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    Clinical Trial Results:
    Protocol I8B-MC-ITSI A Prospective, Randomized, Double-Blind, Crossover Comparison Evaluating Compatibility and Safety of LY900014 and Insulin Lispro with an External Continuous Subcutaneous Insulin Infusion System in Adult Patients with Type 1 Diabetes (PRONTO-Pump)

    Summary
    EudraCT number
    		 2017-002374-39
    Trial protocol
    		 ES  
    Global end of trial date
    04 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I8B-MC-ITSI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03433677
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16908
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    04 Sep 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Feb 2018
    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: 28
    Country: Number of subjects enrolled
    Spain: 21
    Worldwide total number of subjects
    49
    EEA total number of subjects
    21
    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)
    47
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No Text Available

    Pre-assignment
    Screening details
    		 2-period crossover with no washout between periods and a 4 week safety follow-up.

    Period 1
    Period 1 title
    Lead In
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Sequence 1 (LY900014/Insulin Lispro)
    Arm description
    		 All participants received insulin lispro via CSII during lead in.
    Arm type
    		 Baseline insulin lispro

    Investigational medicinal product name
    Baseline insulin lispro
    Investigational medicinal product code
    Other name
    Humalog®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL insulin lispro (Humalog®) administered by individualized CSII

    Arm title
    		 Sequence 2 (Insulin Lispro/LY900014)
    Arm description
    		 All participants received insulin lispro via CSII during lead in.
    Arm type
    		 Baseline insulin lispro

    Investigational medicinal product name
    Baseline insulin lispro
    Investigational medicinal product code
    Other name
    Humalog®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL insulin lispro (Humalog®) administered by individualized CSII

    Number of subjects in period 1
    		Sequence 1 (LY900014/Insulin Lispro) Sequence 2 (Insulin Lispro/LY900014)
    Started
    24
    25
    Completed
    24
    25
    Period 2
    Period 2 title
    Period 1
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence 1 (LY900014/Insulin Lispro)
    Arm description
    		 1. 100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks 2. 100 U/mL insulin lispro (Humalog®) administered by CSII for six weeks with no washout between periods
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY900014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1. 100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks

    Arm title
    		 Sequence 2 (Insulin Lispro/LY900014)
    Arm description
    		 1. 100 U/mL insulin lispro (Humalog®) administered by CSII for 6 weeks 2. 100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks with no washout between periods
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Humalog®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL insulin lispro (Humalog®) administered by CSII for 6 weeks

    Number of subjects in period 2
    		Sequence 1 (LY900014/Insulin Lispro) Sequence 2 (Insulin Lispro/LY900014)
    Started
    24
    25
    Received at Least 1 Dose of Study Drug
    24
    25
    Completed
    23
    25
    Not completed
    1
    0
         Protocol deviation
    1
    -
    Period 3
    Period 3 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence 1 (LY900014/Insulin Lispro)
    Arm description
    		 1. 100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks 2. 100 U/mL insulin lispro (Humalog®) administered by CSII for six weeks with no washout between periods
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Humalog®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL insulin lispro (Humalog®) administered by CSII for 6 weeks

    Arm title
    		 Sequence 2 (Insulin Lispro/LY900014)
    Arm description
    		 1. 100 U/mL insulin lispro (Humalog®) administered by CSII for 6 weeks 2. 100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks with no washout between periods
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY900014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks with no washout between periods

    Number of subjects in period 3
    		Sequence 1 (LY900014/Insulin Lispro) Sequence 2 (Insulin Lispro/LY900014)
    Started
    23
    25
    Received at Least 1 Dose of Study Drug
    23
    25
    Completed
    22
    24
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sequence 1 (LY900014/Insulin Lispro)
    Reporting group description
    		 All participants received insulin lispro via CSII during lead in.

    Reporting group title
    Sequence 2 (Insulin Lispro/LY900014)
    Reporting group description
    		 All participants received insulin lispro via CSII during lead in.

    Reporting group values
    		 Sequence 1 (LY900014/Insulin Lispro) Sequence 2 (Insulin Lispro/LY900014) Total
    Number of subjects
    		 24 25 49
    Age categorical
    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)
    		 22 24 46
        From 65-84 years
    		 2 1 3
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.50 ± 12.47 36.72 ± 10.37 -
    Gender categorical
    Units: Subjects
        Female
    		 12 14 26
        Male
    		 12 11 23
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 23 25 48
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 1 0 1
        White
    		 23 25 48
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        United States
    		 14 14 28
        Spain
    		 10 11 21

    End points

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    End points reporting groups
    Reporting group title
    Sequence 1 (LY900014/Insulin Lispro)
    Reporting group description
    		 All participants received insulin lispro via CSII during lead in.

