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    Clinical Trial Results:
    Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients with Type 2 Diabetes.

    Summary
    EudraCT number
    		 2013-003552-21
    Trial protocol
    		 GR   PL   RO  
    Global end of trial date
    25 Aug 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 May 2021
    First version publication date
    04 Apr 2021
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Adjust to align with other database.

    Trial information

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    Trial identification
    Sponsor protocol code
    I7I-MC-XNAA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02119819
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15062
    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‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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 Aug 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (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
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 May 2014
    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: 193
    Country: Number of subjects enrolled
    Greece: 32
    Country: Number of subjects enrolled
    Mexico: 60
    Country: Number of subjects enrolled
    Poland: 66
    Country: Number of subjects enrolled
    Puerto Rico: 12
    Country: Number of subjects enrolled
    Romania: 57
    Worldwide total number of subjects
    420
    EEA total number of subjects
    155
    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)
    333
    From 65 to 84 years
    87
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No Text Available

    Pre-assignment
    Screening details
    		 No Text Available

    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
    		 10 mg LY2944876
    Arm description
    		 10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks, plus background PO metformin.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2944876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10 mg of LY2944876 administered subcutaneously.

    Arm title
    		 15 mg LY2944876
    Arm description
    		 15 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2944876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    15 mg of LY2944876 administered Subcutaneously.

    Arm title
    		 30 mg LY2944876
    Arm description
    		 30 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2944876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg of LY2944876 administered Subcutaneously.

    Arm title
    		 50 mg LY2944876
    Arm description
    		 50 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2944876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    50 mg of LY2944876 administered Subcutaneously.

    Arm title
    		 Exenatide extended-release
    Arm description
    		 2 mg exenatide extended-release given SC once weekly for 24 weeks, plus background PO metformin..
    Arm type
    		 Experimental

    Investigational medicinal product name
    Exenatide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 mg of exenatide administered Subcutaneously.

    Arm title
    		 Placebo
    Arm description
    		 Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks,plus background PO metformin. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for LY2944876 and Exenatide administered Subcutaneously.

    Number of subjects in period 1
    		10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Started
    66
    71
    73
    70
    69
    71
    Completed
    57
    66
    69
    63
    62
    56
    Not completed
    9
    5
    4
    7
    7
    15
         Physician decision
    1
    1
    -
    -
    -
    1
         Consent withdrawn by subject
    5
    3
    -
    -
    6
    10
         Adverse event, non-fatal
    3
    1
    2
    3
    -
    1
         Jury Duty
    -
    -
    1
    -
    -
    -
         Lost to follow-up
    -
    -
    1
    2
    1
    2
         Left the city to get a job
    -
    -
    -
    1
    -
    -
         Protocol deviation
    -
    -
    -
    1
    -
    -
         Lack of efficacy
    -
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    10 mg LY2944876
    Reporting group description
    		 10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks, plus background PO metformin.

    Reporting group title
    15 mg LY2944876
    Reporting group description
    		 15 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..

    Reporting group title
    30 mg LY2944876
    Reporting group description
    		 30 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..

    Reporting group title
    50 mg LY2944876
    Reporting group description
    		 50 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..

    Reporting group title
    Exenatide extended-release
    Reporting group description
    		 2 mg exenatide extended-release given SC once weekly for 24 weeks, plus background PO metformin..

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks,plus background PO metformin. Participants assigned to placebo will have no injections during the second 12 weeks of the study.

    Reporting group values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo Total
    Number of subjects
    		 66 71 73 70 69 71 420
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.1 ± 9.4 59.0 ± 8.5 56.1 ± 8.3 55.6 ± 8.4 57.6 ± 9.1 56.5 ± 9.7 -
    Gender categorical
    Units: Subjects
        Female
    		 33 40 26 33 32 35 199
        Male
    		 33 31 47 37 37 36 221
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 19 21 26 19 22 22 129
        Not Hispanic or Latino
    		 42 42 42 47 44 47 264
        Unknown or Not Reported
    		 5 8 5 4 3 2 27
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0
        Asian
    		 1 2 1 1 2 1 8
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0
        Black or African American
    		 4 3 5 5 2 6 25
        White
    		 55 59 59 58 59 58 348
        More than one race
    		 6 6 8 6 6 6 38
        Unknown or Not Reported
    		 0 1 0 0 0 0 1
    Region of Enrollment
    Units: Subjects
        Greece
    		 6 6 5 4 5 6 32
        Puerto Rico
    		 1 2 2 1 3 3 12
        Romania
    		 9 10 10 9 9 10 57
        United States
    		 32 33 33 34 31 30 193
        Poland
    		 9 10 12 12 12 11 66
        Mexico
    		 9 10 11 10 9 11 60

    End points

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    End points reporting groups
    Reporting group title
    10 mg LY2944876
    Reporting group description
    		 10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks, plus background PO metformin.

