mixed model arm 1 v 6
    Comparison groups
    Laevolac® liquid 20 g v Water
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    405.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -633.92
         upper limit
    		 1444.39
    Statistical analysis title
    		 Mixed model arm 2 v 6
    Comparison groups
    Laevolac® liquid 30 g v Water
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    219.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -855.54
         upper limit
    		 1295.12
    Statistical analysis title
    		 Mixed model arm 3 v 6
    Comparison groups
    Laevolac® crystals 20 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    -21.5269
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1095.13
         upper limit
    		 1052.08
    Statistical analysis title
    		 Mixed model arm 4 v 6
    Comparison groups
    Laevolac® crystals 30 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    405.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -667.49
         upper limit
    		 1478.51
    Statistical analysis title
    		 Mixed model arm 5 v 2
    Comparison groups
    Glucose 30 g v Laevolac® liquid 30 g
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    9024.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7917.58
         upper limit
    		 10131
    Statistical analysis title
    		 Mixed model arm 5 v 4
    Comparison groups
    Glucose 30 g v Laevolac® crystals 30 g
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    8838.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7781.86
         upper limit
    		 9895.09
    Statistical analysis title
    		 Mixed model arm 5 v 6
    Comparison groups
    Glucose 30 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    9243.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8170.95
         upper limit
    		 10317
    Statistical analysis title
    		 Mixed model arm 1 v 3
    Comparison groups
    Laevolac® liquid 20 g v Laevolac® crystals 20 g
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    426.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -627.87
         upper limit
    		 1481.39
    Statistical analysis title
    		 Mixed model arm 2 v 4
    Comparison groups
    Laevolac® liquid 30 g v Laevolac® crystals 30 g
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    -185.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1289.75
         upper limit
    		 918.31

    Secondary: Maximum blood glucose concentration: Cmax

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    End point title
    		 Maximum blood glucose concentration: Cmax
    End point description
    Maximum blood glucose concentration derived from the individual blood glucose concentration time curves from time 0 to 180 minutes after intake of the study products.
    End point type
    Secondary
    End point timeframe
    From 5 min before (blood glucose baseline value) to 180 min after ingestion of study product. Further blood glucose measurements 15, 30, 45, 60, 90, 150 and 180 min after ingestion of study product.
    End point values
    		 Laevolac® liquid 20 g Laevolac® liquid 30 g Laevolac® crystals 20 g Laevolac® crystals 30 g Glucose 30 g Water
    Number of subjects analysed
    17
    15
    16
    16
    16
    16
    Units: mg/dL
        arithmetic mean (standard deviation)
    141.6 ( 16.71 )
    149.2 ( 19.91 )
    131.4 ( 17.88 )
    139.5 ( 25.44 )
    236.5 ( 29.95 )
    136.6 ( 15.76 )
    Statistical analysis title
    		 Mixed model arm 1 v 6
    Comparison groups
    Laevolac® liquid 20 g v Water
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least squares means
    Point estimate
    5.5231
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.164
         upper limit
    		 13.2102
    Statistical analysis title
    		 Mixed model arm 2 v 6
    Comparison groups
    Laevolac® liquid 30 g v Water
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least squares means
    Point estimate
    11.321
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3808
         upper limit
    		 19.2611
    Statistical analysis title
    		 Mixed model arm 3 v 6
    Comparison groups
    Laevolac® crystals 20 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least squares means
    Point estimate
    1.0074
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9024
         upper limit
    		 8.9172
    Statistical analysis title
    		 Mixed model arm 4 v 6
    Comparison groups
    Laevolac® crystals 30 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least squares means
    Point estimate
    5.8679
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.0297
         upper limit
    		 13.7655
    Statistical analysis title
    		 Mixed model arm 5 v 2
    Comparison groups
    Glucose 30 g v Laevolac® liquid 30 g
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least squares means
    Point estimate
    92.881
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 84.7739
         upper limit
    		 100.99
    Statistical analysis title
    		 Mixed model arm 5 v 4
    Comparison groups
    Glucose 30 g v Laevolac® crystals 30 g
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least squares means
    Point estimate
    98.3341
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 90.5138
         upper limit
    		 106.15
    Statistical analysis title
    		 Mixed model arm 5 v 6
    Comparison groups
    Glucose 30 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least squares means
    Point estimate
    104.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 96.3025
         upper limit
    		 112.1
    Statistical analysis title
    		 Mixed model arm 1 v 3
    Comparison groups
    Laevolac® liquid 20 g v Laevolac® crystals 20 g
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least squares means
    Point estimate
    4.5157
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2607
         upper limit
    		 12.292
    Statistical analysis title
    		 Mixed model arm 2 v 4
    Comparison groups
    Laevolac® liquid 30 g v Laevolac® crystals 30 g
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least squares means
    Point estimate
    5.4531
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6411
         upper limit
    		 13.5472

