Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 29 09:05:47 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA