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    Clinical Trial Results:
    A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900027 in Patients with Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy

    Summary
    EudraCT number
    		 2019-002318-37
    Trial protocol
    		 DE  
    Global end of trial date
    14 Jul 2020

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

    Trial information

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    Trial identification
    Sponsor protocol code
    J2H-MC-IUAA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04161976
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17489
    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
    14 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.
    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
    27 Dec 2019
    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
    Germany: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Not Applicable.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence 1 (LY900027 - Insulin Lispro)
    Arm description
    		 Participants received LY900027 and Insulin lispro in one of two dosing periods as per below dosing schedule: Period 1: 100 units/milliliter (U/mL) LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) for 10 days; Period 2: 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY900027
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 /mL LY900027 administered to participants with T1DM using CSII for 10 days.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    LY275585
    Other name
    Humalog
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days.

    Arm title
    		 Sequence 2 (Insulin Lispro - LY900027)
    Arm description
    		 Participants received insulin lispro and LY900027 in one of two dosing periods as per below dosing schedule: Period 1: 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII; Period 2: 100 U/mL LY900027 administered to participants with T1DM using CSII.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    LY275585
    Other name
    Humalog
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days.

    Investigational medicinal product name
    LY900027
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 /mL LY900027 administered to participants with T1DM using CSII for 10 days.

    Number of subjects in period 1
    		Sequence 1 (LY900027 - Insulin Lispro) Sequence 2 (Insulin Lispro - LY900027)
    Started
    10
    10
    Received at Least One Dose of Study Drug
    10
    10
    Completed
    10
    9
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1
    Period 2
    Period 2 title
    Washout of 7-21 days
    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 (LY900027 - Insulin Lispro)
    Arm description
    		 Participants received LY900027 and Insulin lispro in one of two dosing periods as per below dosing schedule: Period 1: 100 units/milliliter (U/mL) LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) for 10 days; Period 2: 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY900027
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL LY900027 administered to participants with T1DM using CSII for 10 days.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    LY275585
    Other name
    Humalog
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days.

    Arm title
    		 Sequence 2 (Insulin Lispro - LY900027)
    Arm description
    		 Participants received insulin lispro and LY900027 in one of two dosing periods as per below dosing schedule: Period 1: 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII; Period 2: 100 U/mL LY900027 administered to participants with T1DM using CSII.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    LY275585
    Other name
    Humalog
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days.

    Investigational medicinal product name
    LY900027
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL LY900027 administered to participants with T1DM using CSII for 10 days.

    Number of subjects in period 2
    		Sequence 1 (LY900027 - Insulin Lispro) Sequence 2 (Insulin Lispro - LY900027)
    Started
    10
    9
    Completed
    10
    9
    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 (LY900027 - Insulin Lispro)
    Arm description
    		 Participants received LY900027 and Insulin lispro in one of two dosing periods as per below dosing schedule: Period 1: 100 units/milliliter (U/mL) LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) for 10 days; Period 2: 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY900027
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL LY900027 administered to participants with T1DM using CSII for 10 days.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    LY275585
    Other name
    Humalog
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL LY900027 administered to participants with T1DM using CSII for 10 days.

    Arm title
    		 Sequence 2 (Insulin Lispro - LY900027)
    Arm description
    		 Participants received insulin lispro and LY900027 in one of two dosing periods as per below dosing schedule: Period 1: 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII; Period 2: 100 U/mL LY900027 administered to participants with T1DM using CSII.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    LY275585
    Other name
    Humalog
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days.

    Investigational medicinal product name
    LY900027
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL LY900027 administered to participants with T1DM using CSII for 10 days.

    Number of subjects in period 3
    		Sequence 1 (LY900027 - Insulin Lispro) Sequence 2 (Insulin Lispro - LY900027)
    Started
    10
    9
    Completed
    10
    8
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 100 U/mL LY900027 administered to participants with T1DM using CSII for 10 days and 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days as per the dosing sequence in each period.

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.0 ± 12.50 -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 18 18
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 20 20
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    Region of Enrollment
    Units: Subjects
        Germany
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    Sequence 1 (LY900027 - Insulin Lispro)
    Reporting group description
    		 Participants received LY900027 and Insulin lispro in one of two dosing periods as per below dosing schedule: Period 1: 100 units/milliliter (U/mL) LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) for 10 days; Period 2: 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days.

