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    Clinical Trial Results:
    Albiglutide versus Placebo in insulin-treated Subjects with new-onset type 1 diabetes mellitus

    Summary
    EudraCT number
    		 2014-001825-33
    Trial protocol
    		 DE   IT   GB  
    Global end of trial date
    18 Oct 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 Apr 2019
    First version publication date
    28 Oct 2018
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    110933
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    27 Apr 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Oct 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the effect of albiglutide therapy versus placebo on endogenous insulin secretion over 52 weeks when added to standard of care in subjects with new onset type 1 diabetes mellitus (NOT1DM)
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Oct 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Spain: 29
    Country: Number of subjects enrolled
    United Kingdom: 14
    Worldwide total number of subjects
    67
    EEA total number of subjects
    67
    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)
    67
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a multicenter study conducted at 29 sites in Europe (Spain 10, United Kingdom (UK) 9, Germany 4, France 3 and Italy 3). A total of 67 participants with New-onset type 1 diabetes mellitus (NOT1DM) were randomized.

    Pre-assignment
    Screening details
    		 Study was terminated early as part of the decision to withdraw albiglutide for commercial reasons. Study stopped after 67 participants were randomized instead of 68 as per protocol. Impact of early termination was minimal and did not affect the interpretation of results.

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was administered once weekly by SC injection in the abdomen, thigh or upper arm region in addition to insulin

    Arm title
    		 Albiglutide
    Arm description
    		 Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Albiglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Albiglutide 30 mg was administered once weekly by SC injection in the abdomen, thigh or upper arm region in addition to insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated)

    Number of subjects in period 1
    		Placebo Albiglutide
    Started
    17
    50
    Completed
    11
    40
    Not completed
    6
    10
         Consent withdrawn by subject
    2
    5
         Physician decision
    -
    2
         Adverse event, non-fatal
    3
    -
         Lost to follow-up
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.

    Reporting group title
    Albiglutide
    Reporting group description
    		 Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).

    Reporting group values
    		 Placebo Albiglutide Total
    Number of subjects
    		 17 50
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 22.8 ± 3.83 22.7 ± 3.72 -
    Gender categorical
    Units: Subjects
        Female
    		 7 21 28
        Male
    		 10 29 39
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American
    		 0 1 1
        White
    		 17 49 66
        Multi Racial
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    defend-1 placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.

    Subject analysis sets values
    		 defend-1 placebo
    Number of subjects
    53
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    22.7 ± 4.00
    Gender categorical
    Units: Subjects
        Female
    20
        Male
    33
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American
    2
        White
    49
        Multi Racial
    2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.

    Reporting group title
    Albiglutide
    Reporting group description
    		 Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).

    Subject analysis set title
    defend-1 placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.

    Primary: Mean change from Baseline in time normalized stimulated (from mixed meal tolerance test [MMTT]) 2-hour plasma C-peptide area under the curve (AUC) at Week 52

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    End point title
    		 Mean change from Baseline in time normalized stimulated (from mixed meal tolerance test [MMTT]) 2-hour plasma C-peptide area under the curve (AUC) at Week 52
    End point description
    Participants (parts) had a balanced diet consistent with dietitian’s advice and made no major changes in exercise regimens. Evening before the MMTT, participants had a full meal then fasted from 9 post meridiem (pm) until MMTT was completed. Water, black coffee or tea without sugar or artificial sweeteners was allowed. Plasma glucose was measured prior to the finger-stick test and MMTT was performed only if in range > 3.9 millimoles per liter (mmol/L) [70 mg/deciliter (dL)] and <= 11.1 mmol/L (200 mg/dL). Baseline was defined as the last non-missing value with assessment date on or before the 1st day of study medication. Change from Baseline was calculated by subtracting Baseline value from Week 52 value. Intent-to-treat (ITT) Population comprised of all randomly assigned participants who received at least 1 dose of study medication with at least 1 post-Baseline assessment of the primary endpoint.
    End point type
    Primary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Placebo Albiglutide defend-1 placebo
    Number of subjects analysed
    11 [1]
    40 [2]
    53 [3]
    Units: Nanomoles per liter
    arithmetic mean (standard deviation)
        Nanomoles per liter
    -0.16 ± 0.366
    -0.13 ± 0.244
    -0.27 ± 0.314
    Notes
    [1] - Intent to treat (ITT) Population.
    [2] - ITT Population.
    [3] - ITT Population.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Analysis was performed using a Bayesian model incorporating historical placebo data using a robust mixture prior. Values above are 95% credible intervals. Probability of treatment difference (Albiglutide – Placebo) >= 0.2 nmol/L = 0.097. Fifty one participants from current study and 53 participants from the DEFEND-1 study were included in the analysis.
    Comparison groups
    Albiglutide v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.24

