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    Clinical Trial Results:
    A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide with Once-Daily Liraglutide in Patients with Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)

    Summary
    EudraCT number
    		 2011-003810-18
    Trial protocol
    		 CZ   HU   DE   PL   ES   SK  
    Global end of trial date
    25 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jul 2016
    First version publication date
    02 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H9X-MC-GBDE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01624259
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 11377, Trial Alias: H9X-MC-GBDE
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    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 Nov 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.
    Protection of trial subjects
    The study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 Metformin: at least 1500 mg/day, oral, for 26 weeks
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Jun 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
    United States: 194
    Country: Number of subjects enrolled
    Czech Republic: 55
    Country: Number of subjects enrolled
    Hungary: 40
    Country: Number of subjects enrolled
    Mexico: 41
    Country: Number of subjects enrolled
    Slovakia: 42
    Country: Number of subjects enrolled
    Puerto Rico: 7
    Country: Number of subjects enrolled
    Poland: 81
    Country: Number of subjects enrolled
    Spain: 48
    Country: Number of subjects enrolled
    Romania: 37
    Country: Number of subjects enrolled
    Germany: 54
    Worldwide total number of subjects
    599
    EEA total number of subjects
    357
    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)
    488
    From 65 to 84 years
    111
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No text entered

    Pre-assignment
    Screening details
    		 No text entered

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LY2189265
    Arm description
    		 LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2189265
    Investigational medicinal product code
    Other name
    Dulaglutide
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks

    Arm title
    		 Liraglutide
    Arm description
    		 Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks

    Number of subjects in period 1
    		LY2189265 Liraglutide
    Started
    299
    300
    Received at Least One Dose of Study Drug
    299
    300
    Completed
    269
    269
    Not completed
    30
    31
         Physician decision
    1
    1
         Adverse event, non-fatal
    18
    18
         Withdrawal by Subject
    5
    7
         Lost to follow-up
    2
    3
         Protocol deviation
    1
    2
         Abnormal laboratory measure
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LY2189265
    Reporting group description
    		 LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks

    Reporting group title
    Liraglutide
    Reporting group description
    		 Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks

    Reporting group values
    		 LY2189265 Liraglutide Total
    Number of subjects
    		 299 300 599
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.49 ± 9.34 56.81 ± 9.91 -
    Gender, Male/Female
    Units: participants
        Female
    		 161 151 312
        Male
    		 138 149 287
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 75 72 147
        Not Hispanic or Latino
    		 221 223 444
        Unknown or Not Reported
    		 3 5 8
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 20 23 43
        Asian
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 21 16 37
        White
    		 256 259 515
        More than one race
    		 1 2 3
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        United States
    		 97 97 194
        Czech Republic
    		 27 28 55
        Hungary
    		 21 19 40
        Mexico
    		 20 21 41
        Slovakia
    		 20 22 42
        Puerto Rico
    		 3 4 7
        Poland
    		 39 42 81
        Spain
    		 24 24 48
        Romania
    		 20 17 37
        Germany
    		 28 26 54
    Body Weight
    Units: kilograms (kg)
        arithmetic mean (standard deviation)
    		 93.82 ± 18.23 94.35 ± 18.96 -
    Body Mass Index (BMI)
    BMI is an estimate of body fat based on body weight divided by height squared
    Units: kilograms per meter squared (kg/m^2)
        arithmetic mean (standard deviation)
    		 33.5 ± 5.07 33.62 ± 5.16 -
    Glycosylated hemoglobin (HbA1c)
    Units: percentage of glycosylated hemoglobin
        arithmetic mean (standard deviation)
    		 8.06 ± 0.81 8.05 ± 0.79 -
    Duration of diabetes
    Units: years
        arithmetic mean (standard deviation)
    		 7.13 ± 5.41 7.28 ± 5.41 -

    End points

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    End points reporting groups
    Reporting group title
    LY2189265
    Reporting group description
    		 LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks

    Reporting group title
    Liraglutide
    Reporting group description
    		 Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks

    Primary: 1: Change from Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

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    End point title
    		 1: Change from Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
    End point description
    Least Squares (LS) means of the glycosylated hemoglobin A1c (HbA1c) change from baseline to the primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect, and baseline HbA1c as covariates, via a mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).
    End point type
    Primary
    End point timeframe
    Baseline, 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    279 [1]
    272 [2]
    Units: percentage of glycosylated hemoglobin
        least squares mean (standard error)
    -1.42 ± 0.05
    -1.36 ± 0.05
    Notes
    [1] - Received at least 1 dose of LY2189265 with evaluable HbA1c data.
    [2] - Received at least 1 dose of Liraglutide with evaluable HbA1c data.
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 1
    Statistical analysis description
    To show noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide with 90% power, 222 completers (444 total) at 26 weeks were required. Noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide was demonstrated if the upper bound of the two‑sided 95% Confidence Interval (CI) for the difference in mean change in HbA1c between the 1.5 mg LY2189265 arm and 1.8 mg liraglutide arm was below 0.4%.
    Comparison groups
    Liraglutide v LY2189265
    Number of subjects included in analysis
    551
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.07
    Notes
    [3] - Family-wise Type I error rate was controlled by applying a serial gatekeeping strategy. This calculation assumed a 0 difference in HbA1c between the 1.5 mg LY2189265 1.5-mg arm and 1.8 mg liraglutide, 0.4% margin of noninferiority, common Standard Deviation (SD) of 1.3% for change from baseline in HbA1c, 0.05 two-sided significance level, and 25% dropout rate at 26 weeks. 1-sided raw p-value (no multiplicity adjustment).
    Statistical analysis title
    		 Statistical Analysis 2 for End Point 1
    Statistical analysis description
    Superiority analysis
    Comparison groups
    LY2189265 v Liraglutide
    Number of subjects included in analysis
    551
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.186 [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.07
    Notes
    [4] - 1-sided raw p-value (no multiplicity adjustment)

    Secondary: 2: Change from Baseline in Body Weight at 26 Weeks

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    End point title
    		 2: Change from Baseline in Body Weight at 26 Weeks
    End point description
    LS means of the weight change from baseline to primary endpoint at Week 26 were calculated using analysis of covariance (ANCOVA) with HbA1c Strata, country, and treatment as fixed effects and baseline body weight as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, Up to 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    299 [5]
    299 [6]
    Units: kilograms (kg)
        least squares mean (standard error)
    -2.9 ± 0.22
    -3.61 ± 0.22
    Notes
    [5] - Received at least 1 dose of LY2189265 with evaluable body weight data.
    [6] - Received at least 1 dose of Liraglutide with evaluable body weight data.
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 2
    Statistical analysis description
    Treatment comparison from ANCOVA model at 26 weeks.
    Comparison groups
    LY2189265 v Liraglutide
    Number of subjects included in analysis
    598
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.01 [8]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 1.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Notes
    [7] - Analysis type other: Test for Difference
    [8] - No adjustment for multiplicity.

    Secondary: 3: Change from Baseline in Body Mass Index (BMI) at 26 Weeks

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    End point title
    		 3: Change from Baseline in Body Mass Index (BMI) at 26 Weeks
    End point description
    BMI is an estimate of body fat based on body weight divided by height squared. LS means of the BMI change from baseline to primary endpoint at Week 26 were calculated using ANCOVA with HbA1c Strata, country, and treatment as fixed effects and baseline BMI as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, Up to 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    299 [9]
    299 [10]
    Units: kilograms/square meter (kg/m^2)
        least squares mean (standard error)
    -1.05 ± 0.08
    -1.3 ± 0.08
    Notes
    [9] - Received at least 1 dose of LY2189265 with evaluable BMI data.
    [10] - Received at least 1 dose of liraglutide with evaluable BMI data.
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 3
    Statistical analysis description
    Treatment comparison from ANCOVA model.
    Comparison groups
    LY2189265 v Liraglutide
    Number of subjects included in analysis
    598
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.013 [12]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 0.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Notes
    [11] - Analysis type other: Test for Difference
    [12] - No adjustment for multiplicity.

    Secondary: 4: Change from Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks

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    End point title
    		 4: Change from Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks
    End point description
    LS means of the FPG from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FPG as covariates, via ANCOVA with LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Up to 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    281 [13]
    277 [14]
    Units: milligrams/deciliter (mg/dL)
        least squares mean (standard error)
    -34.81 ± 2.13
    -34.25 ± 2.11
    Notes
    [13] - Received at least 1 dose of LY2189265 with evaluable FPG data.
    [14] - Received at least 1 dose of liraglutide with evaluable FPG data.
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 4
    Statistical analysis description
    Treatment comparison from ANCOVA model.
    Comparison groups
    LY2189265 v Liraglutide
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    P-value
    		 = 0.828 [16]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.69
         upper limit
    		 4.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.61
    Notes
    [15] - Analysis type other: Test for Difference
    [16] - No adjustment for multiplicity.

    Secondary: 5: Change from Baseline Daily Mean in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks

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    End point title
    		 5: Change from Baseline Daily Mean in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks
    End point description
    The SMPG data were collected at the following 7 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; and bedtime. The mean of the 7 time points (Daily Mean) was also calculated. LS means of the SMPG change from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, HbA1c strata, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG as a covariate, via a MMRM analysis using REML.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    248 [17]
    256 [18]
    Units: mg/dL
        least squares mean (standard error)
    -40.76 ± 1.5
    -38.51 ± 1.45
    Notes
    [17] - Received at least 1 dose of LY2189265 with evaluable 7-Point SMPG data.
    [18] - Received at least 1 dose of liraglutide with evaluable 7-Point SMPG data.
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 5
    Comparison groups
    LY2189265 v Liraglutide
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    P-value
    		 = 0.228 [20]
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -2.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.91
         upper limit
    		 1.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.86
    Notes
    [19] - P-value from pairwise comparison of LS means at 26 weeks from REML-based MMRM. Analysis type other: Test for Difference
    [20] - No adjustment for multiplicity.

    Secondary: 6: Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks

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    End point title
    		 6: Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks
    End point description
    The percentage of participants who achieved the target HbA1c values at the primary endpoint were analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes pooled country, treatment, visit, treatment-by-visit interaction, and baseline HbA1c as continuous covariates.
    End point type
    Secondary
    End point timeframe
    Up to 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    293 [21]
    293 [22]
    Units: percentage of participants
        HbA1c levels ≤6.5%
    55
    51
        HbA1c levels <7.0%
    68
    68
    Notes
    [21] - Received at least 1 dose of LY2189265 with evaluable HbA1c data.
    [22] - Received at least 1 dose of Liraglutide with evaluable HbA1c data.
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 6
    Statistical analysis description
    Treatment comparison for HbA1c levels ≤6.5%
    Comparison groups
    LY2189265 v Liraglutide
    Number of subjects included in analysis
    586
    Analysis specification
    Pre-specified
    Analysis type
    		 other [23]
    P-value
    		 = 0.322 [24]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.86
    Notes
    [23] - No adjustment for multiplicity. Analysis type other: Test for Difference
    [24] - P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).
    Statistical analysis title
    		 Statistical Analysis 2 for End Point 6
    Statistical analysis description
    Treatment comparison for HbA1c levels <7.0%.
    Comparison groups
    LY2189265 v Liraglutide
    Number of subjects included in analysis
    586
    Analysis specification
    Pre-specified
    Analysis type
    		 other [25]
    P-value
    		 = 0.925 [26]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.63
    Notes
    [25] - P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model). Analysis type other: Test for Difference
    [26] - No adjustment for multiplicity.

    Secondary: 7: Change from Baseline in Homeostasis Model Assessment 2 steady-state Beta (β)- cell function (HOMA2-%B) at 26 Weeks

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    End point title
    		 7: Change from Baseline in Homeostasis Model Assessment 2 steady-state Beta (β)- cell function (HOMA2-%B) at 26 Weeks
    End point description
    The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means of the HOMA2-%B change from baseline to primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline HOMA2-%B value as covariate, via an ANCOVA analysis using LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Up to 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    275 [27]
    265 [28]
    Units: percentage of HOMA2-%B
        least squares mean (standard error)
    37.03 ± 2.26
    35.59 ± 2.27
    Notes
    [27] - Received at least 1 dose of LY2189265 with evaluable HOMA2-%B data.
    [28] - Received at least 1 dose of liraglutide with evaluable HOMA2-%B data.
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 7
    Comparison groups
    LY2189265 v Liraglutide
    Number of subjects included in analysis
    540
    Analysis specification
    Pre-specified
    Analysis type
    		 other [29]
    P-value
    		 = 0.608
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.06
         upper limit
    		 6.92
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.79
    Notes
    [29] - No adjustment for multiplicity. Analysis type other: Test for Difference

    Secondary: 9: Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks

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    End point title
    		 9: Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks
    End point description
    ECG HR was measured. LS means of change from baseline were analyzed using ANCOVA with HbA1c strata, country, and treatment as fixed effects and baseline HR as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, Up to 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    273 [30]
    284 [31]
    Units: beats per minute (bpm)
        least squares mean (standard error)
    1.9 ± 0.55
    4.1 ± 0.54
    Notes
    [30] - Received at least 1 dose of LY2189265 with evaluable ECG heart rate data.
    [31] - Received at least 1 dose of liraglutide with evaluable ECG heart rate data.
    No statistical analyses for this end point

    Secondary: 10: Change from Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) intervals at 26 Weeks

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    End point title
    		 10: Change from Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) intervals at 26 Weeks
    End point description
    The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. QTcF is the measure of the time between the start of the Q wave and the end of the T wave adjusted using Fridericia's formula. PR is the interval between the P wave and the QRS complex. These parameters were calculated from electrocardiogram (ECG) data. LS means of change from baseline for the PR and QTcF intervals will be analyzed using the MMRM similar to MMRM model for primary outcome, using corresponding baseline and HbA1c strata. Only ECGs obtained at scheduled visits will be used in these summaries and analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    273 [32]
    284 [33]
    Units: milliseconds (msec)
    least squares mean (standard error)
        PR interval (n=270, 278)
    3.8 ± 0.81
    3.3 ± 0.8
        QTcF interval (n=273, 284)
    0.39 ± 0.9
    -0.72 ± 0.89
    Notes
    [32] - Received at least 1 dose of LY2189265 with evaluable ECG PR or QTcF interval data.
    [33] - Received at least 1 dose of Liraglutide with evaluable ECG PR or QTcF interval data.
    No statistical analyses for this end point

    Secondary: 11: Change from Baseline in Heart Rate (HR) at 26 Weeks

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    End point title
    		 11: Change from Baseline in Heart Rate (HR) at 26 Weeks
    End point description
    Descriptive statistics for the actual measurements and LS means of change from baseline for HR (sitting) by treatment arm were analyzed using the MMRM model with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline rate as a covariate, and participant as a random effect.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    288 [34]
    288 [35]
    Units: bpm
        least squares mean (standard error)
    2.37 ± 0.4
    3.12 ± 0.4
    Notes
    [34] - Received at least 1 dose of LY2189265 with evaluable heart rate data.
    [35] - Received at least 1 dose of liraglutide with evaluable heart rate data.
    No statistical analyses for this end point

    Secondary: 12: Change from Baseline in Blood Pressure (BP) at 26 Weeks

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    End point title
    		 12: Change from Baseline in Blood Pressure (BP) at 26 Weeks
    End point description
    Descriptive statistics for the actual measurements and change from baseline for sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline BP as a covariate, and participant as a random effect.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    278 [36]
    281 [37]
    Units: milliliters of mercury (mmHg)
    least squares mean (standard error)
        Sitting DBP
    -0.22 ± 0.4
    -0.31 ± 0.4
        Sitting SBP
    -3.36 ± 0.7
    -2.82 ± 0.7
    Notes
    [36] - Received at least 1 dose of LY2189265 with evaluable BP data.
    [37] - Received at least 1 dose of liraglutide with evaluable BP data.
    No statistical analyses for this end point

    Secondary: 13: Number of Participants with Adjudicated Acute Pancreatitis Events

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    End point title
    		 13: Number of Participants with Adjudicated Acute Pancreatitis Events
    End point description
    The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 26 weeks (including a 30-day follow up). Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
    End point type
    Secondary
    End point timeframe
    Baseline up to 30 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    299 [38]
    300 [39]
    Units: participants
        number (not applicable)
    0
    0
    Notes
    [38] - Received at least 1 dose of LY2189265 with evaluable adverse event data.
    [39] - Received at least 1 dose of Liraglutide with evaluable adverse event data.
    No statistical analyses for this end point

    Secondary: 14: Change from Baseline in Calcitonin at 26 Weeks

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    End point title
    		 14: Change from Baseline in Calcitonin at 26 Weeks
    End point description
    A summary of participants having changes in calcitonin values from baseline to primary endpoint of 26 weeks is presented.
    End point type
    Secondary
    End point timeframe
    Baseline, Up to 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    292 [40]
    294 [41]
    Units: picograms/milliliter (pcg/mL)
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [40] - Received at least 1 dose of LY2189265 with evaluable calcitonin laboratory data.
    [41] - Received at least 1 dose of liraglutide with evaluable calcitonin laboratory data.
    No statistical analyses for this end point

    Secondary: 15: Change from Baseline in Lipase at 26 Weeks

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    End point title
    		 15: Change from Baseline in Lipase at 26 Weeks
    End point description
    A summary of participants having changes in lipase evaluation from baseline to primary endpoint of 26 weeks is presented.
    End point type
    Secondary
    End point timeframe
    Baseline, Up to 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    288 [42]
    289 [43]
    Units: units/liter (U/L)
        median (inter-quartile range (Q1-Q3))
    7 (0.5 to 17.5)
    11 (2 to 23)
    Notes
    [42] - Received at least 1 dose of LY2189265 with evaluable lipase laboratory data.
    [43] - Received at least 1 dose of liraglutide with evaluable lipase laboratory data.
    No statistical analyses for this end point

    Secondary: 16: Change from Baseline in Amylase at 26 Weeks

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    End point title
    		 16: Change from Baseline in Amylase at 26 Weeks
    End point description
    A summary of participants having changes in amylase evaluation from baseline to primary endpoint of 26 weeks is presented.
    End point type
    Secondary
    End point timeframe
    Baseline, Up to 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    287 [44]
    289 [45]
    Units: U/L
        median (inter-quartile range (Q1-Q3))
    7 (0 to 14)
    6 (0 to 13)
    Notes
    [44] - Received at least 1 dose of LY2189265 with evaluable amylase laboratory data.
    [45] - Received at least 1 dose of liraglutide with evaluable amylase laboratory data.
    No statistical analyses for this end point

    Secondary: 17: Percentage of Participants with Self-Reported Hypoglycemia Events

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    End point title
    		 17: Percentage of Participants with Self-Reported Hypoglycemia Events
    End point description
    Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a plasma glucose [PG] concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    299 [46]
    300 [47]
    Units: percentage of participants
    number (not applicable)
        Documented symptomatic HE
    2.7
    2.7
        Asymptomatic HE
    6.7
    3.3
        Severe HE
    0
    0
        Nocturnal HE
    1.3
    2
        Probable symptomatic HE
    1
    1
    Notes
    [46] - Received at least 1 dose of LY2189265 with evaluable hypoglycemia event data
    [47] - Received at least 1 dose of liraglutide with evaluable hypoglycemia event data
    No statistical analyses for this end point

    Secondary: 18: Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia

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    End point title
    		 18: Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia
    End point description
    An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    299 [48]
    300 [49]
    Units: percentage of participants
        number (not applicable)
    0.3
    1
    Notes
    [48] - Received at least 1 dose of LY2189265 with evaluable concomitant medication data.
    [49] - Received at least 1 dose of liraglutide with evaluable concomitant medication data.
    No statistical analyses for this end point

    Secondary: 19: Rate of Hypoglycemic Events Adjusted per 30 Days

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    End point title
    		 19: Rate of Hypoglycemic Events Adjusted per 30 Days
    End point description
    HE were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL). The hypoglycemia rate per 30 days was calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    299 [50]
    300 [51]
    Units: number of events/participant/30 days
    arithmetic mean (standard deviation)
        Total HE
    0.03 ± 0.12
    0.04 ± 0.25
        Documented symptomatic HE
    0.01 ± 0.08
    0.02 ± 0.17
        Asymptomatic HE
    0.02 ± 0.07
    0.01 ± 0.08
        Severe HE
    0 ± 0
    0 ± 0
        Nocturnal HE
    0.01 ± 0.05
    0.01 ± 0.1
        Probable symptomatic HE
    0 ± 0.02
    0.01 ± 1.12
    Notes
    [50] - Received at least 1 dose of LY2189265 with evaluable hypoglycemic episode data.
    [51] - Received at least 1 dose of liraglutide with evaluable hypoglycemic episode data.
    No statistical analyses for this end point

    Secondary: 20: Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia

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    End point title
    		 20: Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia
    End point description
    An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. A median time to initiation of additional intervention could not be calculated due to the small number of events requiring rescue therapy. Value 999999 represents NA.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    299 [52]
    300 [53]
    Units: weeks
        median (confidence interval 95%)
    999999 (999999 to 9999999)
    999999 (999999 to 9999999)
    Notes
    [52] - 999999 represents NA. A small number of events requiring rescue therapy, therefore no evaluation.
    [53] - 999999 represents NA. A small number of events requiring rescue therapy, therefore no evaluation.
    No statistical analyses for this end point

    Secondary: 21: Number of Participants with Allergic or Hypersensitivity Reactions

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    End point title
    		 21: Number of Participants with Allergic or Hypersensitivity Reactions
    End point description
    Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    299
    300
    Units: Participants
    1
    5
    No statistical analyses for this end point

