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    Clinical Trial Results:
    A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus™ in Subjects With Type 1 Diabetes Mellitus

    Summary
    EudraCT number
    		 2011-003971-12
    Trial protocol
    		 ES  
    Global end of trial date
    18 Nov 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    27 Jan 2017
    First version publication date
    11 Nov 2016
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MK-1293-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02059161
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in participants with Type 1 diabetes mellitus (T1DM). The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior in participants treated with MK-1293 compared with participants treated with Lantus™.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 Participants will continue their prandial insulin during the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 21
    Country: Number of subjects enrolled
    Colombia: 24
    Country: Number of subjects enrolled
    Mexico: 34
    Country: Number of subjects enrolled
    Spain: 51
    Country: Number of subjects enrolled
    New Zealand: 20
    Country: Number of subjects enrolled
    Peru: 31
    Country: Number of subjects enrolled
    South Africa: 65
    Country: Number of subjects enrolled
    United States: 262
    Worldwide total number of subjects
    508
    EEA total number of subjects
    51
    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)
    466
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants at least 18 years of age who have had T1DM for at least one year prior to study start.

    Pre-assignment
    Screening details
    		 Participants had Type 1 diabetes mellitus for at least one year prior to the study start and be 18 years or older.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MK-1293
    Arm description
    		 MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1293
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. The initial dose will be determined based on the participant's previous insulin therapy. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

    Arm title
    		 Lantus
    Arm description
    		 Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lantus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lantus dosed subcutaneously once daily at bedtime for 52 weeks. The initial dose will be determined based on the participant's previous insulin therapy. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

    Number of subjects in period 1
    		MK-1293 Lantus
    Started
    245
    263
    Treated
    241
    258
    Completed
    196
    222
    Not completed
    49
    41
         Physician decision
    4
    4
         Consent withdrawn by subject
    16
    13
         randomized in error, did not take study drug
    -
    1
         Adverse event, non-fatal
    2
    6
         Pregnancy
    -
    2
         Non-compliance with study drug
    6
    2
         Lost to follow-up
    20
    12
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MK-1293
    Reporting group description
    		 MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

    Reporting group title
    Lantus
    Reporting group description
    		 Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

    Reporting group values
    		 MK-1293 Lantus Total
    Number of subjects
    		 245 263 508
    Age Categorical
    One participant in the Lantus group was "Unknown" regarding baseline age characteristics so was added to the 18-64 years group
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 224 241 465
        From 65-84 years
    		 21 21 42
        85 years and over
    		 0 0 0
        Unknown
    		 0 1 1
    Age Continuous
    One participant in the Lantus group was "Unknown" regarding baseline age characteristics
    Units: years
        arithmetic mean (standard deviation)
    		 41.8 ( 14.5 ) 41.6 ( 14.8 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 106 111 217
        Male
    		 139 152 291

    End points

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    End points reporting groups
    Reporting group title
    MK-1293
    Reporting group description
    		 MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

    Reporting group title
    Lantus
    Reporting group description
    		 Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

    Primary: Change from Baseline in Hemoglobin A1c (A1C) at Week 24

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    End point title
    		 Change from Baseline in Hemoglobin A1c (A1C) at Week 24
    End point description
    A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 24 A1C minus the Week 0 A1C. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    241
    258
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.62 (-0.79 to -0.45)
    -0.66 (-0.82 to -0.5)
    Statistical analysis title
    		 Difference in Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.19
    Notes
    [1] - The criterion for declaring non-inferiority was for the upper bound of the 95% CI to lie below 0.4%.

    Primary: Percentage of Participants With Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24

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    End point title
    		 Percentage of Participants With Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24
    End point description
    Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline. The analysis population included all randomized, treated participants who had data for AIA at or before Week 24.
    End point type
    Primary
    End point timeframe
    Up to Week 24 including baseline
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    241
    258
    Units: Percentage of participants
        number (not applicable)
    70.1
    74
    Statistical analysis title
    		 Difference in Percentages
    Statistical analysis description
    Difference in the percentage of participants who were AIA positive at or before Week 24.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.8
         upper limit
    		 4

    Primary: Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24

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    End point title
    		 Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24
    End point description
    Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline. The analysis population included all randomized, treated participants who were AIA negative at baseline and had data for AIA at or before Week 24.
    End point type
    Primary
    End point timeframe
    Up to Week 24
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    101
    98
    Units: Percentage of participants
        number (not applicable)
    32.7
    35.7
    Statistical analysis title
    		 Difference in Percentages
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.1
         upper limit
    		 10.1

