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    Clinical Trial Results:
    A Randomized, Double-Blind Study with an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide with Placebo in Pediatric Patients with Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    		 2016-000361-22
    Trial protocol
    		 DE   GB   FR   HU  
    Global end of trial date
    12 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jun 2022
    First version publication date
    23 Jun 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    H9X-MC-GBGC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02963766
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 14171
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000783-PIP01-09
    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
    12 Jan 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 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
    		 Background therapy included diet and exercise with or without metformin and/or basal insulin.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Dec 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 16
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    India: 11
    Country: Number of subjects enrolled
    Mexico: 36
    Country: Number of subjects enrolled
    Puerto Rico: 2
    Country: Number of subjects enrolled
    Saudi Arabia: 3
    Country: Number of subjects enrolled
    Turkey: 3
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    United States: 71
    Worldwide total number of subjects
    154
    EEA total number of subjects
    7
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    15
    Adolescents (12-17 years)
    139
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were randomized at 46 centers in 9 countries.

    Pre-assignment
    Screening details
    		 Not Applicable.

    Period 1
    Period 1 title
    Double-Blind 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
    		 Placebo
    Arm description
    		 Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo administered SC for 26 weeks during the double-blind period.

    Arm title
    		 0.75 milligram (mg) Dulaglutide
    Arm description
    		 Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dulaglutide
    Investigational medicinal product code
    LY2189265
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period.

    Arm title
    		 1.5 mg Dulaglutide
    Arm description
    		 Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dulaglutide
    Investigational medicinal product code
    LY2189265
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants assigned to the dulaglutide 1.5-mg group were administered the 0.75-mg/week dose for the first 4 weeks and were then escalated to the 1.5-mg/week dose if they tolerated the 0.75-mg dose based on investigator assessment

    Number of subjects in period 1
    		Placebo 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide
    Started
    51
    51
    52
    Received at Least 1 Dose of Study Drug
    51
    51
    52
    Completed
    47
    49
    50
    Not completed
    4
    2
    2
         Physician decision
    1
    -
    -
         Consent withdrawn by subject
    1
    1
    -
         Adverse event, non-fatal
    1
    -
    1
         Withdrawal by Parent or Guardian
    -
    -
    1
         Lost to follow-up
    -
    1
    -
         Protocol deviation
    1
    -
    -
    Period 2
    Period 2 title
    Open Label Extension (OLE)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo/0.75 milligram (mg) Dulaglutide
    Arm description
    		 Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dulaglutide
    Investigational medicinal product code
    LY2189265
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.75 mg/week dulaglutide administered SC for 26 weeks during the OLE.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo administered SC for 26 weeks during the double-blind period.

    Arm title
    		 0.75 mg Dulaglutide
    Arm description
    		 Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dulaglutide
    Investigational medicinal product code
    LY2189265
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.

    Arm title
    		 1.5 mg Dulaglutide
    Arm description
    		 Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dulaglutide
    Investigational medicinal product code
    LY2189265
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.

    Number of subjects in period 2
    		Placebo/0.75 milligram (mg) Dulaglutide 0.75 mg Dulaglutide 1.5 mg Dulaglutide
    Started
    47
    49
    50
    Completed
    45
    46
    48
    Not completed
    2
    3
    2
         Physician decision
    1
    2
    2
         Consent withdrawn by subject
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period.

    Reporting group title
    0.75 milligram (mg) Dulaglutide
    Reporting group description
    		 Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period.

    Reporting group title
    1.5 mg Dulaglutide
    Reporting group description
    		 Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period.

    Reporting group values
    		 Placebo 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Total
    Number of subjects
    		 51 51 52 154
    Age categorical
    Units: Subjects
    Age continuous
    All randomized participants.
    Units: years
        arithmetic mean (standard deviation)
    		 14.20 ( 2.08 ) 14.70 ( 2.21 ) 14.70 ( 1.81 ) -
    Gender categorical
    All randomized participants.
    Units: Subjects
        Female
    		 41 35 34 110
        Male
    		 10 16 18 44
    Ethnicity (NIH/OMB)
    All randomized participants.
    Units: Subjects
        Hispanic or Latino
    		 26 31 28 85
        Not Hispanic or Latino
    		 25 18 22 65
        Unknown or Not Reported
    		 0 2 2 4
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 6 6 4 16
        Asian
    		 11 4 4 19
        Native Hawaiian or Other Pacific Islander
    		 1 0 0 1
        Black or African American
    		 5 9 9 23
        White
    		 25 29 30 84
        More than one race
    		 3 1 3 7
        Unknown or Not Reported
    		 0 2 2 4
    Region of Enrollment
    All randomized participants.
    Units: Subjects
        Brazil
    		 4 7 5 16
        France
    		 0 2 2 4
        Germany
    		 2 1 0 3
        India
    		 3 4 4 11
        Mexico
    		 14 12 10 36
        Puerto Rico
    		 0 1 1 2
        Saudi Arabia
    		 2 0 1 3
        Turkey
    		 1 1 1 3
        United Kingdom
    		 3 2 0 5
        United States
    		 22 21 28 71
    Percentage of Hemoglobin A1c (HbA1c) at Baseline
    All randomized participants.
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    		 8.14 ( 1.12 ) 7.92 ( 1.27 ) 8.16 ( 1.39 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period.

