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    Clinical Trial Results:
    Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents with Type 2 Diabetes

    Summary
    EudraCT number
    		 2011-005196-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    01 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Oct 2020
    First version publication date
    09 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5550C00002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00658021
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 AstraZeneca: H8O-MC-GWBQ
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Pepparredsleden 1, Mölndal, Sweden, 431 83
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000689-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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To test the hypothesis that glycemic control, as measured by change in glycated hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide 5 microgram (mcg) twice daily or 10 mcg twice daily is superior to that of placebo, after 28 weeks of treatment in adolescent participants with type 2 diabetes who are naïve to antidiabetes agents, or participants who were treated with metformin, an sulfonylurea (SU), or a combination of metformin and an SU.
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation/Good Clinical Practice, applicable regulatory requirements and the AstraZeneca policy on Bioethics.
    Background therapy
    		 Participants who were naïve to antidiabetic treatment, or who were receiving metformin and/or an SU, were enrolled in this study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 May 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    India: 6
    Country: Number of subjects enrolled
    Mexico: 27
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Russian Federation: 2
    Country: Number of subjects enrolled
    South Africa: 1
    Country: Number of subjects enrolled
    United States: 83
    Worldwide total number of subjects
    122
    EEA total number of subjects
    0
    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)
    14
    Adolescents (12-17 years)
    108
    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
    		 This study was conducted in adolescents (aged 10 to 17 years inclusive) with type 2 diabetes who were naïve to antidiabetics, or were receiving metformin, an SU or a combination of metformin and an SU in 7 countries between 30 May 2008 and 01 April 2020.

    Pre-assignment
    Screening details
    		 The study commenced with a 1-week, single-blind, injectable placebo lead-in period before participants were randomized to 1 of 3 treatment groups: exenatide 5 mcg twice daily, exenatide 10 mcg twice daily, or placebo twice daily. A total of 122 participants were randomized in this study.

    Period 1
    Period 1 title
    28-Week Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Exenatide 5 mcg
    Arm description
    		 Adolescent participants received exenatide 5 mcg subcutaneous (SC) injection twice daily for 28 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Exenatide
    Investigational medicinal product code
    Other name
    BYETTA®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Exenatide 5 mcg was self-administered twice daily by SC injection using prefilled pens for 28 weeks.

    Arm title
    		 Exenatide 10 mcg
    Arm description
    		 Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Exenatide
    Investigational medicinal product code
    Other name
    BYETTA®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Exenatide 5 mcg was self-administered twice daily by SC injection using prefilled pens for 4 weeks after randomization. At the end of 4 weeks post-randomization, the dose increased to 10 mcg twice daily for next 24 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matching with exenatide 5 mcg or 10 mcg was self-administered twice daily by SC injection using prefilled pens for 28 weeks.

    Number of subjects in period 1
    		Exenatide 5 mcg Exenatide 10 mcg Placebo
    Started
    42
    38
    42
    Received treatment
    40
    38
    42
    Completed
    31
    25
    25
    Not completed
    11
    13
    17
         Consent withdrawn by subject
    1
    1
    3
         Physician decision
    1
    2
    1
         Adverse event, non-fatal
    3
    1
    -
         Loss of glucose control
    1
    1
    10
         Unspecified
    2
    3
    1
         Did not receive treatment
    2
    -
    -
         Withdrawal by parent/guardian
    1
    1
    1
         Developed study withdrawal criteria
    -
    2
    -
         Protocol deviation
    -
    2
    1
    Period 2
    Period 2 title
    Long-term Safety Follow-up Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Exenatide 5 mcg
    Arm description
    		 Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks. Participants with a height difference of at least 5 millimeter (mm) between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Exenatide
    Investigational medicinal product code
    Other name
    BYETTA®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Exenatide 5 mcg was self-administered twice daily by SC injection using prefilled pens for 28 weeks. Study treatment was not received in the Safety Follow-up Period.

    Arm title
    		 Exenatide 10 mcg
    Arm description
    		 Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. Participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Exenatide
    Investigational medicinal product code
    Other name
    BYETTA®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Exenatide 5 mcg was self-administered twice daily by SC injection using prefilled pens for 4 weeks after randomization. At the end of 4 weeks post-randomization, the dose increased to 10 mcg twice daily for next 24 weeks. Study treatment was not received in the Safety Follow-up Period.

