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    Clinical Trial Results:
    Protocol I8B-MC-ITRN A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination with Insulin Glargine or Insulin Degludec in Adults with Type 2 Diabetes

    Summary
    EudraCT number
    		 2015-005357-12
    Trial protocol
    		 HU   ES   SK   DE   IT  
    Global end of trial date
    13 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2020
    First version publication date
    29 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I8B-MC-ITRN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03214380
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16314
    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
    13 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).
    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
    		 Participants were required to use the same basal insulin regimen throughout the study with allowed regimens as follows: 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) insulin degludec given SC once daily. Participants may have continued the use of metformin and/or a sodium glucose cotransporter 2 inhibitor (SGLT-2) during the lead-in and treatment phase.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jul 2017
    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
    Argentina: 56
    Country: Number of subjects enrolled
    Puerto Rico: 14
    Country: Number of subjects enrolled
    Hungary: 28
    Country: Number of subjects enrolled
    United States: 187
    Country: Number of subjects enrolled
    Japan: 93
    Country: Number of subjects enrolled
    India: 100
    Country: Number of subjects enrolled
    Russian Federation: 50
    Country: Number of subjects enrolled
    Spain: 30
    Country: Number of subjects enrolled
    Korea, Republic of: 69
    Country: Number of subjects enrolled
    Taiwan: 33
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Mexico: 45
    Country: Number of subjects enrolled
    Slovakia: 28
    Country: Number of subjects enrolled
    Australia: 15
    Country: Number of subjects enrolled
    Germany: 40
    Country: Number of subjects enrolled
    Czech Republic: 40
    Worldwide total number of subjects
    837
    EEA total number of subjects
    175
    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)
    530
    From 65 to 84 years
    306
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Maximum Extended Enrollment (MEE) cohorts are implemented in certain countries to meet regulatory requirements for submission. Data from MEE cohort will not be incorporated into the analysis of the global study cohort.

    Pre-assignment
    Screening details
    		 The purpose of the Lead-in Period was to titrate basal insulin prior to randomization. Participants were then randomized to receive Insulin lispro (Humalog) or LY900014 in the Treatment Period (Period 2).

    Period 1
    Period 1 title
    Lead-in
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Insulin Lispro (Humalog) Lead-In
    Arm description
    		 100 U/mL Insulin lispro(Humalog) given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Humalog
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

    Arm title
    		 Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment
    Arm description
    		 100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Humalog
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

    Number of subjects in period 1
    		Insulin Lispro (Humalog) Lead-In Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment
    Started
    750
    183
    Received at least 1 dose Lead-in Insulin
    750
    183
    Completed
    673
    164
    Not completed
    77
    19
         Consent withdrawn by subject
    41
    14
         Physician decision
    6
    -
         Adverse event, non-fatal
    3
    1
         Non compliance
    1
    -
         Eligibility criteria
    3
    -
         Natural disaster
    9
    -
         Participant schedule
    2
    -
         Lost to follow-up
    4
    1
         Family emergency
    1
    -
         Protocol deviation
    7
    3
    Period 2
    Period 2 title
    Treatment Period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Insulin Lispro (Humalog)
    Arm description
    		 100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Humalog
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

    Arm title
    		 LY900014
    Arm description
    		 100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY900014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

    Arm title
    		 Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)
    Arm description
    		 100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Humalog
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

    Arm title
    		 LY900014 (MEE)
    Arm description
    		 100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY900014
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The Lead-in Period (Period 1) was used to titrate basal insulin, to allow the participants to reach the target fasting blood glucose (FBG) by the end of this period, prior to randomization. Baseline analysis population is based on all randomized participants. Participants were randomized to Insulin Lispro or LY900014 in Period 2.
    Number of subjects in period 2
    		Insulin Lispro (Humalog) LY900014 Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE) LY900014 (MEE)
    Started
    337
    336
    82
    82
    Received at least 1 dose of study drug
    337
    336
    82
    82
    Completed
    319
    320
    73
    71
    Not completed
    18
    16
    9
    11
         Consent withdrawn by subject
    10
    8
    7
    11
         Non-Compliance with Study Drug
    -
    -
    1
    -
         Adverse event, non-fatal
    1
    1
    1
    -
         Death
    1
    2
    -
    -
         Participant schedule
    -
    1
    -
    -
         Treatment interruption
    -
    1
    -
    -
         Lost to follow-up
    6
    3
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Insulin Lispro (Humalog)
    Reporting group description
    		 100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.

