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    Clinical Trial Results:
    The effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes

    Summary
    EudraCT number
    		 2011-002696-41
    Trial protocol
    		 DE   NL   FI  
    Global end of trial date
    22 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2016
    First version publication date
    21 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN2211-3917
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01617434
    WHO universal trial number (UTN)
    		 U1111-1121-9874
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.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
    25 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm superiority on glycaemic control of liraglutide versus liraglutide placebo after 26 weeks of treatment when added to pre-existing basal insulin analogue treatment (with or without concomitant metformin treatment) in subjects with type 2 diabetes.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2008) and ICH Good Clinical Practice (1996) and FDA 21 CFR 312.120.
    Background therapy
    		 All subjects were on pre-trial basal insulin analogue regimen ± metformin. Basal insulin therapy was insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral antidiabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    10 Sep 2012
    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: 47
    Country: Number of subjects enrolled
    Canada: 41
    Country: Number of subjects enrolled
    India: 69
    Country: Number of subjects enrolled
    Mexico: 10
    Country: Number of subjects enrolled
    Serbia: 38
    Country: Number of subjects enrolled
    United States: 127
    Country: Number of subjects enrolled
    Netherlands: 23
    Country: Number of subjects enrolled
    Finland: 34
    Country: Number of subjects enrolled
    Germany: 61
    Worldwide total number of subjects
    450
    EEA total number of subjects
    118
    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)
    330
    From 65 to 84 years
    120
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 76 sites in 9 countries as follows: Argentina: 3 sites; Canada: 9 sites; Finland: 5 sites; Germany: 9 sites; India: 9 sites; Mexico: 2 sites; Netherlands: 7 sites; Serbia: 3 sites; United States: 29 sites.

    Pre-assignment
    Screening details
    		 All subjects were on pre-trial basal insulin analogue regimen ± metformin. Basal insulin therapy was insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral antidiabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day

    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
    Blinding implementation details
    The subjects were randomised in a 1:1 manner to receive either liraglutide or liraglutide placebo using the interactive voice/web response system (IV/WRS, Visit 2). Liraglutide and liraglutide placebo were considered investigational medicinal products (IMPs), and were blinded throughout the trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental: Liraglutide
    Arm description
    		 Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Victoza
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

    Arm title
    		 Placebo Comparator: Placebo
    Arm description
    		 Liraglutide placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

    Number of subjects in period 1
    		Experimental: Liraglutide Placebo Comparator: Placebo
    Started
    225
    225
    Completed
    191
    174
    Not completed
    34
    51
         Adverse event, non-fatal
    12
    3
         Withdrawal criteria
    12
    37
         Unclassified
    2
    4
         Protocol deviation
    8
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental: Liraglutide
    Reporting group description
    		 Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin.

    Reporting group title
    Placebo Comparator: Placebo
    Reporting group description
    		 Liraglutide placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin.

    Reporting group values
    		 Experimental: Liraglutide Placebo Comparator: Placebo Total
    Number of subjects
    		 225 225 450
    Age categorical
    Units: Subjects
        65-74 years
    		 54 50 104
        Adults (18-64 years)
    		 165 165 330
        Elderly (≥75 years)
    		 6 10 16
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.3 ( 9.2 ) 57.5 ( 11.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 105 89 194
        Male
    		 120 136 256
    Body Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 90.23 ( 19.98 ) 91.85 ( 21.33 ) -
    Fasting Plasma Glucose (FPG)
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 8.32 ( 2.89 ) 8.21 ( 2.9 ) -
    Glycosylated Haemoglobin (HbA1c)
    Units: percentage of glycosylated haemoglobin
        arithmetic mean (standard deviation)
    		 8.22 ( 0.81 ) 8.28 ( 0.9 ) -

    End points

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    End points reporting groups
    Reporting group title
    Experimental: Liraglutide
    Reporting group description
    		 Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin.

    Reporting group title
    Placebo Comparator: Placebo
    Reporting group description
    		 Liraglutide placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin.