    Secondary: Mean change from Baseline in time normalized stimulated (from MMTT) 2 hour plasma C-peptide AUC at Week 16, 28 and Week 64

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    End point title
    		 Mean change from Baseline in time normalized stimulated (from MMTT) 2 hour plasma C-peptide AUC at Week 16, 28 and Week 64
    End point description
    Participants had a balanced diet consistent with dietitian’s advice and made no major changes in exercise regimens. On the evening before the MMTT, participants had a full meal and then fasted from 9 pm until the MMTT was completed. Water, black coffee or tea without sugar or artificial sweeteners was allowed. Plasma glucose was measured prior to the test using a finger-stick test and MMTT was performed only if it was in range > 3.9 mmol/L (70 mg/dL) and <= 11.1 mmol/L (200 mg/dL). Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 16, 28 and 64
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [4]
    46 [5]
    Units: Nanomoles per liter
    arithmetic mean (standard deviation)
        Week 16, n=15,44
    0.00 ± 0.216
    0.07 ± 0.234
        Week 28, n=13,41
    -0.14 ± 0.177
    0.01 ± 0.225
        Week 64, n=11,36
    -0.22 ± 0.277
    -0.22 ± 0.246
    Notes
    [4] - ITT Population.
    [5] - ITT Population.
    No statistical analyses for this end point

    Secondary: Maximum stimulated plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64

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    End point title
    		 Maximum stimulated plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64
    End point description
    Maximum stimulated plasma C-peptide was the highest value at any time point during the 2 hour MMTT after the participant has ingested the mixed meal at Baseline, Week 16, Week 28, Week 52 and Week 64. Blood samples were taken to assess levels of C-peptide at: 10 minutes before Time 0 (-10 minutes), immediately before the participant starts drinking the nutritional drink (Time 0) and 15, 30, 60, 90, and 120 minutes after Time 0. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 16, 28, 52 and 64
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [6]
    46 [7]
    Units: Nanomoles per liter
    arithmetic mean (standard deviation)
        Baseline, n=15,46
    0.86 ± 0.382
    0.82 ± 0.448
        Week 16, n=15,45
    0.84 ± 0.481
    1.02 ± 0.558
        Week 28,n=13,42
    0.68 ± 0.442
    0.91 ± 0.594
        Week 52,n=11,41
    0.63 ± 0.516
    0.69 ± 0.479
        Week 64, n=11,37
    0.58 ± 0.453
    0.48 ± 0.363
    Notes
    [6] - ITT Population
    [7] - ITT Population.
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in time normalized plasma glucagon AUC (from MMTT) at Week 16, 28, 52 and 64

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    End point title
    		 Mean change from Baseline in time normalized plasma glucagon AUC (from MMTT) at Week 16, 28, 52 and 64
    End point description
    Blood samples were taken to assess levels of glucagon at: 10 minutes before Time 0 (-10 minutes), immediately before the participant started drinking the nutritional drink (Time 0) and 15, 30, 60, 90, and 120 minutes after Time 0. Mean change from Baseline in time normalized plasma glucagon AUC (from MMTT) at Week 16, 28, 52 and 64 was reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 16, 28, 52 and 64
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [8]
    46 [9]
    Units: Nanograms per liter
    arithmetic mean (standard deviation)
        Week 16,n=15,45
    -2.28 ± 11.221
    -1.10 ± 4.496
        Week 28,n=13,43
    -2.97 ± 11.574
    3.91 ± 22.197
        Week 52,n=11,40
    -0.31 ± 15.989
    4.66 ± 13.628
        Week 64,n=11,37
    3.19 ± 18.279
    8.82 ± 17.650
    Notes
    [8] - ITT Population.
    [9] - ITT Population.
    No statistical analyses for this end point

    Secondary: Percentage of responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64