    Arm title
    		 Placebo
    Arm description
    		 Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. Participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matching with exenatide 5 mcg or 10 mcg was self-administered twice daily by SC injection using prefilled pens for 28 weeks. Study treatment was not received in the Safety Follow-up Period.

    Number of subjects in period 2 [1]
    		Exenatide 5 mcg Exenatide 10 mcg Placebo
    Started
    7
    5
    7
    Completed
    7
    2
    7
    Not completed
    0
    3
    0
         Consent withdrawn by subject
    -
    1
    -
         Physician decision
    -
    2
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only participants entering safety follow-up period are presented.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Exenatide 5 mcg
    Reporting group description
    		 Adolescent participants received exenatide 5 mcg subcutaneous (SC) injection twice daily for 28 weeks.

    Reporting group title
    Exenatide 10 mcg
    Reporting group description
    		 Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks.

    Reporting group values
    		 Exenatide 5 mcg Exenatide 10 mcg Placebo Total
    Number of subjects
    		 42 38 42 122
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 5 5 4 14
        Adolescents (12-17 years)
    		 37 33 38 108
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.7 ± 1.94 14.0 ± 1.95 14.4 ± 1.82 -
    Sex: Female, Male
    Units: participants
        Female
    		 31 22 29 82
        Male
    		 11 16 13 40
    Race/Ethnicity, Customized
    Ethnicity not collected and Hispanic was collected as a Race in this study.
    Units: Subjects
        White
    		 7 5 13 25
        Black or African American
    		 14 8 7 29
        Asian
    		 3 2 5 10
        American Indian or Alaska Native
    		 0 1 0 1
        Hispanic
    		 18 22 17 57
    Subject analysis sets

    Subject analysis set title
    Total Exenatide twice daily (EBID)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo. Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks.

    Subject analysis sets values
    		 Total Exenatide twice daily (EBID) Placebo
    Number of subjects
    78
    42
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    10
    4
        Adolescents (12-17 years)
    68
    38
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    13.9 ± 1.96
    14.4 ± 1.82
    Sex: Female, Male
    Units: participants
        Female
    51
    29
        Male
    27
    13
    Race/Ethnicity, Customized
    Ethnicity not collected and Hispanic was collected as a Race in this study.
    Units: Subjects
        White
    12
    13
        Black or African American
    20
    7
        Asian
    5
    5
        American Indian or Alaska Native
    1
    0
        Hispanic
    40
    17

    End points

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    End points reporting groups
    Reporting group title
    Exenatide 5 mcg
    Reporting group description
    		 Adolescent participants received exenatide 5 mcg subcutaneous (SC) injection twice daily for 28 weeks.

    Reporting group title
    Exenatide 10 mcg
    Reporting group description
    		 Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks.
    Reporting group title
    Exenatide 5 mcg
    Reporting group description
    		 Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks. Participants with a height difference of at least 5 millimeter (mm) between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.

    Reporting group title
    Exenatide 10 mcg
    Reporting group description
    		 Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. Participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.

    Reporting group title
    Placebo
    Reporting group description
    		 Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. Participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.

    Subject analysis set title
    Total Exenatide twice daily (EBID)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo. Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks.

    Primary: Adjusted Change From Baseline in HbA1c at Week 28

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    End point title
    		 Adjusted Change From Baseline in HbA1c at Week 28
    End point description
    Change from baseline in HbA1c is reported as adjusted least square (LS) mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A mixed model with repeated measures (MMRM) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation. The Evaluable Analysis Set included all randomized participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline HbA1c assessment.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and Week 28
    End point values
    		 Total Exenatide twice daily (EBID) Placebo
    Number of subjects analysed
    78 [1]
    42 [2]
    Units: percentage (%HbA1c)
        least squares mean (standard error)
    0.11 ± 0.215
    0.38 ± 0.293
    Notes
    [1] - All participants in Evaluable Analysis set population.
    [2] - All participants in Evaluable Analysis set population.
    Statistical analysis title
    		 Treatment difference in HbA1c at Week 28
    Statistical analysis description
    Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline HbA1c, background diabetes therapy strata, week of visit, baseline HbA1c-by-visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.444
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.01
         upper limit
    		 0.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.363

    Primary: Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period

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    End point title
    		 Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period [3]
    End point description
    Post-treatment adverse events (AEs) were defined as AEs that started or worsened during the off-treatment period (Safety Follow-up Period), which was defined as the day after the Week 28/early discontinuation (ED) visit to the date of completion of the Safety Follow-up Period. The AESIs recorded were as follows: hematological malignancies, thyroid neoplasms, pancreas neoplasms, aplastic anemia, pancreatitis, pregnancy and pregnancy outcomes (including congenital anomalies). The Safety Follow-up Analysis Set included all participants who had at least 1 safety follow-up period assessment visit.
    End point type
    Primary
    End point timeframe
    From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics were determined for this endpoint.
    End point values
    		 Exenatide 5 mcg Exenatide 10 mcg Placebo
    Number of subjects analysed
    7
    5
    7
    Units: participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28

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    End point title
    		 Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28
    End point description
    The percentage of participants achieving HbA1c goals of < 7%, <= 6.5%, and < 6.5% through Week 28 were compared between treatments using the Cochran-Mantel-Haenszel (CMH) procedure, in which screening HbA1c strata and background diabetes therapy strata served as the stratification factors. The CMH analysis excluded measurements after initiation of rescue medication and study drug discontinuation with missing data treated as non-responder. The Evaluable Analysis Set included all randomized participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline HbA1c assessment.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 4, 12, 20 and 28
    End point values
    		 Total Exenatide twice daily (EBID) Placebo
    Number of subjects analysed
    78 [4]
    42 [5]
    Units: percentage of participants
    number (confidence interval 95%)
        HbA1c < 7%: Week 0
    37.2 (26.5 to 47.9)
    38.1 (23.4 to 52.8)
        HbA1c < 7%: Week 4
    44.9 (33.8 to 55.9)
    42.9 (27.9 to 57.8)
        HbA1c < 7%: Week 12
    43.6 (32.6 to 54.6)
    33.3 (19.1 to 47.6)
        HbA1c < 7%: Week 20
    35.9 (25.3 to 46.5)
    35.7 (21.2 to 50.2)
        HbA1c < 7%: Week 28
    33.3 (22.9 to 43.8)
    28.6 (14.9 to 42.2)
        HbA1c <=6.5%: Week 0
    17.9 (9.4 to 26.5)
    16.7 (5.4 to 27.9)
        HbA1c <=6.5%: Week 4
    29.5 (19.4 to 39.6)
    23.8 (10.9 to 36.7)
        HbA1c <=6.5%: Week 12
    33.3 (22.9 to 43.8)
    23.8 (10.9 to 36.7)
        HbA1c <=6.5%: Week 20
    24.4 (14.8 to 33.9)
    19.0 (7.2 to 30.9)
        HbA1c <=6.5%: Week 28
    23.1 (13.7 to 32.4)
    19.0 (7.2 to 30.9)
        HbA1c <6.5%: Week 0
    15.4 (7.4 to 23.4)
    7.1 (0.0 to 14.9)
        HbA1c <6.5%: Week 4
    26.9 (17.1 to 36.8)
    21.4 (9.0 to 33.8)
        HbA1c <6.5%: Week 12
    30.8 (20.5 to 41.0)
    19.0 (7.2 to 30.9)
        HbA1c <6.5%: Week 20
    21.8 (12.6 to 31.0)
    19.0 (7.2 to 30.9)
        HbA1c <6.5%: Week 28
    23.1 (13.7 to 32.4)
    14.3 (3.7 to 24.9)
    Notes
    [4] - All participants in Evaluable Analysis set population.
    [5] - All participants in Evaluable Analysis set population.
    Statistical analysis title
    		 Treatment difference in HbA1c < 7% at Week 28
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.562 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [6] - Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics.
    Statistical analysis title
    		 Treatment difference in HbA1c <= 6.5% at Week 28
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.621 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [7] - Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics.
    Statistical analysis title
    		 Treatment difference in HbA1c < 6.5% at Week 28
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.229 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [8] - Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics.