    Reporting group title
    15 mg LY2944876
    Reporting group description
    		 15 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..

    Reporting group title
    30 mg LY2944876
    Reporting group description
    		 30 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..

    Reporting group title
    50 mg LY2944876
    Reporting group description
    		 50 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin..

    Reporting group title
    Exenatide extended-release
    Reporting group description
    		 2 mg exenatide extended-release given SC once weekly for 24 weeks, plus background PO metformin..

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks,plus background PO metformin. Participants assigned to placebo will have no injections during the second 12 weeks of the study.

    Primary: Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12

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    End point title
    		 Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12
    End point description
    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Analysis Population Description (APD): All randomized participants with at least 1 post-baseline measurement and evaluable data. Missing observations are imputed using the Bayesian simple linear regression longitudinal model.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    57
    68
    68
    65
    63
    62
    Units: percentage of HbA1c
        least squares mean (standard error)
    -1.080 ± 0.108
    -1.119 ± 0.103
    -1.429 ± 0.102
    -1.361 ± 0.105
    -1.428 ± 0.105
    -0.283 ± 0.104
    Statistical analysis title
    		 Hemoglobin A1c (HbA1c) at Week 12
    Comparison groups
    10 mg LY2944876 v Placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.459
    Method
    		 Bayesian
    Parameter type
    		 Posterior Mean Difference
    Point estimate
    -0.78
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 -0.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Hemoglobin A1c (HbA1c) at Week 12
    Comparison groups
    Placebo v 15 mg LY2944876
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.511
    Method
    		 Bayesian
    Parameter type
    		 Posterior Mean Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.07
         upper limit
    		 0.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Hemoglobin A1c (HbA1c) at Week 12
    Comparison groups
    Placebo v 30 mg LY2944876
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.988
    Method
    		 Bayesian
    Parameter type
    		 Posterior Mean Difference
    Point estimate
    -1.15
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.41
         upper limit
    		 -0.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Hemoglobin A1c (HbA1c) at Week 12
    Comparison groups
    50 mg LY2944876 v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.934
    Method
    		 Bayesian
    Parameter type
    		 Posterior Mean Difference
    Point estimate
    -1.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.78
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Hemoglobin A1c (HbA1c) at Week 12
    Comparison groups
    Exenatide extended-release v 10 mg LY2944876
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.373
    Method
    		 Bayesian
    Parameter type
    		 Posterior Mean Difference
    Point estimate
    0.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 0.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Hemoglobin A1c (HbA1c) at Week 12
    Comparison groups
    Exenatide extended-release v 15 mg LY2944876
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.433
    Method
    		 Bayesian
    Parameter type
    		 Posterior Mean Difference
    Point estimate
    0.33
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 0.59
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Hemoglobin A1c (HbA1c) at Week 12
    Comparison groups
    Exenatide extended-release v 30 mg LY2944876
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.978
    Method
    		 Bayesian
    Parameter type
    		 Posterior Mean Difference
    Point estimate
    -0.02
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Hemoglobin A1c (HbA1c) at Week 12
    Comparison groups
    Exenatide extended-release v 50 mg LY2944876
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.904
    Method
    		 Bayesian
    Parameter type
    		 Posterior Mean Difference
    Point estimate
    0.09
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16

    Secondary: Change from Baseline in HbA1c at Week 24

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    End point title
    		 Change from Baseline in HbA1c at Week 24
    End point description
    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. APD: All randomized participants with baseline and at least one post-baseline HbA1c data. Missing observations are imputed using the Bayesian simple linear regression longitudinal model.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    55
    66
    68
    62
    60
    51
    Units: percentage of HbA1c
        least squares mean (standard error)
    -0.859 ± 0.128
    -1.162 ± 0.121
    -1.359 ± 0.119
    -1.318 ± 0.123
    -1.486 ± 0.123
    -0.357 ± 0.126
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Body Weight