    Primary: Change in glycosylated haemoglobin (HbA1c) from baseline to week 26

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    End point title
    		 Change in glycosylated haemoglobin (HbA1c) from baseline to week 26
    End point description
    The estimated mean change from baseline in HbA1c after 26 weeks of treatment.
    End point type
    Primary
    End point timeframe
    Week 0 to week 26
    End point values
    		 Experimental: Liraglutide Placebo Comparator: Placebo
    Number of subjects analysed
    215
    217
    Units: percentage of glycosylated haemoglobin
        least squares mean (standard deviation)
    -1.3 ( 1.015 )
    -0.11 ( 1.088 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Experimental: Liraglutide v Placebo Comparator: Placebo
    Number of subjects included in analysis
    432
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.39
         upper limit
    		 -0.99
    Notes
    [1] - The null hypothesis of no difference between the two treatment arms with regard to changes from baseline in HbA1c (%) after 26 weeks of randomised treatment was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline HbA1c as a covariate, all nested within visit.

    Secondary: Change in fasting plasma glucose (FPG) from baseline to week 26

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    End point title
    		 Change in fasting plasma glucose (FPG) from baseline to week 26
    End point description
    The estimated mean change from baseline in FPG after 26 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Week 0 to week 26
    End point values
    		 Experimental: Liraglutide Placebo Comparator: Placebo
    Number of subjects analysed
    213
    217
    Units: mmol/L
        least squares mean (standard deviation)
    -1.44 ( 2.494 )
    -0.16 ( 3.006 )
    No statistical analyses for this end point

    Secondary: Change in mean self-measured plasma glucose (SMPG) of 7-point profile from baseline to week 26

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    End point title
    		 Change in mean self-measured plasma glucose (SMPG) of 7-point profile from baseline to week 26
    End point description
    The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Week 0 to week 26
    End point values
    		 Experimental: Liraglutide Placebo Comparator: Placebo
    Number of subjects analysed
    191
    196
    Units: mmol/L
        least squares mean (standard deviation)
    -2.61 ( 2.248 )
    -1.02 ( 3.061 )
    No statistical analyses for this end point

    Secondary: Change in body weight from baseline to week 26

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    End point title
    		 Change in body weight from baseline to week 26
    End point description
    The estimated mean change in body weight after 26 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Week 0 to week 26
    End point values
    		 Experimental: Liraglutide Placebo Comparator: Placebo
    Number of subjects analysed
    215
    216
    Units: kg
        least squares mean (standard deviation)
    -3.54 ( 3.669 )
    -0.42 ( 3.909 )
    No statistical analyses for this end point

    Secondary: Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target)

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    End point title
    		 Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target)
    End point description
    Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    After 26 weeks of treatment
    End point values
    		 Experimental: Liraglutide Placebo Comparator: Placebo
    Number of subjects analysed
    211
    217
    Units: Percentage of subjects
        number (not applicable)
    59.24
    14.02
    No statistical analyses for this end point

    Secondary: Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)

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    End point title
    		 Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)
    End point description
    Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    After 26 weeks of treatment
    End point values
    		 Experimental: Liraglutide Placebo Comparator: Placebo
    Number of subjects analysed
    211
    217
    Units: Percentage of subjects
        number (not applicable)
    42.91
    3.6
    No statistical analyses for this end point

    Secondary: Number of minor hypoglycaemic episodes during the randomised treatment period

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    End point title
    		 Number of minor hypoglycaemic episodes during the randomised treatment period
    End point description
    A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL).
    End point type
    Secondary
    End point timeframe
    Week 0 to week 26 + 7 days follow-up.
    End point values
    		 Experimental: Liraglutide Placebo Comparator: Placebo
    Number of subjects analysed
    225
    225
    Units: Events/100 years of patient exposure
    126
    83
    No statistical analyses for this end point

    Secondary: Number of severe hypoglycaemic episodes during the randomised treatment period

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    End point title
    		 Number of severe hypoglycaemic episodes during the randomised treatment period
    End point description
    Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 26 + 7 days follow-up
    End point values
    		 Experimental: Liraglutide Placebo Comparator: Placebo
    Number of subjects analysed
    225
    225
    Units: Events/100 years of patient exposure
    0
    0
    No statistical analyses for this end point