    Secondary: Adjusted Change From Baseline in Body Weight Through Week 28

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    End point title
    		 Adjusted Change From Baseline in Body Weight Through Week 28
    End point description
    Change from baseline in body weight is reported as adjusted LS mean values at Weeks 4, 12, 20 and 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A MMRM analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation. The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Week 28
    End point values
    		 Total Exenatide twice daily (EBID) Placebo
    Number of subjects analysed
    78 [9]
    42 [10]
    Units: kilogram
    least squares mean (standard error)
        Week 4
    -0.89 ± 0.196
    0.04 ± 0.260
        Week 12
    -1.09 ± 0.401
    -0.42 ± 0.534
        Week 20
    -0.71 ± 0.559
    -0.33 ± 0.755
        Week 28
    -0.81 ± 0.632
    -0.36 ± 0.857
    Notes
    [9] - All participants in Full Analysis set population.
    [10] - All participants in Full Analysis set population.
    Statistical analysis title
    		 Treatment difference in body weight at Week 4
    Statistical analysis description
    Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.58
         upper limit
    		 -0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.327
    Statistical analysis title
    		 Treatment difference in body weight at Week 12
    Statistical analysis description
    Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.314
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 0.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.669
    Statistical analysis title
    		 Treatment difference in body weight at Week 20
    Statistical analysis description
    Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.692
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.24
         upper limit
    		 1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.94
    Statistical analysis title
    		 Treatment difference in body weight at Week 28
    Statistical analysis description
    Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.679
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.56
         upper limit
    		 1.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.065

    Secondary: Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28

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    End point title
    		 Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28
    End point description
    Change from baseline in FSG is reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An analysis of covariance (ANCOVA) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation. The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 28
    End point values
    		 Total Exenatide twice daily (EBID) Placebo
    Number of subjects analysed
    78 [11]
    42 [12]
    Units: millimoles per liter (mmol/L)
        least squares mean (standard error)
    0.791 ± 0.4010
    1.072 ± 0.5466
    Notes
    [11] - All participants in Full Analysis set population.
    [12] - All participants in Full Analysis set population.
    Statistical analysis title
    		 Treatment difference in FSG
    Statistical analysis description
    Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum glucose, screening HbA1c strata and background diabetes therapy strata as fixed effects.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.679
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.281
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.614
         upper limit
    		 1.052
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.68

    Secondary: Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28

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    End point title
    		 Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28
    End point description
    Change from baseline in SMBG measurements are reported as adjusted LS mean values at Week 28. SMBG measurements were taken before (pre-prandial) and 2 hours after (post-prandial) the 2 main meals of the day on 3 separate days during the week before baseline (Day 1) and Week 28. Post-prandial excursions were calculated as the difference between the pre-prandial and post-prandial blood glucose concentrations (post-prandial – pre-prandial) and averaged (mean) over the 2 main meals over the 3 separate days in each period. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation. The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication.
    End point type
    Secondary
    End point timeframe
    Pre-meal and 2 hours post-meal on Baseline (Day 1) and Week 28
    End point values
    		 Total Exenatide twice daily (EBID) Placebo
    Number of subjects analysed
    78 [13]
    42 [14]
    Units: mmol/L
    least squares mean (standard error)
        Pre-meal SMBG
    -0.699 ± 0.2709
    -0.888 ± 0.4511
        Post-meal SMBG
    -1.029 ± 0.2722
    -1.542 ± 0.4503
        Post-prandial excursion SMBG
    -0.181 ± 0.2107
    -0.391 ± 0.3418
        Overall SMBG
    -0.877 ± 0.2468
    -1.193 ± 0.4117
    Notes
    [13] - All participants in Full Analysis set population.
    [14] - All participants in Full Analysis set population.
    Statistical analysis title
    		 Treatment difference for pre-meal SMBG
    Statistical analysis description
    Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.714
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.189
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.821
         upper limit
    		 1.199
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5151
    Statistical analysis title
    		 Treatment difference for post-meal SMBG
    Statistical analysis description
    Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.329
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.513
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.516
         upper limit
    		 1.541
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5245
    Statistical analysis title
    		 Treatment difference post-prandial excursion SMBG
    Statistical analysis description
    Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.601
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.577
         upper limit
    		 0.997
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4015
    Statistical analysis title
    		 Treatment difference for overall SMBG
    Statistical analysis description
    Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.505
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.316
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.615
         upper limit
    		 1.248
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4749

