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    Clinical Trial Results:
    Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Subjects Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents

    Summary
    EudraCT number
    2015-003761-28
    Trial protocol
    DE  
    Global end of trial date
    31 Aug 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Jun 2022
    First version publication date
    26 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VP-00525
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02542631
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Johnson & Johnson Diabetes Companies
    Sponsor organisation address
    965 Chesterbrook Boulevard, Wayne, Pennsylvania, United States, 19087
    Public contact
    Clinical Registry Group, Johnson & Johnson Diabetes Companies, clinicaltrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Johnson & Johnson Diabetes Companies, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Aug 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to compare Finesse to a Pen to initiate and maintain bolus insulin dosing assessed by comparing change in glycated hemoglobin (A1C) from Baseline to the completion of 24 weeks of basal and bolus insulin therapy on each treatment.
    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 was evaluated based on treatment-emergent adverse events, adverse device effect, serious adverse events, serious adverse device effect, hypoglycemic events, physical examination findings, vital signs, body weight, body mass index, clinical laboratory parameters (including serum chemistry, hematology, and urinalysis) and concomitant medication monitoring.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Aug 2015
    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
    United States: 217
    Country: Number of subjects enrolled
    France: 33
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    United Kingdom: 22
    Worldwide total number of subjects
    278
    EEA total number of subjects
    39
    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)
    192
    From 65 to 84 years
    86
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects took part in the study at 53 investigative sites in France, Germany, the United Kingdom, and the United States from 01 August 2015 to 31 August 2017.

    Pre-assignment
    Screening details
    A total of 388 subjects were screened, 110 subjects were screen failures mainly due to not meeting inclusion criteria and 278 subjects were randomised to receive study treatment.

    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
    Bolus Insulin Patch
    Arm description
    Experimental Treatment Arm
    Arm type
    Experimental

    Investigational medicinal product name
    Bolus Insulin Patch
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Bolus insulin dosing with Finesse up to 24 months.

    Arm title
    Insulin Pen
    Arm description
    Comparator Treatment Arm
    Arm type
    Active comparator

    Investigational medicinal product name
    Insulin Pen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bolus insulin dosing with Pen device up to 24 months.

    Number of subjects in period 1
    Bolus Insulin Patch Insulin Pen
    Started
    139
    139
    Completed
    108
    108
    Not completed
    31
    31
         Adverse event, serious fatal
    1
    2
         Consent withdrawn by subject
    11
    16
         Physician decision
    6
    4
         Adverse event, non-fatal
    1
    1
         Sponsor Termination
    1
    -
         Used Prohibited Medication
    2
    1
         Unspecified
    2
    1
         Lost to follow-up
    6
    5
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bolus Insulin Patch
    Reporting group description
    Experimental Treatment Arm

    Reporting group title
    Insulin Pen
    Reporting group description
    Comparator Treatment Arm

    Reporting group values
    Bolus Insulin Patch Insulin Pen Total
    Number of subjects
    139 139 278
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    58.1 ( 9.7 ) 60.4 ( 7.9 ) -
    Sex: Female, Male
    Units:
        Female
    58 52 110
        Male
    81 87 168
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 1 1
        Asian
    3 0 3
        Native Hawaiian or Other Pacific Islander
    4 1 5
        Black or African American
    12 11 23
        White
    120 126 246
        More than one race
    0 0 0
        Unknown or Not Reported
    0 0 0
    A1C
    The intent-to-treat (ITT) analysis set consisted of all randomized subjects who initiated bolus insulin therapy.
    Units: A1C %
        arithmetic mean (standard deviation)
    8.6 ( 0.9 ) 8.7 ( 1.0 ) -

    End points

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    End points reporting groups
    Reporting group title
    Bolus Insulin Patch
    Reporting group description
    Experimental Treatment Arm

    Reporting group title
    Insulin Pen
    Reporting group description
    Comparator Treatment Arm

    Primary: Change in A1C from Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy

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    End point title
    Change in A1C from Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy
    End point description
    The primary outcome measure analysis used a modified intent-to-treat (mITT) population data set which included all ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the last observation carried forward (LOCF) imputation method was used.
    End point type
    Primary
    End point timeframe
    Baseline to Week 24
    End point values
    Bolus Insulin Patch Insulin Pen
    Number of subjects analysed
    136
    138
    Units: A1C %
        least squares mean (standard error)
    -1.69 ( 0.08 )
    -1.60 ( 0.08 )
    Statistical analysis title
    Bolus Insulin Patch versus Insulin Pen
    Comparison groups
    Bolus Insulin Patch v Insulin Pen
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    [1]
    P-value
    < 0.0001 [2]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.32
         upper limit
    0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [1] - The sample size determination was based on the primary endpoint, A1C change from Baseline to Week 24. Assuming that the true mean difference in A1C change for Finesse versus Pen was -0.1% with a standard deviation (SD) of 1.2%, a study population of 250 completers (125 per arm) was required to achieve a power of 90% for non-inferiority with a margin of 0.4%. ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.
    [2] - Non-inferiority p-value was calculated with 2-sided comparison of the difference in treatment effects between Finesse and Pen with a non-inferiority margin of 0.4%.