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    End point title
    		 Percentage of responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64
    End point description
    Responders were defined as participants achieving glycosylated hemoglobin A1c (HbA1c) <= 7.0 percent and mean daily insulin use < 0.5 units per kilograms (kg) per day. Percentages are based on the number of participants with available HbA1c and insulin use data in each treatment group at that visit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [10]
    46 [11]
    Units: Percentage of participants
    number (not applicable)
        Baseline, n=15, 46
    26.7
    37.0
        Week 4,n=14,42
    71.4
    78.6
        Week 8,n=14,46
    85.7
    67.4
        Week 16,n=15,45
    86.7
    73.3
        Week 28,n=12,42
    75.0
    73.8
        Week 40,n=13,40
    76.9
    62.5
        Week 52,n=12,41
    41.7
    48.8
        Week 64,n=11,38
    36.4
    34.2
    Notes
    [10] - ITT Population.
    [11] - ITT Population.
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving partial remission status (insulin dose-adjusted hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64

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    End point title
    		 Percentage of participants achieving partial remission status (insulin dose-adjusted hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64
    End point description
    Participant achieving partial remission status was defined as a participant with IDAA1C <=9.0 . Percentages were based on the number of participants with available IDAA1c data in each treatment group at that visit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [12]
    46 [13]
    Units: Percentage of participants
    number (not applicable)
        Baseline, n= 15, 46
    73.3
    60.9
        Week 4,n=14,42
    92.9
    88.1
        Week 8,n=14,46
    92.9
    87.0
        Week 16,n=15,45
    86.7
    86.7
        Week 28,n=12,42
    75.0
    85.7
        Week 40,n=13,40
    84.6
    82.5
        Week 52,n=12,41
    58.3
    70.7
        Week 64,n=11,38
    54.5
    55.3
    Notes
    [12] - ITT Population.
    [13] - ITT Population.
    No statistical analyses for this end point

    Secondary: Change from Baseline in percent HbA1c at Week 52

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    End point title
    		 Change from Baseline in percent HbA1c at Week 52
    End point description
    Change from Baseline in percent HbA1c was reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value the Week 52 value. Only those participants with available data at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    12 [14]
    43 [15]
    Units: Percentage of HbA1c
    arithmetic mean (standard deviation)
        Percentage of HbA1c
    -0.73 ± 1.033
    -0.59 ± 1.649
    Notes
    [14] - ITT Population.
    [15] - ITT Population.
    No statistical analyses for this end point

    Secondary: Percent HbA1c over time (at Weeks 4, 8, 16, 28, 40, 52 and 64)

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    End point title
    		 Percent HbA1c over time (at Weeks 4, 8, 16, 28, 40, 52 and 64)
    End point description
    Blood samples were collected from participants for analysis of HbA1c at indicated time points and percentage of HbA1c has been calculated for Weeks 4, 8, 16, 28, 40, 52 and 64. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles).
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 16, 28, 40, 52 and 64
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [16]
    46 [17]
    Units: Percentage of HbA1c
    arithmetic mean (standard deviation)
        Week 4,n=15,43
    6.29 ± 0.688
    6.10 ± 0.725
        Week 8,n=15,46
    5.91 ± 0.689
    5.82 ± 0.725
        Week 16,n=15,46
    5.97 ± 0.801
    5.78 ± 0.733
        Week 28,n=13,43
    6.03 ± 0.747
    6.00 ± 0.824
        Week 40,n=13,42
    6.22 ± 0.860
    6.20 ± 0.894
        Week 52,n=12,43
    6.56 ± 0.950
    6.58 ± 1.512
        Week 64,n=12,40
    7.12 ± 1.335
    6.92 ± 1.176
    Notes
    [16] - ITT Population.
    [17] - ITT Population.
    No statistical analyses for this end point

    Secondary: Change from Baseline in mean daily insulin use at Week 4, 8, 16, 28, 40, 52 and 64