    Secondary: Adjusted Change From Baseline in Fasting Serum Insulin at Week 28

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    End point title
    		 Adjusted Change From Baseline in Fasting Serum Insulin at Week 28
    End point description
    Change from baseline in fasting serum insulin is reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation. The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 28
    End point values
    		 Total Exenatide twice daily (EBID) Placebo
    Number of subjects analysed
    78 [15]
    42 [16]
    Units: picomoles per liter
        least squares mean (standard error)
    1.67 ± 25.323
    12.49 ± 34.825
    Notes
    [15] - All participants in Full Analysis set population.
    [16] - All participants in Full Analysis set population.
    Statistical analysis title
    		 Treatment difference in fasting serum insulin
    Statistical analysis description
    Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum insulin, screening HbA1c strata and background diabetes therapy strata as fixed effects.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.802
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -10.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -95.48
         upper limit
    		 73.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    43.187

    Secondary: Adjusted Change From Baseline in Homeostasis Model Assessments – Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) at Week 28

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    End point title
    		 Adjusted Change From Baseline in Homeostasis Model Assessments – Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) at Week 28
    End point description
    Change from baseline in HOMA-B and HOMA-S are reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation. The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 28
    End point values
    		 Total Exenatide twice daily (EBID) Placebo
    Number of subjects analysed
    78 [17]
    42 [18]
    Units: percentage (%HOMA-B and %HOMA-S)
    least squares mean (standard error)
        HOMA-B
    -25.93 ± 10.404
    -22.10 ± 14.885
        HOMA-S
    -3.18 ± 2.172
    -2.90 ± 3.117
    Notes
    [17] - All participants in Full Analysis set population.
    [18] - All participants in Full Analysis set population.
    Statistical analysis title
    		 Treatment difference for HOMA-B
    Statistical analysis description
    Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-B, screening HbA1c strata and background diabetes therapy strata as fixed effects.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.836
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -3.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.19
         upper limit
    		 32.51
    Variability estimate
    Standard error of the mean
    Dispersion value
    18.542
    Statistical analysis title
    		 Treatment difference for HOMA-S
    Statistical analysis description
    Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-S, screening HbA1c strata and background diabetes therapy strata as fixed effects.
    Comparison groups
    Total Exenatide twice daily (EBID) v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.941
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.82
         upper limit
    		 7.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.846

    Secondary: Percentage of Participants Discontinuing the Study Due to Failure to Maintain Glycemic Control Through Week 28

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    End point title
    		 Percentage of Participants Discontinuing the Study Due to Failure to Maintain Glycemic Control Through Week 28
    End point description
    Participants were discontinued from the study due to failure to maintain glycemic control if either discontinuation reason on summary case report form was “Loss of glucose control” or AE with lower level Medical Dictionary for Regulatory Activities (MedDRA) term “Loss of control of blood sugar” or “Hyperglycaemia” leading to study drug discontinuation, using MedDRA Version 23.0. The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication. Here, "n" is defined as number of participants analysed at each time point.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 16, 20, 24 and 28
    End point values
    		 Total Exenatide twice daily (EBID) Placebo
    Number of subjects analysed
    78 [19]
    42 [20]
    Units: percentage of participants
    number (not applicable)
        Week 2 (n= 40, 38, 42)
    0
    0
        Week 4 (n= 40, 38, 42)
    0
    2.4
        Week 8 (n= 39, 38, 41)
    0
    0
        Week 12 (n= 37, 35, 40)
    1.4
    5.0
        Week 16 (n= 36, 33, 36)
    1.4
    0
        Week 20 (n= 35, 30, 34)
    0
    14.7
        Week 24 (n= 35, 30, 29)
    0
    6.9
        Week 28 (n= 33, 28, 26)
    1.6
    0
    Notes
    [19] - All participants in Full Analysis set population.
    [20] - All participants in Full Analysis set population.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious AEs: From first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 32 weeks. Non-serious AEs: From first dose of study drug (Day 1) up to 1 day after last dose of study drug, approximately 28 weeks.
    Adverse event reporting additional description
    The Safety Analysis Set included all participants who received at least 1 dose of randomized study medication. Treatment-emergent AEs are reported for the 28-week treatment period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Exenatide 5 mcg
    Reporting group description
    		 Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks.

    Reporting group title
    Exenatide 10 mcg
    Reporting group description
    		 Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks.