    Secondary: Number of Subjects with A1C less than or equal to (<=) 7.0 Percent (%) at Week 24

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    End point title
    Number of Subjects with A1C less than or equal to (<=) 7.0 Percent (%) at Week 24
    End point description
    Number of subjects with A1C <=7.0% at Week 24 were reported. The secondary outcome measure analysis used a mITT population data set which included all the ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the LOCF imputation method was used.
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    Bolus Insulin Patch Insulin Pen
    Number of subjects analysed
    136
    138
    Units: subjects
    85
    77
    Statistical analysis title
    Bolus Insulin Patch versus Insulin Pen
    Comparison groups
    Bolus Insulin Patch v Insulin Pen
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.26 [3]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    2.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Notes
    [3] - Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.

    Secondary: Change in Percent of Glucose Values of Continuous Glucose Monitoring (CGM) Measurements Within Targeted Range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) From Baseline to Week 24

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    End point title
    Change in Percent of Glucose Values of Continuous Glucose Monitoring (CGM) Measurements Within Targeted Range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) From Baseline to Week 24
    End point description
    Change in percent of glucose values of CGM measurements within targeted range of 71 and 180 milligram per deciliter (mg/dl) (4.0 and 10.0 millimoles per liter [mmol/l]) from baseline to week 24 (in a subset of subjects) was reported. The CGM analysis set included all ITT subjects who had CGM measurements at a 1 to 2 week period of Week 2 to Week 0 and a 1 to 2 week period from Week 22 to Week 24.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    Bolus Insulin Patch Insulin Pen
    Number of subjects analysed
    52
    49
    Units: Percent change
        least squares mean (standard error)
    26.87 ( 2.33 )
    29.84 ( 2.40 )
    Statistical analysis title
    Bolus Insulin Patch versus Insulin Pen
    Statistical analysis description
    ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.
    Comparison groups
    Bolus Insulin Patch v Insulin Pen
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.38 [4]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.97
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.63
         upper limit
    3.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.36
    Notes
    [4] - Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and CI was calculated at 95%, 2-sided.

    Secondary: Change in A1C from Baseline to Week 44

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    End point title
    Change in A1C from Baseline to Week 44
    End point description
    Change in A1C from baseline to the completion of 44 weeks of basal and bolus insulin therapy was reported. The secondary outcome measure analysis used a mITT population data set which included all the ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the LOCF imputation method was used.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 44
    End point values
    Bolus Insulin Patch Insulin Pen
    Number of subjects analysed
    108
    109
    Units: A1C %
        least squares mean (standard error)
    -1.63 ( 0.10 )
    -1.63 ( 0.10 )
    Statistical analysis title
    Bolus Insulin Patch versus Insulin Pen
    Statistical analysis description
    ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.
    Comparison groups
    Bolus Insulin Patch v Insulin Pen
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.99 [5]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.28
         upper limit
    0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [5] - Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.

    Secondary: Number of Subjects with A1C <=7.0% at Week 44

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    End point title
    Number of Subjects with A1C <=7.0% at Week 44
    End point description
    Number of subjects with A1C <=7.0% after 44 weeks of basal and bolus insulin therapy were reported. The secondary outcome measure analysis used a mITT population data set which included all the ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the LOCF imputation method was used.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 44
    End point values
    Bolus Insulin Patch Insulin Pen
    Number of subjects analysed
    108
    109
    Units: subjects
    70
    68
    Statistical analysis title
    Bolus Insulin Patch versus Insulin Pen
    Comparison groups
    Bolus Insulin Patch v Insulin Pen
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.71 [6]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.64
         upper limit
    1.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Notes
    [6] - Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.

    Secondary: Change in A1C from Week 24 to Week 44

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    End point title
    Change in A1C from Week 24 to Week 44
    End point description
    Change in A1C from week 24 to week 44 after basal and bolus insulin therapy were reported. The secondary outcome measure analysis used a mITT population data set which included all the ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the LOCF imputation method was used.
    End point type
    Secondary
    End point timeframe
    Week 24 to Week 44
    End point values
    Bolus Insulin Patch Insulin Pen
    Number of subjects analysed
    108
    109
    Units: A1C %
        least squares mean (standard error)
    0.12 ( 0.06 )
    0.07 ( 0.06 )
    Statistical analysis title
    Bolus Insulin Patch versus Insulin Pen
    Statistical analysis description
    ANCOVA model with treatment group as a factor and week 24 value as a covariate was used to compare devices for continuous measures.
    Comparison groups
    Bolus Insulin Patch v Insulin Pen
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.52 [7]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.12
         upper limit
    0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Notes
    [7] - Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.