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    End point title
    		 Change from Baseline in mean daily insulin use at Week 4, 8, 16, 28, 40, 52 and 64
    End point description
    The mean daily insulin use value was calculated, in units per kg per day (units/kg/day) as the sum of average prandial insulin doses and average of basal insulin doses for each participant recorded daily for the 3 days prior to the specified visits, divided by the participant's body weight in kg. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [18]
    46 [19]
    Units: Units/kg/day
    arithmetic mean (standard deviation)
        Week 4,n=14,43
    -0.02 ± 0.076
    -0.03 ± 0.093
        Week 8,n=14,46
    -0.04 ± 0.105
    -0.02 ± 0.123
        Week 16,n=15,45
    -0.05 ± 0.100
    -0.01 ± 0.148
        Week 28,n=12,42
    -0.01 ± 0.139
    0.03 ± 0.145
        Week 40,n=13,40
    -0.01 ± 0.151
    0.03 ± 0.145
        Week 52,n=12,41
    0.04 ± 0.119
    0.11 ± 0.215
        Week 64,n=11,38
    0.04 ± 0.140
    0.10 ± 0.187
    Notes
    [18] - ITT Population
    [19] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of events of participant-reported significant hypoglycemia, occurring > Week 24 and <= Week 52

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    End point title
    		 Number of events of participant-reported significant hypoglycemia, occurring > Week 24 and <= Week 52
    End point description
    Significant hypoglycemia was defined as an event with plasma glucose level <= 3.9 mmol/L (<= 70 mg/dL) and/or requiring third party intervention. This corresponds to American Diabetes Association (ADA) category definitions of severe, documented symptomatic, and asymptotic hypoglycemia. The time period was defined as: > Week 24 to <= Week 52 = Day 169 to Day 364. Number of Events were defined as the total number of significant hypoglycemic events at each level of summarization. Number of events of hypoglycemia with confirmed self plasma glucose monitoring <=3.9 mmol/L and/or requiring third party intervention (i.e., severe, documented symptomatic and asymptomatic hypoglycemic events) occurring >Week 24 and <=Week 52 are presented. Only those participants with available data at specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24 to 52
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    13 [20]
    45 [21]
    Units: Hypoglycemic events
        Any Significant Hypoglycemia
    472
    1592
        Severe Hypoglycemia
    0
    0
        Documented Symptomatic Hypoglycemia
    241
    996
        Asymptomatic Hypoglycemia
    231
    596
    Notes
    [20] - ITT Population
    [21] - ITT Population
    No statistical analyses for this end point

    Secondary: Time Spent with Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 measured by 72 hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52

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    End point title
    		 Time Spent with Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 measured by 72 hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52
    End point description
    Three days before the visit, the participants made an additional visit to the study site to have the CGM fitted/inserted. It was worn for 3 consecutive days and was removed at the scheduled study visit. Whilst wearing the CGM, participants continued to monitor their plasma glucose at least 4 times a day and on one of the days, conducted 7-point glucose profile (Before breakfast, 2 hours after breakfast, Before lunch, 2 hours after lunch, Before dinner, 2 hours after dinner, At bedtime). Time spent with a plasma glucose <=3.9 millimoles per liter (mmol/L), between >3.9 and 10.0 mmol/L, and >10.0 mmol/L, respectively as performed by 72-hour CGM at Baseline, Week 28 and Week 52 was reported. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [22]
    46 [23]
    Units: hours per day
    arithmetic mean (standard deviation)
        <= 3.9 mmol/L, Baseline,n=14,42
    0.80 ± 1.251
    0.98 ± 1.400
        <= 3.9 mmol/L, Week 28,n=12,36
    1.72 ± 1.248
    1.38 ± 1.808
        <= 3.9 mmol/L, Week 52,n=10,31
    1.60 ± 2.142
    1.36 ± 2.405
        > 3.9 to <= 10.0 mmol/L,Baseline,n=14,42
    20.14 ± 3.675
    19.11 ± 3.732
        > 3.9 to <= 10.0 mmol/L,Week 28,n=12,36
    18.93 ± 3.452
    18.83 ± 4.009
        > 3.9 to <= 10.0 mmol/L,Week 52,n=10,31
    17.98 ± 4.491
    18.19 ± 4.772
        > 10.0 mmol/L, Baseline,n=14,42
    3.06 ± 3.560
    3.90 ± 3.727
        > 10.0 mmol/L,Week 28,n=12,36
    3.35 ± 3.115
    3.79 ± 3.782
        > 10.0 mmol/L,Week 52,n=10,31
    4.42 ± 4.597
    4.45 ± 4.781
    Notes
    [22] - ITT Population.
    [23] - ITT Population.
    No statistical analyses for this end point

    Secondary: Number of Hypoglycemic Excursions for each participant from 7-Point Glucose Profile at Baseline, Week 28 and 52

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    End point title
    		 Number of Hypoglycemic Excursions for each participant from 7-Point Glucose Profile at Baseline, Week 28 and 52
    End point description
    A hypoglycemic excursion was defined as an occurrence where the plasma glucose level was <=3.9 mmol/L (<=70 mg/dL). At each visit, only evaluable participants, defined as those with >= 4 non-missing glucose values or >= 1 hypoglycemic excursions were included. Number of Hypoglycemic Excursions for each participant from 7-Point Glucose Profile (Before breakfast, 2 hours after breakfast, Before lunch, 2 hours after lunch, Before dinner, 2 hours after dinner, At bedtime) were reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Only evaluable participants, as defined above were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [24]
    46 [25]
    Units: Hypoglycemic excursions
    arithmetic mean (standard deviation)
        Bseline,n=15,42
    0.40 ± 0.632
    0.36 ± 0.656
        Week 28,n=13,40
    0.31 ± 0.630
    0.28 ± 0.554
        Week 52,n=12,40
    0.25 ± 0.452
    0.40 ± 0.672
    Notes
    [24] - ITT Population.
    [25] - ITT Population.
    No statistical analyses for this end point

    Secondary: Greatest magnitude of Hypoglycemic Excursions for each participant from 7-Point Glucose Profile at Baseline, Week 28 and 52

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    End point title
    		 Greatest magnitude of Hypoglycemic Excursions for each participant from 7-Point Glucose Profile at Baseline, Week 28 and 52
    End point description
    A hypoglycemic excursion was defined as an occurrence where the plasma glucose level was <=3.9 mmol/L (<= 70 mg/dL). At each visit, only evaluable participants, defined as those with >= 4 non-missing glucose values or >= 1 hypoglycemic excursions were included. Greatest hypoglycemic excursion was calculated as 3.9 mmol/L minus the lowest recorded glucose level during the 7-point glucose profile (Before breakfast, 2 hours after breakfast, Before lunch, 2 hours after lunch, Before dinner, 2 hours after dinner, At bedtime). If a participant had data recorded at that visit, but did not have a value <= 3.9 mmol/L, their greatest hypoglycemic excursion were 0 mmol/L for that visit. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Only evaluable participants, as defined above were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [26]
    46 [27]
    Units: mmol/L
    arithmetic mean (standard deviation)
        Baseline,n=15,42
    0.24 ± 0.470
    0.22 ± 0.597
        Week 28,n=13,40
    0.18 ± 0.359
    0.08 ± 0.231
        Week 52,n=12,40
    0.22 ± 0.484
    0.17 ± 0.393
    Notes
    [26] - ITT Population.
    [27] - ITT Population.
    No statistical analyses for this end point

    Secondary: Number of Hyperglycemic Excursions for each participant from 7-Point Glucose Profile at Baseline, Week 28 and 52

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    End point title
    		 Number of Hyperglycemic Excursions for each participant from 7-Point Glucose Profile at Baseline, Week 28 and 52
    End point description
    A hyperglycemic excursion was defined as an occurrence where the plasma glucose level was > 10.0 mmol/L (> 180 mg/dL). At each visit, only evaluable participants, defined as those with >= 4 non-missing glucose values or >= 1 hyperglycemic excursions were included. Number of Hyperglycemic Excursions for each participant from 7-Point Glucose Profile (Before breakfast, 2 hours after breakfast, Before lunch, 2 hours after lunch, Before dinner, 2 hours after dinner, At bedtime) were reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Only evaluable participants, as defined above were analyzed (represented by n=X in the category titles)
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [28]
    46 [29]
    Units: Hyperglycemic excursions
    arithmetic mean (standard deviation)
        Baseline,n=15,43
    0.80 ± 1.014
    1.53 ± 1.502
        Week 28,n=13,40
    1.23 ± 1.301
    0.73 ± 0.933
        Week 52,n=12,40
    1.17 ± 1.115
    1.30 ± 1.522
    Notes
    [28] - ITT Population.
    [29] - ITT Population.
    No statistical analyses for this end point

    Secondary: Greatest magnitude of Hyperglycemic Excursions for each participant from 7-Point Glucose Profile at Baseline, Week 28 and 52

