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    Clinical Trial Results:
    SIMPONI® to Arrest β-cell Loss in Type 1 Diabetes

    Summary
    EudraCT number
    		 2021-000189-13
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2021
    First version publication date
    14 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO148DML2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02846545
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research and Development, LLC
    Sponsor organisation address
    920, US Highway, Route 202, South Raritan, United States, 08869
    Public contact
    Clinical Registry Group, Janssen Research and Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research and Development, LLC, ClinicalTrialsEU@its.jnj.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to determine if golimumab could preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety evaluations included Monitoring and evaluation of participants in this study focused on study agent, device-related, and disease-related safety issues. Monitoring included physical examinations (PEs), clinical laboratory tests, vital signs, concomitant medications, and adverse events (AEs) including injection site reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Oct 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 84
    Worldwide total number of subjects
    84
    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)
    28
    Adolescents (12-17 years)
    40
    Adults (18-64 years)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 84 subjects with newly diagnosed T1D were enrolled. Of these, 56 subjects were randomized to the golimumab treatment arm and 28 subjects to the placebo treatment arm.

    Period 1
    Period 1 title
    Double-blind Period: Week 0-52
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo (Week 0-52)
    Arm description
    		 Subjects received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) through Week 52 to match the active arm.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC injection of placebo q2w through Week 52 to match the active arm.

    Arm title
    		 Golimumab (Week 0-52)
    Arm description
    		 Subjects weighing less than (<) 45 kg received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC at Weeks 0 and 2 followed by a maintenance dose of 30 mg/m^2 SC at Week 4 and q2w through Week 52. Subjects weighing >=45 kg received an induction dose of golimumab 100 mg SC at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC at Week 4 and q2w through Week 52.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    SIMPONI
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects weighing <45 kg received an induction dose of golimumab 60 mg/m^2 SC at Weeks 0 and 2 followed by a maintenance dose of 30 mg/m^2 SC at Week 4 and q2w through Week 52. Subjects weighing >=45 kg received an induction dose of golimumab 100 mg SC at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC at Week 4 and q2w through Week 52.

    Number of subjects in period 1
    		Placebo (Week 0-52) Golimumab (Week 0-52)
    Started
    28
    56
    Completed
    25
    50
    Not completed
    3
    6
         Consent withdrawn by subject
    1
    5
         Non-compliance with study drug
    1
    -
         Lost to follow-up
    1
    1
    Period 2
    Period 2 title
    Off-therapy Follow-up Period:Week 52-104
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo (Week 52-104)
    Arm description
    		 Following the 52-week double-blind period, subjects were monitored for an additional 52 weeks for safety.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Golimumab (Week 52-104)
    Arm description
    		 Following the 52-week double-blind period, subjects were monitored for an additional 52 weeks for safety.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2 [1]
    		Placebo (Week 52-104) Golimumab (Week 52-104)
    Started
    25
    49
    Completed
    23
    47
    Not completed
    2
    2
         Unspecified
    1
    1
         Lost to follow-up
    1
    1
    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: 1 subject from the golimumab treatment group terminated study participation on the day of the Week 52 visit.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo (Week 0-52)
    Reporting group description
    		 Subjects received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) through Week 52 to match the active arm.

    Reporting group title
    Golimumab (Week 0-52)
    Reporting group description
    		 Subjects weighing less than (<) 45 kg received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC at Weeks 0 and 2 followed by a maintenance dose of 30 mg/m^2 SC at Week 4 and q2w through Week 52. Subjects weighing >=45 kg received an induction dose of golimumab 100 mg SC at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC at Week 4 and q2w through Week 52.

    Reporting group values
    		 Placebo (Week 0-52) Golimumab (Week 0-52) Total
    Number of subjects
    		 28 56 84
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 8 20 28
        Adolescents (12-17 years)
    		 13 27 40
        Adults (18-64 years)
    		 7 9 16
        From 65 to 84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.5 ( 4.01 ) 13.3 ( 3.73 ) -
    Title for Gender
    Units: subjects
        Female
    		 10 25 35
        Male
    		 18 31 49

    End points

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    End points reporting groups
    Reporting group title
    Placebo (Week 0-52)
    Reporting group description
    		 Subjects received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) through Week 52 to match the active arm.