    Reporting group title
    0.75 milligram (mg) Dulaglutide
    Reporting group description
    		 Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period.

    Reporting group title
    1.5 mg Dulaglutide
    Reporting group description
    		 Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period.
    Reporting group title
    Placebo/0.75 milligram (mg) Dulaglutide
    Reporting group description
    		 Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE).

    Reporting group title
    0.75 mg Dulaglutide
    Reporting group description
    		 Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.

    Reporting group title
    1.5 mg Dulaglutide
    Reporting group description
    		 Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.

    Subject analysis set title
    Placebo/0.75 mg Dulaglutide
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received placebo administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the OLE.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received placebo administered SC for 26 weeks.

    Subject analysis set title
    Pooled Dulaglutide
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.

    Primary: Change from Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26

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    End point title
    		 Change from Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26
    End point description
    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline). Analysis population description (APD) included all randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c. APD is
    End point type
    Primary
    End point timeframe
    Baseline, Week 26
    End point values
    		 Placebo Pooled Dulaglutide
    Number of subjects analysed
    45
    100
    Units: percentage of HbA1C
        least squares mean (standard error)
    0.5 ( 0.24 )
    -0.7 ( 0.16 )
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Placebo v Pooled Dulaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 -0.7

    Secondary: Change from Baseline in HbA1c (Individual Doses) at Week 26

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    End point title
    		 Change from Baseline in HbA1c (Individual Doses) at Week 26 [1]
    End point description
    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean in HbA1c was calculated using a REML based MMRM and adjusted by, baseline + insulin use + metformin use + treatment + time + treatment*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline). APD included all randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo
    Number of subjects analysed
    50
    50
    45
    Units: percentage of HbA1c
        least squares mean (standard error)
    -0.5 ( 0.22 )
    -1.0 ( 0.22 )
    0.5 ( 0.24 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    0.75 milligram (mg) Dulaglutide v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 -0.4
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    1.5 mg Dulaglutide v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -0.9

    Secondary: Change from Baseline in Fasting Blood Glucose (FBG) at Week 26

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    End point title
    		 Change from Baseline in Fasting Blood Glucose (FBG) at Week 26 [2]
    End point description
    Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group [ less than (<) 8%, greater than or equal to (>=) 8%). APD included all randomized participants who received at least one dose of study drug and had evaluable fasting blood glucose data. Only pre-rescue measurements were used.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo Pooled Dulaglutide
    Number of subjects analysed
    49
    50
    43
    99
    Units: millimoles per liter (mmol/L)
        least squares mean (standard error)
    -0.47 ( 0.41 )
    -1.54 ( 0.41 )
    0.96 ( 0.45 )
    -1.03 ( 0.29 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    0.75 milligram (mg) Dulaglutide v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -1.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.65
         upper limit
    		 -0.22
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    1.5 mg Dulaglutide v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -2.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.72
         upper limit
    		 -1.29
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v Pooled Dulaglutide
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -1.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.03
         upper limit
    		 -0.91

    Secondary: Percentage of Participants with HbA1c ≤7.0%

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    End point title
    		 Percentage of Participants with HbA1c ≤7.0% [3]
    End point description
    The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. APD included all randomized participants who received at least 1 dose of study drug and had evaluable baseline and post-baseline HbA1c.
    End point type
    Secondary
    End point timeframe
    Week 26
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo Pooled Dulaglutide
    Number of subjects analysed
    50
    50
    45
    100
    Units: percentage of participants
        number (not applicable)
    60.00
    53.19
    18.42
    56.52
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    0.75 milligram (mg) Dulaglutide v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    11.038
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.491
         upper limit
    		 34.902
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    1.5 mg Dulaglutide v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    11.666
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.653
         upper limit
    		 37.253
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v Pooled Dulaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    11.348
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.163
         upper limit
    		 30.932