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    End point title
    		 Percent Change from Baseline in Body Weight
    End point description
    APD: All randomized participants with baseline and at least one post-baseline data for body weight. Missing observations are imputed using the Bayesian simple linear regression longitudinal model.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12; Baseline, Week 24
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    57 [1]
    68 [2]
    68 [3]
    65 [4]
    63 [5]
    63 [6]
    Units: Percentage change
    least squares mean (standard error)
        Week 12
    -1.255 ± 0.371
    -2.004 ± 0.352
    -2.074 ± 0.348
    -3.397 ± 0.357
    -2.183 ± 0.358
    -1.331 ± 0.356
        Week 24
    -1.708 ± 0.496
    -2.269 ± 0.465
    -2.147 ± 0.460
    -3.572 ± 0.475
    -2.293 ± 0.477
    -1.777 ± 0.491
    Notes
    [1] - Week 12-n=57 Week 24-n= 55
    [2] - Week 12-n=68 Week 24-n= 67
    [3] - Week 12-n=67 Week 24-n= 68
    [4] - Week 12-n=65 Week 24-n= 62
    [5] - Week 12-n=63 Week 24-n= 60
    [6] - Week 12-n=63 Week 24-n= 51
    No statistical analyses for this end point

    Secondary: Change from Baseline in Fasting Blood Glucose

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    End point title
    		 Change from Baseline in Fasting Blood Glucose
    End point description
    Least square means (LSM) was calculated from mixed-effects model with repeated measures (MMRM) analysis using restricted maximum likelihood (REML) with metformin use, baseline body mass index (BMI) category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect. APD: All randomized participants with baseline and at least one post-baseline data for fasting blood glucose. Missing observations are imputed using last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12; Baseline, Week 24
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    55 [7]
    68 [8]
    67
    62 [9]
    62 [10]
    58 [11]
    Units: milligrams per deciliter (mg/dL)
    least squares mean (standard error)
        Week 12
    -20.881 ± 4.618
    -21.991 ± 4.371
    -31.309 ± 4.305
    -28.405 ± 4.506
    -39.074 ± 4.419
    -1.588 ± 4.519
        Week 24
    -21.497 ± 4.919
    -30.186 ± 4.639
    -29.875 ± 4.548
    -31.390 ± 4.785
    -40.328 ± 4.726
    0.124 ± 4.973
    Notes
    [7] - Week 12: 55 Week 24: 54
    [8] - Week 12: 68 Week 24: 66
    [9] - Week 12: 62 Week 24: 60
    [10] - Week 12: 62 Week 24: 59
    [11] - Week 12: 58 Week 24: 49
    No statistical analyses for this end point

    Secondary: Change from Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values