    Reporting group title
    Sequence 2 (Insulin Lispro - LY900027)
    Reporting group description
    		 Participants received insulin lispro and LY900027 in one of two dosing periods as per below dosing schedule: Period 1: 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII; Period 2: 100 U/mL LY900027 administered to participants with T1DM using CSII.
    Reporting group title
    Sequence 1 (LY900027 - Insulin Lispro)
    Reporting group description
    		 Participants received LY900027 and Insulin lispro in one of two dosing periods as per below dosing schedule: Period 1: 100 units/milliliter (U/mL) LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) for 10 days; Period 2: 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days.

    Reporting group title
    Sequence 2 (Insulin Lispro - LY900027)
    Reporting group description
    		 Participants received insulin lispro and LY900027 in one of two dosing periods as per below dosing schedule: Period 1: 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII; Period 2: 100 U/mL LY900027 administered to participants with T1DM using CSII.
    Reporting group title
    Sequence 1 (LY900027 - Insulin Lispro)
    Reporting group description
    		 Participants received LY900027 and Insulin lispro in one of two dosing periods as per below dosing schedule: Period 1: 100 units/milliliter (U/mL) LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) for 10 days; Period 2: 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days.

    Reporting group title
    Sequence 2 (Insulin Lispro - LY900027)
    Reporting group description
    		 Participants received insulin lispro and LY900027 in one of two dosing periods as per below dosing schedule: Period 1: 100 U/mL Insulin lispro (Humalog) administered to participants with T1DM using CSII; Period 2: 100 U/mL LY900027 administered to participants with T1DM using CSII.

    Subject analysis set title
    LY900027
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    100 U/mL LY900027 administered to participants with T1DM using CSII for 10 days in treatment period 1 or treatment period 2.

    Subject analysis set title
    Insulin Lispro (Humalog)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    100 U/mL insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days in treatment period 1 or treatment period 2.

    Primary: Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT)

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    End point title
    		 Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT) [1]
    End point description
    Area under the concentration curve from time Zero to 5 hours post dose [AUC(0-5h)] after bolus administration prior to a mixed meal tolerance text was evaluated. Analysis population included all randomized participants who received at least one dose of study drug with evaluable PK data
    End point type
    Primary
    End point timeframe
    Day 1; day 3; day 5; day 7 and day 10 postdose in each dosing period
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistical analysis planned for this end point between two treatment groups.
    End point values
    		 LY900027 Insulin Lispro (Humalog)
    Number of subjects analysed
    18 [2]
    18 [3]
    Units: picogram*hour per milliliter (pg*h/mL)
    geometric mean (geometric coefficient of variation)
        Day 1
    4470 ± 34.2
    4270 ± 32.6
        Day 3
    4510 ± 33.9
    4270 ± 34.1
        Day 5
    4240 ± 37.8
    4180 ± 33.2
        Day 7
    4090 ± 37.7
    4130 ± 27.2
        Day 10
    3640 ± 35.1
    3620 ± 45.0
    Notes
    [2] - Day 1: n = 17, Day 3: n = 18, Day 5: n = 17, Day 7: n = 17, Day 10: n =17
    [3] - Day 1: n = 18, Day 3: n = 16, Day 5: n = 15, Day 7: n = 15, Day 10: n =15.
    No statistical analyses for this end point

    Primary: PK: Maximum Observed Insulin Lispro Concentration (Cmax)

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    End point title
    		 PK: Maximum Observed Insulin Lispro Concentration (Cmax) [4]
    End point description
    Cmax of insulin lispro was evaluated. Analysis population included all randomized participants who received at least one dose of study drug with evaluable PK data.
    End point type
    Primary
    End point timeframe
    Day 1; day 3; day 5; day 7 and day 10 postdose in each dosing period
    Notes
    [4] - 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 inferential statistical analysis planned for this end point between two treatment groups.
    End point values
    		 LY900027 Insulin Lispro (Humalog)
    Number of subjects analysed
    18 [5]
    18 [6]
    Units: picogram per milliliter (pg/mL)
    geometric mean (geometric coefficient of variation)
        Day 1
    1630.107 ± 29.9
    1531.681 ± 40.2
        Day 3
    1777.294 ± 35.5
    1811.699 ± 40.1
        Day 5
    1943.419 ± 45.0
    2070.839 ± 46.4
        Day 7
    2089.719 ± 53.6
    2523.452 ± 43.1
        Day 10
    2057.372 ± 53.6
    2702.065 ± 48.3
    Notes
    [5] - Day 1: n = 17, Day 3: n = 18, Day 5: n = 17, Day 7: n = 17, Day 10: n =17
    [6] - Day 1: n = 18, Day 3: n = 16, Day 5: n = 15, Day 7: n = 15, Day 10: n =15
    No statistical analyses for this end point