    Reporting group title
    LY900014
    Reporting group description
    		 100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.

    Reporting group title
    Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)
    Reporting group description
    		 100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.

    Reporting group title
    LY900014 (MEE)
    Reporting group description
    		 100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.

    Reporting group values
    		 Insulin Lispro (Humalog) LY900014 Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE) LY900014 (MEE) Total
    Number of subjects
    		 337 336 82 82 837
    Age categorical
    Units: Subjects
    Age continuous
    All randomized participants.
    Units: years
        arithmetic mean (standard deviation)
    		 61.0 ( 9.2 ) 60.2 ( 9.4 ) 56.6 ( 9.4 ) 57.2 ( 10.1 ) -
    Gender categorical
    All randomized participants.
    Units: Subjects
        Female
    		 162 152 47 27 388
        Male
    		 175 184 35 55 449
    Race (NIH/OMB)
    All randomized participants.
    Units: Subjects
        American Indian or Alaska Native
    		 3 1 0 0 4
        Asian
    		 81 83 70 69 303
        Native Hawaiian or Other Pacific Islander
    		 1 0 0 0 1
        Black or African American
    		 16 14 0 0 30
        White
    		 229 233 12 13 487
        More than one race
    		 6 5 0 0 11
        Unknown or Not Reported
    		 1 0 0 0 1
    Region of Enrollment
    All randomized participants.
    Units: Subjects
        Argentina
    		 29 27 0 0 56
        Puerto Rico
    		 7 7 0 0 14
        Hungary
    		 13 15 0 0 28
        United States
    		 95 92 0 0 187
        Czechia
    		 20 20 0 0 40
        Japan
    		 46 47 0 0 93
        India
    		 9 7 40 44 100
        Russia
    		 14 13 11 12 50
        Spain
    		 16 14 0 0 30
        South Korea
    		 16 16 21 16 69
        Taiwan
    		 7 8 9 9 33
        Italy
    		 4 5 0 0 9
        Mexico
    		 21 22 1 1 45
        Slovakia
    		 14 14 0 0 28
        Australia
    		 7 8 0 0 15
        Germany
    		 19 21 0 0 40
    Hemoglobin A1c
    All randomized participants.
    Units: percentage of HbA1c
        arithmetic mean (standard deviation)
    		 7.31 ( 0.72 ) 7.27 ( 0.68 ) 7.53 ( 0.69 ) 7.67 ( 0.89 ) -

    End points

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    End points reporting groups
    Reporting group title
    Insulin Lispro (Humalog) Lead-In
    Reporting group description
    		 100 U/mL Insulin lispro(Humalog) given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.

    Reporting group title
    Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment
    Reporting group description
    		 100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.
    Reporting group title
    Insulin Lispro (Humalog)
    Reporting group description
    		 100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.

    Reporting group title
    LY900014
    Reporting group description
    		 100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.

    Reporting group title
    Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)
    Reporting group description
    		 100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.

    Reporting group title
    LY900014 (MEE)
    Reporting group description
    		 100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.

    Subject analysis set title
    Insulin Lispro (Humalog)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily.

    Subject analysis set title
    LY900014
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) insulin degludec given SC once daily.

    Primary: Change from Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26

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    End point title
    		 Change from Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
    End point description
    Change from baseline in HbA1c was performed using mixed model repeated measure (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. Analysis Population Description (APD): All randomized participants with baseline and at least one post-baseline HbA1c data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
    End point type
    Primary
    End point timeframe
    Baseline, Week 26
    End point values
    		 Insulin Lispro (Humalog) LY900014
    Number of subjects analysed
    335
    334
    Units: percentage of HbA1c
        least squares mean (standard error)
    -0.43 ( 0.042 )
    -0.38 ( 0.042 )
    Statistical analysis title
    		 Change from Baseline in Hemoglobin A1c (HbA1c)
    Comparison groups
    Insulin Lispro (Humalog) v LY900014
    Number of subjects included in analysis
    669
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Least Square Mean Difference (LSMean)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.16

    Secondary: 1-hour Postprandial Glucose (PPG) Excursion during Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand

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    End point title
    		 1-hour Postprandial Glucose (PPG) Excursion during Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
    End point description
    1-hour PPG excursion during MMTT uses the analysis of covariance (ANCOVA) model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. APD: All randomized participants with baseline and at least one post-baseline 1-hour PPG excursion data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Insulin Lispro (Humalog) LY900014
    Number of subjects analysed
    307
    304
    Units: milligrams per deciliter (mg/dL)
        least squares mean (standard error)
    74.9 ( 3.60 )
    63.1 ( 3.60 )
    Statistical analysis title
    		 1-hour Postprandial Glucose (PPG) Excursion
    Comparison groups
    Insulin Lispro (Humalog) v LY900014
    Number of subjects included in analysis
    611
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -11.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.1
         upper limit
    		 -5.5

    Secondary: 2-hour PPG Excursion during MMTT Efficacy Estimand

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    End point title
    		 2-hour PPG Excursion during MMTT Efficacy Estimand
    End point description
    2-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. APD: All randomized participants with baseline and at least one post-baseline 2-hour PPG excursion data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Insulin Lispro (Humalog) LY900014
    Number of subjects analysed
    306
    305
    Units: mg/dL
        least squares mean (standard error)
    97.8 ( 4.50 )
    80.4 ( 4.50 )
    Statistical analysis title
    		 2-hour PPG Excursion during MMTT Efficacy Estimand
    Comparison groups
    Insulin Lispro (Humalog) v LY900014
    Number of subjects included in analysis
    611
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.3
         upper limit
    		 -9.5

    Secondary: Rate of Severe Hypoglycemia

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    End point title
    		 Rate of Severe Hypoglycemia
    End point description
    Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525. Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience com with or without seizures, and may require parenteral therapy. APD: All randomized participants with evaluable hypoglycemic data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 26
    End point values
    		 Insulin Lispro (Humalog) LY900014
    Number of subjects analysed
    337
    336
    Units: Events per 100 participant years
        number (not applicable)
    4.19
    2.44
    No statistical analyses for this end point

    Secondary: Rate of Documented Symptomatic Hypoglycemia

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    End point title
    		 Rate of Documented Symptomatic Hypoglycemia
    End point description
    Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of <54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable. APD: All randomized participants with evaluable hypoglycemic data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 26
    End point values
    		 Insulin Lispro (Humalog) LY900014
    Number of subjects analysed
    337
    336
    Units: Events per participant per year
        least squares mean (standard error)
    1.34 ( 0.164 )
    2.21 ( 0.318 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26

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    End point title
    		 Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
    End point description
    Change From baseline in 1,5-AG LSMean was calculated using Mixed Model Repeated Measures (MMRM) model including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug. APD: All randomized participants with baseline and at least one post-baseline 1,5-AG data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 Insulin Lispro (Humalog) LY900014
    Number of subjects analysed
    334
    331
    Units: milligram per liter (mg/L)
        least squares mean (standard error)
    2.15 ( 0.234 )
    1.99 ( 0.235 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26