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    End point title
    		 Change from Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
    End point description
    SMBG 7-point profiles were measured at morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. LSM were calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect. LSM were calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect. APD: All randomized participants with baseline and at least one post-baseline data for SMBG. Missing observations are imputed using last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, Week (Wk) 12; Baseline, Week 24
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    56
    64
    66
    60
    61
    62
    Units: mg/dL
    least squares mean (standard error)
        Pre-Morning Meal (Week 12)
    -26.8 ± 3.9
    -28.4 ± 3.8
    -34.3 ± 3.7
    -34.8 ± 3.8
    -38.7 ± 3.8
    -7.4 ± 3.8
        Pre-Morning Meal (Week 24)
    -23.5 ± 4.7
    -29.1 ± 4.5
    -29.6 ± 4.3
    -34.2 ± 4.5
    -36.8 ± 4.5
    -14.4 ± 4.9
        Morning Meal 2hr (Week 12)
    -27.9 ± 6.7
    -34.2 ± 6.8
    -36.0 ± 6.3
    -26.4 ± 6.6
    -43.5 ± 6.5
    -1.5 ± 6.5
        Morning Meal 2 hr (Week 24)
    -29.9 ± 6.5
    -35.9 ± 6.5
    -37.1 ± 6.1
    -42.8 ± 6.4
    -42.7 ± 6.4
    -6.3 ± 6.8
        Pre-Midday Meal (Week 12)
    -17.1 ± 5.1
    -19.6 ± 5.1
    -26.1 ± 4.8
    -24.2 ± 5.0
    -23.5 ± 5.0
    -2.3 ± 5.0
        Pre-Midday Meal (Week 24)
    -16.3 ± 5.6
    -23.4 ± 5.6
    -22.4 ± 5.3
    -23.5 ± 5.4
    -23.9 ± 5.5
    -4.0 ± 6.0
        Midday Meal 2hr (Week 12)
    -17.1 ± 6.4
    -20.7 ± 6.3
    -24.6 ± 6.0
    -22.2 ± 6.2
    -27.4 ± 6.2
    -8.9 ± 6.1
        Midday Meal 2hr (Week 24)
    -12.2 ± 6.1
    -26.6 ± 5.9
    -21.9 ± 5.7
    -33.4 ± 5.9
    -37.2 ± 5.9
    -8.5 ± 6.4
        Pre-Evening Meal (Week 12)
    -24.1 ± 5.3
    -24.8 ± 5.2
    -28.5 ± 4.9
    -30.1 ± 5.1
    -24.7 ± 5.1
    -1.5 ± 5.1
        Pre-Evening Meal (Week 24)
    -24.9 ± 5.7
    -24.3 ± 5.6
    -33.0 ± 5.3
    -29.6 ± 5.4
    -36.4 ± 5.6
    -5.7 ± 6.0
        Evening Meal (Week 12)
    -25.1 ± 5.9
    -26.5 ± 5.7
    -33.4 ± 5.4
    -32.8 ± 5.7
    -33.5 ± 5.7
    4.0 ± 5.6
        Evening Meal 2hr (Week 24)
    -30.2 ± 5.9
    -27.9 ± 5.8
    -26.0 ± 5.5
    -37.2 ± 5.8
    -36.9 ± 5.8
    1.1 ± 6.2
        Bedtime (Week 12)
    -19.3 ± 5.7
    -33.5 ± 5.8
    -33.2 ± 5.8
    -36.2 ± 5.6
    -41.6 ± 5.7
    5.6 ± 5.7
        Bedtime (Week 24)
    -28.9 ± 6.0
    -25.4 ± 6.0
    -32.3 ± 5.7
    -38.5 ± 5.9
    -42.9 ± 6.0
    -6.9 ± 6.4
    No statistical analyses for this end point

    Secondary: Change from Baseline in Lipids

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    End point title
    		 Change from Baseline in Lipids
    End point description
    Change from baseline in high-density lipoprotein cholesterol (HDL-C), total cholesterol, triglycerides, and low-density lipoprotein cholesterol (LDL-C). LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant an a random effect. APD: All randomized participants with baseline and at least one post-baseline data for lipids. Missing observations are imputed using last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    55
    66
    68
    61
    61
    53
    Units: mg/dL
    least squares mean (standard error)
        HDL-C
    1.56 ± 1.03
    0.92 ± 0.98
    0.90 ± 0.96
    1.04 ± 1.01
    2.35 ± 0.990
    2.17 ± 1.04
        Total Cholesterol
    -1.26 ± 4.37
    -1.12 ± 4.16
    -1.46 ± 4.09
    -5.11 ± 4.24
    -0.12 ± 4.22
    7.32 ± 4.40
        Triglycerides
    -14.63 ± 11.49
    -13.32 ± 10.93
    -15.40 ± 10.59
    -20.96 ± 11.16
    -11.83 ± 11.01
    10.61 ± 11.58
        LDL-C
    -1.37 ± 3.75
    -0.40 ± 3.57
    -0.24 ± 3.56
    -0.04 ± 3.72
    0.37 ± 3.65
    4.55 ± 3.81
    No statistical analyses for this end point

    Secondary: Change from Baseline in Fasting Fibroblast Growth Factor 21

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    End point title
    		 Change from Baseline in Fasting Fibroblast Growth Factor 21
    End point description
    LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. APD: All randomized participants with baseline and at least one post-baseline data for fasting fibroblast growth factor 21. Missing observations are imputed using last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12; Baseline, Week 24
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    56
    68
    65
    64
    63
    58
    Units: microgram per liter (µg/L)
    least squares mean (standard error)
        Week 12
    -0.07 ± 0.071
    0.06 ± 0.068
    -0.03 ± 0.068
    -0.14 ± 0.069
    -0.09 ± 0.069
    -0.11 ± 0.071
        Week 24
    0.06 ± 0.071
    -0.04 ± 0.068
    -0.07 ± 0.067
    -0.12 ± 0.070
    -0.06 ± 0.069
    -0.09 ± 0.073
    No statistical analyses for this end point