    Primary: Change from Baseline in AIA Titer After 24 weeks of Treatment

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    End point title
    		 Change from Baseline in AIA Titer After 24 weeks of Treatment [2]
    End point description
    This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on anti-insulin antibody development after 24 weeks of treatment. This change from baseline reflects the Week 24 AIA titer minus the Week 0 AIA titer. The analysis population included all randomized, treated participants who had AIA data at baseline and Week 24.
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    Notes
    [2] - 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: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    185
    198
    Units: AIA Titers
        arithmetic mean (standard deviation)
    0.4 ( 15.9 )
    0.3 ( 23.2 )
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24

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    End point title
    		 Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24 [3]
    End point description
    Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INab) development up through 24 weeks of treatment. The analysis population included all randomized, treated participants who were INAb negative at baseline and who had data for INAb at or before Week 24.
    End point type
    Primary
    End point timeframe
    Up to Week 24
    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: No statistical analysis was planned or performed for this endpoint.
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    232
    246
    Units: Percentage of participants
        number (not applicable)
    3.9
    5.3
    No statistical analyses for this end point

    Secondary: Change from Baseline in A1C at Week 52

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    End point title
    		 Change from Baseline in A1C at Week 52
    End point description
    A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    241
    258
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.35 (-0.53 to -0.17)
    -0.33 (-0.5 to -0.16)
    Statistical analysis title
    		 Difference in Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.14
    Notes
    [4] - The criterion for declaring non-inferiority was for the upper bound of the 95% CI to lie below 0.4%.

    Secondary: Total Insulin Dose at Week 24

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    End point title
    		 Total Insulin Dose at Week 24
    End point description
    Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    224
    235
    Units: Insulin units
        least squares mean (confidence interval 95%)
    58.74 (53.39 to 64.1)
    60.51 (55.21 to 65.81)
    Statistical analysis title
    		 Difference in Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -1.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.69
         upper limit
    		 1.16

    Secondary: Total Insulin Dose Per Kilogram (kg) of Body Weight (unit/kg) at Week 24

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    End point title
    		 Total Insulin Dose Per Kilogram (kg) of Body Weight (unit/kg) at Week 24
    End point description
    Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    224
    235
    Units: Insulin units/kg.
        least squares mean (confidence interval 95%)
    0.75 (0.69 to 0.81)
    0.77 (0.72 to 0.83)
    Statistical analysis title
    		 Difference in Least Squares means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.01

    Secondary: Change from Baseline in Fasting Plasma Glucose (FPG) at Week 24

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    End point title
    		 Change from Baseline in Fasting Plasma Glucose (FPG) at Week 24
    End point description
    Blood glucose was measured on a fasting basis (collected after a 10-hour fast). This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    241
    258
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -16.8 (-33.4 to -0.2)
    -26.4 (-42.5 to -10.3)
    Statistical analysis title
    		 Difference in Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    9.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 22.2

    Secondary: Percentage of Participants With Confirmed Positive AIA Up Through Week 52

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    End point title
    		 Percentage of Participants With Confirmed Positive AIA Up Through Week 52
    End point description
    Percentage of participants with confirmed positive AIA at any time up through Week 52 including baseline. The analysis population included all randomized, treated participants who had data for AIA at or before Week 52.
    End point type
    Secondary
    End point timeframe
    Up to Week 52 including baseline
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    241
    258
    Units: Percentage of participants
        number (not applicable)
    73.4
    75.6
    Statistical analysis title
    		 Differences in percentages
    Statistical analysis description
    Difference in the percentage of participants who were AIA positive at or before Week 52.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Miettinen & Nurminen
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.8
         upper limit
    		 5.5

    Secondary: Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52

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    End point title
    		 Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52
    End point description
    Percentage of participants who became positive to AIA at or before Week 52, among participants who were AIA negative at baseline. The analysis population included all randomized, treated participants who had data for AIA at baseline and Week 52.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    101
    98
    Units: Percentage of participants
        number (not applicable)
    40.6
    39.8
    Statistical analysis title
    		 Differences in Percentages
    Statistical analysis description
    Miettinen & Nurminen
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Diffefence in Percentages
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.8
         upper limit
    		 14.3

    Secondary: Change From Baseline in AIA Titers After 52 Weeks of Treatment

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    End point title
    		 Change From Baseline in AIA Titers After 52 Weeks of Treatment
    End point description
    This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on anti-insulin antibody development after 52 weeks of treatment. This change from baseline reflects the AIA titers at Week 52 minus the AIA titers at Week 0. The analysis population included all randomized, treated participants who had AIA data at baseline and Week 52.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    164
    177
    Units: AIA Titers
        arithmetic mean (standard deviation)
    -1.6 ( 9.9 )
    0.1 ( 20.3 )
    No statistical analyses for this end point

    Secondary: Total Insulin Dose at Week 52

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    End point title
    		 Total Insulin Dose at Week 52
    End point description
    Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    228
    240
    Units: Insulin units
        least squares mean (confidence interval 95%)
    59.16 (53.97 to 64.34)
    60.93 (55.79 to 66.06)
    Statistical analysis title
    		 Difference in Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -1.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.92
         upper limit
    		 1.39