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    End point title
    		 Change from Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
    End point description
    Change from baseline in 10-point SMBG values was calculated using MMRM model including fixed class effects of treatment, strata (pooled country, type of basal insulin, and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug. APD: All randomized participants with baseline and at least one post-baseline SMBG data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 Insulin Lispro (Humalog) LY900014
    Number of subjects analysed
    276
    270
    Units: mg/dL
    least squares mean (standard error)
        Morning Premeal
    -0.8 ( 2.72 )
    1.5 ( 2.74 )
        Morning 1-hour Postmeal
    -2.0 ( 3.44 )
    -14.1 ( 3.44 )
        Morning 2-hour Postmeal
    0.6 ( 3.38 )
    -14.9 ( 3.38 )
        Midday Premeal
    2.4 ( 2.83 )
    4.1 ( 2.84 )
        Midday 1-hour Postmeal
    3.0 ( 3.48 )
    -2.0 ( 3.47 )
        Midday 2-hour Postmeal
    -2.2 ( 3.28 )
    -6.5 ( 3.27 )
        Evening Premeal
    7.0 ( 3.38 )
    10.1 ( 3.38 )
        Evening 1-hour Postmeal
    -2.1 ( 3.24 )
    -3.0 ( 3.27 )
        Evening 2-hour Postmeal
    0.2 ( 3.68 )
    -2.1 ( 3.73 )
        Bedtime
    -3.4 ( 4.00 )
    -2.2 ( 4.02 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Insulin Dose at Week 26

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    End point title
    		 Change from Baseline in Insulin Dose at Week 26
    End point description
    Change from baseline in insulin dose was analyzed using mixed model repeated measure (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data prior to permanent discontinuation (d/c) of study drug (IP). APD: All randomized participants with baseline and at least one post-baseline basal insulin dose data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 Insulin Lispro (Humalog) LY900014
    Number of subjects analysed
    330
    330
    Units: Units (U)
    least squares mean (standard error)
        Basal Insulin Dose (n=317, 323)
    4.2 ( 0.82 )
    4.6 ( 0.81 )
        Prandial Insulin Dose (n=330, 330)
    8.3 ( 1.41 )
    12.0 ( 1.41 )
        Total Daily Insulin Dose (n=316, 321)
    12.1 ( 1.93 )
    17.3 ( 1.92 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26

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    End point title
    		 Change from Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26
    End point description
    ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. Change from baseline in ITSQ regimen inconvenience domain score was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. Analysis includes data collected prior to d/c of IP. APD: All randomized participants with baseline and post-baseline data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 Insulin Lispro (Humalog) LY900014
    Number of subjects analysed
    319 [1]
    319 [2]
    Units: units on a scale
        least squares mean (standard error)
    -0.9 ( 1.36 )
    -2.4 ( 1.37 )
    Notes
    [1] - Missing endpoints were imputed by applying the LOCF method to post-baseline data.
    [2] - Missing endpoints were imputed by applying the LOCF method to post-baseline data.
    No statistical analyses for this end point

    Secondary: Change from Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26

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    End point title
    		 Change from Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26
    End point description
    ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. Change from baseline in ITSQ lifestyle flexibility domain score was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. Analysis includes data collected prior to d/c of IP. APD: All randomized participants with baseline and post-baseline data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 Insulin Lispro (Humalog) LY900014
    Number of subjects analysed
    319 [3]
    319 [4]
    Units: units on a scale
        least squares mean (standard error)
    1.4 ( 1.60 )
    0.2 ( 1.60 )
    Notes
    [3] - Missing endpoints were imputed by applying the LOCF method to the post-baseline data.
    [4] - Missing endpoints were imputed by applying the LOCF method to the post-baseline data.
    No statistical analyses for this end point

    Secondary: Number of Participants with HbA1c <7%

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    End point title
    		 Number of Participants with HbA1c <7%
    End point description
    Number of participants with HbA1c <7% at Week 26. APD: All participants with baseline and 1 post-baseline observation while on study drug. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Insulin Lispro (Humalog) LY900014
    Number of subjects analysed
    320
    316
    Units: Count of participants
        number (not applicable)
    168
    184
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 30 weeks
    Adverse event reporting additional description
    I8B-MC-ITRN
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Insulin Lispro (Humalog) Lead-in
    Reporting group description
    		 -

    Reporting group title
    Insulin Lispro (Humalog)
    Reporting group description
    		 -

    Reporting group title
    LY900014
    Reporting group description
    		 -

    Reporting group title
    Insulin Lispro (Humalog) Lead-in Maximum Extended Enrollment
    Reporting group description
    		 -

    Reporting group title
    Insulin Lispro (Humalog) Maximum Extended Enrollment
    Reporting group description
    		 -

    Reporting group title
    LY900014 Maximum Extended Enrollment Cohort
    Reporting group description
    		 -

