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    Clinical Trial Results:
    A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide with Placebo in Patients with Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes – 8)

    Summary
    EudraCT number
    		 2012-002911-24
    Trial protocol
    		 AT   SI  
    Global end of trial date
    02 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    13193
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01769378
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Alias: H9X-MC-GBDG , Trial Number: 13193
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, 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
    02 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide compared to placebo in participants with type 2 diabetes who have inadequate glycemic control with sulfonylurea monotherapy.
    Protection of trial subjects
    This study was conducted in accordance with 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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jan 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 37
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Romania: 96
    Country: Number of subjects enrolled
    United States: 71
    Country: Number of subjects enrolled
    South Africa: 10
    Country: Number of subjects enrolled
    Mexico: 50
    Country: Number of subjects enrolled
    Slovenia: 16
    Country: Number of subjects enrolled
    Croatia: 12
    Country: Number of subjects enrolled
    Puerto Rico: 3
    Worldwide total number of subjects
    300
    EEA total number of subjects
    129
    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)
    232
    From 65 to 84 years
    68
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 not applicable

    Pre-assignment
    Screening details
    		 All randomized participants, except for 1, in the dulaglutide group, were treated with at least 1 dose of study drug and comprised the ITT population. One participant did not receive study drug because after randomization the physician determined that the participant would be unable to successfully comply with the protocol.

    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, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dulaglutide
    Arm description
    		 Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dulaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Participants meeting the eligibility criteria on glimeperide will continue glimepiride at their prestudy dose.

    Arm title
    		 Placebo
    Arm description
    		 Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.

    Investigational medicinal product name
    Glimeperide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Participants who met eligibility criteria on glimeperide will continue glimepiride at their prestudy dose.

    Number of subjects in period 1
    		Dulaglutide Placebo
    Started
    240
    60
    Received at least 1 dose of study drug
    239
    60
    Completed
    215
    56
    Not completed
    25
    4
         Consent withdrawn by subject
    10
    3
         Adverse event, non-fatal
    10
    -
         Sponsor Decision
    1
    -
         Lost to follow-up
    2
    -
         Entry criteria not met
    1
    -
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dulaglutide
    Reporting group description
    		 Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.

    Reporting group values
    		 Dulaglutide Placebo Total
    Number of subjects
    		 240 60 300
    Age Categorical
    Units: participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 183 49 232
        >=65 years
    		 57 11 68
    Gender, Male/Female
    Units: participants
        Female
    		 135 32 167
        Male
    		 105 28 133
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 112 27 139
        Not Hispanic or Latino
    		 128 33 161
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 21 5 26
        Asian
    		 3 2 5
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 7 4 11
        White
    		 203 47 250
        More than one race
    		 6 2 8
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Argentina
    		 29 8 37
        Austria
    		 4 1 5
        Romania
    		 78 18 96
        United States
    		 57 14 71
        South Africa
    		 7 3 10
        Mexico
    		 40 10 50
        Slovenia
    		 13 3 16
        Croatia
    		 10 2 12
        Puerto Rico
    		 2 1 3

    End points

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    End points reporting groups
    Reporting group title
    Dulaglutide
    Reporting group description
    		 Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.

    Primary: Change from Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks

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    End point title
    		 Change from Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks
    End point description
    Least Squares Means (LS Means) of the HbA1c change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline HbA1c as covariate, via a Mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).
    End point type
    Primary
    End point timeframe
    Baseline, 24 Weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    215 [1]
    53 [2]
    Units: percent change of HbA1c
        least squares mean (standard error)
    -1.38 ± 0.08
    -0.11 ± 0.14
    Notes
    [1] - All randomized participants who received ≥1 dose of study drug and had evaluable HbA1c data.
    [2] - All randomized participants who received ≥1 dose of study drug and had evaluable HbA1c data.
    Statistical analysis title
    		 Statistical Analysis for Primary Endpoint
    Comparison groups
    Dulaglutide v Placebo
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Squares Mean Difference
    Point estimate
    -1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.57
         upper limit
    		 -0.97
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15

    Secondary: Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks

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    End point title
    		 Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks
    End point description
    The percentage of participants who achieved the target HbA1c values at endpoint will be analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes country, treatment, visit and treatment interaction and baseline HbA1c as a continuous covariate.
    End point type
    Secondary
    End point timeframe
    24 Weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    215 [3]
    53 [4]
    Units: percentage of participants
    number (not applicable)
        Percent Achieved <7.0 HbA1c Level
    55.3
    18.9
        Percent Achieved ≤6.5 HbA1c Level
    40
    9.4
    Notes
    [3] - All randomized participants who received ≥1 dose of study drug and had evaluable HbA1c data.
    [4] - All randomized participants who received ≥1 dose of study drug and had evaluable HbA1c data.
    Statistical analysis title
    		 Statistical Analysis for <7.0% HbA1c
    Statistical analysis description
    <7.0% HbA1c
    Comparison groups
    Dulaglutide v Placebo
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    11.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.82
         upper limit
    		 33.84
    Statistical analysis title
    		 Statistical Analysis for ≤6.5% HbA1c
    Statistical analysis description
    ≤6.5% HbA1c
    Comparison groups
    Dulaglutide v Placebo
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    11.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.71
         upper limit
    		 35.34

    Secondary: Change from Baseline in Fasting Serum Glucose (FSG) at 24 Weeks

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    End point title
    		 Change from Baseline in Fasting Serum Glucose (FSG) at 24 Weeks
    End point description
    LS Means of the FSG from baseline to primary endpoint was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FSG as covariate, via Analysis of Covariance Model (ANCOVA) with Last Observation Carried Forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 24 Weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    218 [5]
    51 [6]
    Units: milligrams per deciliter (mg/dL)
        least squares mean (standard error)
    -30.6 ± 4.46
    2.93 ± 6.76
    Notes
    [5] - Participants received ≥1 dose of study drug and had evaluable FSG data at baseline, post baseline.
    [6] - Participants received ≥1 dose of study drug and had evaluable FSG data at baseline, post baseline.
    Statistical analysis title
    		 Statistical Analysis for Change from Baseline FSG
    Comparison groups
    Dulaglutide v Placebo
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -33.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46.55
         upper limit
    		 -20.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.6

    Secondary: Change from Baseline in Body Weight at 24 Weeks

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    End point title
    		 Change from Baseline in Body Weight at 24 Weeks
    End point description
    LS Means of the body weight change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline body weight as covariate, via a MMRM analysis using REML.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 Weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    212 [7]
    53 [8]
    Units: kilograms (kg)
        least squares mean (standard error)
    -0.91 ± 0.21
    -0.24 ± 0.4
    Notes
    [7] - Participants received ≥1 dose of study drug and had evaluable body weight data.
    [8] - Participants received ≥1 dose of study drug and had evaluable body weight data.
    Statistical analysis title
    		 Statistical Analysis for Body Weight
    Comparison groups
    Dulaglutide v Placebo
    Number of subjects included in analysis
    265
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.12
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.53
         upper limit
    		 0.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.43

    Secondary: Change from Baseline in Body Mass Index (BMI) at 24 Weeks

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    End point title
    		 Change from Baseline in Body Mass Index (BMI) at 24 Weeks
    End point description
    LS Means of the BMI change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline BMI as covariate, via a MMRM analysis using REML.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 Weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    212 [9]
    53 [10]
    Units: kilograms per/square meter kg/m^2
        least squares mean (standard error)
    -0.32 ± 0.08
    -0.1 ± 0.15
    Notes
    [9] - Participants who received ≥1 dose of study drug and evaluable BMI at baseline and post-baseline.
    [10] - Participants who received ≥1 dose of study drug and evaluable BMI at baseline and post-baseline.
    Statistical analysis title
    		 Statistical Analysis for Body Mass Index
    Comparison groups
    Dulaglutide v Placebo
    Number of subjects included in analysis
    265
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.161 [11]
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 0.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Notes
    [11] - No adjustment for multiplicity

    Secondary: Change from Baseline in Mean of all 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks

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    End point title
    		 Change from Baseline in Mean of all 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks
    End point description
    LS Means of the SMPG change from baseline to primary endpoint at week 24 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG value as covariate, via a MMRM analysis using REML.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 Weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    203 [12]
    49 [13]
    Units: mg/dL
        least squares mean (standard error)
    -37.22 ± 3.1
    -8.27 ± 4.77
    Notes
    [12] - Participants who received ≥1 dose of study drug and had evaluable SMPG data.
    [13] - Participants who received ≥1 dose of study drug and had evaluable SMPG data.
    Statistical analysis title
    		 Statistical Analysis for 7-Point SMPG
    Comparison groups
    Dulaglutide v Placebo
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -28.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.49
         upper limit
    		 -19.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.85

    Secondary: Number of Participants with Reported and Adjudicated Cardiovascular Events

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    End point title
    		 Number of Participants with Reported and Adjudicated Cardiovascular Events
    End point description
    Information on cardiovascular (CV) risk factors was collected at baseline. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.
    End point type
    Secondary
    End point timeframe
    Baseline through 24 Weeks, 30-day Follow Up
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    239
    60
    Units: participants
    number (not applicable)
        Any reported CV events
    2
    0
        Any adjudicated nonfatal CV events
    2
    0
        Any confirmed adjudicated CV deaths
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Adjudicated Acute Pancreatitis Events

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    End point title
    		 Number of Participants with Adjudicated Acute Pancreatitis Events
    End point description
    The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
    End point type
    Secondary
    End point timeframe
    Baseline through 24 Weeks, 30-day Follow Up
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    239
    60
    Units: participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Calcitonin at 24 Weeks