    Reporting group title
    Sequence 2 (Insulin Lispro/LY900014)
    Reporting group description
    		 All participants received insulin lispro via CSII during lead in.
    Reporting group title
    Sequence 1 (LY900014/Insulin Lispro)
    Reporting group description
    		 1. 100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks 2. 100 U/mL insulin lispro (Humalog®) administered by CSII for six weeks with no washout between periods

    Reporting group title
    Sequence 2 (Insulin Lispro/LY900014)
    Reporting group description
    		 1. 100 U/mL insulin lispro (Humalog®) administered by CSII for 6 weeks 2. 100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks with no washout between periods
    Reporting group title
    Sequence 1 (LY900014/Insulin Lispro)
    Reporting group description
    		 1. 100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks 2. 100 U/mL insulin lispro (Humalog®) administered by CSII for six weeks with no washout between periods

    Reporting group title
    Sequence 2 (Insulin Lispro/LY900014)
    Reporting group description
    		 1. 100 U/mL insulin lispro (Humalog®) administered by CSII for 6 weeks 2. 100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII) for six weeks with no washout between periods

    Subject analysis set title
    Insulin Lispro (Humalog®)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    100 U/mL insulin lispro (Humalog®) administered by CSII

    Subject analysis set title
    LY900014
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    100 U/mL LY900014 administered by continuous subcutaneous insulin infusion (CSII)

    Primary: Rate of Infusion Set Failures

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    End point title
    		 Rate of Infusion Set Failures
    End point description
    Infusion set failure events are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [mmol/L]) that does not decrease within 1 hour following a correction bolus delivered via the pump during the 6 week treatment period. Aggregate rate was calculated for each participant as the total number of events while the participant is on study treatment divided by the days of exposure [last dose date and time –first dose date and time –duration of pump or treatment interruption] times 30.
    End point type
    Primary
    End point timeframe
    6 Weeks
    End point values
    		 Insulin Lispro (Humalog®) LY900014
    Number of subjects analysed
    48 [1]
    49 [2]
    Units: events per 30 participant days
        number (not applicable)
    0.05
    0.03
    Notes
    [1] - All randomized participants who received at least 1 dose of study drug.
    [2] - All randomized participants who received at least 1 dose of study drug.
    Statistical analysis title
    		 Rate of Infusion Set Failures
    Statistical analysis description
    Based on crossover design, 49 participants who received LY900014 and 48 participants who received insulin lispro (Humalog) were included in the analysis.
    Comparison groups
    Insulin Lispro (Humalog®) v LY900014
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.375
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0

    Secondary: Percentage of Participants with at Least 1 Event of Infusion Set Failure

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    End point title
    		 Percentage of Participants with at Least 1 Event of Infusion Set Failure
    End point description
    Infusion set failures are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) >250mg/dL (13.9 mmol/L) that does not decrease within 1 hour following a correction bolus delivered via the pump
    End point type
    Secondary
    End point timeframe
    6 Weeks
    End point values
    		 Insulin Lispro (Humalog®) LY900014
    Number of subjects analysed
    48 [3]
    49 [4]
    Units: percentage of participants
        number (not applicable)
    6.3
    4.1
    Notes
    [3] - All randomized participants who received at least 1 dose of study drug.
    [4] - All randomized participants who received at least 1 dose of study drug.
    Statistical analysis title
    		 Percentage of Participants with at Least 1 Event
    Statistical analysis description
    Based on crossover design, 49 participants who received LY900014 and 48 participants who received insulin lispro (Humalog) were included in the analysis.
    Comparison groups
    Insulin Lispro (Humalog®) v LY900014
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.468
    Method
    		 Prescott's Exact Test
    Confidence interval

    Secondary: Rate of Premature Infusion Set Changes

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    End point title
    		 Rate of Premature Infusion Set Changes
    End point description
    Rate of premature infusion set changes.
    End point type
    Secondary
    End point timeframe
    6 Weeks
    End point values
    		 Insulin Lispro (Humalog®) LY900014
    Number of subjects analysed
    48 [5]
    49 [6]
    Units: events per 30 participant days
        number (not applicable)
    0.78
    1.13
    Notes
    [5] - All randomized participants who received at least 1 dose of study drug.
    [6] - All randomized participants who received at least 1 dose of study drug.
    Statistical analysis title
    		 Rate of Premature Infusion Set Changes
    Statistical analysis description
    Based on crossover design, 49 participants who received LY900014 and 48 participants who received insulin lispro (Humalog) were included in the analysis.
    Comparison groups
    Insulin Lispro (Humalog®) v LY900014
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Time Interval until Infusion Set Change

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    End point title
    		 Time Interval until Infusion Set Change
    End point description
    Time interval until infusion set change reflects the time interval in hours until infusion set change from first to last dose. MMRM model for post-baseline measures: Variable = Baseline + Period + Sequence + Strata(Region + Historical Use of SmartGuard/Threshold Suspend + HbA1c(<=7.3%, >7.3%)) + Treatment (Type III sum of squares). All randomized participants who received at least 1 dose of study drug and non-missing baseline value and at least one non-missing post-baseline value.
    End point type
    Secondary
    End point timeframe
    6 Weeks
    End point values
    		 Insulin Lispro (Humalog®) LY900014
    Number of subjects analysed
    46 [7]
    47 [8]
    Units: hours
        least squares mean (standard error)
    76.1 ± 1.52
    74.3 ± 1.51
    Notes
    [7] - All randomized participants who received at least 1 dose of study drug.
    [8] - All randomized participants who received at least 1 dose of study drug.
    Statistical analysis title
    		 Time Interval until Infusion Set Change
    Statistical analysis description
    Based on crossover design, 47 out of 49 participants who received LY900014 and 46 out of 48 participants who received insulin lispro (Humalog) were included in the analysis.
    Comparison groups
    Insulin Lispro (Humalog®) v LY900014
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.304
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 1.7
    Notes
    [9] - Week 0-6