    Serious adverse events
    		 Insulin Lispro (Humalog) Lead-in Insulin Lispro (Humalog) LY900014 Insulin Lispro (Humalog) Lead-in Maximum Extended Enrollment Insulin Lispro (Humalog) Maximum Extended Enrollment LY900014 Maximum Extended Enrollment Cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 750 (1.73%)
    26 / 337 (7.72%)
    26 / 336 (7.74%)
    3 / 183 (1.64%)
    4 / 82 (4.88%)
    2 / 82 (2.44%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    clear cell renal cell carcinoma
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    meningioma
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal neoplasm
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intermittent claudication
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 750 (0.13%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral arterial occlusive disease
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral artery stenosis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral vascular disorder
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    non-cardiac chest pain
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sudden death
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    drug hypersensitivity
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 750 (0.13%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute pulmonary oedema
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    acute respiratory failure
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    2 / 336 (0.60%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    bronchitis chronic
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    3 / 336 (0.89%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dyspnoea
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    2 / 336 (0.60%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    laryngeal disorder
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 750 (0.13%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    blood potassium decreased
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    concussion
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 750 (0.13%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 750 (0.13%)
    1 / 337 (0.30%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    heat stroke
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ligament sprain
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    multiple fractures
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal compression fracture
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    angina pectoris
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    angina unstable
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac failure
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coronary artery stenosis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    2 / 337 (0.59%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 750 (0.13%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypoglycaemic coma
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 750 (0.13%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lumbar radiculopathy
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 750 (0.13%)
    1 / 337 (0.30%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    eye haemorrhage
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    papilloedema
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 750 (0.13%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    gastritis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    1 / 183 (0.55%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatitis acute
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    bile duct stone
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 750 (0.13%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholelithiasis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    diabetic ulcer
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    1 / 183 (0.55%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    nephrolithiasis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ureteric compression
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lumbar spinal stenosis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    cellulitis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    empyema
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    1 / 183 (0.55%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    eye infection viral
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteomyelitis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 750 (0.13%)
    0 / 337 (0.00%)
    4 / 336 (1.19%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    pyelonephritis acute
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    septic shock
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    1 / 336 (0.30%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    sinusitis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 750 (0.13%)
    0 / 337 (0.00%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    hypoglycaemia
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    2 / 750 (0.27%)
    5 / 337 (1.48%)
    3 / 336 (0.89%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    2 / 2
    4 / 6
    4 / 4
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    shock hypoglycaemic
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 750 (0.00%)
    1 / 337 (0.30%)
    0 / 336 (0.00%)
    0 / 183 (0.00%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Insulin Lispro (Humalog) Lead-in Insulin Lispro (Humalog) LY900014 Insulin Lispro (Humalog) Lead-in Maximum Extended Enrollment Insulin Lispro (Humalog) Maximum Extended Enrollment LY900014 Maximum Extended Enrollment Cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 750 (5.87%)
    60 / 337 (17.80%)
    79 / 336 (23.51%)
    12 / 183 (6.56%)
    8 / 82 (9.76%)
    5 / 82 (6.10%)
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    11 / 750 (1.47%)
    10 / 337 (2.97%)
    11 / 336 (3.27%)
    2 / 183 (1.09%)
    5 / 82 (6.10%)
    0 / 82 (0.00%)
         occurrences all number
    11
    10
    12
    2
    5
    0
    Infections and infestations
    nasopharyngitis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    23 / 750 (3.07%)
    38 / 337 (11.28%)
    47 / 336 (13.99%)
    7 / 183 (3.83%)
    4 / 82 (4.88%)
    5 / 82 (6.10%)
         occurrences all number
    25
    47
    56
    7
    4
    5
    upper respiratory tract infection
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    13 / 750 (1.73%)
    20 / 337 (5.93%)
    27 / 336 (8.04%)
    3 / 183 (1.64%)
    0 / 82 (0.00%)
    0 / 82 (0.00%)
         occurrences all number
    13
    21
    29
    3
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 May 2017
    - Immunogenicity follow-up shortened. - Primary analysis modified.

    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.
    As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
    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.

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