    Reporting group title
    Golimumab (Week 0-52)
    Reporting group description
    		 Subjects weighing less than (<) 45 kg received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC at Weeks 0 and 2 followed by a maintenance dose of 30 mg/m^2 SC at Week 4 and q2w through Week 52. Subjects weighing >=45 kg received an induction dose of golimumab 100 mg SC at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC at Week 4 and q2w through Week 52.
    Reporting group title
    Placebo (Week 52-104)
    Reporting group description
    		 Following the 52-week double-blind period, subjects were monitored for an additional 52 weeks for safety.

    Reporting group title
    Golimumab (Week 52-104)
    Reporting group description
    		 Following the 52-week double-blind period, subjects were monitored for an additional 52 weeks for safety.

    Primary: Double-blind Period: C-peptide Area Under the Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) at Week 52

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    End point title
    		 Double-blind Period: C-peptide Area Under the Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) at Week 52 [1]
    End point description
    MMTT-Stimulated 4-Hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 4-hour period divided by the duration after a mixed-meal tolerance test. Full Analysis Set (FAS) included all randomized subjects who took at least one dose (complete or partial) of study agent. Here 'N' (number of subjects analyzed) included all subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Week 52
    Notes
    [1] - 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: Descriptive statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Placebo (Week 0-52) Golimumab (Week 0-52)
    Number of subjects analysed
    25
    50
    Units: picomoles per millilitre (pmol/mL)
        arithmetic mean (standard deviation)
    0.43 ( 0.388 )
    0.64 ( 0.423 )
    No statistical analyses for this end point

    Secondary: Double-blind Period: Change From Baseline in Insulin use in Units per Kilogram Body Weight per day

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    End point title
    		 Double-blind Period: Change From Baseline in Insulin use in Units per Kilogram Body Weight per day
    End point description
    Change from baseline in daily insulin use at Week 52 was reported. FAS included all randomized subjects who took at least one dose (complete or partial) of study agent.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Placebo (Week 0-52) Golimumab (Week 0-52)
    Number of subjects analysed
    28
    56
    Units: units/kilogram/day
        least squares mean (standard error)
    0.243 ( 0.0419 )
    0.066 ( 0.0267 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo (Week 0-52) v Golimumab (Week 0-52)
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Square (LS) Mean
    Point estimate
    -0.178
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 -0.08

    Secondary: Double-blind Period: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 52

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    End point title
    		 Double-blind Period: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 52
    End point description
    Change from baseline in glycosylated HbA1c at Week 52 was reported. FAS included all randomized subjects who take at least one dose (complete or partial) of study agent.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Placebo (Week 0-52) Golimumab (Week 0-52)
    Number of subjects analysed
    28
    56
    Units: HbA1C %
        least squares mean (standard error)
    0.56 ( 0.294 )
    0.47 ( 0.210 )
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo (Week 0-52) v Golimumab (Week 0-52)
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.802
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.81
         upper limit
    		 0.63

    Secondary: Double-blind Period: Hypoglycemic Event Rates

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    End point title
    		 Double-blind Period: Hypoglycemic Event Rates
    End point description
    A hypoglycemic event is defined as either a biochemically confirmed hypoglycemic episode or a severe hypoglycemic event. Hypoglycemic event rates (defined as blood glucose (BG) levels of greater than equal to (<=) 70, 55, and 35 milligrams/deciliter (mg/dL) or clinical sequelae in the absence of a BG reading) up to Week 52. FAS which had all randomized subjects who took at least one dose (complete or partial) of study agent.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Placebo (Week 0-52) Golimumab (Week 0-52)
    Number of subjects analysed
    28
    56
    Units: events per year
        number (not applicable)
    43.36
    39.01
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Hypoglycemia rate was analyzed by using a Poisson regression model with the number of hypoglycemia events through Week 52 as the response, treatment and gender as fixed factors, age and baseline HbA1c as covariates, and the duration of study participation through week 52 in logarithm as an offset variable.
    Comparison groups
    Placebo (Week 0-52) v Golimumab (Week 0-52)
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0036
    Method
    		 Poisson regression model
    Parameter type
    		 Ratio of hypoglycemia rates
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.838
         upper limit
    		 0.966

    Secondary: Double-blind Period: C-peptide Area Under the Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time