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

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    End point title
    		 Change from Baseline in Body Mass Index (BMI) at Week 26 [4]
    End point description
    BMI is an estimate of body fat based on body weight divided by height squared. LS mean were calculated using a MMRM analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group (< 8%, >= 8%). APD included all randomized participants who received at least one dose of study drug and had evaluable BMI data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    Notes
    [4] - 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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo Pooled Dulaglutide
    Number of subjects analysed
    51
    52
    50
    103
    Units: kilograms/square meter (kg/m^2)
        least squares mean (standard error)
    -0.2 ( 0.20 )
    -0.1 ( 0.19 )
    -0.0 ( 0.21 )
    -0.1 ( 0.14 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    0.75 milligram (mg) Dulaglutide v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.689
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.5
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    1.5 mg Dulaglutide v Placebo
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.924
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.5
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v Pooled Dulaglutide
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.776
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.4

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

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    End point title
    		 Percentage of Participants with Self-Reported Events of Hypoglycemia [5]
    End point description
    Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose <54mg/dL. APD included all randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 26
    Notes
    [5] - 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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo
    Number of subjects analysed
    51
    52
    51
    Units: percentage of participants
        number (not applicable)
    3.92
    3.85
    1.96
    No statistical analyses for this end point

    Secondary: Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia

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    End point title
    		 Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia [6]
    End point description
    Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized. APD included all randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 26
    Notes
    [6] - 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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo Pooled Dulaglutide
    Number of subjects analysed
    51
    52
    51
    103
    Units: percentage of participants
        number (not applicable)
    3.9
    1.9
    17.6
    2.9
    No statistical analyses for this end point

    Secondary: Number of Participants with Adjudicated Pancreatitis

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    End point title
    		 Number of Participants with Adjudicated Pancreatitis [7]
    End point description
    The number of participants with pancreatitis confirmed by adjudication is 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. APD included all randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 26
    Notes
    [7] - 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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo Pooled Dulaglutide
    Number of subjects analysed
    51
    52
    51
    103
    Units: participants
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pancreatic Enzymes at Week 26

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    End point title
    		 Change from Baseline in Pancreatic Enzymes at Week 26 [8]
    End point description
    Serum Amylase (total and pancreas-derived) and lipase concentrations were measured. APD included all randomized participants who received at least one dose of study drug and had evaluable pancreatic enzymes data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    Notes
    [8] - 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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo Pooled Dulaglutide
    Number of subjects analysed
    51
    52
    47
    103
    Units: Units/Liter (U/L)
    arithmetic mean (standard deviation)
        Serum Amylase
    4.80 ( 9.39 )
    6.50 ( 8.91 )
    0.09 ( 17.36 )
    5.64 ( 9.15 )
        Serum Amylase, Pancreatic
    1.77 ( 4.72 )
    2.90 ( 6.10 )
    0.60 ( 9.94 )
    2.32 ( 5.45 )
        Serum Lipase
    4.37 ( 8.28 )
    3.88 ( 6.63 )
    2.23 ( 31.99 )
    4.12 ( 7.47 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Thyroid Treatment-Emergent Adverse Events

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    End point title
    		 Number of Participants with Thyroid Treatment-Emergent Adverse Events [9]
    End point description
    Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized. APD included all randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 26
    Notes
    [9] - 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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo Pooled Dulaglutide
    Number of subjects analysed
    51
    52
    51
    103
    Units: participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Serum Calcitonin at Week 26

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    End point title
    		 Change from Baseline in Serum Calcitonin at Week 26 [10]
    End point description
    Change from Baseline in Serum Calcitonin was evaluated. APD included all randomized participants who received at least one dose of study drug and had evaluable serum calcitonin data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    Notes
    [10] - 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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo Pooled Dulaglutide
    Number of subjects analysed
    48
    48
    47
    96
    Units: nanograms per liter (ng/L)
        arithmetic mean (standard deviation)
    0.28 ( 0.72 )
    0.10 ( 0.50 )
    0.38 ( 1.70 )
    0.19 ( 0.62 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Allergic, Hypersensitivity Reactions

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    End point title
    		 Percentage of Participants with Allergic, Hypersensitivity Reactions [11]
    End point description
    The percentage of Participants with Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. APD included all randomized participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 26
    Notes
    [11] - 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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo Pooled Dulaglutide
    Number of subjects analysed
    51
    52
    51
    103
    Units: percentage of participants
        number (not applicable)
    3.9
    1.9
    2.0
    2.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Injection Site Reactions

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    End point title
    		 Percentage of Participants With Injection Site Reactions [12]
    End point description
    The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. APD included all randomized participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 26
    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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo Pooled Dulaglutide
    Number of subjects analysed
    51
    52
    51
    103
    Units: percentage of participants
        number (not applicable)
    9.8
    7.7
    9.8
    8.7
    No statistical analyses for this end point