    Secondary: Ratio of Bolus/Total Insulin Dose

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    End point title
    		 Ratio of Bolus/Total Insulin Dose
    End point description
    The bolus and total insulin doses for each visit was calculated as the mean of the doses for the last 3 days prior to the visit date that are entered in the eCRF. The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit. All randomized participants who received at least 1 dose of study drug and non-missing baseline value and at least one non-missing post-baseline value.
    End point type
    Secondary
    End point timeframe
    6 Weeks
    End point values
    		 Insulin Lispro (Humalog®) LY900014
    Number of subjects analysed
    47 [10]
    46 [11]
    Units: percent
        least squares mean (standard error)
    46.6 ± 1.17
    44.2 ± 1.17
    Notes
    [10] - All randomized participants who received at least 1 dose of study drug.
    [11] - All randomized participants who received at least 1 dose of study drug.
    Statistical analysis title
    		 Ratio of Bolus/Total Insulin Dose
    Statistical analysis description
    Based on crossover design, 46 out of 49 participants who received LY900014 and 47 out of 48 participants who received insulin lispro (Humalog) were included in the analysis.
    Comparison groups
    Insulin Lispro (Humalog®) v LY900014
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.057
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 0.1

    Secondary: Interstitial Glucose Reduction Rate from Hyperglycemia Following a Non-Meal-Related Correction Bolus Delivered Via the Pump

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    End point title
    		 Interstitial Glucose Reduction Rate from Hyperglycemia Following a Non-Meal-Related Correction Bolus Delivered Via the Pump
    End point description
    Interstitial glucose reduction rate milligram per deciliter per minute (glucose reduction [mg/dL] per minute) within 4 hours following a non-meal-related correction bolus via the pump, from hyperglycemia (interstitial glucose >180 mg/dL [10 mmol/L]) to recovery (interstitial glucose ≤180 mg/dL). All randomized participants who received at least 1 dose of study drug and non-missing baseline value and at least one non-missing post-baseline value of the response.
    End point type
    Secondary
    End point timeframe
    6 Weeks
    End point values
    		 Insulin Lispro (Humalog®) LY900014
    Number of subjects analysed
    33 [12]
    31 [13]
    Units: mg/dL/min
        least squares mean (standard error)
    0.71 ± 0.062
    0.82 ± 0.063
    Notes
    [12] - All randomized participants who received at least 1 dose of study drug.
    [13] - All randomized participants who received at least 1 dose of study drug.
    Statistical analysis title
    		 Interstitial Glucose Reduction Rate from Hypergly
    Statistical analysis description
    Based on crossover design, 37 out of 49 participants who received LY900014 and 37 out of 48 participants who received insulin lispro (Humalog) were included in the analysis.
    Comparison groups
    Insulin Lispro (Humalog®) v LY900014
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.177
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.27

    Secondary: Number of Participants with Severe Hypoglycemic Events

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    End point title
    		 Number of Participants with Severe Hypoglycemic Events
    End point description
    Number of participants with severe hypoglycemic events. Severe hypoglycemia was defined as participants with an altered mental status and could not assist in their own care, may have been semiconscious or unconscious, or experienced coma with or without seizures, and the event required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Blood glucose measurements may not have been available during such an event, but neurological recovery attributable to the restoration of BG concentration to normal was considered sufficient evidence that the event was induced by a low BG concentration (BG ≤70 mg/dL [3.9 mmol/L]).
    End point type
    Secondary
    End point timeframe
    6 Weeks
    End point values
    		 Insulin Lispro (Humalog®) LY900014
    Number of subjects analysed
    48 [14]
    49 [15]
    Units: participants
        number (not applicable)
    1
    1
    Notes
    [14] - All randomized participants who received at least 1 dose of study drug.
    [15] - All randomized participants who received at least 1 dose of study drug.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 12 weeks
    Adverse event reporting additional description
    I8B-MC-ITSI
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    LY900014
    Reporting group description
    		 100 LY900014 administered by continuous subcutaneous insulin infusion (CSII)

    Reporting group title
    Insulin Lispro (Humalog®)
    Reporting group description
    		 Insulin lispro (Humalog®) administered by CSII

    Serious adverse events
    		 LY900014 Insulin Lispro (Humalog®)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 48 (2.08%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Metabolism and nutrition disorders
    hypoglycaemia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LY900014 Insulin Lispro (Humalog®)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 49 (36.73%)
    6 / 48 (12.50%)
    General disorders and administration site conditions
    infusion site pain
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    9 / 49 (18.37%)
    2 / 48 (4.17%)
         occurrences all number
    11
    2
    infusion site reaction
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    9 / 49 (18.37%)
    4 / 48 (8.33%)
         occurrences all number
    36
    5

    More information

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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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