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    End point title
    		 Double-blind Period: C-peptide Area Under the Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time
    End point description
    MMTT-Stimulated 4-Hour C-peptide AUC is the mean area under the C-peptide level-time curve over the 4-hour period divided by the duration after a mixed-meal tolerance test. Full Analysis Set (FAS) included all randomized subjects who took at least one dose (complete or partial) of study agent. Here 'n' (number analyzed) included all subjects who were analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 26, 38, and 52
    End point values
    		 Placebo (Week 0-52) Golimumab (Week 0-52)
    Number of subjects analysed
    28
    56
    Units: pmol/mL
    arithmetic mean (standard deviation)
        Baseline (n=28,56)
    0.88 ( 0.634 )
    0.78 ( 0.396 )
        Week 12 (n=26,52)
    0.62 ( 0.426 )
    0.78 ( 0.355 )
        Week 26 (n=25,49)
    0.55 ( 0.424 )
    0.76 ( 0.380 )
        Week 38 (n=24,49)
    0.53 ( 0.423 )
    0.73 ( 0.424 )
        Week 52 (n=25,50)
    0.43 ( 0.388 )
    0.64 ( 0.423 )
    No statistical analyses for this end point

    Secondary: Double-blind Period: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability

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    End point title
    		 Double-blind Period: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in clinical study subject administered medicinal product. It could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Treatment emergent AEs were defined as AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.The safety analysis set included all randomized subjects who received at least 1 (partial or complete) dose of study agent, that is, the treated population.
    End point type
    Secondary
    End point timeframe
    Up to Week 52 and Week 104
    End point values
    		 Placebo (Week 0-52) Placebo (Week 52-104) Golimumab (Week 0-52) Golimumab (Week 52-104)
    Number of subjects analysed
    28
    25
    56
    49
    Units: subjects
    23
    19
    51
    38
    No statistical analyses for this end point

    Secondary: Double-blind Period: Number of Subjects With Severe Adverse Events

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    End point title
    		 Double-blind Period: Number of Subjects With Severe Adverse Events
    End point description
    An AE was defined as any untoward medical occurrence in clinical study subject administered medicinal product. It could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. A SAE was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious treatment via medicinal product and was medically important. The safety analysis set included all randomized subjects who received at least 1 (partial or complete) dose of study agent, that is, the treated population.
    End point type
    Secondary
    End point timeframe
    Through Week 52
    End point values
    		 Placebo (Week 0-52) Golimumab (Week 0-52)
    Number of subjects analysed
    28
    56
    Units: subjects
    1
    1
    No statistical analyses for this end point

    Secondary: Double-blind Period: Percentage of Participants With Severe Infections Through Week 52 and Week 104

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    End point title
    		 Double-blind Period: Percentage of Participants With Severe Infections Through Week 52 and Week 104
    End point description
    Subjects having 1 or more severe infections were evaluated and reported. The safety analysis set included all randomized subjects who received at least 1 (partial or complete) dose of study agent, that is, the treated population.
    End point type
    Secondary
    End point timeframe
    Up to Week 52 and Week 104
    End point values
    		 Placebo (Week 0-52) Placebo (Week 52-104) Golimumab (Week 0-52) Golimumab (Week 52-104)
    Number of subjects analysed
    28
    25
    56
    49
    Units: percentage of subjects
        number (not applicable)
    60.7
    52.0
    71.4
    34.7
    No statistical analyses for this end point

    Secondary: Double-blind Period: Percentage of Participants With Study Agent Injection Site Reactions Up to Week 52

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    End point title
    		 Double-blind Period: Percentage of Participants With Study Agent Injection Site Reactions Up to Week 52
    End point description
    Percentage of participants with study agent injection site reactions up to Week 52 was reported. The safety analysis set included all randomized subjects who received at least 1 (partial or complete) dose of study agent, that is, the treated population.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Placebo (Week 0-52) Golimumab (Week 0-52)
    Number of subjects analysed
    28
    56
    Units: percentage of subjects
        number (not applicable)
    28.6
    23.2
    No statistical analyses for this end point

