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    Clinical Trial Results:
    A 12-week randomized, patient and investigator blinded, placebo-controlled, parallel group study to investigate the efficacy of LIK066 in obese patients with NASH.

    Summary
    EudraCT number
    		 2017-002046-71
    Trial protocol
    		 NL  
    Global end of trial date
    14 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2020
    First version publication date
    27 Nov 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CLIK066X2204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03205150
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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
    14 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to determine the effect of LIK066 on liver function test (circulating ALT) after 12 weeks of treatment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 All prescription medications, over-the-counter drugs and significant non-drug therapies (including physical therapy and blood transfusions) administered or taken within the timeframe defined in the entry criteria prior to the start of the study and during the study, were recorded on the Concomitant medications/Significant non-drug therapies CRF.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Oct 2017
    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
    Argentina: 23
    Country: Number of subjects enrolled
    Canada: 18
    Country: Number of subjects enrolled
    Israel: 11
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Russian Federation: 9
    Country: Number of subjects enrolled
    Taiwan: 9
    Country: Number of subjects enrolled
    Thailand: 3
    Country: Number of subjects enrolled
    United States: 27
    Worldwide total number of subjects
    107
    EEA total number of subjects
    7
    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)
    95
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 107 participants were enrolled in 15 centers across 8 countries: Argentina (2), Canada (1), Israel (3), Netherlands (1), Russia federation (1), Taiwan (2), Thailand (1), United States (4).

    Pre-assignment
    Screening details
    		 Participants were randomized in 2:2:1 ratio to the 3 groups: LIK066 150 mg, LIK066 30 mg and placebo.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LIK066 30 mg
    Arm description
    		 Film coated tablet of LIK066 30 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LIK066
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily oral dose of LIK066 30 mg

    Arm title
    		 LIK066 150 mg
    Arm description
    		 Film coated tablet of LIK066 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LIK066
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily oral dose of LIK066 150 mg

    Arm title
    		 Placebo
    Arm description
    		 LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily oral dose of LIK066 0 mg

    Number of subjects in period 1
    		LIK066 30 mg LIK066 150 mg Placebo
    Started
    43
    43
    21
    Safety analysis set
    43
    43
    21
    Pharmacodynamics (PD) anlysis set
    43
    41
    21
    Completed
    41
    36
    19
    Not completed
    2
    7
    2
         Adverse event, non-fatal
    1
    1
    1
         Protocol deviation
    1
    3
    -
         Patient/guardian decision
    -
    3
    -
         Lost to follow-up
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LIK066 30 mg
    Reporting group description
    		 Film coated tablet of LIK066 30 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.

    Reporting group title
    LIK066 150 mg
    Reporting group description
    		 Film coated tablet of LIK066 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.

    Reporting group title
    Placebo
    Reporting group description
    		 LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.

    Reporting group values
    		 LIK066 30 mg LIK066 150 mg Placebo Total
    Number of subjects
    		 43 43 21 107
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 35 40 20 95
        From 65-84 years
    		 8 3 1 12
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.1 ± 12.57 49.5 ± 11.10 48.0 ± 11.16 -
    Sex: Female, Male
    Units: Participants
        Female
    		 25 22 12 59
        Male
    		 18 21 9 48
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 34 35 17 86
        Asian
    		 8 4 3 15
        Black or African American
    		 1 3 1 5
        Other
    		 0 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    LIK066 30 mg
    Reporting group description
    		 Film coated tablet of LIK066 30 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.

    Reporting group title
    LIK066 150 mg
    Reporting group description
    		 Film coated tablet of LIK066 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.

    Reporting group title
    Placebo
    Reporting group description
    		 LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.

    Primary: Change from baseline in Alanine aminotransferase (ALT) at Week 12

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    End point title
    		 Change from baseline in Alanine aminotransferase (ALT) at Week 12
    End point description
    Alanine aminotransferase (ALT) is an enzyme found primarily in the liver. ALT is increased with liver damage. In this study, the blood levels of ALT was used to detect liver injury. Baseline is defined as the mean of measurements taken at the Screening and Baseline visits.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 LIK066 30 mg LIK066 150 mg Placebo
    Number of subjects analysed
    40
    34
    20
    Units: Units per Liter (U/L)
        arithmetic mean (standard error)
    -22.06 ± 4.16
    -30.41 ± 4.52
    -8.77 ± 5.99
    Statistical analysis title
    		 Change from baseline in ALT
    Comparison groups
    Placebo v LIK066 30 mg
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.075
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -13.29
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -22.8
         upper limit
    		 -3.78
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.35
    Statistical analysis title
    		 Change from baseline in ALT
    Comparison groups
    LIK066 150 mg v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -21.64
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -31.33
         upper limit
    		 -11.94
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.49
    Statistical analysis title
    		 Change from baseline in ALT
    Comparison groups
    LIK066 30 mg v LIK066 150 mg
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.178
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    8.35
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 16.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.14

    Secondary: Change from baseline in percent liver fat at Week 12

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    End point title
    		 Change from baseline in percent liver fat at Week 12
    End point description
    Percent (%) Liver fat was measured by Magnetic Resonance Imaging Proton Density Liver Fat Fraction(MRIPDFF). Patients underwent magnetic resonance imaging twice during the course of the study ( baseline and end of treatment) to quantitate liver fat.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 LIK066 30 mg LIK066 150 mg Placebo
    Number of subjects analysed
    39
    33
    19
    Units: Percentage of Liver Fat
        arithmetic mean (standard error)
    -4.40 ± 0.81
    -6.92 ± 0.87
    -2.67 ± 1.17
    Statistical analysis title
    		 Change from baseline in percent liver fat
    Comparison groups
    LIK066 30 mg v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.235
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.73
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.45
    Statistical analysis title
    		 Change from baseline in percent liver fat
    Comparison groups
    LIK066 150 mg v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -4.26
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -6.14
         upper limit
    		 -2.37
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.46
    Statistical analysis title
    		 Change from baseline in percent liver fat
    Comparison groups
    LIK066 30 mg v LIK066 150 mg
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.037
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    2.52
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 4.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.19

    Secondary: Percent change from baseline in total body weight at Week 12

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    End point title
    		 Percent change from baseline in total body weight at Week 12
    End point description
    Body weight (to the nearest 0.1 kilogram [kg] was measured on a calibrated scale. The measurement was performed with the study subject in underwear and without shoes; or while wearing minimal indoor clothing.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 LIK066 30 mg LIK066 150 mg Placebo
    Number of subjects analysed
    40
    34
    19
    Units: percentage
        arithmetic mean (standard error)
    -3.48 ± 0.47
    -4.51 ± 0.52
    -0.33 ± 0.68
    Statistical analysis title
    		 Change from baseline in total body weight
    Comparison groups
    LIK066 30 mg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -3.15
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -4.22
         upper limit
    		 -2.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.83
    Statistical analysis title
    		 Change from baseline in total body weight
    Comparison groups
    LIK066 150 mg v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -4.18
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -5.28
         upper limit
    		 -3.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.85
    Statistical analysis title
    		 Change from baseline in total body weight
    Comparison groups
    LIK066 30 mg v LIK066 150 mg
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.148
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.03
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 1.94
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.71

    Secondary: Change from baseline in the Enhanced Liver Fibrosis Test score at week 12

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    End point title
    		 Change from baseline in the Enhanced Liver Fibrosis Test score at week 12
    End point description
    The Enhanced Liver Fibrosis (ELF) score is an ECM marker set consisting of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP) and hyaluronic acid (HA) showing good correlations with fibrosis stages in chronic liver disease.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 LIK066 30 mg LIK066 150 mg Placebo
    Number of subjects analysed
    40
    34
    21
    Units: Score
        arithmetic mean (standard deviation)
    -0.2 ± 0.65
    -0.1 ± 0.61
    0.1 ± 0.37
    No statistical analyses for this end point

    Secondary: Change from baseline in the concentration of Hyaluronic Acid at Week 12.

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    End point title
    		 Change from baseline in the concentration of Hyaluronic Acid at Week 12.
    End point description
    Hyaluronic Acid is a non-invasive marker of liver fibrosis. It was accessed by Enhanced liver fibrosis Test (ELF).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 LIK066 30 mg LIK066 150 mg Placebo
    Number of subjects analysed
    40
    34
    21
    Units: ug/L
        arithmetic mean (standard deviation)
    -3.4 ± 75.38
    0.4 ± 30.56
    4.7 ± 21.73
    No statistical analyses for this end point

    Secondary: Change from baseline in the concentration of Procollagen Type Iii N-Terminal Peptide (PIIINP) at Week 12.

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    End point title
    		 Change from baseline in the concentration of Procollagen Type Iii N-Terminal Peptide (PIIINP) at Week 12.
    End point description
    PIIINP is a non-invasive marker of liver fibrosis. It was accessed by Enhanced liver fibrosis Test (ELF).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 LIK066 30 mg LIK066 150 mg Placebo
    Number of subjects analysed
    40
    34
    20
    Units: ug/L
        arithmetic mean (standard deviation)
    -1.7 ± 2.73
    -1.2 ± 3.66
    0.3 ± 1.88
    No statistical analyses for this end point

    Secondary: Change from baseline in the concentration of Tissue Inhibitor Of Metalloproteinase 1 (TIMP-1) at Week 12.

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    End point title
    		 Change from baseline in the concentration of Tissue Inhibitor Of Metalloproteinase 1 (TIMP-1) at Week 12.
    End point description
    TIMP-1 is a non-invasive marker of liver fibrosis. It was accessed by Enhanced liver fibrosis Test (ELF).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 LIK066 30 mg LIK066 150 mg Placebo
    Number of subjects analysed
    40
    34
    20
    Units: ug/L
        arithmetic mean (standard deviation)
    -3.0 ± 38.98
    -10.9 ± 38.21
    10.3 ± 25.73
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of LIK066: Observed maximum plasma concentration (Cmax) following drug administration

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    End point title
    		 Pharmacokinetics of LIK066: Observed maximum plasma concentration (Cmax) following drug administration [1]
    End point description
    Cmax is the observed maximum plasma concentration following drug administration (ng/mL)
    End point type
    Secondary
    End point timeframe
    Day 56 (pre-dose and 1, 2, 4 and 6 hours post-dose)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo patients were excluded from the PK analyses
    End point values
    		 LIK066 30 mg LIK066 150 mg
    Number of subjects analysed
    38
    32
    Units: ng/mL
        arithmetic mean (standard deviation)
    405 ± 109
    1810 ± 729
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of LIK066: Observed maximum time duration of maximum concentration (Tmax) following drug administration

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    End point title
    		 Pharmacokinetics of LIK066: Observed maximum time duration of maximum concentration (Tmax) following drug administration [2]
    End point description
    Tmax is the time to reach the maximum concentration after drug administration (hour). The time points presented are the actual and not the planned time points.
    End point type
    Secondary
    End point timeframe
    Day 56 (pre-dose and 1, 2, 4 and 6 hours post-dose)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo patients were excluded from the PK analyses
    End point values
    		 LIK066 30 mg LIK066 150 mg
    Number of subjects analysed
    38
    32
    Units: hours
        median (full range (min-max))
    1.00 (0.500 to 6.00)
    1.51 (0.567 to 6.00)
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of LIK066: Observed area under the curve up to the last measurable concentration (AUClast) following drug administration

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    End point title
    		 Pharmacokinetics of LIK066: Observed area under the curve up to the last measurable concentration (AUClast) following drug administration [3]
    End point description
    AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (hour*ng/mL)
    End point type
    Secondary
    End point timeframe
    Day 56 (pre-dose and 1, 2, 4 and 6 hours post-dose)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo patients were excluded from the PK analyses
    End point values
    		 LIK066 30 mg LIK066 150 mg
    Number of subjects analysed
    38
    32
    Units: hour*ng/mL
        arithmetic mean (standard deviation)
    1280 ± 413
    5770 ± 1680
    No statistical analyses for this end point

    Secondary: Change from baseline in Aspartate aminotransferase (AST) at Week 12

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    End point title
    		 Change from baseline in Aspartate aminotransferase (AST) at Week 12
    End point description
    Aspartate aminotransferase (AST) is an enzyme found in many cells of the body specifically those of the liver, heart and skeletal muscle. In healthy individuals, levels of AST in the blood are low. When liver or muscle cells are injured, they release AST into the blood. In this study, the blood levels of AST was used to detect liver injury. Baseline is defined as the mean of measurements taken at the Screening and Baseline visits.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 LIK066 30 mg LIK066 150 mg Placebo
    Number of subjects analysed
    40
    34
    20
    Units: Units per liter (U/L)
        arithmetic mean (standard error)
    -13.45 ± 2.46
    -17.01 ± 2.68
    -2.30 ± 3.54
    Statistical analysis title
    		 Change from baseline in AST
    Comparison groups
    LIK066 30 mg v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -11.15
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -16.79
         upper limit
    		 -5.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.36
    Statistical analysis title
    		 Change from baseline in AST
    Comparison groups
    LIK066 150 mg v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -14.71
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -20.43
         upper limit
    		 -8.98
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.43
    Statistical analysis title
    		 Change from baseline in AST
    Comparison groups
    LIK066 30 mg v LIK066 150 mg
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.332
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    3.56
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -1.15
         upper limit
    		 8.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.65