    Secondary: Total Insulin Dose Per Kilogram (kg) of Body Weight (unit/kg) at Week 52

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    End point title
    		 Total Insulin Dose Per Kilogram (kg) of Body Weight (unit/kg) at Week 52
    End point description
    Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    228
    240
    Units: Insulin units/kg.
        least squares mean (confidence interval 95%)
    0.75 (0.7 to 0.81)
    0.77 (0.71 to 0.82)
    Statistical analysis title
    		 Difference in Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.02

    Secondary: Change from Baseline in FPG at Week 52

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    End point title
    		 Change from Baseline in FPG at Week 52
    End point description
    Blood glucose was measured on a fasting basis (collected after a 10-hour fast). This change from baseline reflects the FPG level at Week 52 minus the FPG level at Week 0. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    241
    258
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -17.9 (-35.8 to 0.1)
    -12.5 (-29.9 to 4.9)
    Statistical analysis title
    		 Difference in Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.7
         upper limit
    		 8.9

    Secondary: Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52

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    End point title
    		 Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52
    End point description
    Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Thought Week 52. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INAb) development up through 52 weeks of treatment. The analysis population included all randomized, treated participants who were INAb negative at baseline and who had data for INAb at or before Week 52.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    232
    246
    Units: Percentage of participants
        number (not applicable)
    4.7
    6.9
    No statistical analyses for this end point

    Secondary: Change from Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24

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    End point title
    		 Change from Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24
    End point description
    The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre-meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    226
    248
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -4.9 (-15.8 to 5.9)
    -4.6 (-14.9 to 5.8)
    Statistical analysis title
    		 Difference in Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    474
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.9
         upper limit
    		 8.2

    Secondary: Change from Baseline in 7-point SMBG at Week 52

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    End point title
    		 Change from Baseline in 7-point SMBG at Week 52
    End point description
    The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre-meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    229
    249
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -12 (-25.8 to 1.7)
    -4 (-16.3 to 8.4)
    Statistical analysis title
    		 Difference in Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -8.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.6
         upper limit
    		 2.4

    Secondary: Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 24 weeks of treatment

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    End point title
    		 Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 24 weeks of treatment
    End point description
    Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 24 weeks of treatment. The analysis population included all randomized, treated participants with a Week 24 A1C measurement.
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    219
    236
    Units: Percentage of participants
    number (not applicable)
        A1C < 7.0%
    37
    37.7
        A1C < 6.5%
    20.5
    21.6
    Statistical analysis title
    		 Adjusted Difference in Percentages (A1C < 7.0%)
    Statistical analysis description
    Miettinen and Nurminen, stratified by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    455
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted Difference in Percentages
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 8.1
    Statistical analysis title
    		 Adjusted Difference in Percentages (A1C < 6.5%)
    Statistical analysis description
    Miettinen and Nurminen, stratified by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    455
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted Difference in Percentages
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.6
         upper limit
    		 6.5

    Secondary: Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 52 weeks of treatment.

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    End point title
    		 Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 52 weeks of treatment.
    End point description
    Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 52 weeks of treatment. The analysis population included all randomized, treated participants with a Week 52 A1C measurement.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    197
    221
    Units: Percentage of participants
    number (not applicable)
        A1C < 7.0%
    31
    30.8
        A1C < 6.5%
    14.2
    18.6
    Statistical analysis title
    		 Adjusted Difference (A1C < 7.0%)
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Miettinen and Nurminen
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.7
         upper limit
    		 9.1
    Statistical analysis title
    		 Adjusted Difference (A1C < 6.5%)
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Miettinen and Nurminen
    Point estimate
    -4.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.5
         upper limit
    		 2.8

    Secondary: Basal Insulin Dose at Week 52

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    End point title
    		 Basal Insulin Dose at Week 52
    End point description
    Basal Insulin Dose at Week 52. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    241
    258
    Units: Units
        least squares mean (confidence interval 95%)
    36.08 (33.14 to 39.03)
    36.51 (33.63 to 39.39)
    Statistical analysis title
    		 Difference in Least Means Squares
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Least Means Squares
    Point estimate
    -0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.33
         upper limit
    		 1.48

    Secondary: Basal Insulin Dose per kg of Body Weight at Week 52

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    End point title
    		 Basal Insulin Dose per kg of Body Weight at Week 52
    End point description
    Basal Insulin Dose per kg of Body Weight at Week 52. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    241
    258
    Units: Units/kg
        least squares mean (confidence interval 95%)
    0.46 (0.43 to 0.5)
    0.47 (0.43 to 0.5)
    Statistical analysis title
    		 Difference in Least Means Squares
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Least Means Squares
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.02