    Secondary: Double-blind Period: Serum Golimumab Concentrations

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    End point title
    		 Double-blind Period: Serum Golimumab Concentrations [2]
    End point description
    Serum samples were collected for the measurement of golimumab concentrations. PK Analysis Set included all subjects who received at least 1 golimumab injection and had sufficient PK samples for analysis. Here 'n' (number analyzed) included all subjects who were analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Preinjection: Week 0, Week 2, Week 4, Week 8, Week 12, and Week 26; Week 33, Week 38 (preinjection), Week 45 and Week 52 (preinjection)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Golimumab (Week 0-52)
    Number of subjects analysed
    56
    Units: micrograms per millilitre (mcg/mL)
    arithmetic mean (standard deviation)
        Week 0 (n=56)
    0.00 ( 0.000 )
        Week 2 (n=56)
    4.64 ( 1.506 )
        Week 4 (n=56)
    6.85 ( 2.168 )
        Week 8 (n=54)
    4.67 ( 1.930 )
        Week 12 (n=52)
    3.74 ( 2.032 )
        Week 26 (n=50)
    3.37 ( 2.011 )
        Week 33 (n=49)
    4.41 ( 2.825 )
        Week 38 (n=50)
    3.06 ( 2.127 )
        Week 45 (n=49)
    4.44 ( 2.828 )
        Week 52 (n=49)
    2.89 ( 2.022 )
    No statistical analyses for this end point

    Secondary: Double-blind Period: Number of Subjects with Antibodies to Golimumab

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    End point title
    		 Double-blind Period: Number of Subjects with Antibodies to Golimumab [3]
    End point description
    Number of subjects with antibodies to golimumab were reported. Population analyzed included all subjects with appropriate samples (had 1 or more samples) obtained after their first study agent administration.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Golimumab (Week 0-52)
    Number of subjects analysed
    56
    Units: subjects
    30
    No statistical analyses for this end point

    Secondary: Double-blind Period: Titers of Antibodies to Golimumab

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    End point title
    		 Double-blind Period: Titers of Antibodies to Golimumab [4]
    End point description
    Titers of antibodies to golimumab were evaluated. Population analyzed included all the subjects who were antibody positive, the peak titers for them were evaluated. Here '99999' is used as a placeholder because the data was not analyzed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Golimumab (Week 0-52)
    Number of subjects analysed
    30
    Units: titers
        median (standard deviation)
    99999 ( 99999 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 104
    Adverse event reporting additional description
    The safety analysis set included all randomized subjects who received at least 1 (partial or complete) dose of study agent.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo (Week 0 - 52)
    Reporting group description
    		 Subjects received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) through Week 52 to match the active arm.

    Reporting group title
    Golimumab (Week 0 - 52)
    Reporting group description
    		 Subjects weighing less than (<) 45 kg received an induction dose of golimumab 60 mg/m^2 SC at Weeks 0 and 2 followed by a maintenance dose of 30 mg/m2 SC at Week 4 and q2w through Week 52. Subjects weighing >=45 kg received an induction dose of golimumab 100 mg SC at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC at Week 4 and q2w through Week 52.

    Reporting group title
    Placebo (Week 52 - 104)
    Reporting group description
    		 Following the 52-week double-blind period, subjects were monitored for an additional 52 weeks for safety.

    Reporting group title
    Golimumab (Week 52 - 104)
    Reporting group description
    		 Following the 52-week double-blind period, subjects were monitored for an additional 52 weeks for safety.