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    End point title
    		 Change from Baseline in Calcitonin at 24 Weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 24 Weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    215 [14]
    59 [15]
    Units: picogram per milliliter (pg/ml)
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [14] - Participants who received at least one dose of study drug and evaluable calcitonin data.
    [15] - Participants who received at least one dose of study drug and evaluable calcitonin data.
    No statistical analyses for this end point

    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
    End point description
    Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). Percentage is calculated as the number of participants reporting HE each visit/ the total number of participants reporting HE during the entire study treatment period.
    End point type
    Secondary
    End point timeframe
    Baseline through 24 Weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    239 [16]
    60 [17]
    Units: percentage of participants
    number (not applicable)
        Symptomatic
    11.3
    1.7
        Asymptomatic
    13.4
    1.7
        Probable
    2.5
    0
        Severe
    0
    0
        Nocturnal
    6.7
    1.7
    Notes
    [16] - All randomized participants who received at least one dose of study drug.
    [17] - All randomized participants who received at least one dose of study drug.
    No statistical analyses for this end point

    Secondary: Rate of HE Adjusted Per 30 Days

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    End point title
    		 Rate of HE Adjusted Per 30 Days
    End point description
    The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days.
    End point type
    Secondary
    End point timeframe
    Baseline through 24 weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    239
    60
    Units: number of events/participants/30 days
    arithmetic mean (standard deviation)
        Total HE
    0.19 ± 0.59
    0.01 ± 0.03
        Documented symptomatic HE
    0.07 ± 0.33
    0 ± 0.02
        Asymptomatic HE
    0.11 ± 0.45
    0 ± 0.02
        Severe HE
    0 ± 0
    0 ± 0
        Nocturnal HE
    0.02 ± 0.16
    0 ± 0.02
        Probable symptomatic HE
    0.01 ± 0.04
    0 ± 0
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia
    End point description
    Additional Intervention: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.
    End point type
    Secondary
    End point timeframe
    Baseline through 24 Weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    239
    60
    Units: percentage of participants
        number (not applicable)
    2.1
    11.7
    No statistical analyses for this end point

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

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    End point title
    		 Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia
    End point description
    An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.
    End point type
    Secondary
    End point timeframe
    Baseline through 24 Weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    239
    60
    Units: weeks
        arithmetic mean (standard error)
    22.59 ± 0.36
    22.47 ± 0.66
    No statistical analyses for this end point

    Secondary: Dulaglutide Anti-Drug Antibodies (ADA)

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    End point title
    		 Dulaglutide Anti-Drug Antibodies (ADA) [18]
    End point description
    Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant is considered to have TE dulaglutide ADA if the participant has at least one titer that is treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.
    End point type
    Secondary
    End point timeframe
    Baseline up to 4 Weeks Post-Last Dose of Study Drug
    Notes
    [18] - 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: The study was double-blinded and samples were collected from all participants. Those participants in the dulaglutide treatment group were tested for anti-drug antibody positive samples; placebo participants were not tested for ADA’s.
    End point values
    		 Dulaglutide
    Number of subjects analysed
    239
    Units: participants
        number (not applicable)
    2
    No statistical analyses for this end point

    Secondary: Change from Baseline in Lipase

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    End point title
    		 Change from Baseline in Lipase
    End point description
    A summary of changes in lipase evaluation from baseline to endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 Weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    233 [19]
    60 [20]
    Units: Units/Liter
        median (inter-quartile range (Q1-Q3))
    8 (1 to 18)
    4.5 (-2.5 to 15.5)
    Notes
    [19] - All participants who received at least one dose of study drug and had evaluable lipase data.
    [20] - All participants who received at least one dose of study drug and had evaluable lipase data.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Amylase

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    End point title
    		 Change from Baseline in Amylase
    End point description
    A summary of changes in amylase evaluation from baseline to endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 Weeks
    End point values
    		 Dulaglutide Placebo
    Number of subjects analysed
    233 [21]
    60 [22]
    Units: Units/Liter
        median (inter-quartile range (Q1-Q3))
    8 (1 to 18)
    2 (-5 to 11)
    Notes
    [21] - Participants who received at least one dose of study drug and had evaluable amylase data.
    [22] - Participants who received at least one dose of study drug and had evaluable amylase data.
    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
    H9X-MC-GBDG
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Dula 1.5
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Dula 1.5
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
    9 / 239 (3.77%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    anaplastic astrocytoma
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ulna fracture
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    cerebrovascular accident
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    rheumatoid arthritis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    osteomyelitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    otitis media
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary tuberculosis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    hypoglycaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Dula 1.5
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 60 (5.00%)
    44 / 239 (18.41%)
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 60 (0.00%)
    20 / 239 (8.37%)
         occurrences all number
    0
    30
    eructation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 60 (0.00%)
    14 / 239 (5.86%)
         occurrences all number
    0
    24
    nausea
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 60 (0.00%)
    25 / 239 (10.46%)
         occurrences all number
    0
    31
    Metabolism and nutrition disorders
    hyperglycaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 239 (0.42%)
         occurrences all number
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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