    Secondary: Bolus Insulin Dose at Week 52

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    End point title
    		 Bolus Insulin Dose at Week 52
    End point description
    Bolus Insulin Dose at Week 52. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    228
    240
    Units: Units
        least squares mean (confidence interval 95%)
    22.15 (19.03 to 25.27)
    23.65 (20.57 to 26.73)
    Statistical analysis title
    		 Difference in the Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.69
         upper limit
    		 0.69

    Secondary: Bolus Insulin Dose per kg of Body Weight at Week 52

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    End point title
    		 Bolus Insulin Dose per kg of Body Weight at Week 52
    End point description
    Bolus Insulin Dose per kg of Body Weight at Week 52. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    228
    240
    Units: Units
        least squares mean (confidence interval 95%)
    0.28 (0.24 to 0.31)
    0.3 (0.26 to 0.33)
    Statistical analysis title
    		 Difference in the Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.01

    Secondary: Basal Insulin Dose at Week 24

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    End point title
    		 Basal Insulin Dose at Week 24
    End point description
    Basal Insulin Dose at Week 24. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    241
    258
    Units: Units
        least squares mean (confidence interval 95%)
    36.33 (33.24 to 39.42)
    37.07 (34.03 to 40.12)
    Statistical analysis title
    		 Difference in the Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.52
         upper limit
    		 1.04

    Secondary: Basal Insulin Dose per kg of Body Weight at Week 24

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    End point title
    		 Basal Insulin Dose per kg of Body Weight at Week 24
    End point description
    Basal Insulin Dose per kg of Body Weight at Week 24. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    241
    258
    Units: Units/kg
        least squares mean (confidence interval 95%)
    0.46 (0.43 to 0.5)
    0.48 (0.44 to 0.51)
    Statistical analysis title
    		 Difference in the Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.01

    Secondary: Bolus Insulin Dose at Week 24

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    End point title
    		 Bolus Insulin Dose at Week 24
    End point description
    Bolus Insulin Dose at Week 24. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    224
    235
    Units: Units
        least squares mean (confidence interval 95%)
    21.65 (18.5 to 24.81)
    22.91 (19.8 to 26.02)
    Statistical analysis title
    		 Difference in the Least Squares Means
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -1.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.34
         upper limit
    		 0.83

    Secondary: Bolus Insulin Dose per kg of Body Weight at Week 24

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    End point title
    		 Bolus Insulin Dose per kg of Body Weight at Week 24
    End point description
    Bolus Insulin Dose per kg of Body Weight at Week 24. The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 MK-1293 Lantus
    Number of subjects analysed
    224
    235
    Units: Units/kg
        least squares mean (confidence interval 95%)
    0.28 (0.24 to 0.31)
    0.29 (0.26 to 0.33)
    Statistical analysis title
    		 Difference in the Least Means Squares
    Statistical analysis description
    Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.
    Comparison groups
    MK-1293 v Lantus
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in the Least Means Squares
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.01

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 54 weeks
    Adverse event reporting additional description
    The safety population consisted of all randomized participants who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Lantus
    Reporting group description
    		 Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

    Reporting group title
    MK-1293
    Reporting group description
    		 MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

    Serious adverse events
    		 Lantus MK-1293
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 258 (11.63%)
    23 / 241 (9.54%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    2 / 258 (0.78%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic seizure
         subjects affected / exposed
    4 / 258 (1.55%)
    2 / 241 (0.83%)
         occurrences causally related to treatment / all
    3 / 4
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic unconsciousness
         subjects affected / exposed
    2 / 258 (0.78%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIth nerve paresis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric haemorrhage
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    bile duct stone
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (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
    Diabetic foot
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Postoperative wound infection
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 258 (0.39%)
    2 / 241 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oseomyelitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    2 / 258 (0.78%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    11 / 258 (4.26%)
    5 / 241 (2.07%)
         occurrences causally related to treatment / all
    8 / 14
    4 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lantus MK-1293
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    216 / 258 (83.72%)
    190 / 241 (78.84%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    23 / 258 (8.91%)
    19 / 241 (7.88%)
         occurrences all number
    29
    23
    Upper respiratory tract infection
         subjects affected / exposed
    28 / 258 (10.85%)
    27 / 241 (11.20%)
         occurrences all number
    34
    40
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    204 / 258 (79.07%)
    185 / 241 (76.76%)
         occurrences all number
    7544
    7617

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 May 2013
    Amendment 3 - Updated primary and secondary objectives for change from baseline in A1C.
    28 Jun 2013
    Amendment 2 - Increase in number of participants, added a hypothesis for A1C equivalence, and updated Tier1 adverse events (AEs) to include additional AEs.
    17 Jan 2014
    Amendment 4 - permitted alternative dosing schedules for study drugs and added 2 new exclusion criteria.

    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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