    Serious adverse events
    		 Placebo (Week 0 - 52) Golimumab (Week 0 - 52) Placebo (Week 52 - 104) Golimumab (Week 52 - 104)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 56 (1.79%)
    1 / 25 (4.00%)
    4 / 49 (8.16%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 56 (1.79%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 56 (0.00%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic Ketoacidosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 56 (0.00%)
    1 / 25 (4.00%)
    4 / 49 (8.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo (Week 0 - 52) Golimumab (Week 0 - 52) Placebo (Week 52 - 104) Golimumab (Week 52 - 104)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 28 (75.00%)
    45 / 56 (80.36%)
    14 / 25 (56.00%)
    26 / 49 (53.06%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 56 (5.36%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Injection Site Erythema
         subjects affected / exposed
    3 / 28 (10.71%)
    9 / 56 (16.07%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    4
    36
    0
    0
    Injection Site Pain
         subjects affected / exposed
    2 / 28 (7.14%)
    6 / 56 (10.71%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    11
    0
    0
    Injection Site Swelling
         subjects affected / exposed
    0 / 28 (0.00%)
    4 / 56 (7.14%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    14
    0
    0
    Injection Site Urticaria
         subjects affected / exposed
    3 / 28 (10.71%)
    2 / 56 (3.57%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    13
    4
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 28 (3.57%)
    4 / 56 (7.14%)
    0 / 25 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    1
    5
    0
    2
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    0 / 28 (0.00%)
    6 / 56 (10.71%)
    1 / 25 (4.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    6
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 28 (28.57%)
    9 / 56 (16.07%)
    1 / 25 (4.00%)
    1 / 49 (2.04%)
         occurrences all number
    10
    10
    1
    1
    Dyspnoea
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 56 (0.00%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nasal Congestion
         subjects affected / exposed
    4 / 28 (14.29%)
    5 / 56 (8.93%)
    1 / 25 (4.00%)
    1 / 49 (2.04%)
         occurrences all number
    6
    9
    1
    1
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 28 (3.57%)
    8 / 56 (14.29%)
    0 / 25 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    8
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 56 (5.36%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Investigations
    Glycosylated Haemoglobin Increased
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 56 (0.00%)
    0 / 25 (0.00%)
    3 / 49 (6.12%)
         occurrences all number
    0
    0
    0
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 56 (0.00%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Limb Injury
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 56 (5.36%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 28 (10.71%)
    11 / 56 (19.64%)
    1 / 25 (4.00%)
    2 / 49 (4.08%)
         occurrences all number
    4
    27
    1
    3
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 56 (3.57%)
    0 / 25 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    2
    2
    0
    1
    Neutropenia
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 56 (5.36%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 56 (5.36%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Abdominal Pain Upper
         subjects affected / exposed
    3 / 28 (10.71%)
    3 / 56 (5.36%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    3
    3
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 28 (3.57%)
    5 / 56 (8.93%)
    0 / 25 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    5
    0
    1
    Nausea
         subjects affected / exposed
    2 / 28 (7.14%)
    5 / 56 (8.93%)
    1 / 25 (4.00%)
    3 / 49 (6.12%)
         occurrences all number
    2
    7
    1
    3
    Vomiting
         subjects affected / exposed
    2 / 28 (7.14%)
    5 / 56 (8.93%)
    0 / 25 (0.00%)
    4 / 49 (8.16%)
         occurrences all number
    2
    5
    0
    5
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 56 (1.79%)
    1 / 25 (4.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in Extremity
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 56 (5.36%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 56 (5.36%)
    1 / 25 (4.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    3
    1
    1
    Ear Infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 56 (0.00%)
    2 / 25 (8.00%)
    0 / 49 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 28 (7.14%)
    5 / 56 (8.93%)
    0 / 25 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    2
    6
    0
    1
    Influenza
         subjects affected / exposed
    2 / 28 (7.14%)
    6 / 56 (10.71%)
    2 / 25 (8.00%)
    1 / 49 (2.04%)
         occurrences all number
    2
    6
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    5 / 28 (17.86%)
    10 / 56 (17.86%)
    3 / 25 (12.00%)
    4 / 49 (8.16%)
         occurrences all number
    8
    16
    4
    5
    Otitis Media
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 56 (0.00%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Pharyngitis Streptococcal
         subjects affected / exposed
    2 / 28 (7.14%)
    3 / 56 (5.36%)
    0 / 25 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    2
    4
    0
    1
    Sinusitis
         subjects affected / exposed
    2 / 28 (7.14%)
    4 / 56 (7.14%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    5
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    9 / 28 (32.14%)
    17 / 56 (30.36%)
    4 / 25 (16.00%)
    8 / 49 (16.33%)
         occurrences all number
    11
    31
    4
    9
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    2 / 28 (7.14%)
    14 / 56 (25.00%)
    2 / 25 (8.00%)
    9 / 49 (18.37%)
         occurrences all number
    63
    104
    90
    141

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jun 2016
    The overall reason for the amendment was to incorporate feedback from health authorities into the protocol.
    09 May 2017
    The overall reason for the amendment was to update testing parameters, to address clarifications needed for severe hypoglycemia definition and to correct inconsistencies within the protocol.
    27 Aug 2019
    Subsequent to the granting of a single subject investigational new drug for a subject who had shown an increase in C-peptide at Week 52 and who had an insulin dose adjusted HbA1c (IDAA1c) score less than 9, the Data Monitoring Committee had recommended to re start active treatment for other subjects showing a similar response profile.

    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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