    Secondary: Number of Subjects with Severe Hypoglycemic Event

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    End point title
    Number of Subjects with Severe Hypoglycemic Event
    End point description
    An event requiring the assistance of another person to actively administer carbohydrate (including intravenous dextrose), glucagon, or other resuscitative actions. Neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. The ITT analysis set consisted of all randomized subjects who initiated bolus insulin therapy.
    End point type
    Secondary
    End point timeframe
    44 weeks
    End point values
    Bolus Insulin Patch Insulin Pen
    Number of subjects analysed
    139
    139
    Units: subjects
    3
    3
    Statistical analysis title
    Bolus Insulin Patch versus Insulin Pen
    Comparison groups
    Bolus Insulin Patch v Insulin Pen
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 1
    Method
    Chi-squared
    Confidence interval

    Other pre-specified: Change in Treatment Satisfaction from Baseline to Week 24

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    End point title
    Change in Treatment Satisfaction from Baseline to Week 24
    End point description
    Change in treatment satisfaction with insulin delivery system from baseline to week 24 was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better. The other pre-specified outcome measure analysis used a mITT population data set which included all the ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the LOCF imputation method was used.
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 24
    End point values
    Bolus Insulin Patch Insulin Pen
    Number of subjects analysed
    124
    117
    Units: units on a scale
        least squares mean (standard error)
    13.63 ( 1.94 )
    4.47 ( 2.01 )
    Statistical analysis title
    Bolus Insulin Patch versus Insulin Pen
    Statistical analysis description
    ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.
    Comparison groups
    Bolus Insulin Patch v Insulin Pen
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001 [8]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    9.16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.65
         upper limit
    14.67
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.8
    Notes
    [8] - Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.

    Other pre-specified: Change in Diabetes-specific Quality of Life from Baseline to Week 24

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    End point title
    Change in Diabetes-specific Quality of Life from Baseline to Week 24
    End point description
    Change in Diabetes-Specific Quality of Life (QOL), baseline to week 24 was assessed by self-report on the validated Diabetes Specific Quality of Life Survey. Scale is 0-100. Higher score is better. The pre-specified outcome measure analysis used a mITT population data set which included all the ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the LOCF imputation method was used.
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 24
    End point values
    Bolus Insulin Patch Insulin Pen
    Number of subjects analysed
    124
    123
    Units: units on a scale
        least squares mean (standard error)
    2.37 ( 1.43 )
    -1.95 ( 1.44 )
    Statistical analysis title
    Bolus Insulin Patch versus Insulin Pen
    Statistical analysis description
    ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.
    Comparison groups
    Bolus Insulin Patch v Insulin Pen
    Number of subjects included in analysis
    247
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.03 [9]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    4.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.33
         upper limit
    8.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.03
    Notes
    [9] - Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    44 weeks
    Adverse event reporting additional description
    SAE: event that led to death; life-threatening illness or injury; impairment of body structure or function; in-patient or prolongation of hospitalisation; medical or surgical intervention to prevent life threatening illness or injury; impairment to body structure or function; or fetal distress or death; congenital abnormality; birth defect.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Insulin Pen
    Reporting group description
    Comparator Treatment Arm

    Reporting group title
    Bolus Insulin Patch
    Reporting group description
    Experimental Treatment Arm

    Serious adverse events
    Insulin Pen Bolus Insulin Patch
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 139 (9.35%)
    10 / 139 (7.19%)
         number of deaths (all causes)
    2
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant, and unspecified
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    2 / 139 (1.44%)
    2 / 139 (1.44%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    2 / 139 (1.44%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    2 / 139 (1.44%)
    5 / 139 (3.60%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    2 / 139 (1.44%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General Disorders
         subjects affected / exposed
    0 / 139 (0.00%)
    2 / 139 (1.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    0 / 139 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections and Infestations
         subjects affected / exposed
    3 / 139 (2.16%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Insulin Pen Bolus Insulin Patch
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    99 / 139 (71.22%)
    100 / 139 (71.94%)
    Investigations
    Investigations
         subjects affected / exposed
    14 / 139 (10.07%)
    10 / 139 (7.19%)
         occurrences all number
    14
    10
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    8 / 139 (5.76%)
    12 / 139 (8.63%)
         occurrences all number
    9
    12
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    16 / 139 (11.51%)
    13 / 139 (9.35%)
         occurrences all number
    19
    15
    General disorders and administration site conditions
    General disorders
         subjects affected / exposed
    15 / 139 (10.79%)
    28 / 139 (20.14%)
         occurrences all number
    15
    39
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    21 / 139 (15.11%)
    23 / 139 (16.55%)
         occurrences all number
    31
    37
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic, and mediastinal disorders
         subjects affected / exposed
    17 / 139 (12.23%)
    14 / 139 (10.07%)
         occurrences all number
    22
    18
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue
         subjects affected / exposed
    32 / 139 (23.02%)
    34 / 139 (24.46%)
         occurrences all number
    42
    48
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    60 / 139 (43.17%)
    51 / 139 (36.69%)
         occurrences all number
    85
    84

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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