    Secondary: Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion

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    End point title
    		 Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion
    End point description
    PD: Incremental area under the plasma glucose curve above baseline between 0-5 hours after bolus infusion was evaluated. Analysis population included all randomized participants who received at least one dose of study drug with evaluable PD data.
    End point type
    Secondary
    End point timeframe
    Day 1; day 3; day 5; day 7 and day 10 postdose in each dosing period
    End point values
    		 LY900027 Insulin Lispro (Humalog)
    Number of subjects analysed
    18
    18
    Units: milligram*hour per deciliter(mg*hr/dL)
    arithmetic mean (standard deviation)
        Day 1
    683.076 ± 233.4230
    695.868 ± 187.8017
        Day 3
    649.082 ± 186.3946
    643.283 ± 197.5600
        Day 5
    741.215 ± 185.9439
    721.094 ± 192.6689
        Day 7
    871.364 ± 212.5231
    868.358 ± 204.0137
        Day 10
    972.250 ± 213.6539
    1043.319 ± 184.4819
    No statistical analyses for this end point

    Secondary: PD: Total Daily Insulin Dose

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    End point title
    		 PD: Total Daily Insulin Dose
    End point description
    Total daily insulin dose analysed using a linear mixed model. Analysis population included all randomized participants who received at least one dose of study drug with evaluable PD data.
    End point type
    Secondary
    End point timeframe
    Day 1; day 3; day 5; day 7 and day 10 postdose in each dosing period
    End point values
    		 LY900027 Insulin Lispro (Humalog)
    Number of subjects analysed
    18
    18
    Units: units of insulin
    arithmetic mean (standard deviation)
        Day 1
    52.885 ± 15.7492
    49.911 ± 12.9665
        Day 3
    53.779 ± 15.1662
    52.878 ± 16.5585
        Day 5
    51.852 ± 12.6773
    54.393 ± 17.0805
        Day 7
    55.464 ± 13.8645
    58.134 ± 19.7199
        Day 10
    22.827 ± 5.1951
    24.549 ± 7.3692
    No statistical analyses for this end point

    Secondary: Duration Until Catheter Failure

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    End point title
    		 Duration Until Catheter Failure
    End point description
    No participants had a catheter failure after Day 3, so time to catheter failure after Day 3 was not assessed.
    End point type
    Secondary
    End point timeframe
    Day -1 through Day 10 in each dosing period
    End point values
    		 LY900027 Insulin Lispro (Humalog)
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: days
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [7] - Time to catheter failure after Day 3 was not assessed.
    [8] - Time to catheter failure after Day 3 was not assessed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up To 120 days
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Insulin Lispro (Humalog)
    Reporting group description
    		 100 U/mL insulin lispro (Humalog) administered to participants with T1DM using CSII for 10 days in treatment period 1 or treatment period 2.

    Reporting group title
    LY900027
    Reporting group description
    		 100 U/mL LY900027 administered to participants with T1DM using CSII for 10 days in treatment period 1 or treatment period 2.

    Serious adverse events
    		 Insulin Lispro (Humalog) LY900027
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Insulin Lispro (Humalog) LY900027
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 20 (80.00%)
    13 / 19 (68.42%)
    Injury, poisoning and procedural complications
    phlebitis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    2
    Vascular disorders
    thrombophlebitis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    injection site reaction
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    15 / 20 (75.00%)
    12 / 19 (63.16%)
         occurrences all number
    18
    12
    pyrexia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    noninfective gingivitis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    pulpitis dental
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1

    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? Yes
    Date
    Interruption
    Restart date
    23 Mar 2020
    New enrollment was paused during the initial global pause of Lilly studies due to COVID.
    18 May 2020

    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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