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    End point title
    		 Greatest magnitude of Hyperglycemic Excursions for each participant from 7-Point Glucose Profile at Baseline, Week 28 and 52
    End point description
    A hyperglycemic excursion is defined as an occurrence where the plasma glucose level > 10.0 mmol/L (> 180 mg/dL). At each visit, only evaluable participants, defined as those with >= 4 non-missing glucose values or >= 1 hyperglycemic excursions were included. Greatest hyperglycemic excursion was calculated as the largest recorded glucose level during the 7-point glucose profile (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner) minus 10.0 mmol/L. If a participant had data recorded at that visit, but did not have a value >10.0 mmol/L, their greatest hyperglycemic excursion would be 0 mmol/L for that visit. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Only evaluable participants, as defined above were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [30]
    46 [31]
    Units: mmol/L
    arithmetic mean (standard deviation)
        Baseline,n=15,43
    0.94 ± 1.805
    2.72 ± 3.466
        Week 28,n=13,40
    2.05 ± 2.154
    1.52 ± 2.493
        Week 52,n=12,40
    2.19 ± 2.823
    2.42 ± 3.042
    Notes
    [30] - ITT Population.
    [31] - ITT Population.
    No statistical analyses for this end point

    Secondary: Change from Baseline in body weight (kilograms) at Week 52

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    End point title
    		 Change from Baseline in body weight (kilograms) at Week 52
    End point description
    Change from Baseline in body weight of participants was reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value the Week 52 value. Only those participants with available data at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    12
    43
    Units: Kilograms
    arithmetic mean (standard deviation)
        Kilograms
    0.26 ± 2.738
    0.77 ± 3.504
    No statistical analyses for this end point

    Secondary: Weight over time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64)

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    End point title
    		 Weight over time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64)
    End point description
    Body weight was measured in kilograms for participants at indicated time points. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64
    End point values
    		 Placebo Albiglutide
    Number of subjects analysed
    15 [32]
    46 [33]
    Units: kilograms
    arithmetic mean (standard deviation)
        Week 2,n=15, 43
    70.16 ± 14.087
    66.16 ± 11.944
        Week 4,n=15, 44
    69.87 ± 14.409
    66.39 ± 11.952
        Week 6,n=15, 46
    69.83 ± 14.013
    65.65 ± 12.559
        Week 8,n=15, 46
    70.08 ± 14.121
    65.32 ± 12.825
        Week 16,n=15, 46
    69.40 ± 15.191
    65.41 ± 12.824
        Week 28,n=13, 43
    66.08 ± 11.767
    65.32 ± 13.252
        Week 40,n=13, 42
    66.08 ± 11.266
    66.20 ± 13.146
        Week 52,n=12, 43
    66.86 ± 12.401
    66.80 ± 12.696
        Week 64,n=12, 40
    68.29 ± 11.511
    68.13 ± 12.649
    Notes
    [32] - ITT Population
    [33] - ITT Population
    No statistical analyses for this end point

    Secondary: Population estimates of Pharmacokinetic (PK) parameters: apparent clearance [CL/F]

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    End point title
    		 Population estimates of Pharmacokinetic (PK) parameters: apparent clearance [CL/F] [34]
    End point description
    PK of Albiglutide was evaluated in participants using CL/F using PK samples collected on Weeks 4, 6, 8, 16. CL/F was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean bodyweights of 67 kilograms, and electronic glomerular filtration rate (eGFR) of 123 milliliters per minute. PK population comprised of participants in Safety Population for whom a PK sample was obtained and analyzed. Only participants who received albiglutide were included in PK Population.
    End point type
    Secondary
    End point timeframe
    48 hours after the most recent dose at Week 4, 6, 8 and 16
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis for this endpoint.
    End point values
    		 Albiglutide
    Number of subjects analysed
    49 [35]
    Units: Milliliters per hour
    arithmetic mean (standard error)
        Milliliters per hour
    45.1 ± 2.56
    Notes
    [35] - PK Population
    No statistical analyses for this end point

    Secondary: Population estimates of PK parameters: apparent volume of distribution [V/F]