    Secondary: Maximum increase of blood glucose concentration (Cmax minus baseline value): Max_increase

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    End point title
    		 Maximum increase of blood glucose concentration (Cmax minus baseline value): Max_increase
    End point description
    Maximum increase of blood glucose concentration (Cmax minus baseline value) derived from the individual blood glucose concentration time curves from time 0 to 180 minutes after intake of the study products.
    End point type
    Secondary
    End point timeframe
    From 5 min before (blood glucose baseline value) to 180 min after ingestion of study product. Further blood glucose measurements 15, 30, 45, 60, 90, 150 and 180 min after ingestion of study product.
    End point values
    		 Laevolac® liquid 20 g Laevolac® liquid 30 g Laevolac® crystals 20 g Laevolac® crystals 30 g Glucose 30 g Water
    Number of subjects analysed
    17
    15
    16
    16
    16
    16
    Units: mg/dL
        arithmetic mean (standard deviation)
    12.62 ( 7.208 )
    18.43 ( 10.321 )
    7.688 ( 7.1969 )
    12.81 ( 11.180 )
    110.9 ( 20.99 )
    7.875 ( 6.9821 )
    Statistical analysis title
    		 Mixed model arm 1 v 6
    Comparison groups
    Laevolac® liquid 20 g v Water
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    5.5231
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.164
         upper limit
    		 13.2102
    Statistical analysis title
    		 Mixed model arm 2 v 6
    Comparison groups
    Laevolac® liquid 30 g v Water
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    11.321
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3808
         upper limit
    		 19.2611
    Statistical analysis title
    		 Mixed model arm 3 v 6
    Comparison groups
    Laevolac® crystals 20 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    1.0074
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9024
         upper limit
    		 8.9172
    Statistical analysis title
    		 Mixed model arm 4 v 6
    Comparison groups
    Laevolac® crystals 30 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    5.8679
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.0297
         upper limit
    		 13.7655
    Statistical analysis title
    		 Mixed model arm 5 v 2
    Comparison groups
    Laevolac® liquid 30 g v Glucose 30 g
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    92.881
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 84.7739
         upper limit
    		 100.99
    Statistical analysis title
    		 Mixed model arm 5 v 4
    Comparison groups
    Laevolac® crystals 30 g v Glucose 30 g
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    98.3341
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 90.5138
         upper limit
    		 106.15
    Statistical analysis title
    		 Mixed model arm 5 v 6
    Comparison groups
    Glucose 30 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    104.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 96.3025
         upper limit
    		 112.1
    Statistical analysis title
    		 Mixed model arm 1 v 3
    Comparison groups
    Laevolac® liquid 20 g v Laevolac® crystals 20 g
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    4.5157
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2607
         upper limit
    		 12.292
    Statistical analysis title
    		 Mixed model arm 2 v 4
    Comparison groups
    Laevolac® liquid 30 g v Laevolac® crystals 30 g
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    5.4531
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6411
         upper limit
    		 13.5472

    Secondary: Relative maximum increase of blood glucose concentration (Cmax / baseline value): Max_increase_rel

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    End point title
    		 Relative maximum increase of blood glucose concentration (Cmax / baseline value): Max_increase_rel
    End point description
    Relative maximum increase of blood glucose concentration (Cmax / baseline value) derived from the individual blood glucose concentration time curves from time 0 to 180 minutes after intake of the study products.
    End point type
    Secondary
    End point timeframe
    From 5 min before (blood glucose baseline value) to 180 min after ingestion of study product. Further blood glucose measurements 15, 30, 45, 60, 90, 150 and 180 min after ingestion of study product.
    End point values
    		 Laevolac® liquid 20 g Laevolac® liquid 30 g Laevolac® crystals 20 g Laevolac® crystals 30 g Glucose 30 g Water
    Number of subjects analysed
    17
    15
    16
    16
    16
    16
    Units: mg/dL / mg/dL
        arithmetic mean (standard deviation)
    1.101 ( 0.0610 )
    1.145 ( 0.0847 )
    1.063 ( 0.0593 )
    1.108 ( 0.1005 )
    1.897 ( 0.1891 )
    1.066 ( 0.0630 )
    No statistical analyses for this end point

    Secondary: Time to reach maximum blood glucose concentration: Tmax

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    End point title
    		 Time to reach maximum blood glucose concentration: Tmax
    End point description
    End point type
    Secondary
    End point timeframe
    From 5 min before (blood glucose baseline value) to 180 min after ingestion of study product. Further blood glucose measurements 15, 30, 45, 60, 90, 150 and 180 min after ingestion of study product.
    End point values
    		 Laevolac® liquid 20 g Laevolac® liquid 30 g Laevolac® crystals 20 g Laevolac® crystals 30 g Glucose 30 g Water
    Number of subjects analysed
    17
    15
    16
    16
    16
    16
    Units: minutes
        median (full range (min-max))
    30.00 (0.00 to 120.00)
    30.00 (0.00 to 60.00)
    30.00 (0.00 to 180.00)
    30.00 (0.00 to 60.00)
    60.00 (45.00 to 60.00)
    22.50 (0.00 to 150.00)
    No statistical analyses for this end point

    Secondary: Total AUC from 0 to 180 min for blood glucose concentration: AUC (0-180 min)

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    End point title
    		 Total AUC from 0 to 180 min for blood glucose concentration: AUC (0-180 min)
    End point description
    End point type
    Secondary
    End point timeframe
    From 5 min before (blood glucose baseline value) to 180 min after ingestion of study product. Further blood glucose measurements 15, 30, 45, 60, 90, 150 and 180 min after ingestion of study product.
    End point values
    		 Laevolac® liquid 20 g Laevolac® liquid 30 g Laevolac® crystals 20 g Laevolac® crystals 30 g Glucose 30 g Water
    Number of subjects analysed
    17
    15
    16
    16
    16
    16
    Units: min*mg/dL
        arithmetic mean (standard deviation)
    22766 ( 3092.3 )
    22794 ( 3667.5 )
    21311 ( 2806.7 )
    22320 ( 4040.1 )
    31053 ( 4807.7 )
    22417 ( 2953.4 )
    Statistical analysis title
    		 Mixed model arm 1 v 6
    Comparison groups
    Laevolac® liquid 20 g v Water
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    405.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -633.92
         upper limit
    		 1444.39
    Statistical analysis title
    		 Mixed model arm 2 v 6
    Comparison groups
    Laevolac® liquid 30 g v Water
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    219.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -855.54
         upper limit
    		 1295.12
    Statistical analysis title
    		 Mixed model arm 3 v 6
    Comparison groups
    Laevolac® crystals 20 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    -21.5269
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1095.13
         upper limit
    		 1052.08
    Statistical analysis title
    		 Mixed model arm 4 v 6
    Comparison groups
    Laevolac® crystals 30 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    405.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -667.49
         upper limit
    		 1478.51
    Statistical analysis title
    		 Mixed model arm 5 v 2
    Comparison groups
    Glucose 30 g v Laevolac® liquid 30 g
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    9024.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7917.58
         upper limit
    		 10131
    Statistical analysis title
    		 Mixed model arm 5 v 4
    Comparison groups
    Glucose 30 g v Laevolac® crystals 30 g
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    8838.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7781.86
         upper limit
    		 9895.09
    Statistical analysis title
    		 Mixed model arm 5 v 6
    Comparison groups
    Glucose 30 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    9243.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8170.95
         upper limit
    		 10317
    Statistical analysis title
    		 Mixed model arm 1 v 3
    Comparison groups
    Laevolac® liquid 20 g v Laevolac® crystals 20 g
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    426.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -627.87
         upper limit
    		 1481.39
    Statistical analysis title
    		 Mixed model arm 2 v 4
    Comparison groups
    Laevolac® liquid 30 g v Laevolac® crystals 30 g
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    -185.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1289.75
         upper limit
    		 918.31

    Secondary: Incremental AUC from 0 to 180 min for blood glucose concentration: iAUC (0-180 min)

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    End point title
    		 Incremental AUC from 0 to 180 min for blood glucose concentration: iAUC (0-180 min)
    End point description
    AUC above baseline levels for blood glucose concentration derived from the individual blood glucose concentration time curves from time 0 to 180 minutes after intake of the study products.
    End point type
    Secondary
    End point timeframe
    From 5 min before (blood glucose baseline value) to 180 min after ingestion of study product. Further blood glucose measurements 15, 30, 45, 60, 90, 150 and 180 min after ingestion of study product.
    End point values
    		 Laevolac® liquid 20 g Laevolac® liquid 30 g Laevolac® crystals 20 g Laevolac® crystals 30 g Glucose 30 g Water
    Number of subjects analysed
    17
    15
    16
    16
    16
    16
    Units: min*mg/dL
        arithmetic mean (standard deviation)
    619.7 ( 555.28 )
    755.7 ( 673.84 )
    296.3 ( 477.69 )
    503.4 ( 499.11 )
    8677 ( 2384.1 )
    350.7 ( 573.37 )
    Statistical analysis title
    		 Mixed model arm 1 v 6
    Comparison groups
    Laevolac® liquid 20 g v Water
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    288.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -482.47
         upper limit
    		 1058.49
    Statistical analysis title
    		 Mixed model arm 2 v 6
    Comparison groups
    Laevolac® liquid 30 g v Water
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    425.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -369.73
         upper limit
    		 1220.7
    Statistical analysis title
    		 Mixed model arm 3 v 6
    Comparison groups
    Laevolac® crystals 20 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    -25.8996
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -813.73
         upper limit
    		 761.93
    Statistical analysis title
    		 Mixed model arm 4 v 6
    Comparison groups
    Laevolac® crystals 30 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    165.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -619.67
         upper limit
    		 951.57
    Statistical analysis title
    		 Mixed model arm 5 v 2
    Comparison groups
    Laevolac® liquid 30 g v Glucose 30 g
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    7911.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7108.96
         upper limit
    		 8713.89
    Statistical analysis title
    		 Mixed model arm 5 v 4
    Comparison groups
    Laevolac® crystals 30 g v Glucose 30 g
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    8170.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7386.6
         upper limit
    		 8955.33
    Statistical analysis title
    		 Mixed model arm 5 v 6
    Comparison groups
    Glucose 30 g v Water
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    8336.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7550.95
         upper limit
    		 9122.88
    Statistical analysis title
    		 Mixed model arm 1 v 3
    Comparison groups
    Laevolac® liquid 20 g v Laevolac® crystals 20 g
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    872.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -461.79
         upper limit
    		 1089.61
    Statistical analysis title
    		 Mixed model arm 2 v 4
    Comparison groups
    Laevolac® liquid 30 g v Laevolac® crystals 30 g
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference least square means
    Point estimate
    259.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -542.14
         upper limit
    		 1061.22

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period of AE reporting began with the fasting period the day before Screening Visit after Informed Consent (i.e. maximum 21 days before the first Treatment Visit) and ended 24 hours after the last of 4 Treatment Visits.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Laevolac® liquid 20 g
    Reporting group description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 17 received Laevolac® liquid 20 g as one of 4 different study treatments.