    Serious adverse events
    		 Exenatide 5 mcg Exenatide 10 mcg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 37 (2.70%)
    1 / 42 (2.38%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 37 (2.70%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Intentional self-injury
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 37 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 37 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 37 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 37 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal abscess
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 37 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Exenatide 5 mcg Exenatide 10 mcg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 41 (63.41%)
    24 / 37 (64.86%)
    23 / 42 (54.76%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 37 (5.41%)
    2 / 42 (4.76%)
         occurrences all number
    2
    3
    2
    Headache
         subjects affected / exposed
    9 / 41 (21.95%)
    9 / 37 (24.32%)
    11 / 42 (26.19%)
         occurrences all number
    14
    15
    27
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 37 (2.70%)
    3 / 42 (7.14%)
         occurrences all number
    2
    1
    3
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 37 (5.41%)
    3 / 42 (7.14%)
         occurrences all number
    2
    2
    3
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 37 (5.41%)
    2 / 42 (4.76%)
         occurrences all number
    1
    5
    4
    Diarrhoea
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 37 (8.11%)
    5 / 42 (11.90%)
         occurrences all number
    3
    3
    9
    Nausea
         subjects affected / exposed
    4 / 41 (9.76%)
    11 / 37 (29.73%)
    7 / 42 (16.67%)
         occurrences all number
    4
    15
    10
    Vomiting
         subjects affected / exposed
    2 / 41 (4.88%)
    8 / 37 (21.62%)
    3 / 42 (7.14%)
         occurrences all number
    2
    10
    3
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 37 (8.11%)
    4 / 42 (9.52%)
         occurrences all number
    3
    4
    6
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 37 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    3
    0
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 37 (5.41%)
    2 / 42 (4.76%)
         occurrences all number
    1
    4
    2
    Infections and infestations
    Furuncle
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 37 (5.41%)
    0 / 42 (0.00%)
         occurrences all number
    0
    2
    0
    Influenza
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 37 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    3
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    8 / 41 (19.51%)
    2 / 37 (5.41%)
    3 / 42 (7.14%)
         occurrences all number
    10
    4
    3
    Pharyngitis
         subjects affected / exposed
    4 / 41 (9.76%)
    2 / 37 (5.41%)
    1 / 42 (2.38%)
         occurrences all number
    6
    5
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 37 (5.41%)
    0 / 42 (0.00%)
         occurrences all number
    0
    2
    0
    Sinusitis
         subjects affected / exposed
    4 / 41 (9.76%)
    1 / 37 (2.70%)
    2 / 42 (4.76%)
         occurrences all number
    4
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 41 (12.20%)
    3 / 37 (8.11%)
    5 / 42 (11.90%)
         occurrences all number
    8
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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 May 2008
    Protocol addendum (dated: 15-Jan-2008) was added to allow collection (at Visits 3 and 11) and banking of biological samples for genomic/proteomic/biochemical research. Modification of the inclusion criteria to clarify that drug naïve participants be limited to participants with a confirmed diagnosis of type 2 diabetes who were receiving treatment with diet and exercise only. The Schwartz equation for calculating glomerular filtration rate in children and adolescents was substituted for the Cockcroft-Gault creatinine clearance equation.
    09 Feb 2011
    Protocol addendum (dated: 21-May-2008) was added to mention the following exclusions: use of warfarin and other coumarol derivatives, certain conditions known to be associated with improper functioning of the pancreas, and uncontrolled hypertension. Protocol addendum (dated: 01-Feb-2011) was added to allow thorough quantification of the pharmacokinetics disposition of exenatide in adolescents and allow assessment of safety endpoints relative to maximum plasma exenatide concentrations observed in adolescent participants. Updated objectives/statistical measures related to proportion of participants achieving HbA1c milestones. Broadening of HbA1c inclusion criteria was added. The age-related inclusion criterion was expanded to limit the number of participants >= 17 years of age.
    29 May 2012
    Added references to a required Safety Follow-up addendum. In the secondary objectives, the HbA1c endpoints were amended to < 7%, <= 6.5%, and < 6.5%.
    16 May 2013
    Protocol addendum (dated: 29-May-2012) was added to include a long-term Safety Follow-up in which participants were observed following discontinuation of study drug administration. Change in Sponsor from Eli Lilly and Company to Amylin Pharmaceuticals, LLC.
    13 Oct 2017
    Added explanation for the switch of current reusable injection pen (Ypsopen U100) to BYETTA commercial like clinical prefilled injection pen. Updated the study Sponsor as Amylin Pharmaceuticals, LLC, a wholly owned subsidiary of AstraZeneca PLC.

    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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