    Secondary: Number of Participants with Anti-Dulaglutide Antibodies

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    End point title
    		 Number of Participants with Anti-Dulaglutide Antibodies [13]
    End point description
    Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 26 and 56. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. APD included all randomized participants who received at least 1 dose of study drug and had at least one post-baseline Dulaglutide ADA test result.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 56
    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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide Placebo/0.75 mg Dulaglutide
    Number of subjects analysed
    51
    52
    46
    Units: participants
        number (not applicable)
    3
    3
    3
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at steady-state (Cmax,ss)

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    End point title
    		 Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at steady-state (Cmax,ss) [14]
    End point description
    PK: Maximum Concentration of Dulaglutide at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9. APD included all randomized participants who received at least one dose of study drug and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit
    Notes
    [14] - 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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide
    Number of subjects analysed
    51
    52
    Units: nanograms per milliliter (ng/mL)
        arithmetic mean (confidence interval 95%)
    31 (28.4 to 33.5)
    62 (56.9 to 67.2)
    No statistical analyses for this end point

    Secondary: PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State [AUC(0-168)ss]

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    End point title
    		 PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State [AUC(0-168)ss] [15]
    End point description
    PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State [AUC(0-168)ss] was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9. APD included all randomized participants who received at least one dose of study drug and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit
    Notes
    [15] - 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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 0.75 milligram (mg) Dulaglutide 1.5 mg Dulaglutide
    Number of subjects analysed
    51
    52
    Units: nanogram*hour per milliliter (ng*h/ mL)
        arithmetic mean (confidence interval 95%)
    4170 (3770 to 4510)
    8350 (7640 to 9070)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up To 56 Weeks
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Placebo: Double-Blind Period
    Reporting group description
    		 Participants received placebo administered SC for 26 weeks.

    Reporting group title
    0.75 mg Dulaglutide: Double-Blind Period
    Reporting group description
    		 Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.

    Reporting group title
    1.5 mg Dulaglutide: Double-Blind Period
    Reporting group description
    		 Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.

    Reporting group title
    Placebo/0.75 mg Dulaglutide: OLE
    Reporting group description
    		 Participants who had received placebo during the double-blind period were given 0.75 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period.

    Reporting group title
    0.75 mg Dulaglutide: OLE
    Reporting group description
    		 Participants received 0.75 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period.

    Reporting group title
    1.5 mg Dulaglutide: OLE
    Reporting group description
    		 Participants received 1.5 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period.