    Secondary: Number of adverse events (AEs) during the randomised treatment period

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    End point title
    		 Number of adverse events (AEs) during the randomised treatment period
    End point description
    An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events.
    End point type
    Secondary
    End point timeframe
    Week 0 to Week 26 + 7 days follow-up
    End point values
    		 Experimental: Liraglutide Placebo Comparator: Placebo
    Number of subjects analysed
    225
    225
    Units: Events/1000 years of patient exposure
        Adverse events
    4918
    3737
        Serious Adverse Events
    149
    101
        Severe Adverse Events
    169
    101
        Moderate Adverse Events
    1274
    1060
        Mild Adverse Events
    3474
    2575
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 0 to week 26 + 7 days follow-up (From the first trial-related activity after the subject had signed the informed consent through the posttreatment follow-up period.)
    Adverse event reporting additional description
    An adverse event (AE) could be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Safety analysis set includes all subjects who received at least one dose of the trial product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Placebo Comparator: Placebo
    Reporting group description
    		 Liraglutide placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

    Reporting group title
    Experimental: Liraglutide
    Reporting group description
    		 Max. 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

    Serious adverse events
    		 Placebo Comparator: Placebo Experimental: Liraglutide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 225 (3.11%)
    11 / 225 (4.89%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Electrocardiogram change
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Percutaneous coronary intervention
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Intercostal neuralgia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis staphylococcal
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital herpes
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 225 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 225 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Comparator: Placebo Experimental: Liraglutide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 225 (26.67%)
    110 / 225 (48.89%)
    Investigations
    Lipase increased
         subjects affected / exposed
    5 / 225 (2.22%)
    16 / 225 (7.11%)
         occurrences all number
    5
    16
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 225 (7.11%)
    8 / 225 (3.56%)
         occurrences all number
    20
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    11 / 225 (4.89%)
    24 / 225 (10.67%)
         occurrences all number
    14
    29
    Dyspepsia
         subjects affected / exposed
    2 / 225 (0.89%)
    16 / 225 (7.11%)
         occurrences all number
    2
    20
    Nausea
         subjects affected / exposed
    7 / 225 (3.11%)
    50 / 225 (22.22%)
         occurrences all number
    8
    62
    Vomiting
         subjects affected / exposed
    2 / 225 (0.89%)
    20 / 225 (8.89%)
         occurrences all number
    3
    28
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    12 / 225 (5.33%)
    12 / 225 (5.33%)
         occurrences all number
    13
    13
    Infections and infestations
    Influenza
         subjects affected / exposed
    16 / 225 (7.11%)
    8 / 225 (3.56%)
         occurrences all number
    21
    11
    Nasopharyngitis
         subjects affected / exposed
    14 / 225 (6.22%)
    13 / 225 (5.78%)
         occurrences all number
    16
    19
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 225 (2.22%)
    22 / 225 (9.78%)
         occurrences all number
    5
    22

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jul 2012
    Changes to Table of contents; Section 1: Summary; Section 2: Flow chart; Section 4.2.3: Objectives and endpoints; Section 5.3: Treatment of subjects; Section 6.2: Inclusion criteria; Section 6.3: Exclusion criteria; Section 6.6: Rationale for trial population; Section 8.5.4: Insulin dose adjustment; Section 8.6.4: Self-measured plasma glucose; Section 8.6.5: Diabetes Treatment Satisfaction Questionnaire; Section 8.7.4: Eye examination (fundoscopy/ fundus photography); Section 8.7.7: Urinalysis; Section 9.1: Trial products; Section 12.7.2: Event Adjudication Committee; Section 17.4.2: Safety endpoints; Section 18: Ethics; Section 27: References; SI/IC version 1.0; Section 1.1: An invitation to participate; SI/IC version 1.0 Section 2.2: Other risks associated with the treatment; Appendix B: Medical events of special interest
    17 May 2013
    Changes to Tables of contents; List of abbreviations; Section 1: number of subjects; Section 6.4: Withdrawal criteria; Section 7: Trial schedule; Section 8.4: Laboratory assessments; Section 8.7: Assessments for safety; Section 12.3: Follow-up of adverse events; Section 17.3: Primary endpoint; Master SI/IC version 2.0 Section 1.5.3 added and new SI/IC for gene testing added. Attachment I updated.

    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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