    Secondary: Percentage of Participants Requiring Rescue Therapy

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    End point title
    		 Percentage of Participants Requiring Rescue Therapy
    End point description
    Participants who received rescue medication with non-study antihyperglycemic medications or change their stable dose of metformin. APD: All randomized participants with baseline and at least one post-baseline data for participants requiring rescue therapy.
    End point type
    Secondary
    End point timeframe
    Baseline through Therapy Completion (Week 24)
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    66
    71
    73
    69
    69
    71
    Units: percentage of participants
        number (not applicable)
    6.1
    2.8
    2.7
    4.3
    2.9
    11.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants Developing Anti-Drug Antibodies to LY2944876 or Polyethylene Glycol

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    End point title
    		 Percentage of Participants Developing Anti-Drug Antibodies to LY2944876 or Polyethylene Glycol
    End point description
    Participants with a four-fold change in antibody titers from baseline APD: All randomized participants who received study drug and had evaluable immunogenicity.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    66
    71
    73
    70
    69
    71
    Units: percentage of participants
    number (not applicable)
        Week 12
    1.7
    1.4
    1.5
    0
    1.6
    0
        Week 24
    1.8
    0
    1.5
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876

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    End point title
    		 Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876 [12]
    End point description
    Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state. APD: All randomized participants who received study drug LY2944876 and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, Week 12, Week 16, Week 20, Week 24
    Notes
    [12] - 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: No inferential statistics were planned for this endpoint.
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876
    Number of subjects analysed
    66
    71
    73
    70
    Units: nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    607 ± 282
    799 ± 368
    1690 ± 732
    2570 ± 1240
    No statistical analyses for this end point

    Secondary: Change from Baseline in Adiponectin Levels

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    End point title
    		 Change from Baseline in Adiponectin Levels
    End point description
    LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. APD: All randomized participants with baseline and at least one post-baseline data for adiponectin levels. Missing observations are imputed using last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12; Baseline, Week 24
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    66
    71
    73
    69
    69
    71
    Units: µg/L
    least squares mean (standard error)
        Week 12
    0.14 ± 0.168
    0.03 ± 0.160
    -0.10 ± 0.157
    0.12 ± 0.161
    0.04 ± 0.160
    0.03 ± 0.164
        Week 24
    0.03 ± 0.245
    0.30 ± 0.226
    0.28 ± 0.221
    0.58 ± 0.235
    0.14 ± 0.231
    0.25 ± 0.250
    No statistical analyses for this end point

    Secondary: Change from Baseline in Beta-Hydroxy Butyrate Levels

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    End point title
    		 Change from Baseline in Beta-Hydroxy Butyrate Levels
    End point description
    LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. APD: All randomized participants with baseline and at least one post-baseline data for beta-hydroxy butyrate levels. Missing observations are imputed using last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12; Baseline, Week 24
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    55
    67
    64
    63
    62
    58
    Units: mg/dL
    least squares mean (standard error)
        Week 12
    -0.27 ± 0.13
    -0.28 ± 0.12
    -0.13 ± 0.12
    -0.31 ± 0.12
    -0.29 ± 0.12
    -0.23 ± 0.13
        Week 24
    -0.33 ± 0.11
    -0.39 ± 0.10
    -0.34 ± 0.10
    -0.33 ± 0.10
    -0.19 ± 0.10
    -0.37 ± 0.11
    No statistical analyses for this end point

    Secondary: Change from Baseline in Glucagon Levels

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    End point title
    		 Change from Baseline in Glucagon Levels
    End point description
    LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. APD: All randomized participants with baseline and at least one post-baseline data for glucagon levels. Missing observations are imputed using last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12; Baseline, Week 24
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    55
    66
    64
    60
    61
    54
    Units: picomol per liter (pmol/L)
    least squares mean (standard error)
        Week 12
    -1.26 ± 0.82
    -2.65 ± 0.79
    -5.14 ± 0.79
    -6.21 ± 0.81
    -1.58 ± 0.79
    -0.04 ± 0.84
        Week 24
    -2.30 ± 1.15
    -2.25 ± 1.05
    -4.40 ± 1.05
    -4.93 ± 1.11
    -0.19 ± 1.08
    0.66 ± 1.16
    No statistical analyses for this end point