    Serious adverse events
    		 Placebo: Double-Blind Period 0.75 mg Dulaglutide: Double-Blind Period 1.5 mg Dulaglutide: Double-Blind Period Placebo/0.75 mg Dulaglutide: OLE 0.75 mg Dulaglutide: OLE 1.5 mg Dulaglutide: OLE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 51 (1.96%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    1 / 49 (2.04%)
    2 / 50 (4.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    carbon monoxide poisoning
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 49 (0.00%)
    1 / 50 (2.00%)
         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
    stress fracture
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    0 / 49 (0.00%)
    0 / 50 (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
    Cardiac disorders
    right ventricular failure
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 49 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    Hepatobiliary disorders
    nonalcoholic fatty liver disease
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 49 (0.00%)
    0 / 50 (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
    Respiratory, thoracic and mediastinal disorders
    pulmonary embolism
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 49 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    respiratory failure
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 49 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    Psychiatric disorders
    suicide attempt
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 49 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    Infections and infestations
    genital herpes
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 49 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    pilonidal cyst
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    1 / 49 (2.04%)
    0 / 50 (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
    pyelonephritis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 49 (0.00%)
    1 / 50 (2.00%)
         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
    Metabolism and nutrition disorders
    diabetic ketoacidosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    0 / 49 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo: Double-Blind Period 0.75 mg Dulaglutide: Double-Blind Period 1.5 mg Dulaglutide: Double-Blind Period Placebo/0.75 mg Dulaglutide: OLE 0.75 mg Dulaglutide: OLE 1.5 mg Dulaglutide: OLE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 51 (50.98%)
    25 / 51 (49.02%)
    28 / 52 (53.85%)
    18 / 47 (38.30%)
    16 / 49 (32.65%)
    20 / 50 (40.00%)
    Injury, poisoning and procedural complications
    accidental overdose
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 51 (5.88%)
    2 / 52 (3.85%)
    0 / 47 (0.00%)
    0 / 49 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    3
    2
    0
    0
    0
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 51 (1.96%)
    4 / 51 (7.84%)
    2 / 52 (3.85%)
    1 / 47 (2.13%)
    1 / 49 (2.04%)
    1 / 50 (2.00%)
         occurrences all number
    1
    4
    2
    1
    1
    1
    headache
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    5 / 51 (9.80%)
    7 / 51 (13.73%)
    8 / 52 (15.38%)
    2 / 47 (4.26%)
    5 / 49 (10.20%)
    5 / 50 (10.00%)
         occurrences all number
    8
    7
    21
    2
    6
    6
    General disorders and administration site conditions
    pyrexia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 51 (3.92%)
    2 / 51 (3.92%)
    2 / 52 (3.85%)
    2 / 47 (4.26%)
    3 / 49 (6.12%)
    1 / 50 (2.00%)
         occurrences all number
    2
    3
    2
    3
    3
    1
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    3 / 51 (5.88%)
    4 / 51 (7.84%)
    1 / 52 (1.92%)
    0 / 47 (0.00%)
    3 / 49 (6.12%)
    3 / 50 (6.00%)
         occurrences all number
    3
    4
    4
    0
    5
    3
    abdominal pain upper
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    4 / 51 (7.84%)
    3 / 51 (5.88%)
    5 / 52 (9.62%)
    2 / 47 (4.26%)
    0 / 49 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    8
    3
    6
    2
    0
    21
    diarrhoea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    7 / 51 (13.73%)
    8 / 51 (15.69%)
    11 / 52 (21.15%)
    0 / 47 (0.00%)
    1 / 49 (2.04%)
    6 / 50 (12.00%)
         occurrences all number
    9
    13
    19
    0
    1
    21
    nausea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    4 / 51 (7.84%)
    7 / 51 (13.73%)
    8 / 52 (15.38%)
    1 / 47 (2.13%)
    3 / 49 (6.12%)
    6 / 50 (12.00%)
         occurrences all number
    4
    16
    13
    2
    10
    12
    vomiting
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 51 (3.92%)
    9 / 51 (17.65%)
    7 / 52 (13.46%)
    4 / 47 (8.51%)
    4 / 49 (8.16%)
    5 / 50 (10.00%)
         occurrences all number
    2
    10
    14
    6
    4
    8
    Reproductive system and breast disorders
    dysmenorrhoea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed [1]
    1 / 41 (2.44%)
    1 / 35 (2.86%)
    2 / 34 (5.88%)
    0 / 38 (0.00%)
    0 / 34 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    1
    1
    4
    0
    0
    3
    heavy menstrual bleeding
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed [2]
    0 / 41 (0.00%)
    0 / 35 (0.00%)
    2 / 34 (5.88%)
    0 / 38 (0.00%)
    0 / 34 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    epistaxis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    3 / 47 (6.38%)
    0 / 49 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    3
    0
    0
    Infections and infestations
    gastroenteritis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    3 / 52 (5.77%)
    4 / 47 (8.51%)
    0 / 49 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    3
    1
    3
    5
    0
    4
    nasopharyngitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    3 / 51 (5.88%)
    5 / 51 (9.80%)
    2 / 52 (3.85%)
    4 / 47 (8.51%)
    1 / 49 (2.04%)
    3 / 50 (6.00%)
         occurrences all number
    4
    6
    2
    4
    1
    3
    upper respiratory tract infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    4 / 51 (7.84%)
    2 / 51 (3.92%)
    6 / 52 (11.54%)
    3 / 47 (6.38%)
    0 / 49 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    6
    3
    7
    4
    0
    1
    urinary tract infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    3 / 51 (5.88%)
    2 / 51 (3.92%)
    0 / 52 (0.00%)
    2 / 47 (4.26%)
    1 / 49 (2.04%)
    0 / 50 (0.00%)
         occurrences all number
    3
    3
    0
    2
    1
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants were adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants were adjusted accordingly.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Feb 2019
    Exclusion criteria were modified as follows: -To exclude participants with a history of hyperglycemic hyperosmolar syndrome after initial diagnosis of type 2 diabetes mellitus (T2DM). - Clarified that use of bolus insulin at screening is excluded, shortened the exclusion period of bolus insulin to 6 weeks prior to screening, and added exception for short-term use of insulin for medical management of acute conditions. - Specified exclusion of only chronic [greater than (>)14 consecutive days] use of oral steroids. This revision prevents the unnecessary exclusion of participants who may have received short-term steroid therapy to treat an acute condition within 60 days of screening.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Mar 2020
    Global enrollment hold due to Covid-19.
    27 May 2020

    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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