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    End point title
    		 Population estimates of PK parameters: apparent volume of distribution [V/F] [36]
    End point description
    PK of Albiglutide was evaluated in participants using V/F using PK samples collected on Weeks 4, 6, 8, 16. V/F was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean body weights of 67 kilograms, and eGFR of 123 milliliters per minute.
    End point type
    Secondary
    End point timeframe
    48 hours after the most recent dose at Week 4, 6, 8 and 16
    Notes
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis for this endpoint.
    End point values
    		 Albiglutide
    Number of subjects analysed
    49 [37]
    Units: Milliliters
    arithmetic mean (standard error)
        Milliliters
    4830 ± 677
    Notes
    [37] - PK Population
    No statistical analyses for this end point

    Secondary: Population estimates of PK parameters: first-order absorption rate constant [Ka]

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    End point title
    		 Population estimates of PK parameters: first-order absorption rate constant [Ka] [38]
    End point description
    PK of Albiglutide was evaluated in participants using Ka using PK samples collected on Weeks 4, 6, 8, 16. Ka was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean body weights of 67 kilograms, and eGFR of 123 milliliters per minute.
    End point type
    Secondary
    End point timeframe
    48 hours after the most recent dose at Week 4, 6, 8 and 16
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis for this endpoint.
    End point values
    		 Albiglutide
    Number of subjects analysed
    49 [39]
    Units: Per hour
    arithmetic mean (standard error)
        1/hour
    0.0122 ± 0.0022
    Notes
    [39] - PK Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-therapy AEs and SAEs were collected from start of study treatment up to 52-weeks
    Adverse event reporting additional description
    AEs and SAEs were summarized in Safety Population. Safety Population comprised of all participants who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Albiglutide
    Reporting group description
    		 Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.

    Serious adverse events
    		 Albiglutide Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
    2 / 17 (11.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Albiglutide Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 50 (74.00%)
    13 / 17 (76.47%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 50 (8.00%)
    5 / 17 (29.41%)
         occurrences all number
    12
    22
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 50 (2.00%)
    2 / 17 (11.76%)
         occurrences all number
    2
    2
    Injection site erythema
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 17 (0.00%)
         occurrences all number
    18
    0
    Malaise
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 17 (0.00%)
         occurrences all number
    8
    0
    Pyrexia
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 17 (5.88%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    19 / 50 (38.00%)
    5 / 17 (29.41%)
         occurrences all number
    41
    7
    Diarrhoea
         subjects affected / exposed
    13 / 50 (26.00%)
    2 / 17 (11.76%)
         occurrences all number
    32
    2
    Vomiting
         subjects affected / exposed
    10 / 50 (20.00%)
    4 / 17 (23.53%)
         occurrences all number
    23
    7
    Abdominal distension
         subjects affected / exposed
    7 / 50 (14.00%)
    0 / 17 (0.00%)
         occurrences all number
    9
    0
    Abdominal pain
         subjects affected / exposed
    7 / 50 (14.00%)
    0 / 17 (0.00%)
         occurrences all number
    22
    0
    Abdominal pain upper
         subjects affected / exposed
    4 / 50 (8.00%)
    3 / 17 (17.65%)
         occurrences all number
    8
    6
    Dyspepsia
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 17 (0.00%)
         occurrences all number
    3
    0
    Flatulence
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 17 (5.88%)
         occurrences all number
    4
    1
    Gastrointestinal pain
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    5
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 17 (0.00%)
         occurrences all number
    3
    0
    Cough
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Lipodystrophy acquired
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 50 (26.00%)
    5 / 17 (29.41%)
         occurrences all number
    20
    5
    Influenza
         subjects affected / exposed
    4 / 50 (8.00%)
    0 / 17 (0.00%)
         occurrences all number
    5
    0
    Gastroenteritis
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 17 (0.00%)
         occurrences all number
    3
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Folliculitis
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    Sinusitis
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Bronchitis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Candida infection
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Laryngitis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Paronychia
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Varicella
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 50 (12.00%)
    1 / 17 (5.88%)
         occurrences all number
    8
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Sep 2014
    Amendment No. 1: Clarification added to wording in the treatment compliance section regarding Week 2. Clarification added regarding the collection of daily insulin use prior to Baseline and correction of typographical errors was made.
    24 Sep 2014
    Amendment No. 2: Change to the acceptable contraceptive methods for United Kingdom (UK) sites only at the request of the Medicines & Healthcare products Regulatory Agency (MHRA).

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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