    Secondary: Change from Baseline in Insulin Levels

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    End point title
    		 Change from Baseline in Insulin Levels
    End point description
    LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. APD: All randomized participants with baseline and at least one post-baseline data for insulin levels. Missing observations are imputed using last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12; Baseline, Week 24
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876 Exenatide extended-release Placebo
    Number of subjects analysed
    53
    64
    62
    59
    59
    59
    Units: micro-international units/milliliter
    least squares mean (standard error)
        Week 12
    0.30 ± 1.21
    0.97 ± 1.13
    0.03 ± 1.14
    0.96 ± 1.17
    2.78 ± 1.14
    -0.85 ± 1.16
        Week 24
    -1.44 ± 1.51
    0.68 ± 1.39
    0.58 ± 1.40
    0.34 ± 1.48
    1.97 ± 1.40
    1.45 ± 1.51
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876

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    End point title
    		 Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876 [13]
    End point description
    Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state. APD: All randomized participants who received study drug LY2944876 and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, Week 12, Week 16, Week 20, Week 24
    Notes
    [13] - 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: No inferential statistics were planned for this endpoint.
    End point values
    		 10 mg LY2944876 15 mg LY2944876 30 mg LY2944876 50 mg LY2944876
    Number of subjects analysed
    66
    71
    73
    70
    Units: nanograms*hour per milliliter (ng*h/mL)
        arithmetic mean (standard deviation)
    88100 ± 40600
    117000 ± 50800
    247000 ± 106000
    381000 ± 187000
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    I7I-MC-XNAA
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    LY2944876 10mg
    Reporting group description
    		 10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.

    Reporting group title
    LY2944876 15mg
    Reporting group description
    		 15 mg LY2944876 given SC once weekly for 24 weeks.

    Reporting group title
    LY2944876 30mg
    Reporting group description
    		 30 mg LY2944876 given SC once weekly for 24 weeks.

    Reporting group title
    LY2944876 50mg
    Reporting group description
    		 50 mg LY2944876 given SC once weekly for 24 weeks.

    Reporting group title
    Exenatide 2mg
    Reporting group description
    		 2 mg exenatide extended-release given SC once weekly for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.