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the first dose of study treatment until the end of study treatment i.e. Day 84 plus 28 days recovery and follow-up period.
    Adverse event reporting additional description
    Any signs or symptoms that occured from the first dose of study treatment until the end of study treatment i.e. Day 84 plus 28 days recovery and follow-up period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    LIK066 30 mg
    Reporting group description
    		 LIK066 30 mg

    Reporting group title
    LIK066 150 mg
    Reporting group description
    		 LIK066 150 mg

    Reporting group title
    All Patients
    Reporting group description
    		 All Patients

    Serious adverse events
    		 Placebo LIK066 30 mg LIK066 150 mg All Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo LIK066 30 mg LIK066 150 mg All Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 21 (85.71%)
    31 / 43 (72.09%)
    36 / 43 (83.72%)
    85 / 107 (79.44%)
    Vascular disorders
    Diastolic hypotension
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Peripheral coldness
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 43 (2.33%)
    1 / 43 (2.33%)
    3 / 107 (2.80%)
         occurrences all number
    1
    1
    1
    3
    Chills
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Early satiety
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Fatigue
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 43 (4.65%)
    3 / 43 (6.98%)
    5 / 107 (4.67%)
         occurrences all number
    0
    2
    3
    5
    Feeling hot
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Feeling jittery
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Hunger
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    2 / 107 (1.87%)
         occurrences all number
    1
    0
    1
    2
    Thirst
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Vessel puncture site bruise
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Reproductive system and breast disorders
    Nipple pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    2
    0
    0
    2
    Nasal congestion
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    1
    1
    0
    2
    Productive cough
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    2 / 107 (1.87%)
         occurrences all number
    1
    0
    1
    2
    Wheezing
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 43 (4.65%)
    0 / 43 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    0
    2
    0
    2
    Depression
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Insomnia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Mood swings
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Nervousness
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 43 (4.65%)
    0 / 43 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    0
    2
    0
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Blood bilirubin increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Heart rate irregular
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Lymphocyte morphology abnormal
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Joint injury
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 43 (4.65%)
    0 / 43 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    0
    2
    0
    2
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    2 / 107 (1.87%)
         occurrences all number
    1
    0
    2
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 43 (0.00%)
    4 / 43 (9.30%)
    7 / 107 (6.54%)
         occurrences all number
    4
    0
    7
    11
    Head discomfort
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Headache
         subjects affected / exposed
    3 / 21 (14.29%)
    2 / 43 (4.65%)
    5 / 43 (11.63%)
    10 / 107 (9.35%)
         occurrences all number
    3
    2
    13
    18
    Hypoaesthesia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Tremor
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Eye disorders
    Glaucoma
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Abdominal distension
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 43 (4.65%)
    6 / 43 (13.95%)
    8 / 107 (7.48%)
         occurrences all number
    0
    2
    7
    9
    Abdominal pain
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 43 (2.33%)
    5 / 43 (11.63%)
    8 / 107 (7.48%)
         occurrences all number
    2
    1
    10
    13
    Abdominal pain upper
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 43 (0.00%)
    3 / 43 (6.98%)
    5 / 107 (4.67%)
         occurrences all number
    2
    0
    3
    5
    Abdominal tenderness
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Anal pruritus
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Colitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Constipation
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 43 (4.65%)
    3 / 43 (6.98%)
    6 / 107 (5.61%)
         occurrences all number
    1
    2
    3
    6
    Diarrhoea
         subjects affected / exposed
    9 / 21 (42.86%)
    21 / 43 (48.84%)
    33 / 43 (76.74%)
    63 / 107 (58.88%)
         occurrences all number
    30
    51
    191
    272
    Dyspepsia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 43 (2.33%)
    1 / 43 (2.33%)
    3 / 107 (2.80%)
         occurrences all number
    1
    1
    2
    4
    Flatulence
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 43 (4.65%)
    8 / 43 (18.60%)
    12 / 107 (11.21%)
         occurrences all number
    2
    2
    12
    16
    Gastric dilatation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Gastric ulcer
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Large intestine polyp
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Nausea
         subjects affected / exposed
    3 / 21 (14.29%)
    4 / 43 (9.30%)
    3 / 43 (6.98%)
    10 / 107 (9.35%)
         occurrences all number
    3
    5
    4
    12
    Toothache
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    1 / 43 (2.33%)
    2 / 107 (1.87%)
         occurrences all number
    0
    1
    1
    2
    Vomiting
         subjects affected / exposed
    2 / 21 (9.52%)
    5 / 43 (11.63%)
    2 / 43 (4.65%)
    9 / 107 (8.41%)
         occurrences all number
    4
    5
    3
    12
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Portal hypertension
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Night sweats
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Papule
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Renal and urinary disorders
    Ketonuria
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Microalbuminuria
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Nocturia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Polyuria
         subjects affected / exposed
    1 / 21 (4.76%)
    4 / 43 (9.30%)
    1 / 43 (2.33%)
    6 / 107 (5.61%)
         occurrences all number
    1
    4
    1
    6
    Proteinuria
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Urinary incontinence
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Arthritis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    1 / 43 (2.33%)
    2 / 107 (1.87%)
         occurrences all number
    0
    1
    1
    2
    Back pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    2 / 107 (1.87%)
         occurrences all number
    2
    0
    1
    3
    Muscle spasms
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    3 / 107 (2.80%)
         occurrences all number
    2
    0
    4
    6
    Muscular weakness
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Myalgia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    2
    0
    0
    2
    Neck pain
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 43 (2.33%)
    2 / 43 (4.65%)
    4 / 107 (3.74%)
         occurrences all number
    1
    1
    2
    4
    Osteitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Furuncle
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    1
    1
    0
    2
    Gastroenteritis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    1 / 43 (2.33%)
    2 / 107 (1.87%)
         occurrences all number
    0
    1
    1
    2
    Gastroenteritis viral
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Gingival abscess
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Influenza
         subjects affected / exposed
    0 / 21 (0.00%)
    4 / 43 (9.30%)
    0 / 43 (0.00%)
    4 / 107 (3.74%)
         occurrences all number
    0
    5
    0
    5
    Nasopharyngitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    3 / 43 (6.98%)
    4 / 107 (3.74%)
         occurrences all number
    1
    0
    3
    4
    Oral herpes
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Otitis externa
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Rhinitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 43 (6.98%)
    0 / 43 (0.00%)
    4 / 107 (3.74%)
         occurrences all number
    1
    4
    0
    5
    Urinary tract infection
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 43 (4.65%)
    0 / 43 (0.00%)
    3 / 107 (2.80%)
         occurrences all number
    1
    2
    0
    3
    Vaginal infection
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    2 / 43 (4.65%)
    2 / 107 (1.87%)
         occurrences all number
    0
    0
    3
    3
    Viral infection
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 43 (0.00%)
    2 / 43 (4.65%)
    2 / 107 (1.87%)
         occurrences all number
    0
    0
    3
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    1
    1
    0
    2
    Diabetes mellitus
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Food craving
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 43 (4.65%)
    0 / 43 (0.00%)
    3 / 107 (2.80%)
         occurrences all number
    1
    2
    0
    3
    Hypovitaminosis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Polydipsia
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 43 (4.65%)
    1 / 43 (2.33%)
    3 / 107 (2.80%)
         occurrences all number
    0
    2
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Sep 2017
    The purpose of this amendment was to include additional exclusion criteria and patient safety information. This was based on the newly emerging safety data and regulatory guidance. The below exclusion criteria were added: - history of ketoacidosis, lactic acidosis or hyperosmolar coma - history of lower limb amputation
    11 Feb 2019
    The purpose of this amendment was to include additional information on risks and patient safety. This was based on newly emerging safety data and regulatory safety warning about SGLT2 inhibitors. Fournier’s gangrene was added to the exclusion criteria.
    29 Aug 2019
    The purpose of this amendment was to update the language related to sharing the study results from the second interim analysis. This allowed the Sponsor to share the aggregate results from interim analysis of this ongoing study with Investigators and scientific community. Because, the study was fully recruited and had more than 88 patients who had completed the study (as defined in the protocol) by the time the aggregate results were released no impact on patient safety and data integrity was anticipated.

    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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