    Reporting group title
    Laevolac® liquid 30 g
    Reporting group description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 15 received Laevolac® liquid 30 g as one of 4 different study treatments.

    Reporting group title
    Laevolac® crystals 20 g
    Reporting group description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 16 received Laevolac® crystals 20 g as one of 4 different study treatments.

    Reporting group title
    Laevolac® crystals 30 g
    Reporting group description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 16 received Laevolac® crystals 30 g as one of 4 different study treatments.

    Reporting group title
    Glucose 30 g
    Reporting group description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 16 received Glucose 30 g as one of 4 different study treatments.

    Reporting group title
    Water
    Reporting group description
    		 Due to the 4-period cross-over design of the study, each patient was allocated to 4 arms, with a wash-out phase of 4 to 14 days to avoid carry-over effects. Of the 24 study patients, 16 received Water as one of 4 different study treatments.

    Serious adverse events
    		 Laevolac® liquid 20 g Laevolac® liquid 30 g Laevolac® crystals 20 g Laevolac® crystals 30 g Glucose 30 g Water
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Laevolac® liquid 20 g Laevolac® liquid 30 g Laevolac® crystals 20 g Laevolac® crystals 30 g Glucose 30 g Water
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 17 (88.24%)
    15 / 15 (100.00%)
    12 / 16 (75.00%)
    14 / 16 (87.50%)
    9 / 16 (56.25%)
    7 / 16 (43.75%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    1
    1
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    8 / 17 (47.06%)
    4 / 15 (26.67%)
    4 / 16 (25.00%)
    5 / 16 (31.25%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    8
    5
    4
    5
    2
    1
    Abdominal distension
         subjects affected / exposed
    6 / 17 (35.29%)
    7 / 15 (46.67%)
    5 / 16 (31.25%)
    7 / 16 (43.75%)
    4 / 16 (25.00%)
    3 / 16 (18.75%)
         occurrences all number
    11
    8
    5
    7
    4
    3
    Abdominal pain
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    3 / 16 (18.75%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    3
    0
    0
    4
    0
    1
    Diarrhoea
         subjects affected / exposed
    5 / 17 (29.41%)
    9 / 15 (60.00%)
    7 / 16 (43.75%)
    5 / 16 (31.25%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    5
    11
    8
    6
    1
    1
    Dyspepsia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 15 (6.67%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    2
    0
    2
    0
    Eructation
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 15 (13.33%)
    2 / 16 (12.50%)
    3 / 16 (18.75%)
    2 / 16 (12.50%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    2
    3
    2
    2
    Flatulence
         subjects affected / exposed
    11 / 17 (64.71%)
    9 / 15 (60.00%)
    8 / 16 (50.00%)
    6 / 16 (37.50%)
    4 / 16 (25.00%)
    5 / 16 (31.25%)
         occurrences all number
    11
    9
    9
    7
    5
    5
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    11 / 17 (64.71%)
    13 / 15 (86.67%)
    8 / 16 (50.00%)
    11 / 16 (68.75%)
    6 / 16 (37.50%)
    4 / 16 (25.00%)
         occurrences all number
    14
    20
    10
    13
    6
    4
    Nausea
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    0
    Regurgitation
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 15 (13.33%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    2
    0
    2
    1
    Vomiting
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    Nervousness
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Back pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0

    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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    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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