    Serious adverse events
    		 LY2944876 10mg LY2944876 15mg LY2944876 30mg LY2944876 50mg Exenatide 2mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 66 (0.00%)
    2 / 71 (2.82%)
    2 / 73 (2.74%)
    3 / 70 (4.29%)
    3 / 69 (4.35%)
    2 / 71 (2.82%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    endometrial adenocarcinoma
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
    1 / 69 (1.45%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    endometrial cancer
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    branchial cyst
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    vessel perforation
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    angina unstable
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
    1 / 69 (1.45%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    cataract operation
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
    1 / 69 (1.45%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
    1 / 69 (1.45%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain lower
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    blood blister
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
    1 / 70 (1.43%)
    0 / 69 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    nephrolithiasis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    abscess limb
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
    0 / 70 (0.00%)
    0 / 69 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LY2944876 10mg LY2944876 15mg LY2944876 30mg LY2944876 50mg Exenatide 2mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 66 (51.52%)
    47 / 71 (66.20%)
    39 / 73 (53.42%)
    46 / 70 (65.71%)
    38 / 69 (55.07%)
    16 / 71 (22.54%)
    Investigations
    lipase increased
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    4 / 66 (6.06%)
    2 / 71 (2.82%)
    2 / 73 (2.74%)
    5 / 70 (7.14%)
    0 / 69 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    4
    2
    2
    9
    0
    0
    Injury, poisoning and procedural complications
    muscle strain
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    4 / 71 (5.63%)
    1 / 73 (1.37%)
    1 / 70 (1.43%)
    0 / 69 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    4
    1
    1
    0
    0
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    4 / 66 (6.06%)
    2 / 71 (2.82%)
    1 / 73 (1.37%)
    2 / 70 (2.86%)
    1 / 69 (1.45%)
    1 / 71 (1.41%)
         occurrences all number
    4
    2
    1
    2
    1
    1
    headache
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    5 / 66 (7.58%)
    9 / 71 (12.68%)
    5 / 73 (6.85%)
    6 / 70 (8.57%)
    9 / 69 (13.04%)
    4 / 71 (5.63%)
         occurrences all number
    7
    13
    5
    11
    14
    4
    Gastrointestinal disorders
    abdominal pain upper
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 71 (1.41%)
    2 / 73 (2.74%)
    3 / 70 (4.29%)
    4 / 69 (5.80%)
    1 / 71 (1.41%)
         occurrences all number
    1
    1
    7
    3
    5
    2
    constipation
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    3 / 66 (4.55%)
    4 / 71 (5.63%)
    4 / 73 (5.48%)
    5 / 70 (7.14%)
    2 / 69 (2.90%)
    1 / 71 (1.41%)
         occurrences all number
    3
    4
    4
    8
    2
    1
    diarrhoea
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    7 / 66 (10.61%)
    15 / 71 (21.13%)
    13 / 73 (17.81%)
    12 / 70 (17.14%)
    18 / 69 (26.09%)
    4 / 71 (5.63%)
         occurrences all number
    35
    24
    45
    25
    52
    16
    dyspepsia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 71 (1.41%)
    2 / 73 (2.74%)
    5 / 70 (7.14%)
    1 / 69 (1.45%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    3
    8
    2
    0
    flatulence
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 71 (1.41%)
    4 / 73 (5.48%)
    2 / 70 (2.86%)
    1 / 69 (1.45%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    4
    2
    1
    0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
    4 / 70 (5.71%)
    2 / 69 (2.90%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    1
    4
    2
    0
    nausea
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    11 / 66 (16.67%)
    21 / 71 (29.58%)
    20 / 73 (27.40%)
    32 / 70 (45.71%)
    17 / 69 (24.64%)
    4 / 71 (5.63%)
         occurrences all number
    28
    33
    53
    90
    55
    4
    vomiting
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    8 / 66 (12.12%)
    6 / 71 (8.45%)
    10 / 73 (13.70%)
    22 / 70 (31.43%)
    6 / 69 (8.70%)
    2 / 71 (2.82%)
         occurrences all number
    9
    6
    21
    37
    12
    3
    Respiratory, thoracic and mediastinal disorders
    oropharyngeal pain
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    3 / 66 (4.55%)
    3 / 71 (4.23%)
    1 / 73 (1.37%)
    2 / 70 (2.86%)
    4 / 69 (5.80%)
    1 / 71 (1.41%)
         occurrences all number
    3
    3
    1
    2
    4
    1
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    2 / 71 (2.82%)
    0 / 73 (0.00%)
    5 / 70 (7.14%)
    1 / 69 (1.45%)
    0 / 71 (0.00%)
         occurrences all number
    0
    2
    0
    5
    1
    0
    back pain
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    4 / 66 (6.06%)
    6 / 71 (8.45%)
    1 / 73 (1.37%)
    2 / 70 (2.86%)
    2 / 69 (2.90%)
    2 / 71 (2.82%)
         occurrences all number
    4
    7
    1
    2
    3
    3
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    4 / 66 (6.06%)
    1 / 71 (1.41%)
    3 / 73 (4.11%)
    2 / 70 (2.86%)
    0 / 69 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    4
    1
    3
    2
    0
    0
    influenza
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 66 (1.52%)
    4 / 71 (5.63%)
    1 / 73 (1.37%)
    2 / 70 (2.86%)
    1 / 69 (1.45%)
    2 / 71 (2.82%)
         occurrences all number
    1
    5
    3
    2
    1
    3
    nasopharyngitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    8 / 66 (12.12%)
    9 / 71 (12.68%)
    5 / 73 (6.85%)
    4 / 70 (5.71%)
    6 / 69 (8.70%)
    2 / 71 (2.82%)
         occurrences all number
    8
    11
    5
    4
    7
    3
    sinusitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 66 (1.52%)
    5 / 71 (7.04%)
    2 / 73 (2.74%)
    0 / 70 (0.00%)
    2 / 69 (2.90%)
    2 / 71 (2.82%)
         occurrences all number
    1
    6
    2
    0
    2
    2
    upper respiratory tract infection
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 66 (3.03%)
    10 / 71 (14.08%)
    5 / 73 (6.85%)
    3 / 70 (4.29%)
    4 / 69 (5.80%)
    1 / 71 (1.41%)
         occurrences all number
    3
    12
    5
    3
    4
    1
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 71 (0.00%)
    4 / 73 (5.48%)
    1 / 70 (1.43%)
    0 / 69 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    6
    2
    0
    0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    3 / 66 (4.55%)
    6 / 71 (8.45%)
    6 / 73 (8.22%)
    8 / 70 (11.43%)
    2 / 69 (2.90%)
    1 / 71 (1.41%)
         occurrences all number
    3
    6
    6
    9
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jul 2014
    Added Safety and tolerability to secondary outcomes.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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