    Secondary: 22: Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose

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    End point title
    		 22: Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose
    End point description
    LY2189265 (dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation in dulaglutide-treated participants. A participant was considered to have treatment emergent LY2189265 ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The number of participants with treatment-emergent LY2189265 ADA from postbaseline to follow up were summarized.
    End point type
    Secondary
    End point timeframe
    Baseline up to 4 Weeks Post Last Dose of Study Drug
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    290 [54]
    0 [55]
    Units: Participants
    3
    Notes
    [54] - Subject received at least 1 dose of LY2189265 with evaluable LY2189265 ADA data.
    [55] - 99999 represents not applicable values
    No statistical analyses for this end point

    Secondary: 23: Percent Change from Baseline in Lipid Parameters at 26 Weeks

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    End point title
    		 23: Percent Change from Baseline in Lipid Parameters at 26 Weeks
    End point description
    A summary of percent change in lipid parameters (total cholesterol, high-density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], very low-density lipoprotein cholesterol [VLDL], and triglycerides) from baseline to primary endpoint of 26 weeks is presented. LS means of the lipid parameter from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and lipid parameter baseline as covariates, via ANCOVA with LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Up to 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    286
    284
    Units: percent
    least squares mean (standard error)
        Total cholesterol (n=286, 284)
    -1.64 ± 1.18
    0.67 ± 1.18
        HDL-C (n=286, 284)
    6.21 ± 1.02
    6.46 ± 1.02
        LDL-C (n=276, 276)
    -1.09 ± 2.17
    3.2 ± 2.15
        VLDL (n=276, 276)
    1.56 ± 2.63
    2.92 ± 2.6
        Triglycerides (n=286, 284)
    0.59 ± 2.76
    1.35 ± 2.76
    No statistical analyses for this end point

    Secondary: 8: Number of Participants With Reported and Adjudicated Cardiovascular Events [ Time Frame: Baseline up to 26 Weeks ]

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    End point title
    		 8: Number of Participants With Reported and Adjudicated Cardiovascular Events [ Time Frame: Baseline up to 26 Weeks ]
    End point description
    Deaths and nonfatal cardiovascular (CV) adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal CV AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with reported CV events, number of participants with nonfatal CV events confirmed by adjudication, and number of deaths confirmed by adjudication are summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
    End point type
    Secondary
    End point timeframe
    Baseline up to 26 Weeks
    End point values
    		 LY2189265 Liraglutide
    Number of subjects analysed
    299 [56]
    300 [57]
    Units: Participants
        Any reported CV events
    0
    3
        Any adjudicated nonfatal CV events
    0
    1
        Any confirmed adjudicated deaths
    0
    0
    Notes
    [56] - Received at least 1 dose of LY2189265 with evaluable adjudicated CV event data.
    [57] - Received at least 1 dose of liraglutide with evaluable adjudicated CV event data.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Core Study
    Adverse event reporting additional description
    H9X-MC-GBDE
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Reporting group title
    LY2189265
    Reporting group description
    		 -

    Serious adverse events
    		 Liraglutide LY2189265
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 300 (3.67%)
    5 / 299 (1.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    lipase increased
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    papillary thyroid cancer
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    meningioma
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostate cancer
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed [1]
    0 / 149 (0.00%)
    1 / 138 (0.72%)
         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
    ankle fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tachyarrhythmia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    epilepsy
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    polyneuropathy
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    hydronephrosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal failure acute
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    schizophrenia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    bronchopneumonia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia influenzal
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory tract infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vestibular neuronitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Liraglutide LY2189265
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    116 / 300 (38.67%)
    113 / 299 (37.79%)
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    25 / 300 (8.33%)
    22 / 299 (7.36%)
         occurrences all number
    35
    36
    Gastrointestinal disorders
    constipation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    17 / 300 (5.67%)
    11 / 299 (3.68%)
         occurrences all number
    20
    16
    diarrhoea
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    36 / 300 (12.00%)
    36 / 299 (12.04%)
         occurrences all number
    51
    56
    nausea
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    54 / 300 (18.00%)
    61 / 299 (20.40%)
         occurrences all number
    77
    108
    vomiting
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    25 / 300 (8.33%)
    21 / 299 (7.02%)
         occurrences all number
    36
    24
    dyspepsia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    18 / 300 (6.00%)
    24 / 299 (8.03%)
         occurrences all number
    22
    36
    Infections and infestations
    nasopharyngitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    21 / 300 (7.00%)
    23 / 299 (7.69%)
         occurrences all number
    24
    30
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    20 / 300 (6.67%)
    16 / 299 (5.35%)
         occurrences all number
    20
    16

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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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